corporate sun-ranbaxy combine to control … · august 2 - 8, 2014 corporate sun-ranbaxy combine to...

August 2 - 8, 2014

CORPORATE

SUN-RANBAXY COMBINE TO CONTROL OVER 40% MARKET FOR 25 DRUGS

Economic Times, 5 August, 2014

Sun Pharma will have a market share of over 40% in 25 drugs once it takes control of Ranbaxy, according

to an ET analysis, that may be reason for a close look at the deal by the competition watchdog that has

begun to examine the biggest deal in the Indian pharma industry. For nine drugs its market share will be

more than 65% and in another 15 it will be 40-60%, revealed an analysis of the latest data from market

research firm AIOCD Awacs. Sun-Ranbaxy combined market share to be 9.5% In addition, there are 11

drugs in which the Sun-Ranbaxy combine will enjoy a 33-40% market share. In all, the two companies have

128 common formulations. The Competition Commission of India, the country's anti-trust regulator,

recently issued show-cause notices to both companies asking them to explain how the takeover won't result

in the domination of India's Rs 76,000-crore drug market by the merged entity.The combined share of the

two companies in the total drug market is 9.5%, which in itself is not a significant or threatening figure. But

it's the substantial market share in several popular medicines that's likely to be scrutinised by the regulator.

A Sun Pharma spokesperson refused comment on ET's emailed queries.Legal experts said CCI can insist

that some brands or facilities be divested before the merger goes through if it establishes that the combined

entity can dictate prices because of its dominant position in these categories. It could also insist on

undertakings that the merged entity will not raise prices and maintain production at a specified level. Sun-

Ranbaxy combine will have a share of more than 57% in the Rs 430-crore market for common anti-

inflammation drug diclofenac; a 78% market share in somastostatin, which is used to treat gastrointestinal

hemorrhage and which has annual sales of Rs 50 crore; 76% of the Rs 80-crore market in prostate cancer

drug leuprorelin; and 55% of the Rs 48-crore market in quetiapine, a drug used to manage dementia in the

elderly. The proposed entity will also have a 92% market share in the combination of rosuvastatin and

ezetimibe, used to treat high cholesterol.

SANOFI TIES UP WITH EMCURE PHARMA TO MARKET ONCOLOGY PORTFOLIO IN

INDIA

Pharmabiz, 6 August, 2014

Sanofi has entered into a marketing and distribution agreement with Emcure Pharmaceuticals for its

oncology portfolio in India. As per the agreement, while Sanofi will continue to own its oncology range –

comprising 4 brands namely Taxotere, Jevtana, Fludara and Fasturtec, Emcure will market and distribute

these brands through its specialty unit. Dr Shailesh Ayyangar, vice president – South Asia and managing

director of Sanofi India and Sanofi – Synthelabo (India), said “Sanofi is highly committed to the field of

oncology. Realizing that managing the complexities of cancer necessitates the availability of a wide range

of products and supporting therapies, we found that combining our efforts and product range with that of

Emcure Oncology, makes immense sense for both companies. Doctors and patients will now have access –

'under one roof' – to one of the most comprehensive and complementing oncology portfolios in India.

Sanofi will continue to provide strong scientific and medical support to Emcure's already well-established

and fast growing oncology business.” Satish Mehta, managing director, Emcure Pharmaceuticals, said, “We

are delighted to be identified as the partner-of-choice by Sanofi in India; and for being entrusted with such a

prestigious global oncology range with Emcure's oncology portfolio empowers us to provide an even wider

array of value driven healthcare solutions. We are extremely optimistic about its prospects and committed to

creating a long-term partnership with Sanofi.”

LUPIN US FIRMS WEIGH BIDS FOR GSK'S MATURE DRUGS

Western Times, 4 August, 2014

generics firm Lupin, some US drugmakers looking for a tax saving deal in Europe and private equity funds

are planning to bid for a range of older drug being auctioned by GlaxoSmithKline GSK five sources

familiar with the matter said. GSK is looking to divest the mature products in a bid to improve its growth

profile, and wants to dispose of _off patent drugs marketed. in North America and Western Europe with

annual sal,es of around 1 billion pound. Assuming a multiple of between two and three times those sales,

the assets on the block could fetch between $3.5 billion and $5 billion, the sources said. Chief Executive

Andrew Witty said in April GSK was reviewing its portfolio of mature drugs, know as es tablished products

and ini May the group invited sec tor players and private equity firms to consider bidding. Non-binding

offers are expected before the end of the month, according to several sources who asked not to be named

because" the takps are private. GSK brands up for sale include antidepressant Paxil, mi-graine treatment

Paxil, mi-grafne treatment Imitrex, Zamtac for stomach acid and Zofran for nausea. Officials at GSK

declined ; to comment. Dne person* with direct knowledge of the matter said Lupin was seriously looking

at the GSK assets, and was in talks with the British drugmaker.

LUPIN INKS PACT WITH SOUTH KOREAN FIRM TO LAUNCH DIABETES DRUG


Drug major Lupin has inked a marketing pact with South Korea's LG Life Sciences to launch its anti-

diabetes drug in India. As per the strategic distribution pact inked between the two companies, Mumbai-

based Lupin will launch LG Life Sciences' Insulin Glargine, a novel insulin analogue, under the brand name

BasugineTM. "According to the agreement, Lupin would be responsible for marketing and sales of

BasugineTM in India," Lupin Ltd said in a statement. Insulin Glargine is indicated for the treatment of adult

patients with type 1 diabetes mellitus or in type 2 diabetes mellitus. Commenting on the development,

Lupin Group President, India Region Formulations, Shakti Chakraborty said: "I believe that our entry into

the insulin analogue market with launch of BasugineTM is a step in the right direction." Lupin's foray in

this segment will help the company further strengthen its diabetes portfolio enabling it to grow deeper into

the segment and fuel growth in the years to come, he added. According to IMS MAT data, the overall

diabetes market size within the Indian pharmaceutical Market (IPM) stood at Rs 6,032 crore, growing at 18

per cent year-on-year. The total insulin analogue market size is valued at Rs 585 crore with three year

CAGR of 24 per cent while the total Glargine molecule market is estimated to be around Rs 218.5 crore.

Lupin's shares were trading 0.17 per cent down at Rs 1,175.45 apiece during afternoon trade on the BSE.

SRL DIAGNOSTICS INTRODUCES BUTTERFLY NEEDLES TO MAKE BLOOD TEST PAIN

FREE


In an endeavour to minimise the pain and psychological fear associated with a Blood Test, SRL Diagnostics

has recently announced the use of high-end technology needles named, Butterfly Needles, making diagnosis

Pain Free. It is said that Diagnosis is the first step in disease management; thereby SRL is taking steps to

ease the first step of the illness cycle, Diagnosis, through introduction of pain free Butterfly Needles for

blood collections. This is SRL’s effort to curb syringe phobia amongst patients as well. The butterfly

needles serve another purpose of safeguarding the phlebotomists (persons who collect your blood) from

accidental needle stick injuries that are a crisis in the healthcare systems around the globe. Therefore, safer

blood drawing devices like butterfly needleshelp mitigate the dangers of needle stick injuries during routine

blood draws. The butterfly needle is a relatively pain free tool for collecting blood from patients especially

those who are hypersensitive to pain, have syringe phobia (entetophobia), children, newborn babies, have

very fragile or small veins or have tremors. So, butterfly needlescan be used for all age groups (0-70).

Accessing the vein is not always this easy in certain cases such as; Newborn babies and children who have

very thin and superficial veins, Older or geriatric patients with tremors (uncontrolled hand movements),

Combative patients (who are aggressive), Patients for whom it may be necessary to draw blood from the

back of the hand.

SUN PHARMA TO RETAIN RANBAXY'S BRANDS IN MOST MARKETS Business Standard, 8 August, 2014

Sun Pharmaceutical Industries has, in the wake of the acquisition of Ranbaxy Laboratories, prepared

ambitious plans on research and development. A spokesman at Sun, largest pharma company in the country

after the merger (and fifth largest speciality generics one in the world), said: "(We) intend to retain all of

Ranbaxy's brands in, more or less, all markets. The brand itself has a rich heritage and value. Though no

specific details have been worked out, Sun would like to preserve the Ranbaxy brand in geographies where

it is an asset and has a perceived value." The exception might be America where the Ranbaxy brand has

perhaps taken a beating. The company might consider phasing out the brand over time. Otherwise, the

combined Sun-Ranbaxy entity will have operations in 65 countries, 47 manufacturing facilities across five

continents, and a significant platform of speciality and generic products marketed globally, including 629

Abbreviated New Drug Applications. It is approaching $1 billion in yearly sales in high-growth emerging

markets (EMs), plus working on expanding presence in western Europe. The key EMs for it include Russia,

Romania, South Africa, Brazil and Malaysia. In India, it has 31 brands in the top 300. Sun would, however,

focus on remedying the current issues at Ranbaxy, especially those with the US drug regulator, as a high

priority after it takes control of the business. It is important for it to get the US Food and Drug

Administration sanctions lifted from Ranbaxy's India factories.

GILEAD TO SELL HEP C DRUG FOR 99% LESS IN INDIA

Times of India, 6 August, 2014

There is some hope for hepatitis C patients in India. Amid mounting criticism over the eye-popping price of

Sovaldi, the first breakthrough treatment for hepatitis C virus, US pharma firm Gilead Sciences has offered

to introduce the drug in India at nearly 99% discount of the US price. * The blockbuster hepatitis C drug

will cost about $900 (around Rs 54,000) in India for a 12-week course of treatment. That would be a

fraction of the $84,000 (over Rs 50 lakh) price tag for the same treatment in US. Gilead Sciences will adopt

a tiered pricing structure here, liketheoneforHTV treatment in developing countries like India. "The pricing

of Sovaldi in India at $300 per bottle, is our low income pricing, similar to the price negotiated with Egypt

for its government-run programme. We hope with local production by our partners in India, higher volumes

and continued research & development on the drug will lead to a further reduction in prices at a later stage",

Gregg Alton, executive V-P (corporate & medical affairs), Gilead Sciences told TOI in a teleconfrom the

US. "We have set three basic pricing tiers (based on a country's per capita income and hepatitis C

prevalence) that serve as the starting point for negotiations with national governments. The tiers are low-

income, low middle-income and upper-middle income," Alton said. The pricing and launch of the

breakthrough treatment of hepatitis C is crucialfor India, which has one of the highest incidence of the

virus, with over 12 million chronically infected, accordingto WHO. However, even at $900, many patients

will still not be able to afford the therapy in India.

PORTEA MEDICAL TO INVEST $20 MILLION TO ENTER 32 CITIES BY 2015 END


Home healthcare services provider Portea Medical plans to invest $ 20 million (over Rs 120 crore) to

expand its footprint in India across 32 new cities by the end of 2015. The Bangalore-based firm is at present

in 18 cities, including Chennai, Delhi and NCR, Mumbai, Pune, Hyderabad and Kolkata. It is looking to

hire 5,000 people during the period. "We would be investing $ 20 million for expansion in 32 cities by end

of 2015. Our aim is to be present in 50 cities in India that have a population of more then 10 lakh," Portea

Medical Co-Founder & Chairman K Ganesh told PTI. Asked how the company plans to raise funds for the

expansion, Ganesh sad: "It will be through private equity." The company at present has 1,000 employees

and will add another 5,000 more people to its workforce. "We would be employing 5,000 more people as

we expand by end of 2015. We would also impart training to them so that patients get highest quality of

medical care," he added.

FATE OF PFIZER'S THANE PLANT, EMPLOYEES HANGS IN BALANCE

The Hindu Business Line, 4 August, 2014

Two weeks. That is the window of opportunity that multinational drugmajor Pfizer's management and its

workmen at the Thane plant have to sort out their differences and avert a full fledged shutdown. Pfizer had

said, on Friday, that it had been forced to issue a lockout notice at its Thane manufacturing plant to

ensureTwo weeks. That is the window of opportunity that multinational drugmajor Pfizer's management and

its workmen at the Thane plant have to sort out their differences and avert a full fledged shutdown. Pfizer

had said, on Friday, that it had been forced to issue a lockout notice at its Thane manufacturing plant to

ensure the safety of its colleagues. "There have been multiple incidents of indiscipline, threats to our

management personnel as well as attempts to disrupt production lines by certain workmen," Pfizer had said

in its statement. The plant employs 212 workmen. But the disruption would not affect medicine supplies, it

had added. A lockout notice legally gives both sides two weeks to iron out differences, following which it

could lead to a shutdown or the Court if the situation is unresolved, employees familiar with the

development said. In recent years, labour issues have been cropping up in sectors like the automotive

industry. And this time, the fate of the multinational drug company's plant and its employees hangs in

balance.

MEDTRONIC UNVEILS NEW CARDIAC RESYNCHRONISATION THERAPY-PACEMAKER

IN INDIA TO IMPROVE PATIENT RESPONSE


Medtronic Inc has launched its new cardiac resynchronisation therapy-pacemaker, Viva CRT-P in India

which received the CE (Conformité Européenne) mark in May this year. The Viva CRT-P includes the

Medtronic-exclusive AdaptivCRT software, which is the only algorithm demonstrated to improve heart

failure patients’ response to the therapy and reduce the risk of atrial fibrillation (as compared to

conventional biventricular therapy). The AdaptivCRT algorithm works by preserving normal heart rhythms

and automatically adjusting to the patient’s needs every minute, creating a customized therapy for each

patient. Independent studies have validated the benefits of the algorithm and patients with it have a

demonstrated 21 per cent reduction in heart failure hospitalisation and a reduced risk of death. Studies have

also indicated that it increases CRT response rate by 12 per cent; and that patients with it have a 46 per cent

reduced risk of atrial fibrilation (AF). The AdaptivCRT algorithm is unique in its ability to constantly adjust

and preserve patients’ natural heart rhythms," said Shamik Dasgupta, vice president cardiac and vascular

group, India Medtronic.

INTERNATIONAL

ROCHE TO BUY DENMARK-BASED BIOTECH FIRM SANTARIS PHARMA FOR US$ 450 MN


Roche has agreed to acquire Santaris Pharma, a privately held bio-pharmaceutical company based near

Copenhagen, Denmark. Santaris Pharma has pioneered its proprietary Locked Nucleic Acid (LNA) platform

that has contributed to an emerging era of RNA-targeting therapeutics. This new class of medicines has the

potential to address difficult to treat diseases in a range of therapeutic areas. The acquisition, which is

subject to customary closing conditions, is expected to close in August 2014. Roche plans to maintain

Santaris Pharma’s operations in Denmark, where the existing site will be renamed Roche Innovation Center

Copenhagen. Under the terms of the agreement, Roche will make an upfront cash payment of USD 250

million to Santaris Pharma shareholders and make additional contingent payments of up to USD 200

million based on the achievement of certain predetermined milestones. Santaris Pharma’s LNA platform

and drug discovery engine combines the company’s proprietary LNA chemistry with its highly specialised

and targeted drug discovery capabilities to rapidly deliver drug candidates against both mRNA and

microRNA, thus enabling scientists to develop drug candidates for diseases that are difficult, or impossible,

to target with contemporary drug platforms such as antibodies and small molecules.

THROMBOGENICS’ JETREA NOMINATED FOR 2014 PRIX GALIEN USA AWARD IN BEST

BIOTECHNOLOGY PRODUCT CATEGORY


ThromboGenics, a biopharmaceutical company focussed on developing and commercialising innovative

ophthalmic medicines, announces that Jetrea (ocriplasmin) has been nominated for the 2014 Prix Galien

USA Award in the Best Biotechnology Product category. This is the second time that Jetrea, a novel

pharmacological treatment for symptomatic vitreomacular adhesion (VMA), has been nominated for this

award. This latest nomination follows last month’s nomination of Jetrea for the Prix Galien UK Award. The

Prix Galien USA, now in its eighth year, is an international award that recognises outstanding achievements

in improving human health through the development of innovative therapies. The winner is selected by a

committee of nine experts in the biomedical industry and academia, including five Nobel Laureates.

ALLERGAN'S THREE PRODUCTS NOMINATED FOR 2014 US PRIX GALIEN AWARDS


Allergan, a multi-specialty health care company, announced that the company's research and development

pipeline has been recognised by the Galien Foundation, which has nominated three of Allergan's products

for the 2014 US Prix Galien Awards. The Prix Galien Award is considered the biomedical industry's highest

accolade and recognises the technical, scientific and clinical research skills necessary to develop innovative

medicines and devices. The Allergan products that have been nominated for the 2014 US Prix Galien

Awards are Best Biotechnology Product Nominee Botox (onabotulinumtoxinA) for Chronic Migraine

patients. Best Pharmaceutical Agent Nominee Ozurdex (dexamethasone intravitreal implant) 0.7 mg, Best

Medical Technology Nominee SERI Surgical Scaffold. "For more than 64 years, Allergan has remained

committed to developing innovative products to address unmet medical needs," said David E.I. Pyott,

chairman and chief executive officer, Allergan. "We are proud to be recognised for our R&D efforts by the

Prix Galien Committee and especially honoured to be the only company to receive nominations in all three

of the 2014 Prix Galien Award categories." Recipients of the Prix Galien Awards will be announced at the

Prix Galien USA Award Ceremony in New York this fall and are selected by a committee of 10 leaders from

the biomedical industry and academia, including five Nobel Laureates. "Innovation is a key measure of

Allergan's commitment to R&D," said Scott M. Whitcup, M.D., executive vice president, research and

development, chief scientific officer, Allergan.

ENDO INTERNATIONAL COMPLETES ACQUISITION OF DAVA PHARMA


Endo International, a global specialty healthcare company focused on improving patients' lives while

creating shareholder value, has completed the acquisition of DAVA Pharmaceuticals, Inc., a privately-held

company specialising in generic pharmaceuticals, with a portfolio of marketed, pre-launch and pipeline

products, for $575 million in cash, with additional cash consideration of up to $25 million contingent on the

achievement of certain sales milestones. The DAVA portfolio is well-positioned for continued strong

financial performance with its existing commercial products and attractive near-term pipeline, and is a

natural fit with Endo's US generics business. "We are encouraged by the earlier than expected close of the

DAVA acquisition and are excited by the addition of the business to our generics portfolio." said Rajiv De

Silva, president and chief executive officer of Endo. "The closing of DAVA further strengthens Endo's

generics platform and enhances our earnings growth and cash flow in 2014 and beyond." Endo's estimates

are based on projected results for the twelve months ended Dec. 31, 2014 and management's current belief

about prescription and procedure trends, pricing levels, inventory levels and the anticipated timing of future

product launches and events. The company's guidance for reported (GAAP) earnings per share does not

include any estimates for potential new corporate development transactions. For the full twelve months

ended Dec. 31, 2014, at current exchange rates. Endo estimates: Total revenue to be between $2.78 billion

and $2.86 billion, Reported (GAAP) diluted loss per share to be between $1.56 and $1.36, Adjusted diluted

earnings per share to be between $4.00 and $4.20, Adjusted diluted earnings per share assume full year

adjusted diluted shares outstanding of 157 million.

CTI BIOPHARMA'S MYELOFIBROSIS DRUG PACRITINIB RECEIVES FAST TRACK

DESIGNATION FROM US FDA


The US Food and Drug Administration (FDA) has granted Fast Track designation to CTI BioPharma's

pacritinib for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients

with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on

other JAK2 therapy or patients who are intolerant to or whose symptoms are sub-optimally managed on

other JAK2 therapy. Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and

FLT3. The drug candidate is currently being evaluated in two phase 3 clinical trials, known as the PERSIST

programme, for patients with myelofibrosis. "We are very pleased that the pacritinib development

programme in myelofibrosis has been granted Fast Track designation, and we look forward to continuing to

work closely with the FDA on this important drug candidate," stated James A. Bianco, M.D., president and

chief executive officer. "We believe that pacritinib's unique profile has the potential to serve an unmet

medical need that currently exists in this patient population, particularly for those patients with disease or

therapy-related low platelet counts." The Fast Track process is designed to facilitate the development, and

expedite the review of drugs to treat serious conditions and fill an unmet medical need. An unmet need is a

condition whose treatment or diagnosis is not addressed adequately by available therapy. The purpose of the

Fast Track designation is to make important new drugs available to the patient earlier. The Fast Track

programme also enables a company to submit sections of the NDA on a rolling basis as data becomes

available. This enables the FDA to review sections of the NDA as they are received, rather than waiting

until every section of the application is completed before the entire application can be reviewed. NDA

review usually does not begin until the company has submitted the entire application to the FDA. A drug

programme with Fast Track designation enables the company to have early and frequent communication

with the FDA in the development and review of the product candidate, often leading to faster drug approval

and access by patients.

JAZZ PHARMA COMPLETES ACQUISITION OF RIGHTS TO DEFIBROTIDE IN US FROM

SIGMA-TAU


Jazz Pharmaceuticals, announced the closing of its acquisition of rights to defibrotide in the United States

(US) and all other countries in the Americas from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau). Jazz

Pharmaceuticals now owns worldwide rights to defibrotide. Defibrotide is a novel product that is marketed

by Jazz Pharmaceuticals in the European Union (EU) under the name Defitelio for the treatment of severe

hepatic veno-occlusive disease (VOD) in patients over one month of age undergoing hematopoietic stem

cell transplantation (HSCT) therapy. In the U.S., Jazz Pharmaceuticals is working with the Food and Drug

Administration (FDA) on the regulatory pathway for submission of a New Drug Application (NDA) for the

potential approval of defibrotide to treat patients with severe VOD. Under the previously-announced

definitive agreement with Sigma-Tau, a wholly-owned subsidiary of Jazz Pharmaceuticals acquired the

rights to defibrotide in the Americas for an upfront payment of $75 million plus potential milestone

payments of $25 million upon the acceptance for filing by the FDA of the first NDA for defibrotide for

VOD and up to an additional $150 million based on the timing of potential FDA approval of defibrotide for

VOD.

CERNER CORPORATION TO BUY SIEMENS HEALTH SERVICES FOR $1.3 BILLION


Cerner Corporation, a global supplier of health care information technology solutions, services, devices and

hardware, and Siemens AG have signed a definitive agreement for Cerner to acquire the assets of Siemens'

health information technology business unit, Siemens Health Services, for $1.3 billion in cash. By

combining investments in R&D, knowledgeable resources, and complementary client bases, the acquisition

creates scale for future innovation. As part of the agreement, Cerner and Siemens will form a strategic

alliance to bring new solutions to market that combine Cerner's health IT leadership and Siemens' strengths

in medical devices and imaging. "We believe this is an all-win situation for the clients of both organizations

and all of our associates and shareholders," said Neal Patterson, Cerner chairman, CEO and co-founder.

"Through more than $4 billion of cumulative investments in R&D, Cerner has established a strong market

standing and is positioned for continued growth. Siemens' health care IT assets provide additional scale,

R&D, an impressive client base, and knowledgeable and experienced associates who will help Cerner

achieve our plans for the next decade. In addition, the alliance we're creating will drive the next generation

of innovations that embed information from the EMR inside advanced diagnostic and therapeutic

technologies, benefitting our shared clients." Based on 2014 estimates, Cerner and Siemens Health Services

have combined totals of more than: 20,000 associates in more than 30 countries; 18,000 client facilities,

including some of the largest health care organizations in their respective countries; $4.5 billion of annual

revenue; $650 million of annual R&D investment. The transaction is expected to be more than $0.15

accretive to Cerner's non-GAAP diluted EPS in 2015, and more than $0.25 accretive in 2016. Non-GAAP

earnings are expected to exclude share-based compensation expense, one-time transaction costs, and

acquisition-related amortization and deferred revenue adjustments.

AETERNA ZENTARIS, ASCEND INK CO-PROMOTION PACT FOR US MARKET


Aeterna Zentaris Inc., a specialty biopharmaceutical company engaged in developing and commercializing

novel treatments in oncology and endocrinology, announced a strategic co-promotion services agreement

with ASCEND Therapeutics US, LLC, (ASCEND), a specialty pharmaceutical company solely focused on

women's healthcare. Under the terms of the agreement, expected to start in the fourth quarter of 2014,

Aeterna Zentaris will use its newly established commercial structure to market, in specific US territories,

ASCEND's EstroGel a non-patch transdermal US Food & Drug Administration (FDA) approved and

commercialized estrogen replacement therapy. For its part, ASCEND would market, in specific US

territories, Macrilen, Aeterna Zentaris' product for use in the evaluation of adult growth-hormone deficiency

(AGHD), for which a New Drug Application (NDA) is currently under review by the FDA, with a

Prescription Drug User Fee Act (PDUFA) date of November 5, 2014. In consideration for these co-

promotion services, each party will be entitled to receive, from the other party, commissions on net sales of

each other's product. As part of its commercial strategy, Aeterna Zentaris anticipates using approximately 20

sales representatives to cover its assigned U.S. specific territories, while ASCEND will use its existing sales

force of over 35 sales representatives to cover its territories. Overall, more than 50 sales representatives are

expected to promote both EstroGel and Macrilen. Aeterna Zentaris is expected to book all future sales of

Macrilen, while ASCEND will book all sales of EstroGel.

US FDA GRANTS ORPHAN DRUG STATUS TO GENOA'S PIRFENIDONE IN INHALED

TREATMENT OF IPF


The US Food and Drug Administration (FDA) has granted orphan-drug designation to Genoa

Pharmaceuticals' for the use of pirfenidone in their lead programme - inhaled GP-101 for the treatment of

idiopathic pulmonary fibrosis (IPF). "Acquiring orphan status marks an important regulatory milestone in

GP-101's life cycle to treat people with this devastating disease," said Mark Surber, Genoa's president and

chief executive officer. "We are pleased to continue the development of inhaled GP-101, with clinical trials

beginning in early 2015." Oral pirfenidone (Esbriet) has shown promise to slow IPF disease progression.

Unfortunately, a very large oral dose is required to achieve efficacious lung levels. Despite being

established at the upper safety threshold (801 mg TID), the resulting oral-delivered lung dose is too low for

optimal effect. Moreover, gastrointestinal exposure and large-associated blood levels remain poorly

tolerated. For these reasons oral-dose escalation for optimal IPF efficacy is not possible. Complicating

matters, dose-absorbing food, first-pass metabolism, and safety-driven dose-reduction and stoppage

protocols further reduce lung dose and interrupt maintenance therapy. To address oral shortcomings and

maximize IPF efficacy, Genoa has reformulated pirfenidone for aerosol formation and inhaled, direct-lung

delivery (GP-101). By this approach, ~160-fold less inhaled pirfenidone is predicted to deliver Esbriet-

equivalent IPF efficacy (5 mg vs. 801 mg).

DENMARK GRANTS MARKETING AUTHORISATION TO ALIMERA SCIENCES' ILUVIEN

TO TREAT CHRONIC DME


The Danish Health and Medicines Authority has granted marketing authorisation to Alimera Sciences'

Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME)

considered insufficiently responsive to available therapies. With Norway's approval earlier this month,

Denmark is the second country to grant national marketing authorisation following the positive outcome in

June of the Repeat-Use Procedure application. In addition to Denmark, Iluvien is now approved for

marketing in Austria, France, Germany, Italy, Norway, Portugal, Spain and the United Kingdom, and is

commercially available in the United Kingdom and Germany. Iluvien is pending approval in an additional

eight countries included in the Repeat-Use Procedure application. These countries are Belgium, the Czech

Republic, Finland, Ireland, Luxembourg, the Netherlands, Poland and Sweden. A new drug application for

Iluvien is currently under review by the US Food and Drug Administration. "With Iluvien now approved for

marketing in the second Scandinavian country, more patients can gain access across Europe to the only

three-year treatment for DME, and the only treatment for the chronic form of the disease," said Dan Myers,

Alimera's president and chief executive officer.

POSITIVE BIOSCIENCE PARTNERS WITH MEDANTA-THE MEDICITY TO SET UP

PERSONAL GENOMICS CLINIC


Positive Bioscience has partnered with Medanta-The Medicity to launch a Personal Genomics Clinic, which

offers advanced facilities and services in preventive healthcare and personalised medicine within the

country. The company co-founded by Samarth Jain, Bapsy Jain and Dr. Meetha Medhora offers personal

genomics and cancer genomics products. Its objective is to make genomic testing technology widely

accessible in India and teamed up with Medanta-The Medicity, one of India’s largest multi-super specialty

hospitals in Gurgaon. Genomics is the future in healthcare practices and is crucial as it drives preventive

healthcare. While personal genomics is being established in western countries, it is at a nascent stage in

India. With rising diabetics, stroke and cancer patients, genomics would enable complete health risk

assessment. The services of the clinic include pre-empting interventions for disease prevention, pre-test

genetic counselling and DNA sequencing to post-test genetic counselling. Understanding the importance of

personalised treatment and patient care, Positive Bioscience will offer five free cases for underprivileged

cancer patients to The Times Foundation.

NIH LAUNCHES NEW PROGRAMME TO FIND POTENTIAL DRUG TARGETS


National Institutes of Health leaders have announced a new collaborative initiative to improve human health

by exploring poorly understood genes that have the potential to be modified by medicines. The effort is part

of an NIH Common Fund three-year pilot project called Illuminating the Druggable Genome (IDG). For the

initial phase of the programme, NIH has awarded $5.8 million to eight institutions. As many as 3,000 genes

express proteins that could have their activities altered by medicines, according to predictions based on

genomic information. Yet only about 10 percent of these so-called “druggable genes” are targeted by FDA-

approved drugs. The IDG programme is designed to address this gap by supporting research of

understudied genes in four important druggable gene families: nuclear receptors, ion channels, protein

kinases and G-protein coupled receptors, often called GPCRs. Initially researchers will delve into these

uncharacterised genes and share what they learn on a public resource that will enable the larger scientific

community to build on the findings with both basic research and clinical translation. They will also work to

develop ways to rapidly identify and describe the genes they explore, creating a common language that can

be applied across experimental systems, from individual cells to complex biological models.

SOLIGENIX GETS ADDITIONAL FUNDING FROM NIAID TO ADVANCE DEVELOPMENT

OF ORBESHIELD IN GI ARS


Soligenix, Inc., a clinical stage biopharmaceutical company, announced that the National Institute of

Allergy and Infectious Diseases (NIAID) has exercised its option to advance preclinical development of

OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP). The 12-month option provides an

additional $2.1 million to Soligenix to advance OrbeShield as a medical countermeasure (MCM) for the

treatment of gastrointestinal acute radiation syndrome (GI ARS). NIAID granted an initial award of $2.1

million to Soligenix on September 18, 2013. The total contract award is valued at up to $6.4 million over

three years. Soligenix's GI ARS programme is supported by contract awards from both the Biomedical

Advanced Research Development Authority (BARDA) and NIAID, totaling up to approximately $32

million. In addition to developing oral BDP as a MCM, the company is also pursuing oral BDP as a

treatment for GI inflammation in pediatric Crohn's disease, acute radiation enteritis and chronic Graft-

versus-Host disease (cGVHD). "The execution of the first option reflects NIAID's ongoing commitment to

developing MCMs for GI ARS and the compelling nature of Soligenix's OrbeShield product," stated

Christopher J. Schaber, PhD, president & chief executive officer of Soligenix. "This continued funding, plus

the BARDA contract awarded last year, has the potential to provide the necessary funding to advance the

development of OrbeShield while building upon the scientific evidence supporting its use as a potential

MCM in GI ARS. We thank NIAID for their past and present support and look forward to continuing our

close collaboration as we advance this technology."

ABBVIE, CFRI PARTNER TO RAISE AWARENESS OF NUTRITIONAL NEEDS OF CF

PATIENTS THROUGH CFCHEF SHARES PROGRAMME


AbbVie, a global, research-based biopharmaceutical company, and Cystic Fibrosis Research, a nonprofit

organization, announced a partnership to expand awareness of proper nutritional habits in the cystic fibrosis

(CF) community through the CFChef Shares programme. CFChef Shares will run from August 1 to

September 15, 2014, as part of AbbVie's CFChef programme an online resource for CF patients and

caregivers to encourage patients to maintain a healthy diet by submitting recipes to the Chef4CF.com

Online Cookbook. The programme will begin at the CFRI 27th National Family Cystic Fibrosis Education

Conference, on August 1-3, 2014, in Redwood City, California "CFChef has been a vital nutritional

resource for patients and caregivers for years, and we are confident that the CFChef Shares programme will

continue to deliver the message that proper nutrition is extremely important for those living with CF," said

Sue Landgraf, executive director, CFRI. "We are excited to partner with AbbVie, a company that is

committed to the health and well-being of the CF community." AbbVie is kicking off this partnership with a

one-week call for recipes: AbbVie will donate an additional $5,000 if 50 recipes are submitted to the

CFChef Shares website by August 8. The partnership will continue with additional donations of $10 to

CFRI for each recipe submitted to the CFChef website during this six-week period, up to $10,000. CFRI

will put the money raised during the donation period toward providing educational resources and support

for increasing awareness among patients of the importance of maintaining a proper CF diet. The public has

an opportunity to help donate an additional $2 per recipe by sharing any of the recipes in the Online

Cookbook on social media. "CFChef Shares aims to help CF patients find support, nutritional recipes and

meal tips," said Jim Hynd, vice president, GI Care.

ANI PHARMA BUYS US RIGHTS FOR VANCOCIN CAPSULES FROM SHIRE


ANI Pharmaceuticals, an integrated specialty pharmaceutical company, has acquired the US rights for

Vancocin 125 mg and 250 mg capsules from Shire plc, a global biopharmaceutical company. In addition,

ANI acquired from Shire approved ANDAs for the currently non-marketed products vancomycin

hydrochloride injectable 500 mg, 1 gm and 10 gm ($45 million in 2013 market value, per IMS Health) and

vancomycin hydrochloride oral solution 250 mg and 500 mg. ANI paid $11 million in cash for the rights to

Vancocin together with existing inventories on hand. Following a transition period, ANI intends to launch

Vancocin capsules under its own label during the fourth quarter of 2014. The transaction is immediately

accretive and sales of Vancocin capsules are expected to generate approximately $5.4 million in revenues

and $4 million in non-GAAP EBITDA annually. Arthur S. Przybyl, ANI’s president and chief executive

officer, stated, “We are excited to add Vancocin capsules to our portfolio of mature brand products. In

addition, we will immediately begin exploring opportunities to launch both vancomycin injectable and

vancomycin oral solution. Year to date we have invested $23 million in two mature brand acquisitions that

will contribute a combined $9.4 million in annual revenues and $8 million in annual non-GAAP EBITDA.

At the same time, we are continuing to advance our internal generic product development pipeline while

selectively pursuing acquisitions and partnerships that augment those efforts.”

LUMINEX TO SUPPORT USAMRIID IN RESEARCH EFFORTS TO CONTROL AFRICAN

EBOLA OUTBREAK


Luminex Corporation, a company develops, manufactures and markets innovative biological testing

technologies with applications throughout the diagnostic and life science industries, announced that US

Army Medical Research Institute of Infectious Diseases (USAMRIID) Diagnostics Division is working on

rapid diagnostics for the Ebola virus using Luminex xMAP Technology. Luminex's MAGPIX system was

recently deployed to Africa to support research efforts to control the current outbreak. The recent Ebola

outbreak has so far claimed 729 lives across Guinea, Liberia, Nigeria, and Sierra Leone according to the

World Health Organization. Ebola virus disease is a severe, often fatal illness in humans characterized by

the sudden onset of fever, intense weakness, muscle pain, headache and sore throat. Early diagnosis is

critical for proper management of the illness and prevention of spread. Developed by USAMRIID

Diagnostics Division and run on the MAGPIX system, the assays test serum samples for the presence of

viral antigens (proteins) as well as antibodies directed at these antigens. Results of the assays provide

information about replication of the virus and the immune response of the host, respectively. In a study

conducted in rhesus macaques, Dr. Abbe Ames and colleagues showed that some animals may be able to

limit the replication of the virus, and thus have a better chance of survival.1 Understanding the

pathophysiology of the Ebola virus may assist in the development of countermeasures against the disease

that could save lives.

EUROPEAN COMMISSION GRANTS ORPHAN DRUG DESIGNATION TO RAPTOR'S

CYSTEAMINE BITARTRATE TO TREAT HUNTINGTON'S DISEASE


The European Commission (EC) has approved Raptor Pharmaceutical's application for orphan drug

designation of cysteamine bitartrate, the active ingredient in RP103, for the treatment of Huntington's

disease. The decision follows a positive recommendation from the Committee for Orphan Medicinal

Products (COMP) of the European Medicines Agency (EMA) in June. In February of this year, Raptor

announced encouraging top line results from a planned 18-month analysis of the blinded, randomized,

placebo-controlled phase of its ongoing CYST-HD clinical trial of RP103, its proprietary delayed release

cysteamine bitartrate capsule, in patients with early-stage Huntington's disease. "This designation is an

important milestone as Raptor moves through the regulatory process for the potential approval of RP103 as

a treatment for Huntington's disease in the EU," said Christopher M Starr, Raptor's chief executive officer.

CERTARA INTRODUCES DRUG DISCOVERY & DEVELOPMENT DATA ACCESS &

ANALYSIS SOLUTION, D360 IN JAPAN


Certara, the leading global technology-enabled drug development and drug safety consultancy, has launched

in Japan of D360, its integrated solution for the query, analysis and visualisation of drug discovery and

development data. D360 is used by scientists in both discovery and pre-clinical research. It allows them to

search, analyse and share their data without the need for constant IT support, helping to shorten the drug

discovery cycle. In preclinical drug discovery, searching historical control data to answer questions from

regulatory agencies often requires the manual review of multiple study reports, which can entail days or

weeks of effort. With D360, scientists can obtain the necessary cross-study data views in minutes, allowing

them to provide an immediate response to regulatory bodies, and avoiding costly delays in approval

processes and disruptions to ongoing work. In early phase discovery research, scientists use D360 to get a

comprehensive view of all project-relevant data, in which data summarisation is performed, according to

corporate standard scientific business rules, at the click of a button. Decision making at project meetings

becomes more efficient since the effort required for data collation is practically eliminated. Consistent data

presentation minimises discussion about data collation methods, and the ability to drill down on aggregated

data and use follow-on queries allows supporting information to be obtained in situ.

REPROCELL ACQUIRES 3D CELL CULTURE COMPANY REINNERVATE AND HUMAN

TISSUE SUPPLIER BIOSERVE


Reinnervate Ltd, one of the leading companies in the field of 3D cell culture, has been acquired by

ReproCELL of Shin-Yokohama in Japan. ReproCELL, a pioneer in the field of induced pluripotent stem

cell biology supplies iPSC-dervided Hepatocytes, Neurons and Cardiomyocytes as well as a range of media

and reagents for stem cell culture. ReproCELL intends to combine it’s iPSC-derived cells with the Alvetex

range of 3D cell culture products to produce and sell next-generation tools for drug toxicity testing,

neuroscience and cancer research. ReproCELL also announced the acquisition of BioServe Inc of

Maryland, USA, a leading supplier of human tissues and other biological samples with one of the largest

commercial biorepositories in the world. ReproCELL plans to use the unparalleled access to human tissues

to generate a wide range of disease-related iPSC lines for production of human disease cell models.

Commenting on the deal, Reinnervate Ltd CEO. Richard Rowling, said ‘We are delighted to become part of

the ReproCELL group of companies and look forward seeing Alvetex products combined with Reprocell’s

advanced stem cell derived cell products. Our customers are always looking for ways to improve the

biological relevance of cell based assays and to move away from using cell lines. Combining the benefits

offered by iPSC-derived cells and 3D cell culture will lead to exciting new product introductions.’ Chika

Yokoyama, CEO of ReproCELL added, ‘The ReproCELL group of companies now offers products and

services that span the 2D and 3D cell culture, stem cell culture media, iPSC-derived cells and human tissue

samples. We can now help the global scientific community move their basic and pre-clinical research

towards more sustainable and physiologically relevant models.

SAGENT REINTRODUCES IRINOTECAN HCL INJECTION USP


Sagent Pharmaceuticals, a specialty pharmaceutical company, has reintroduced the Irinotecan hydrochloride

injection, USP, an antineoplastic agent, in two preservative-free amber glass vials. According to IMS, for

the 12 months ending June 2014, the US market for Irinotecan approximated $23 million. As with all

products in Sagent's portfolio, Irinotecan features Sagent's PreventIV MeasuresSM, packaging and

labelling, designed to help reduce medication errors. "We are pleased to be partnering with Jiangsu Hengrui

Medicine Co., an injectables leader in China, to launch Irinotecan Hydrochloride Injection, USP," said

Jeffrey M. Yordon, chief executive officer and chairman of the Board. "Hengrui was the first injectable

plant in China, and Irinotecan was the first injectable product, to receive FDA approval." Irinotecan

hydrochloride Injection, USP is indicated for patients with metastatic carcinoma of the colon or rectum

whose disease has recurred or progressed following initial fluorouracil-based therapy.

EU GRANTS ORPHAN MEDICINAL PRODUCT DESIGNATION TO AB103 TO TREAT NSTI


Atox Bio, announced that The European Commission has granted AB103 (Sodium acetate salt of the

synthetic peptide H-D-Ala-Ser-Pro-Met-LeuVal-Ala-Tyr-Asp-D-Ala-OH) orphan medicinal product

designation (EU/3/14/1294) for the treatment of necrotising soft tissue infections. Atox Bio is represented in

the EU by Dr Ulrich Granzer as agent. In addition to a 10-year period of marketing exclusivity in the EU

after product approval, orphan designation provides fee reduction for companies seeking protocol assistance

from the EMA, direct access to centralised marketing authorisation as well as fee reduction for the

centralised marketing authorisation. NSTI are rare, fast progressing infections that result insignificant tissue

destruction and systemic disease leading to multiple organ dysfunction. Currently, there are no approved

treatments for NSTI and the standard of care includes prompt and repeated surgical debridement, aggressive

resuscitation and physiologic support, in addition to antibiotics. AB103, a novel immuno modulator, is a

short peptide that modulates the host’s inflammatory response through binding to the CD28 dimer interface.

It offers a unique approach in the treatment of infectious diseases by modulating, but not inhibiting, the host

immune system. This approach of targeting the host response rather than the pathogen precludes the rapid

generation of drug resistance and provides a multisystem solution for bacterial infections with broad-

spectrum coverage, independent of pathogen type. AB103 successfully completed a phase 2 study in

patients with NSTI.

SIGNET-MEGGLE NEW BUSINESS PARTNERS


Germany based Meggle, one of the world’s leading producers of pharmaceutical lactose, has appointed

Signet Chemical Corporation Pvt Ltd as their sole distribution partner in India for their entire range of

pharmaceutical lactose and co-processed lactose products. Under the new arrangement, Signet will

distribute the complete product portfolio of more than 20 products viz. Tablettose, FlowLac, DuraLac,

RetaLac, InhaLac, MicroceLac and Cellactose, which covers all areas from solid dosage forms (including

tablets, capsules, sachets) to powder formulations and dry powder inhalation. “We very much look forward

to this important new partnership with Meggle”, said Harish Shah, managing director of Signet. “Their

product range compliments our current portfolio and further strengthens our specialty product offering”, he

continued. Dr. Egmont G. Pfeifer, Director Business Group Excipients and Technology of Meggle in a

statement said, “Signet has a long established and proven product management structure in India. Through

their market focused networks, warehousing and logistics expertise supported by their dedicated technical

and regulatory experts; they will effectively supplement Meggle’s market penetration in India”. Keeping in

mind the growing needs of pharma industry, with this strategic partnership Signet and Meggle will redefine

their position as market leaders of excipients and global leaders of lactose respectively.

HELPINGDOC TO INVEST RS.10 CR TO STRENGTHEN TECHNOLOGY BACK-END &

FIELD FORCE


HelpingDoc, a gateway for healthcare providers to connect to their patients, has raised a capital of Rs.10

crore in series of funding from Senior Marketing Systems (SMS), Singapore. The infused funds will be

used for strengthening the field force and enhancing the technology back-end of the company. The fresh

capital will be suitably allocated to expand the services of HelpingDoc by growing beyond the Delhi-NCR

area into other major cities of the country like Mumbai, Bengaluru, Kolkata and Chennai over the next 18 to

24 months. It also aims to scale up by four to five and enroll over 20,000 doctors in the next two years.

Singapore based SMS is a strategic investor that has invested in several online healthcare ventures across

Asia in geographies like Japan, Korea, Malaysia, Indonesia, Thailand, Australia and Sri Lanka. Incepted in

2013, the company is based out of Singapore.

ST JOHN’S OPENS ONCOLOGY CENTRE, UNIT FOR DISABILITY, PLANS FOR E-LIBRARY

& CLINICAL SKILL LAB IN ITS 50TH YEAR


St. John’s Medical College in its golden jubilee year 2014-15 has already opened the St John’s Oncology

Centre, Unit of Hope for treatment of children with disabilities, renovated its auditorium and students’

dining hall last year. Now it is gearing up to commission its new e-library facility and establishing a clinical

skill laboratory to meet the basic and highly advanced training requirements of students and faculty as part

of the 50th year commemoration. The Golden Jubilee celebrations is being held on August 9, 2014 at its

auditorium in Bengaluru. Karnataka chief minister Siddaramaiah is the Chief Guest. Indicating the

highlights of the 50 years, the college in a press release said that it annually reserves 15 medical seats for

religious sisters, who permanently serve in rural areas. It has also ensured a 2-year compulsory rural service

bond for all students from 1973 itself, before the Karnataka government adopted the similar model of

compulsory rural service for doctors on completion of MBBS course. Around 25 per cent of the its medical

graduates are permanently settled and work in the undeserved and remote areas of Jharkhand, Chattisgarh

and Kashmir besides the tribal belts of Orissa, Assam and Meghalaya in addition to the Andaman and

Nicobar islands.

ALVOGEN BUYS KOREAN DREAM PHARMA FOR US$ 187 MN


Alvogen, an international, privately-owned specialty pharmaceutical company, has acquired Dream Pharma

(Dream) in South Korea for US$ 187 million in cash. Dream will be acquired through Alvogen’s Asian

subsidiaries and, on completion, will create one of the largest generic pharmaceutical companies in South

Korea. The transaction represents a significant milestone in Alvogen’s stated ambition to become one of the

top five regional players in the APAC market. The acquisition of Dream will significantly strengthen

Alvogen’s existing business in South Korea, adding a complementary portfolio of over 100 products.

Dream currently has an impressive 35 per cent market share in obesity products in Korea, with no overlap

with Kunwha’s current portfolio in the market. The consolidated business creates a strong platform for

exports and a basis upon which to introduce the Korean portfolio into other APAC markets. Alvogen’s

acquisition of Dream is the third significant acquisition that the Group has made in APAC since 2012. The

transaction will create a strong platform from which Alvogen can drive revenue and profit growth across the

region. APAC is one of the fastest-growing regions globally for generic pharmaceuticals. The market

remains very fragmented, which provides an excellent opportunity for Alvogen to play a leading role in

further industry consolidation, with a focus on building a selective, hiqh quality product portfolio in

markets such as Korea, Taiwan, Thailand, China, Japan and Vietnam.

STERIGENICS COMPLETES ACQUISITION OF NORDION


Sterigenics International LLC, the leading global provider of outsourced contract sterilisation services and a

portfolio company of GTCR, has completed its $826 million acquisition of Nordion Inc. "We are incredibly

excited to welcome the Nordion employees to the global Sterigenics team," said Michael Mulhern,

Sterigenics International LLC chief executive officer, "For more than 30 years, we have known the Nordion

organisation and have deep respect and appreciation for their people and expertise. By completing this

acquisition, we are creating the only vertically integrated sterilization company in the world and will have a

broader product portfolio, service offering, and global footprint to better serve customers worldwide.

Moving forward, Sterigenics is extremely well positioned to build on its mission of improving global public

health." As a standalone business within Sterigenics, Nordion will remain headquartered in Ottawa, Canada,

and will continue to operate under the Nordion name. Headquartered in Deerfield, Illinois, Sterigenics

International LLC operates out of 39 facilities in 11 countries across the Americas, Europe and Asia and is a

global leader in outsourced contract sterilisation services, primarily to the medical device, pharmaceutical,

food safety and high performance/specialty materials industries.

PIVOTAL THERAPEUTICS ENTERS JOINT VENTURE DISTRIBUTION AGREEMENT WITH

ACGT CORPORATION


Pivotal Therapeutics, a specialty pharmaceutical company with a focus on Omega-3 therapies for CVD and

overall health, has entered into a Memorandum of Understanding to create a Joint Venture Distribution

Agreement with ACGT Corporation (ACGT) and associates. A leader in Canada's DNA services industry

with extensive ties to China, ACGT will identify and introduce Pivotal to potential partners for the

commercialisation of its products in China. ACGT was founded by Dr. Hai Shiene Chen in 1995 and is a

privately owned provider of oligonucleotide synthesis and DNA sequencing services to customers in the

Greater Toronto Area and across Canada. ACGT is considered to be one of the prominent Canadian

providers of DNA services. ACGT has consistently been selected as the primary service supplier with

superior quality control and fast delivery time for many well-known medical institutions. "Business in the

life sciences and healthcare sector in China is growing increasingly robust," said Dr. Chen, ACGT's

president and chief executive officer, "ACGT understands the challenges of navigating the route for the

Chinese marketplace. With China expected to move to a new phase as the world's largest market within this

decade, we have relationships with the right partners to help capitalise on the many opportunities in China

now and into the future."

WELLNESS

GSK HEALTHCARE TO ENTER MARKETS

Business Standard, 2 August, 2014 Health food drink company GlaxoSmithKline Consumer Healthcare is planning to penetrate rural and slum

markets by adding a million stores to its network of 2.7 million in 18 months. The company is expecting the

expansion to build the infrastructure for its growth. Executive Vice-President (sales) Sidharth Singh said,

"There are nine million stores in the country, of which we have a reach of 2.7 million, including Horlicks,

which has a reach to 1.6 million."

HINDUSTAN UNILEVER SEES NO DEMAND RECOVERY

Business Recorder, 4 August, 2014

India's Hindustan Unilever Ltd (HUL) sees no immediate sign of recovery in demand for consumer goods

after a transport strike last year helped sales volume in April-June outgrow estimates for the first time in

eight quarters. HUL has been selling Rin detergent, Fair & Lovely skin cream and Dove soap in an

economy witnessing its longest period of sub-5 percent growth in 25 years. Household spending has

suffered as high inflation eclipses city salary rises and a recent drought reduces rural income. The consumer

goods sector in Asia's third-largest economy is worth about $13 billion according to analysts, but consumers

have been "pessimistic" for 33 months, showed a June survey by ZyFin Research. "The environment

continues to be tough and both volume and value growth metrics are not showing substantial signs of

improvement," HUL Chief Financial Officer PB Balaji said in a conference call after the company reported

quarterly earnings. "Discretionary categories continue to be under pressure," he said. Net profit rose 4

percent to 10.57 billion rupees ($175.9 million) in the fiscal first quarter ended June 30, HUL said in a

statement. That compared with the 9.66 billion rupees mean estimate of 11 analysts according to Thomson

Reuters StarMine.

GSK HEALTHCARE Ql PROFIT UP 8.46 PC Daily Post, 8 August, 2014

GlaxoSmithKline Consumer Healthcare on Thursday posted 8.46 per cent increase in net profit at Rs 130.12

crore for the first quarter ended June 30, 2014 due to growth in all categories. The company had reported

net profit of Rs 119.96 crore in the same quarter a year ago. Net sales of the company rose by 8.04 per cent

to Rs 921.55 crore in the April-June quarter as against Rs 852.92 crore in the corresponding period last year,

"This is significant in a scenario where consumption pattern is being impacted by inflation. Our sciences

based products with its superior value, continue to remain relevant for our large consumer base,"

GlaxoSmithKline Consumer Healthcare Managing Director Zubair Ahmed said in a statement. As a market

leader, the company is also growing the category with successful launches of new products which are

driving up consumption experiences, he added. On the future outlook of the company, Ahmed said:

"Customer driven innovations and clutter breaking marketing based on sharp consumer insights will

continue to be our driving force in the coming months to bring in more consumers closer to the product".

Further, the company said it has appointed Sangeeta Talwar as an independent director. Shares of the

company today closed at Rs 4,873.40 apiece on the BSE, down 1.78 per cent from previous close.

NESTLE INDIA NET PROFIT UP 6% Hindu Business Line, 7 August, 2014

Nestle India posted a net profit of ₹288 crore for the quarter ended June 30, up 6.12 per cent compared with

₹271.38 crore in the corresponding quarter of the previous year. The company said operating margins were

adversely impacted due to the record-high cost of milk and its derivatives in India, which was higher than

international markets. Net sales grew by 9.3 per cent to ₹2,419 crore. The company said net domestic sales

grew mainly from better realisations. In a statement, Etienne Benet, Managing Director, Nestle India said,

“The results are broadly as expected and in line with our vision and strategy for Nutrition, Health and

Wellness that we shared in our earlier communications…We will continue to leverage Nestlé’s scientific

and technological expertise, and provide insights into food consumption behaviour and science-based

nutrition to help our consumers live healthier.” “With the final instalment of $35 million paid in July, the

company has repaid the entire external commercial borrowing of $192 million and is now debt free,” he

added. The company recently launched Nestle Sweet Lassi, Nestle Buttermilk and Maggie Oats Noodles.

COLGATE-PALMOLIVE REPORTS SATISFACTION WITH SECOND-QUARTER GROWTH

Zenopa, 4 August, 2014

Colgate-Palmolive has announced its financial results for the second quarter of 2014, during which it

achieved worldwide net sales of $4.35 billion (2.58 billion pounds). This total was roughly even with Q2

2013 due to the impact of negative foreign exchange trends. Organic growth was achieved across all

divisions, with global unit volume rising 2.5 percent and pricing increasing by 1.5 percent. Its overall

organic sales growth rate was four percent, led by a 6.5 percent improvement in emerging market territories,

while the launch of important new products helped to fuel further progress. Meanwhile, Colgate's leading

global market shares in toothpaste and manual toothbrushes remained strong at 44.4 percent and 33.5

percent, with its mouthwash market share rising to a record high of 17.2 percent. Ian Cook, chairman,

president and chief executive officer at Colgate-Palmolive, said: "Our 2012 Restructuring Programme is on

track and proceeding smoothly. We also continue to be sharply focused on our aggressive funding-the-

growth programs and our strategic worldwide pricing initiatives." This comes after the firm achieved a net

sales total of $17.41 billion in 2013, which represented a two percent increase on the previous year.

UNILEVER INITIATES STUDY FOR REDUCING PESTICIDES IN TEA PRODUCTION IN

INDIA

The Hindu, 5 August, 2014

Unilever said this is part of the company’s Sustainable Living Plan, where it has committed that all its

agricultural raw materials will be produced using sustainable crop practices by 2020. Global fast moving

consumer goods (FMCG) major Unilever announced it is initiating a study to evaluate the environmental

and economic feasibility of applying biological or non-pesticide methods for plant protection of tea crops in

India. A statement from Unilever said this is part of the company’s Sustainable Living Plan, where it has

committed that by 2020 all its agricultural raw materials will be produced using sustainable crop practices.

The company is committed to raising standards in tea production by reducing or eliminating pesticides in

tea growing, in partnership with its suppliers and farmers. Unilever has chosen CABI (formerly

Commonwealth Agricultural Bureaux International), an inter-governmental, not-for-profit organisation, to

conduct the research project. Unilever said that in the coming weeks, CABI will review existing practices of

crop protection and the limitations of current techniques in India. In cooperation with the Tea Board of

India, the Tea Research Institutes and key industry partners, CABI will than design protocols for pilot field-

trials to investigate novel approaches for biological, non-pesticide management of pests aiming at a holistic

rejuvenation of the eco system. The Tea Board of India is already doing pioneering work in the area through

Trustea and recently launched a new Plant Protection Code (PPC), Unilever said, adding that the data and

recommendations from the research will be made public and will guide Indian industry and Unilever’s next

steps.

ESSEL PROPACK EYES HUL'S ORAL CARE PACKAGING DEAL


Essel Propack is eyeing a contract for the packaging business of Hindustan Unilever Ltd's oral care brands

Pepso-dent and Close Up in the domestic market. The packaging company already has oral care clients such

as Colgate, Dabur and Vicco in India. "We are looking at the possibility of getting HUL's oral care portfolio,

as globally we do packaging for Unilever and also handle exports in the domestic market," said Ashok

Goel, Vice-President and Managing Director, Essel Propack. HUL is the second largest oral care player

after Colgate. At present, companies such as Betts, SRM and Borkar are handling the oral care packaging of

HUL, say industry sources. Essel Propack, with 65 per cent share in the domestic market, is making plastic

laminated tubes, catering to both oral and non-oral care companies in the FMCG and pharma categories.

Though there has been a slowdown in consumer demand in the FMCG category, the company is undeterred

about growth prospects.

INDUSTRY AND ECONOMY

INDIAN DRUGMAKERS TO PAY HIGHER FACILITY FEES ON US HIKE


Drugmakers from India, the biggest source of medicines to the US, may soon have to cough up 12-15 per

cent more in annual facility fees as the Food and Drug Administration (FDA) has announced new rates. The

US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and

supplements for human generic drug products. The new rates, applicable on companies from all nations, are

effective from October 1 and will remain in force through September 30, 2015, as per a communication

from FDA. A Foreign FDF (Finished Dosage Form) facility will pay USD 262,717 (approx Rs 1.6 crore)

now compared to US$235,152 a year ago -- an increase of 12 per cent. India is home to over 150 FDA-

approved plants, including facilities run by global MNCs. Of the total facilities identified as FDF, there

were 271 domestic facilities and 410 foreign facilities, including those in India. Similarly, a Foreign API (

Active Pharmaceutical Ingredient) facility would attract USD 56,926 (about Rs 34.7 lakh) as fees -- 15 per

cent higher than the current rate.

ALLOW PHARMACISTS AS MEDICAL PRACTITIONERS IN RURAL AREAS: IPA Business Standard, 8 August, 2014

Soon pharmacists may don the role of a medical practitioner in rural areas if the proposal made by the

Indian Pharmacist Association (IPA) to the Union Ministry of Health comes through. The IPA has suggested

that pharmacists be allowed to double up as non-doctor medical cadre in the rural areas with some

additional training as they already have knowledge of pharmacology. IPA has stated in its representation

made to the Union Health minister Harsh Vardhan last month that, "Union Cabinet has approved BSc

Community Health course. The main objective of the course as stated is to create mid-level health

professionals with necessary public health and ambulatory care competencies to serve the rural pop-

ulation.MBBS can't be substituted with any other cadre. The course is against the wishes of 'The

Parliamentary Standing Committee on health'." The IPA has further argued that states are not interested in

starting the course because of inadequate syllabus. Bhupendra Kumar, secretary general of the IPA feels

that, "If the government wishes to introduce non-doctor based cadre in India, working and experienced

pharmacists car) serve the purpose with a short duration up-gradation training curriculum." He added that

pharmacists are vastly available with qualification ranging from D. Pharma, B. Pharma, M. Pharma, PhD to

Pharm D. Pharmacists are already well trained in pharmacology of drugs and other areas.

TN HEALTHCARE ROLE MODEL FOR WORLD: WHO Deccan Chronicle, 8 August, 2014

World Health Organisation's (WHO) representative in India Dr Nata Menabde lauded the efforts of the

Tamil Nadu government in providing quality healthcare to all its citizens. "Tamil Nadu is one of the top

performing states by economic indicators, health indicators or by management and health system

performance indicators. There are many things that TN has accomplished in terms of system impro-

vements;. so many things are possible to do," Dr Nata Menabde said while inaugurating the National

Consultation on "Improving Access; Promoting Innovation" in the context of universal health coverage at

IIT-Madras Research Park on Thursday Pointing out that Tamil Nadu had a lower infant mortality rate and

maternal mortality rate in the country, the WHO official said that the state had several indicators, which

were better than the national average and could be shown to other countries as model in the delivery of

healthcare systems. Dr Nata also raised her concerns over the fact that, even after several decades, the

medical fraternity was still to come up with a vaccine for diseases like tuberculosis and Ebola, of which we

have a most virulent recent outbreak in western Africa.

DRUG MAKERS' PROFITS SOAR OVER INTER-BRAND GAP IN MRP

Business Standard, 4 August, 2014

Even as pharmaceutical companies are opposing the latest regulatory move to keep a check on inter-brand

price difference, market data show that in some cases the maximum retail price (MRP) of various brands of

the same medicine varies by as much as 1,700-1,800 per cent. That leaves a huge profit margin for drug

firms even after paying wholesalers and retailers. Data also depict pricing parity is more significant between

brands sold by domestic manufacturers and those marketed by multinational firms. While most

multinationals attribute high prices of their products to better quality, standard procedures and efficacy,

industry experts and regulatory authorities say the difference in MRP is due to higher cost incurred in

marketing and promotion coupled with better profit margins. This is despite the fact that the ceiling price in

case of even regulated medicines provides for up to 16 and eight per cent extra margin for retailers and

wholesalers, respectively. Besides, it also takes into account packaging and conversion cost. Regulatory

officials say despite having such margins within the price caps, companies make extraordinary profits. For

instance, latest data compiled by Monthly Index of Medical Specialities show a price difference of over

1,733 per cent between Novartis' Femara and Biochem's Oncolet, two different brands of letrozole used in

the treatment of breast cancer. While a strip of 10 tablets of Femara (letrozole 2.5 mg) is priced at Rs1,815,

the MRP of Oncolet is Rs99.

CLUEPOINTS SURVEY REVEALS DETERMINING THE BEST APPROACH IS INDUSTRY'S

BIGGEST CHALLENGE TO IMPLEMENTING RBM STRATEGY


CluePoints, a leading provider of CSM solutions for clinical trials, survey revealed that 42 per cent of

respondents from across the industry consider agreeing the best and most practical approach to be the

biggest challenge their organizations are facing in implementing an effective Risk-Based Monitoring

(RBM) strategy. While two years ago RBM was not at the top of many minds, today 36 per cent of the 520

survey respondents are currently in the process of evaluating practices, calling for greater awareness of how

sponsors and CROs can develop and integrate the approach at a realistic and practical level. The new survey

was developed to gain an understanding of the industry's insights into RBM and how changes to monitoring

strategies are being managed at sponsor and CRO level. The research looked at the techniques that are

currently available to the market with 59 per cent of those surveyed pointing to the use of Central Statistical

Monitoring (CSM) as contributing major advantages from a usability perspective due to its ability to detect

data accuracy and issues earlier, while requiring minimal work from study teams in gaining objective

information.

MORE DRUGS UNDER DPCO CAN INCREASE RELIANCE ON MNCS: IPA Business Standard, 7 August, 2014

As the pharma industry gears up to raise its concern against the recent move by the government to bring

more drugs under the ambit of price control, industry insiders including associations that represent big

pharma are unanimous in saying that such a move is sure to kill the small and medium pharma

manufacturer in the long run and result in an increased dependence on multinationals and big pharma for

medicines. Major industry associations like the Indian Pharmaceutical Alliance (IPA) and the Organization

of Pharmaceutical Producers of India (OPPI) have already made representations to the ministry of health,

while the Indian Drug Manufacturers' Association (IDMA) is planning to do the same in around a week's

time. D G Shah, secretary general of the IPA which has Torrent Pharmaceuticals, Alembic Pharmaceuticals,

Cadila Healthcare, Cadila Pharmaceuticals, Glenmark, Lupin, Intas and several other big pharma as its

members, said that while multinational drug firms as well as large Indian companies will lower prices, it

would push the SMEs to take a price cut too in order to stay competitive. However, "They would find it

difficult to lower their prices further and would thus become victims of the price fixation orders

compressing the band width of prices," he said.

FINANCIALS

TAKEDA PHARMA NET DIPS BY 6.2% IN JUNE QUARTER


Takeda Pharmaceutical Company of Japan has posted lower net profit of Yen 34 billion during the first

quarter ended June 2014 as against Yen 36 billion in the corresponding period of last year due to stagnant

sales, higher input costs and launch of new products in the US. Its revenue improved marginally by 0.2 per

cent to Yen 411 billion from Yen 410 billion. Its earnings per share worked out to Yen 42.40 as compared to

Yen 45.53 in the last period. The company's sales of Ethical drugs improved only by 0.5 per cent to Yen 372

billion as its sales in Japan declined by 2.2 per cent to Yen 138 billion. Contribution from sales increase of

products launched in and after 2010 such as Asilva and Nesina could not fully absorb the decrease in sales

mainly due to the National Health Insurance price reduction and the penetration of generic products.

However, its overseas sales improved by 2.7 per cent to Yen 234 billion due to higher sales of Velcade in

the US and Pantoprazole in emerging markets including Asia. Its R&D expenditure declined 5.1 per cent to

Yen 75 billion from Yen 79 billion.

AUROBINDO PHARMA EYES $2 BILLION REVENUES IN FY15


Aurobindo Pharma aims to achieve USD 2 billion turnover during the current financial year. The city-based

drug maker also hopes to seek approvals for nine more injectables from US FDA. "Leveraging on its large

state-of-the-art manufacturing infrastructure for APIs and formulations, wide and diversified basket of

products and confidence of its customers, the company aims to achieve USD 2 billion revenues by 2014-

15," Aurobindo Pharma said in its latest annual report. The consolidated revenue (net) from operations was

higher over the previous year by 38.3 per cent at nearly Rs 8,100 crore (USD 1.4 billon at Rs 58 per dollar)

during 2013-14 as against Rs 5,855 crore in the previous year. "In the injectable business, going forward,

we are gearing ourselves for a meaningful growth in the medium term. We have 45 files with FDA under

review, and we hope to file 9 more in 2014-15 and another 30 in 2015-16. "Hence, depending on the timing

of the regulatory approvals, we could see significant growth over the next two to three years," it further

said.

SHASUN CUTS LOSSES IN QI The Hindu Business Line, 8 August, 2014

Chennai-based drug-maker Shasun Pharmaceuticals brought down its consolidated net loss in the June

quarter to Rs4.8 crore. Although on a standalone basis, profits grew 46 per cent to Rs3.6 crore, losses of

0.76 million at UK subsidiary resulted in the consolidated losses. Managing Director S Abhaya Kumar said

Dudley, UK-based Shasun Pharma Solutions Ltd faced losses mainly due to "phasing of orders," and is

poised for a 15-20 percent growth in FY-15.The subsidiary has added 10 new customers during the quarter,

cutting reliance on large customers and widening its product base, said Abhaya Kumar

JUBILANT POSTS RS 5 CR PROFIT IN QL


Jubilant Life Sciences has posted a net profit of Rs4.78 crore during the first quarter of the current fiscal.

The pharma and life sciences company had posted a loss of Rs52.62 crore during the same quarter last

fiscal. In a joint statement, Chairman and Managing Director Shyam S. Bhartia and Co-Chairman and

Managing Director Hari S Bhartia, said, "Performance of the quarter was affected due to extended plant

shutdown in CMO (contract manufacturing organisation) business to address the US FDA issues. These

operations have now normalised and, along with new product introductions and strategic initiatives, should

deliver strong performance in our pharmaceutical operations." In the coming quarters, the company expects

strong growth momentum led by the pharma-ceuticals segment. The firm expects this growth to be driven

by new products and new markets, expanding volumes in CMO operations and revenue increase in

radiopharma-ceuticals. Financed by a Sl47.5-million loan from the IFC, the company has consolidated all

the pharmaceutical business under Jubilant Pharma, Singapore, with effect from July l. "Life science

ingredients should continue its robust performance on account of higher capacity utilisation, better pricing

of our key products and expansion into new markets," the company said in a statement. The company saw a

net income of Rs1,473.13 crore during the first quarter ended June 30 against Rs 1,359.27 crore during the

corresponding period of the previous fiscal.

AJANTA PHARMA NET ZOOMS BY 80% IN Q1


Ajanta Pharma, a Rs. 1,079 crore Mumbai based pharma major, has posted strong growth in net profit of

80.5 per cent to Rs. 58.72 crore during the first quarter ended June 2014 from Rs. 32.54 crore in the

corresponding period of last year. Its net also moved up by 30.4 per cent to Rs. 280.79 crore from Rs.

215.39 crore. With hefty jump in profits, its EPS improved to Rs. 16.70 from Rs. 9.26. Its equity capital

increased to Rs. 17.68 crore from Rs. 11.81 crore in the last period due to bonus issue. However, after

announcement of financial performance, Ajanta scrip declined sharply by Rs. 150 on BSE to Rs. 1590.85.

The scrip touched to its highest level at Rs. 1798.45 in the morning session as compared to its opening price

of Rs. 1750.25. However, the scrip movements remained volatile during the day as it declined sharply to Rs.

1525 at one point basically due to lower sales and profit on quarter to quarter basis. During the March

ended quarter, its net sales were at Rs. 301.14 crore and net profit was at Rs. 70.09 crore which is

substantial higher that the June quarter figures.

AUROBINDO NET JUMPS TO RS.415 CR IN Q1, INTERIM DIVIDEND OF 150%


Aurobindo Pharma, a Rs.8,000 crore pharma giant from Hyderabad, has posted impressive performance

during the first quarter ended June 2014 due to acquisition of Western European business of Actavis, higher

sales, foreign exchange gains against loss in the corresponding period of last year. Its consolidated net profit

touched to Rs.415 crore as against Rs.19 crore in the last period. Its net sales also moved up by 70.3 per

cent to Rs.2,895 crore from Rs.1,700 crore. With sharp jump in profits, EPS improved to Rs.14.25 from

Rs.0.64 in the previous period. The company management declared interim dividend of 150 per cent i.e.

Rs.1.50 per share of Rs.1 each. The company's EBDITA improved by 114.7 per cent to Rs.668.96 crore

from Rs.311.63 crore. Its employees cost increased significantly to Rs.308.37 crore from Rs.188.91 crore.

However, it reduced its interest burden to Rs.18.85 crore from Rs.25.39 crore. The foreign exchange gain

amounted to Rs.1.42 crore as compared to foreign exchange loss of Rs.172.41 crore. The company's step

down subsidiary, Agile Pharma B V Netherlands has acquired select Western European business of Actavis.

TARO PHARMA'S NET DIPS BY 22% TO $46 MN IN Q1


Taro Pharma, a subsidiary of Sun Pharmaceutical and Industries, has suffered a setback during the quarter

ended June 2014 due to charges taken to meet contractual obligations associated with price adjustments. Its

net profit declined sharply by 22 per cent to $46 million from $59 million in the same period of last year. Its

net sales also declined by 15 per cent to $130 million from $154 million. Its EPS declined to $1.08 from

$1.32. The net sales declined due to price adjustments. The charges for the quarter amounted to $79 million

as against $24 million in the corresponding quarter of last year. The benefits from these price adjustments

are expected to commence in the second fiscal quarter. Its R&D expenditure increased by 23 per cent to $15

million from $12 million and the company anticipate the increase in R&D spend to continue throughout the

year. Its selling, marketing, general and administrative expenses increased to $22 million from $21 million.

Kal Sundaram, CEO, said, “Our underlying business is stable, with volumes relatively flat from the

comparative 2013 quarter. We continue to increase our investment in our R&D, having filed five ANDAs

this quarter, with 31 total ANDAs awaiting approval with the FDA. Excluding the impact on net sales from

the net charges associated with price adjustments, net sales would have increased by 18 per cent versus the

comparable prior year quarter.” Taro received US FDA approval for Flucinonide cream, USP, - 0.1 percent.

TTK HEALTHCARE NET SURGES IN QI


Chennai-based medical devices and Pharmaceuticals manufacturerTTK Healthcare's profit increased to

Rs3.6 crore in the quarter ended June 30, a jump of 78 per cent from the year-ago period. Revenues

increased 18.9 per cent to Rs129.76 crore due to highersales in its Pharmaceuticals and foods segments.

However, the company has indicated profits duringfirst quarter of 2013-14 of Rs2.02 crore was after a one-

time expense of Rs2.9 crore.The company scrip on the BSE dropped 3.6 per cent to Rs642. Ourbureau

J B CHEMICALS NET SURGES BY 56.4% IN Q1


J B Chemicals & Pharmaceuticals, a Rs.900 crore plus Mumbai based pharma major, has reported

impressive profit growth during the first quarter ended June 2014. Its net profit moved up sharply by 56.4

per cent to Rs.31.79 crore from Rs.20.33 crore in the corresponding period of last year. Its net sales

increased by 12 per cent to Rs.256.71 crore from Rs.229.17 crore. The net sales for the quarter are strictly

not comparable due to the company's wholly owned subsidiary in Dubai commencing sales and distribution

of the products in Russia-CIS countries during the quarter. Its EPS worked out 3.75 as against Rs.2.40 in

the last period. Its EBDITA increased by 18.5 per cent to Rs.49.60 crore from Rs.41.86 crore.

EXCEPTIONAL ITEMS PUSHES NET PROFIT OF PIRAMAL ENTERPRISES IN Q1


Piramal Enterprises, engaged in pharmaceuticals, healthcare, information management and financial

services, has able to pushed its consolidated net profit to Rs.2,896 crore during the first quarter ended June

2014 from a net loss of Rs.147 crore in the corresponding period of last year basically due to gain on sale of

investment in Vodafone India Ltd of Rs.3,036 crore. Its net sales improved by 21.7 per cent to Rs.1,166

crore from Rs.958 crore in the last period. Its consolidated EBDITA declined by 1.4 per cent to Rs.256

crore from Rs.260 crore. The company has reduced its interest cost from Rs.333 crore to Rs.148 crore. After

the announcement of its financial performance, Pirmal scrip has taken a jump of Rs.25.95 or 4.03 per cent

to Rs.669.95 on BSE. The pharmaceutical sales improved by 20.4 per cent to Rs.739 crore from Rs.613

crore and contributed around 63 per cent to its total revenues.

MERCK & CO POSTS NET PROFIT OF $2,004 MILLION IN Q2


Merck & Co has registered strong growth in profits during the second quarter ended June 2014 despite

lower sales. Its net profit increased by 121 per cent to $2,004 million from $906 million in the

corresponding period of last year. However, its net sales declined by 0.7 per cent to $10,934 million from

$11,010 million due to patent expiration, divested products and decline in sales of hepatitis C products.

With impressive growth profits, its EPS moved up to $0.68 from $0.30 in the last period. Its

pharmaceuticals sales during the second quarter ended June 2014 declined by 2.4 per cent to $9,087 million

from $9,310 million due to loss of exclusivity for Temodar and Nasonex. Further, the sales from the

hepatitis franchise of Victrelis and Pegintron declined due to stiff competition.

WANBURY EARNS SMALL NET PROFIT IN Q1


Wanbury, a Rs.400 crore loss making pharma company, has posted small net profit of Rs.1.28 crore during

the first quarter ended June 2014 as against a net loss of Rs.6.72 crore in the similar period of last year

mainly due to lower interest burden. Its net sales also improved marginally to Rs.115.12 crore from

Rs.103.11 crore. The interest cost declined to Rs.9.26 crore from Rs.14.82 crore in the last period. The

company achieved positive EPS of Rs.0.71 as compared negative Rs.3.87. Currently Wanbury scrip of

Rs.10 each is moving in the range of Rs.28-30 on BSE. Wanbury has equity investment of Rs.39.08 crore in

two wholly owned subsidiaries and other company, and has amount recoverable of Rs.189.87 crore from

them and Cantabria Pharma SL, (CP) Spain, a step down subsidiary.

PATENTS

SUVEN LIFE SCIENCES GRANTED PATENTS FOR NEURODEGENRATIVE DRUG


Pharmaceutical firm Suven Life Sciences today said it has been granted one patent each by Australia and

Eurasia for drug used in the treatment of neurodegenrative diseases. Neurodegenrative diseases include

Alzheimer's disease, Schizophrenia and Parkinson's disease. In a BSE filing the company said that it has

been granted "one product patent from Australia and one product patent from Eurasia corresponding to the

new chemical entities for the treatment of disorders associated with neurodegenerative diseases". These

patents are valid until 2030 and 2029 respectively, the company said in a BSE filing. Suven Life Sciences

CEO Venkat Jasti said: "We are very pleased by the grant of these patents to Suven for our pipeline of

molecules in the CNS (central nervous system) arena that are being developed for cognitive disorders with

high unmet medial need with huge market potential globally." With these new patents, Suven has a total of

18 granted patents from Australia and 12 from Eurasia. "These patents are exclusive intellectual property of

Suven...products out of these inventions may be out-licensed at various phases of clinical development like

at Phase-1 and Phase-2," Suven Life Sciences said.

HIGH COURT ISSUES NOTICE ON PIL OVER DISCLOSURE POLICY OF PATENTS ACT


It has been eight years since Right to Information (RTI) Act came into being but the country's activists are

clueless about what happens when India's most potent information weapon clashes with other information

dispensation mechanisms coded in a host of other pre-existing laws--such as Patents Act and Companies

Act. This has become the moot point of a public interest litigation, filed by Shamnad Basheer, a patent

expert in the Delhi High Court, which argued on Wednesday that the government arms are misusing these

grey areas to frustrate RTI seekers and conceal information, which they should be readily sharing under the

transparency law. Appearing in support of the petition, Salman Khurshid, a former law minister, under the

UPA regime sought clarity from the court on this `key issue' of whether the pre-existing laws override RTI

Act, when it comes to gleaning information from the government. The court, which admitted the matter on

Wednesday, sent out a notice to the government seeking its response. Basheer, under RTI had sought

information on the level at which pharma companies are commercialising the patents they hold particularly

in critical and chronic diseases such as cancer, AIDS, diabetes, Hepatitis and more. This sort of information

all patent holders are mandated to file with the patent office annually in a prescribed format. In fact, the

patent office has uploaded part of such information on its website, which Basheer alleges is only for the

years 2012 and 2013.

POLICY AND REGULATIONS

US FDA ANNOUNCES FY 2015 ANIMAL DRUG USER FEE RATES FOR ADUFA & AGDUFA


The US Food and Drug Administration (FDA) announced in the Federal Register the fiscal year 2015 rates

and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee

Amendments of 2013 (ADUFA III) and Animal Generic Drug User Fee Amendments of 2013 (AGDUFA

II). ADUFA, originally signed into law in 2003 and reauthorized in 2008 and 2013, amends the Federal

Food, Drug, and Cosmetic Act and authorizes FDA to collect fees for certain animal drug applications and

supplements, products, establishments, and sponsors of animal drug applications and/or investigational

animal drug submissions. These resources support FDA’s responsibilities to ensure that new animal drug

products are safe and effective for animals as well as for the public with respect to animals that produce

food for consumption. ADUFA III reauthorizes FDA to collect user fees through FY 2018. AGDUFA,

originally signed into law in 2008 and reauthorized in 2013, was designed to enhance the performance of

the generic new animal drug review process and enable FDA to better ensure that generic new animal drug

products are safe and effective, thus giving consumers a lower cost alternative to pioneer drugs. AGDUFA

II reauthorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs,

generic new animal drug products, and from certain sponsors of such abbreviated applications for generic

new animal drugs and/or investigational submissions for generic new animal drugs.

US PHARMA REGULATOR CUTS DRUG FILING FEE BY 8%


The US drug regulator, Food and Drug Administrator (FDA), has lowered the fee charged for generic drug

applications by 8 per cent. This will apply on filings made after October this year and will benefit pharma

companies such as Cadila, Dr Reddy's, Glenmark, Sun, Ranbaxy, and Lupin, which have significant

presence in the US. The FDA is authorised to collect user fee to approve certain human generic drug

products. These filings can be in two categories. Those for finished formulations or abbreviated new drug

applications (ANDAs) and for active ingredients called drug master files (DMFs). The revised fee for

ANDAs and DMFs stands at $ 58,730 (^35.2 lakh) and $29,370 (=517.6 lakh), respectively. The fee has

been arrived at by estimating the FDA's revenue and expenditure—personnel and other costs—for that year.

The regulator expects to collect fee on 1,065 generic drug applications during this period. This has been

derived by annualising the 1,775 filings made between October 2012 and May 2014. Drug-makers Cadila,

Dr Reddy's and Glenmark are likely to save Rs 1-1.5 crore on account of this. These companies file 30-50

ANDAs annually. Sun Pharma and Lupin, which file 20-25 products, may save Rs 0.8 crore on the filings

made in the 12 months beginning October 2014.

HEALTH MINISTER HARSH VARDHAN URGES STATES TO BAN GUTKA, ZARDA, KHAINI


After pressing for a raise in tax on cigarettes in the budget, Health Minister Harsh Vardhan has now urged

the chief ministers of about 20 states to ban all forms of chewing tobacco, including gutka, zarda, khaini. A

handful of states, such as Andhra Pradesh, Telengana, Goa, Maharashtra, Mizoram and Manipur have

already banned such products and some more are in the process of prohibiting sale of one or more forms of

chewing tobacco. Asking states to bear in mind that a shocking 90% of all oral cancer has been found to

have roots in tobacco, Vardhan in a letter on Wednesday told the states that India has the highest number of

this type of cancer in the world. About 206 million Indians use chewing tobacco, he said, citing the Global

Adult Tobacco Survey. Tobacco is often sweetened and flavoured to make it edible and to attract

prospective customers, particularly children, he said. It is also available at low prices, making it affordable

to the poor and vulnerable groups like women and children. Besides the highly fragmented unorganised

smokeless tobacco industry, pegged at more than Rs 15,000 crore, branded products from the stable of

Dhariwal Industries (Manikchand), DS Group (Rajnigandha) and Som Sugandh Industries (Dilbag, Talab)

are likely to be hurt if states decide to act on Vardhan's advice.

FDA REJECTS NEW XARELTO USE, LAWSUITS MOUNTING AGAINST MANUFACTURER Ring of Fire, 6 August, 2014

Despite Bayer and Johnson & Johnson’s best efforts, the money-maker blood thinner Xarelto has been

denied the freedom to expand its use. The manufacturers were seeking to expand the blood thinner’s

approved uses to include heart attacks and strokes, and death, in patients with acute coronary syndrome

(ACS), along with clogging of heart stents. The FDA denied that approval earlier this year, according to

Reuters. “Drug manufacturers are often hungry for expanded uses for their drugs,” commented Ned

McWilliams, a partner with the Levin, Papantonio law firm who practices in the areas of Mass Torts,

product liability, and bad drug litigation. “Often, they fail to disclose the dangers associated with their

products in order to get the approval they need from the FDA. By doing so, they fail to inform not only the

FDA but the patients that use their devices and rely on the information that they have been provided.”

DELHI HIGH COURT DELIVERS SETBACK TO OPPI, REFUSES STAY ON DRUG PRICING

NOTIFICATION

Financial Express, 2 August, 2014

The Delhi High Court on Friday turned down a plea of the Organisation of Phar-ma Producers of India

(OPPI) to stay a recent notification of the National Pharmaceutical Pricing Authority (NPPA) bringing 108

drug formulations used to treat diabetes andcardio-vascular disorders under pricing control. Further, it also

shot down OPPI's demand for a restraint on the NPPA from issuing any subsequent orders in this regard.

Recently, on July 10, the NPPAhadcappedtheprices of these formulations which account for 6 % of the the

Indian pharmaceutical market, or Rs 5,500 crore, according to the All-India Organisation of Chemists and

Druggists-AWACS, the traders' outfit. The regulator has invoked Para 19 of the Drug Pricing Control Order

2013, which gives it the authority to regulate the ceiling price of any drug under "extraordinary

circumstances" in "public interest." The listed drugmakers whose revenues are expected to be hit due to the

NPPAs latest decision to cap the prices of these drugs include Sanofi India, Abbott India, Ranbaxy

Laboratories and As-traZeneca Pharma India. Meanwhile, the high court has directed the NPPA to file its

reply on OPPI's plea and has posted the matter for further hearing on September 29. Before the new

notification, the NPPA regulated prices of only 348 "essential medicines" whose ceiling prices are fixed as

the simple average of all brands with a market share of at least 1 %.

GOVT TO DIP INTO INNOVATION CESS TO FUND INDUSTRY RESEARCH


The Centre is considering ploughing funds collected through the innovation cess towards research, in

collaboration with industry, in three critical areas: biotechnology, Pharmaceuticals and automotives. The

innovation or research and development cess, collected from industry, amounts to 5 per cent of the cost of

technology imports, which include payments made for designs, drawings, and to technical personnel. The

idea of channelling the cess, which remains largely unutilised, into specific sectors emerged in a meeting

between Commerce Minister Nirmala Sith-araman and Managing Director of Biocon Ltd Kiran Mazumdar

Shaw, soon after the new Government was sworn in. Shaw told Business-Line that the Minister was

extremely positive about her suggestion that innovation was the key to building further expertise in areas

where India is already making its presence felt.

The role on innovation "The Government needs to understand the role of innovation in economic development. For instance, Bio

Genetics is the next big thing, where China is already taking the lead. If we invest now in innovation, we

will start getting the fruits in a couple of decades," she said. The Minister is believed to have sounded out

Prime Minister Narendra Modi, who is said to have responded enthusiastically. "The Government

understands that our priorities need to change with the times. There are areas which do not require the

presence of the state but there are sectors which desperately need a state presence. Innovation and R&D is

one such area," Nirmala Sithara-man told BusinessLine. The R&D cess is collected under the Research and

Development Cess Act of 1986 (Act) and is payable by industrial concerns importing technology on or

before making any payment towards such imports.

NEED TO ADDRESS DRUG-RESISTANT TB CASES IN INDIA: UNION HEALTH SECRETARY


India accounts for nearly one-fourth of global incidence of tuberculosis and public health officials here are

working on finding a cure for drug-resistant tuberculosis, Union Health Secretary Luv Verma today said.

"India has the highest tuberculosis burden in the world, accounting for nearly one-fourth of the global

incidence. In 2012, out of the estimated global annual incidence of 8.7 million TB cases, 2 to 2.4 million

were estimated to have occurred in India," he said. Verma was addressing the ASSOCHAM Tuberculosis

Awareness, Prevention and Wellness Programme here. Under the national tuberculosis control programme

(RNTCP), treatment success rates have tripled from 25 per cent in pre-RNTCP era to 88 per cent upto 2012

and TB death rate has reduced from 29 per cent to 4 per cent during the same period. Inception of the

programme has examined more than 144 million TB suspects, also diagnosed more than 18 million TB

cases and saved more than 3.2 million lives.

CCI TO SCAN DRUG PATENT SETTLEMENTS

Mint, 4 August, 2014

The country's competition regulator may examine details of patent settlements being negotiated between

foreign branded medicine companies and local generic drug makers as these agreements may restrict the

access of cheaper drugs to the sick. The cases which the Competition Commission of India (CCI) is likely

to review include the patent deal between Swiss drug maker F Hoffmann-La Roche Ltd and Cipla Ltd on

lung cancer drug erlotinib, and the one between US-drug multinational Merck Sharp and Dohme Corp.

(MSD) and India's Glenmark Pharmaceuticals Ltd on a new diabetes drug called sitagliptin. The antitrust -

agency will also investigate the market impact of ex parte injunctions secured by Swiss drug firm No-vartis

AG and MSD against a dozen local drug makers, blocking them from launching copies of diabetes drugs

vild-agliptin and sitagliptin, according to two people familiar with the development who declined to be

named. CCI's decision to review these settlements follows increased regulatory scrutiny of patent

settlements between brand owners and generic companies in Western countries. Antitrust laws in those

markets are stringent and heavy penalties are being imposed on violators. To prevent generic drug makers

from getting regulatory approval for copies, branded medicine companies often pay generic firms to keep

their medicines off the market. Drug companies can generate billions of dollars as long as a drug is under

patent protection. Sales of those products fall sharply as soon as generic drug makers introduce copies of

the drug. While the settlements may benefit the drug companies involved, patients suffer as access to

cheaper medicine is restricted. In the latest instance of punitive action against drug makers that had entered

such agreements, the antitrust arm of the European Commission in July fined French drug maker Les

Laboratories Servier and five generic companies including the European subsidiaries of Lupin Ltd and

Unichem Laboratories Ltd a total of €425 million, alleging that a patent settlement among them delayed the

launch of a copy of hypertension drug perindopril.

MISUSE OF PHARMA DRUGS

Life 365, 3 August, 2014

Gannabis is easily available in India, Nepal and Bangladesh. Heroin is also available at cheaper rates, but

there are also pharmaceutical drugs which are very cheap in this region and is a serious problem," says

Cristina Albertine, the South . Asia representative of the United Nations Office on Drugs and Crime

(UNODC). Recalling one of her visits to a drug rehabilitation centre in Kolkata, Albertine said: "I had gone

to a Kolkata rehabilitation centre where all the clients were rickshaw pullers who injected heroin to cope up

with the life. "The drugs are very cheap in the region. As India is very close to Afghanistan and Myanmar,

heroin is very cheap. I guess that the regions close to productive sites get heroin at very cheap rates,"

Albertine said in the interaction at the UNODC India office here. According to Albertine, misuse of

pharmaceutical drugs poses a serious problem for India and South Asian countries because of their

availability at low prices. "You don't need too much financial security to be able to afford it," she said.

Codeine-based cough syrups, diazepam and proxyvon are some of the pharmaceutical drugs that are quite

popular among addicts. Yaba pills are very famous in countries like Bangladesh and Myanmar. She said

once hooked on to drugs, it is very difficult to kick the habit. "India, Nepal and Bangladesh cultivate

cannabis. Misuse of synthetic and pharmaceutical drugs is a big concern as they are produced by

pharmaceutical companies in India and Bangladesh," Albertine said. Talking about the sources and routes of

drugs, she said: "Opiate and heroin basically come from Afghanistan. Then it comes through Pakistan to

India." "You also have some influx from Myanmar into northeast (India). Then you have the synthetic drug

which comes from Southeast Asia and often through Myanmar and Bangladesh."

DRUGMAKERS REAP BENEFITS OF PRICING GAP

Business Standard, 4 August, 2014

Even as pharmaceutical companies are opposing the latest regulatory move to keep a check on inter-brand

price difference, market data show that in some cases the maximum retail price (MRP) of various brands of

the same medicine varies by as much as 1,700-1,800 per cent. That leaves a huge profit margin for drug

firms even after paying wholesalers and retailers. Data also depicts pricing parity is more significant

between brands sold by domestic manufacturers and those marketed by multinational firms. While most

multinationals attribute high prices of their products to better quality, standard procedures and efficacy,

industry experts and regulatory authorities say the difference in MRP is due to higher cost incurred in

marketing and promotion coupled with better profit margins. This is despite the fact that the ceiling price in

case of even regulated medicines provides for up to 16 and eight per cent extra margin for retailers and

wholesalers, respectively.

EBOLA OUTBREAK MOVING FASTER THAN EFFORTS TO CONTROL IT: WHO

Indian Express, 2 August, 2014

AN OUTBREAK of the deadly Ebola virus in West Africa is out of control but can be stopped with more

resources and tougher measures, World Health Organization chief Margaret Chan said Friday. The outbreak

is the worst since the disease was discovered in the mid-1970s, with 729 deaths in four different countries.

"This outbreak is moving faster than our efforts to control it," Chan told the presidents of Guinea, Liberia

and Sierra Leone at an emergency meeting in Guinea's capital Conakry. "If the situation continues to

deteriorate, the consequences can be catastrophic in terms of lost lives but also severe socio-economic

disruption and a high risk of spread to other countries," she said, according to a WHO transcript. But the

outbreak could be stopped and the public was not at high risk of infection, she said. Governments might

need to restrict population movements and public gatherings, and use the police and civil defence forces to

guarantee the security of response teams, she said. With healthcare systems struggling to cope, more than

60 medical workers have lost their lives, hampering efforts to tackle the disease.

CLINICAL TRIAL APPROVAL PROCESS MAY GO ONLINE


The Drug Controller General of India's (DCGI) office is planning to shift the process of approving clinical

trial applications online. Every trial would be accorded a unique identity number and pharmaceutical

companies, ethics committees, doctors or investigators conducting trials would be asked to regularly update

information in the online database, including patients' personal details, serious adverse effects that they may

suffer and compensation paid out to them by companies, according to a draft proposal firmed up by the drug

regulator earlier this week. This is in addition to other details, which the regulator may seek before

considering an application. The information around investiga-tional product such as the medical condition it

seeks to address, the profile of that disease in India, would have to be uploaded as well as the specifics of

the investigator or doctor conducting the trial such as his team, site and whether parts of clinical trials are

being conducted in other parts of the world.

US FDA TAKES STEPS TO HELP ENSURE RELIABILITY OF CERTAIN DIAGNOSTIC TESTS


The US Food and Drug Administration (US FDA) took important steps to ensure that certain tests used by

health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.

First, the FDA is issuing a final guidance on the development, review and approval or clearance of

companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by

treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting

appropriate therapies for individual patients. These tests are commonly used to detect certain types of gene-

based cancers. Second, consistent with the requirements of the Food and Drug Administration Safety and

Innovation Act of 2012 (FDASIA), the agency is notifying Congress of its intention to publish a proposed

risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured

and used within a single laboratory. They include some genetic tests and tests that are used by health care

professionals to guide medical treatment for their patients. The FDA already oversees direct-to-consumer

tests regardless of whether they are LDTs or traditional diagnostics. “Ensuring that doctors and patients

have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for

the FDA,” said FDA Commissioner Margaret A. Hamburg, M.D. “Inaccurate test results could cause

patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action

demonstrates the agency’s commitment to personalised medicine, which depends on accurate and reliable

tests to get the right treatment to the right patient.”

US FDA ISSUES DRAFT GUIDANCE FOR INDUSTRY ON CELL-BASED PRODUCTS FOR

ANIMAL USE


The US Food and Drug Administration (FDA) issued a draft Guidance for Industry describing the agency’s

current thinking on cell-based products for animal use that meet the definition of a new animal drug. The

draft guidance is directed at facilities and individuals manufacturing and marketing such products for

animal use. FDA is aware that many potential veterinary therapies may be produced using cell-based

products. Developers of such products for animal use have asked how the agency intends to regulate these

products. Cell-based products that meet the definition of a new animal drug are subject to the same statutory

and regulatory requirements as other new animal drugs. A cell-based product, including an animal stem

cell-based product, that is intended to diagnose, cure, mitigate, treat, or prevent disease in animals or is

intended to affect the structure or function of the animal generally meets the definition of a new animal

drug. To be legally marketed, a new animal drug requires an approved or conditionally approved new

animal drug application (NADA) or index listing.

PURUSHOTTAM BHAPKAR TO TAKE OVER AS NEW COMMISSIONER OF

MAHARASHTRA FDA


Director of municipal administration in Maharashtra, Purushottam Bhapkar will replace Mahesh Zagade as

the new Commissioner of Maharashtra Food and Drug Administration (FDA). Bhapkar is expected to

assume charge as FDA Commissioner in the afternoon today. According to sources, Zagade has not been

assigned any posting so far. Ever since he took over the charge as FDA Maharashtra Commissioner more

than three years back, Zagade spearheaded a massive crackdown on errant chemists operating without

pharmacists and dispensing medicines without proper prescriptions across the state. Taking action against

chemists for overcharging drugs like paracetamol brands in contravention to Drug Price Control Order

(DPCO) 2013 and NPPA policy was also lauded by the government and helped the government to recover

around rupees one crore. He started a drive against doctors illegally stocking antibiotics in bulk and played

a major role in detecting and taking strict action on internet pharmacy rackets since the start of the year.

Under his leadership, state FDA seized and prohibited illegal trade of addictive prescription drugs like anti-

depressants and sex boosters worth crore of rupees. The drugs were being illegally exported to Japan,

Western Europe and other countries, without prescriptions and valid licence. His work on the ban of

tobacco-related products was recognized by World Health Organization (WHO) for which he was given a

global award.

CLINICAL TRIAL APPROVAL PROCESS MAY GO ONLINE


The Drug Controller General of India's office is planning to shift the process of approving clinical trial

applications online. Every trial would be accorded a unique identity number and pharmaceutical companies,

ethics committees, doctors or investigators conducting trials would be asked to regularly update information

in the online database, including patients' personal details, serious adverse effects that they may suffer and

compensation paid out to them by companies, according to a draft proposal firmed up by the drug regulator

earlier this week. This is in addition to other details which the regulator may seek before considering an

application. The information around investigational product such as the medical condition it seeks to

address, the profile of that disease in India, would have to be uploaded. So also the specifics of the

investigator or doctor conducting the trial such as his team, site and whether parts of clinical trials are being

conducted in other parts of the world. The proposed comprehensive database would also contain

information about the targeted patient population, whether any high risk or vulnerable patients' groups such

as infants, children, women of childbearing potential, lactating women are participating in the trial. Also,

detailed disclosures may be sought not only on the composition of the ethics committee and how frequently

they meet but also the proceedings of their meeting may have to be uploaded once the trial begins,

according to the draft.

PRODUCT APPROVALS

US FDA APPROVES STRIVERDI RESPIMAT FOR COPD TREATMENTS


The US Food and Drug Administration (FDA) approved Striverdi Respimat (olodaterol) inhalation spray to

treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or

emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a

long period of time. COPD is a serious lung disease that makes breathing difficult and worsens over time.

Symptoms can include wheezing, cough, chest tightness, and shortness of breath. Cigarette smoking is the

leading cause of COPD. According to the National Heart, Lung, and Blood Institute, COPD is the third

leading cause of death in the United States. “The availability of this new long-term maintenance medication

provides an additional treatment options for the millions of Americans who suffer with COPD,” said Curtis

Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug

Evaluation and Research. Striverdi Respimat is a long-acting beta-adrenergic agonist (LABA) that helps the

muscles around the airways in the lungs stay relaxed to prevent symptoms. The safety and effectiveness of

Striverdi Respimat was evaluated in 3,104 people diagnosed with COPD. People who received Striverdi

Respimat showed improved lung function compared to placebo. The drug carries a boxed warning that

LABAs increase the risk of asthma-related death. The safety and effectiveness of Striverdi Respimat in

people with asthma has not been established and it is not approved to treat asthma. Striverdi Respimat

should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm).

US FDA APPROVES LABEL EXPANSION FOR GENZYME'S LUMIZYME TO TREAT POMPE

DISEASE


The US Food and Drug Administration (FDA) has approved a supplement to expand the indication for

Genzyme's Lumizyme (alglucosidase alfa). Lumizyme manufactured at the 4000L scale is now indicated

for all Pompe patients of any age or phenotype. The approval of this indication is now consistent with that

of the rest of the world, where alglucosidase alfa manufactured at the 4000L is the only scale available.

Previously, in the United States, Lumizyme had been approved only for patients with late onset Pompe

disease.

ROCHE’S AVASTIN RECEIVES EUROPEAN APPROVAL TO TREAT PLATINUM-

RESISTANT RECURRENT OVARIAN CANCER


The European Commission (EU) has approved the use of Roche's Avastin (bevacizumab) in combination

with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy as a treatment for women

with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy. The EU approval was

based on results of the phase III AURELIA study which involved women with recurrent, platinum-resistant

ovarian cancer who received either chemotherapy or Avastin in combination with chemotherapy. Results

showed that the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling

the median progression free survival (PFS) from 3.4 months to 6.7 months (HR=0.38, p<0.0001).

EU GRANTS CONDITIONAL MARKETING NOD TO PTC THERAPEUTICS' TRANSLARNA

FOR NMDMD TREATMENTS


The European Commission has granted conditional marketing authorization for PTC Therapeutics'

Translarna (ataluren), in the European Union (EU) for the treatment of nonsense mutation Duchenne

muscular dystrophy (nmDMD) in ambulatory patients aged five years and older. "We are delighted that

Translarna was approved for the treatment of nonsense mutation Duchenne muscular dystrophy. By

targeting the underlying cause of DMD, it has the potential to change the course of the disease. We are

moving rapidly to make this product available to patients in the EU as we continue our global efforts to

fulfill our vision of making Translarna available to all the boys it may benefit," stated Stuart W. Peltz,

Ph.D., CEO of PTC Therapeutics, Inc.

VERTEX PHARMA'S KALYDECO APPROVED IN EUROPE TO TREAT CF IN PEOPLE WITH

SPECIFIC NON-G551D GATING MUTATIONS


The European Commission has approved Vertex Pharmaceuticals' Kalydeco (ivacaftor) for people with

cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the cystic

fibrosis transmembrane conductance regulator (CFTR) gene. This approval follows the positive opinion

from the Committee for Medicinal Products for Human Use (CHMP) in June 2014. Kalydeco was first

approved in Europe in July 2012 for people with CF ages 6 and older who have the G551D mutation, which

is the most common gating mutation. The eight additional gating mutations included in approval are:

G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D. In Europe, approximately 250

people ages 6 and older have one of these non-G551D gating mutations. "Today's approval in people with

additional gating mutations marks another step toward our goal of helping more people with this disease,"

said Simon Bedson, senior vice president and international general manager at Vertex. "We are committed

to working closely with the appropriate national authorities to make Kalydeco available for these patients as

soon as possible." The approval is based on previously announced data from the first part of a Phase 3, two-

part, randomised, double-blind, placebo-controlled, cross-over study of 39 people with CF ages 6 and older

who have a non-G551D gating mutation. The first part of the study showed statistically significant

improvements in lung function (FEV1), sweat chloride, body mass index and CFQ-R scores. Data from the

second part of the study were presented at the European Cystic Fibrosis Society Conference in June 2014

and showed that these improvements were maintained through 24 weeks of treatment. The safety profile

was similar to prior Phase 3 studies of Kalydeco in people with the G551D mutation.

US FDA APPROVES JARDIANCE TABLETS FOR ADULTS WITH TYPE 2 DIABETES


Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company announced the US Food and

Drug Administration (FDA) approved Jardiance (empagliflozin) tablets as an adjunct to diet and exercise to

improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). Jardiance is not for

people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or

urine). Jardiance, a once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 (SGLT2)

inhibitor. Jardiance works by blocking the reabsorption of glucose in the kidney, increasing glucose

excretion and lowering blood glucose levels in adults with T2D who have elevated blood glucose levels.

Patients should not take Jardiance if they have severe kidney problems or are on dialysis, or if they are

allergic to empagliflozin or any ingredient in Jardiance. Jardiance can cause some people to have

dehydration (the loss of body water and salt), which may lead to a drop in blood pressure, and may cause

atients to feel dizzy or faint.

CLINICAL TRIALS

GSK, GENMAB REPORT POSITIVE INTERIM RESULT FOR PHASE III STUDY OF

OFATUMUMAB AS MAINTENANCE THERAPY FOR RELAPSED CLL


GlaxoSmithKline plc and Genmab announced that an Independent Data Monitoring Committee (IDMC)

interim analysis of a phase III study, PROLONG (OMB 112517), reached the predefined significance level

for efficacy (p=0.001). The interim analysis demonstrated that treatment with ofatumumab (Arzerra) met

the primary endpoint of improving progression free survival (PFS). The study evaluated ofatumumab

maintenance therapy versus no further treatment (observation) in patients with relapsed chronic

lymphocytic leukaemia (CLL) who responded to treatment at relapse. The IDMC did not identify any new

safety signals and will continue to monitor patients for safety until all study patients complete therapy.

Further analysis of the safety and efficacy data is underway and will be shared with regulators and the

scientific community in the coming months. “This interim result from the PROLONG study demonstrated

that maintenance therapy with ofatumumab lowered the risk of disease progression in patients who

responded to treatment at relapse. We look forward to sharing the results of the interim analysis with

regulatory agencies to evaluate the potential for future regulatory filings,” said Dr. Rafael Amado, Head of

Oncology R&D, GSK.

ROCK CREEK PHARMA SELECTS QUOTIENT CLINICAL FOR EARLY DEVELOPMENT OF

ITS LEAD MOLECULE, ANATABINE CITRATE


Rock Creek Pharmaceuticals, has initiated the development of its lead molecule, Anatabine Citrate, in

Europe; and that it has selected Quotient Clinical, The Translational Pharmaceutics Company, based in the

United Kingdom to run its early development programmes. The company expects to file a Clinical Trial

Application (CTA) by the end of the third quarter with the Medicines Healthcare products Regulatory

Agency (MHRA) seeking regulatory approval to initiate its clinical trials. Upon CTA approval, a safety and

tolerability study will be initiated to investigate escalating doses of Anatabine Citrate. At the same time,

Quotient Clinical will employ its RapidFACT (Rapid Formulation development And Clinical Testing)

service to identify the next generation of oral Anatabine Citrate formulations for progression into multiple

pivotal phase 2 proof of concept studies. Michael J. Mullan MBBS (MD) PhD, Rock Creek

Pharmaceutical's chairman and chief executive officer, said, "We are excited to be working with the

Quotient Clinical team who provide a unique blend of services that integrate formulation development, real

time GMP manufacturing and rapid clinical testing. These are exactly the resources and expertise our lead

compound needs to expedite the drug development process to prepare us for phase II clinical trials expected

to begin in 2015. "

CYTORI THERAPEUTICS WITHHOLDS ENROLLMENT IN ATHENA TRIALS


Cytori Therapeutics, a company developing cell therapies based on autologous adipose-derived regenerative

cells (ADRCs) to treat cardiovascular disease and other medical conditions, has placed enrollment in the

ATHENA and ATHENA II trials on clinical hold and therefore anticipates that it will not be possible to

complete enrollment of the ATHENA I trial prior to the end of 2014 as previously anticipated. The decision

to place the trials on hold was based on a safety review of reported cerebrovascular events. Symptoms

occurred in three patients, of which two patients’ symptoms fully resolved within a short period of time and

the third patient has had substantial resolution of symptoms. Such events had not been previously reported

in Cytori’s other cardiovascular trials and appear to be related in part to the medical co-morbidities in the

treated population and the complex nature of the procedures involved in the trial. The US ATHENA and

ATHENA II clinical trials are randomised, double-blind, placebo controlled studies designed to evaluate the

safety and feasibility of adipose-derived regenerative cells (ADRCs) in heart failure patients with ischemic

heart disease who are already receiving maximal therapy with no options for revasculariasation.

JENTADUETO TABLETS LABEL UPDATED TO INCLUDE NEW DATA ON BLOOD

GLUCOSE REDUCTIONS IN TREATMENT-NAIVE ADULTS WITH TYPE 2 DIABETES &

HIGH BASELINE A1C


The US Prescribing Information for Jentadueto (linagliptin and metformin hydrochloride) tablets now

includes clinical trial data that showed linagliptin co-administered with metformin provided statistically

significant decreases in blood glucose compared with linagliptin alone in treatment-naive adults with type 2

diabetes and high baseline A1C levels (A1C of > /=8.5 to < /=12.0 per cent). Boehringer Ingelheim

Pharmaceuticals, & Eli Lilly and Company announced that the data, based on results from a prospective 24-

week phase IV clinical trial, have been added to the "Clinical Studies" section of the Jentadueto US

Prescribing Information. "We are extremely pleased with the addition to the Jentadueto label. These data

support the use of Jentadueto as an initial type 2 diabetes treatment option in an important patient

population treatment-naive adults who have high baseline A1C levels," said Christophe Arbet-Engels, M.D.,

Ph.D., vice president, metabolic clinical development and medical affairs, BIPI. "In addition, these data

reinforce the use of Jentadueto, as an adjunct to diet and exercise, in helping adults with type 2 diabetes

improve glycemic control." The 24-week, randomised, double-blind study assessed the efficacy and safety

of linagliptin (5 mg per day) in combination with metformin (1500 to 2000 mg per day; n=159) vs.

linagliptin (5 mg per day; n=157) alone in treatment-naive adults with type 2 diabetes and high baseline

A1C (A1C of > /=8.5 to < /=12.0 per cent). The primary endpoint of the trial change from baseline in A1C

after 24 weeks demonstrated that initial therapy with the combination of linagliptin and metformin reduced

A1C levels from baseline by 2.9 per cent compared with 2.0 percent for linagliptin alone.

NEURALSTEM TREATS FINAL PATIENT IN PHASE II ALS STEM CELL TRIAL


Neuralstem, announced that the final patient was treated in its Phase II trial using NSI-566 spinal cord-

derived neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

The multicentre phase II trial treated 15 ambulatory patients in five different dosing cohorts. The first 12

patients received injections in the cervical region of the spinal cord only, where the stem cells could help

preserve breathing function, in escalating doses ranging from five injections of 200,000 cells per injection,

to 20 injections of 400,000 cells each. The final three patients in the trial received both cervical and lumbar

injections, for a total of 40 injections of 400,000 cells each, or a total of 16 million cells transplanted. In

contrast, the final three patients in the phase I trial received the maximum 15 injections of 100,000 cells

each, for a total of 1.5 million cells. The trial will continue until six months past the final surgery, at which

point the data will be evaluated. "We are all extremely pleased to have completed the transplantations in this

historic phase II trial," said principal investigator, Dr. Eva Feldman, MD, PhD, Director of the A. Alfred

Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of

Michigan Health System. "By early next year, we will have six-month follow up data on the last patients

who received what we believe will be the maximum safe tolerated-dose for this therapy. We look forward to

seeing what the data tell us about safety and efficacy of this approach. It is also worth noting that we will

have completed this Phase II trial within a year, roughly. I would like to thank Dr. Parag Patil, and my

collaborators at Emory, Drs. John Glass and Nick Boulis, and at Mass General, Drs. Merit Cudkowicz and

Larry Borges, for helping us reach this goal."

SOLIGENIX'S ANTHRAX VACCINE, VELOTHRAX DEMONSTRATES PROMISING RESULTS


Soligenix, Inc., a clinical stage biopharmaceutical company, announced results demonstrating the improved

immunogenicity and rapid action of its anthrax vaccine, VeloThrax. Previous studies had demonstrated that

VeloThrax also possesses enhanced thermostability, enabling distribution without cold chain requirements.

VeloThrax is the company's proprietary DNI (dominant negative inhibitor) anthrax rPA (recombinant

protective antigen) subunit protein vaccine. Recent developments in the VeloThrax formulation have

resulted in immune responses indicative of protection after no more than two administrations of the vaccine

in a shortened (less than one month) vaccination regimen, in an animal model. These results are indicative

of a vaccine that can be given to humans in an abbreviated regimen, compared to the current vaccination

that requires up to five administrations over a period of 18 months for full protective immunity in humans.

Next generation anthrax vaccines have been targeting a shortened vaccination schedule with fewer

vaccinations for both pre and post-exposure use. A rapidly acting form of VeloThrax has been developed by

combining Soligenix's proprietary vaccine thermostabilization platform technology, ThermoVax, and a

potent adjuvant compound to yield a vaccine that is stable to high temperatures and induces neutralizing

antibodies in an animal model. The enhanced DNI vaccine was formulated with a synthetic

immunostimulatory adjuvant that activates toll-like receptor 4 (TLR-4), a receptor that is important in

recognition of pathogens. The immune responses indicative of protective immunity were observed in fewer

doses than the vaccine that did not contain the additional immunostimulatory adjuvant. In mice, stimulation

of TLR-4 by the use of the synthetic adjuvant improved the outcome of vaccination by enhancing anthrax

toxin neutralizing antibodies after a single immunization. Antibodies that neutralize anthrax toxin are

critical for protective immunity. The enhanced vaccine was also stable at 40 degrees Celsius (104 degrees

Fahrenheit) for at least 3 months, indicating that the synthetic adjuvant component and the DNI antigen

component were both stabilized. Furthermore, even when VeloThrax was stored at 40 degrees Celsius for

up to 3 months prior to administration, there was no evident loss of the ability to induce antibodies that

neutralize anthrax toxin.

ISIS PHARMA BEGINS PHASE 3 STUDY OF ISIS-SMN RX IN INFANTS WITH SPINAL

MUSCULAR ATROPHY


Isis Pharmaceuticals, Inc. announced the initiation of a pivotal phase 3 study evaluating ISIS-SMNRx in

infants with spinal muscular atrophy (SMA), the most common genetic cause of infant mortality. Isis plans

to dose the first infant in this study within the next few weeks, at which time Isis will earn an $18 million

milestone payment from its development partner, Biogen Idec. The phase 3 study, ENDEAR, is the first of

several planned studies in a broad and comprehensive late-stage clinical development programme for ISIS-

SMNRx. Isis plans to initiate a second pivotal study in children with SMA later this year. "The successful

advancement of ISIS-SMNRx from a preclinical drug candidate to late-stage studies within just a few years

reflects the effectiveness of our strategic alliance with Biogen Idec and the benefit of working closely

together with combined expertise, and the support from the SMA community. As we continue development

of ISIS-SMNRx and initiate the two pivotal studies in infants and children with SMA, we are in the

planning stages for clinical studies in additional patient populations," said B. Lynne Parshall, chief

operating officer at Isis. "The clinical and preclinical data we have generated to date, including data in

multiple open-label clinical studies, across multiple measures with ISIS-SMNRx, support the initiation of

these studies, which fully assess the safety and efficacy benefits of this experimental treatment."

AFFIRIS PRESENTS PHASE I TRIAL DATA ON A FIRST-OF-ITS-KIND TREATMENT

PARKINSON'S DISEASE VACCINE


AFFiRiS AG, a company develops tailor-made drugs mainly as peptide-based vaccines, announced the

results of AFF008, a phase I clinical trial of PD01A, a vaccine against Parkinson´s disease. PD01A is the

first therapy against the protein alpha-synuclein, a promising Parkinson’s drug target, to enter clinical

testing. The Michael J. Fox Foundation for Parkinson’s Research (MJFF) supported the study with a $1.5

million grant, and presented at the press conference on the impact a disease-modifying therapy would have

for patients. The Foundation will support a follow-up study testing a boost vaccination, the next step toward

a phase II trial. "A treatment that could slow or stop Parkinson’s progression would be a game changer for

the five million worldwide living with this disease and the many more who will become at risk as our

population ages," said MJFF chief executive officer, Todd Sherer, PhD. "The AFF008 trial is one of the

most promising efforts toward that goal, and we’re proud to support this work of AFFiRiS AG.”

BIOTA PHARMA ANNOUNCES POSITIVE RESULTS FROM PHASE 2 IGLOO TRIAL OF

LANINAMIVIR OCTANOATE


Biota Pharmaceuticals, a biopharmaceutical company focused on the discovery and development of

products to prevent and treat serious and potentially life-threatening viral respiratory infectious diseases,

announced top-line data from a randomised, double-blind, placebo-controlled, parallel-arm phase 2 clinical

trial comparing the safety and efficacy of a 40 mg and 80 mg dose of laninamivir octanoate (LANI) to

placebo. The trial, referred to as IGLOO, enrolled 639 patients across 12 countries in the Northern and

Southern Hemisphere from June 2013 to April 2014. Of the 639 patients enrolled, 248, or 39 per cent, had

PCR confirmed influenza A or B virus and were included in the intent-to-treat efficacy analyses.

Approximately 75 per cent and 19 per cent of the influenza-confirmed patients were infected with influenza

A H1N1 2009 and H3N2, respectively, with 6 per cent being infected with influenza B. As compared to

placebo, neither the 40 mg or 80 mg cohort achieved a statistically significant reduction in the median time

to alleviation of influenza symptoms as measured by the Flu-iiQ patient-recorded outcome questionnaire

(p=0.248 and p=0.776, respectively), which was the primary endpoint of the study. The median time to

alleviation of influenza symptoms was 102.3 hours for the 40 mg cohort and 103.2 hours for the 80 mg

cohort, as compared to 104.1 hours for the placebo cohort. Patients in both the 40 mg (p < 0.001) and 80 mg

(p=0.070) cohorts demonstrated a statistically significant reduction in viral shedding on Day 3 of the study

compared to placebo as quantified by qRT-PCR. In addition, a statistically significant proportion of patients

in both the 40 mg (p=0.002) and 80 mg (p=0.020) cohorts were culture negative on Day 3 of the study as

compared to placebo. Influenza-infected patients in the 40 mg cohort also demonstrated a statistically

significant reduction in the incidence of secondary bacterial infections as compared to placebo (p=0.013).

The nature and extent of adverse events were similar in the three cohorts, with diarrhoea (3.1 per cent vs.

0.9 per cent), headache (1.4 per cent vs. 0.5 per cent), gastritis (1.4per cent vs. 0 per cent), urinary tract

infection (1.4 per cent vs. 0 per cent), and sinusitis (1.2 per cent vs. 0.9 per cent) being the most common

adverse events that occurred more frequently in the treatment cohorts as compared to placebo. The

incidence of serious adverse events was low and balanced across the three cohorts.

RESEARCH

EARLY TREATMENT BENEFITS INFANTS WITH SEVERE COMBINED

IMMUNODEFICIENCY: STUDY


Early transplantation of blood-forming stem cells is a highly effective treatment for infants with severe

combined immunodeficiency (SCID), a group of rare, life-threatening inheritedc, a study funded by the

National Institutes of Health suggests. Approximately three-quarters of SCID infants who received

transplants survived for at least five years. Infants who received transplants within the first 3.5 months of

life had the best outcomes. Researchers from the Primary Immune Deficiency Treatment Consortium

External Web Site Policy (PIDTC), funded by NIH’s National Institute of Allergy and Infectious Diseases

(NIAID), report their findings in the July 31 issue of the New England Journal of Medicine. SCID is caused

by defects in genes involved in the development and function of infection-fighting T and B cells. Infants

with SCID appear healthy at birth but are highly susceptible to infections. If untreated, SCID is fatal,

usually within the first year of life. Development of a newborn screening test has made it possible to detect

SCID before symptoms appear. The test was added to the US Department of Health and Human Services’

Recommended Uniform Screening Panel External Web Site Policy for newborns in 2010, but to date, only

21 states External Web Site Policy have implemented newborn screening for SCID. “The findings from this

study highlight the positive impact of treating SCID early in life,” said NIAID director Anthony S. Fauci,

M.D. “They also suggest that widespread use of newborn screening tests for SCID is warranted to ensure

that infants with this rare syndrome receive life-saving transplants.”

NIH AWARDS TWO NEW GRANTS TO EXPLORE UNDERSTANDING OF GENOMICS

RESEARCH IN AFRICA


Two grants totalling more than $300,000 will support studies on genomic literacy among Africans as it

relates to research conducted in Africa by African investigators. The three-year grants are part of the Human

Heredity and Health in Africa (H3Africa) programme, funded by the National Institutes of Health’s

Common Fund in partnership with Britain’s Wellcome Trust. One of the grants will support a research

project to understand cultural and language concepts of genomics in Nigeria. The goal is to develop a

participant consent form for a diabetes study that better relays genetic concepts in terms that people from

both rural and urban environments in Nigeria understand. The other grant will support a project to

determine Ethiopians’ understanding of gene-environment interactions, with a goal of also increasing

awareness about disease susceptibility. Both grants are part of the Ethical, Legal and Social Implications

(ELSI) component of H3Africa. The programme has disbursed approximately $78 million to date. “These

grants will help us begin to get a better sense of what people in two different African countries understand

about genomics concepts,” said H3Africa programme Director Ebony Madden, Ph.D., an epidemiologist in

the Division of Genomic Medicine at the National Human Genome Research Institute (NHGRI), part of

NIH. “We hope that what we learn from this work will lead to more effective informed consent discussions

with potential research participants and to new culturally appropriate educational strategies about

genomics.” The following groups have been awarded grants (pending available funds), Institute of Human

Virology, Nigeria, $162,000, Principal Investigator: Clement Adebayo Adebamowo, M.D., Sc.D. Dr.

Adebamowo and his colleagues will conduct interviews with community leaders and focus groups in rural

and urban populations to gauge how concepts on heritability and genomics are understood in local

languages.

STUDY SHOWS HERPES ZOSTER VACCINE REMAINS EFFECTIVE IN PROTECTING

OLDER ADULTS AGAINST SHINGLES AFTER CHEMOTHERAPY


Kaiser Permanente study found that the herpes zoster vaccine continues to be effective in protecting older

adults against shingles, even after they undergo chemotherapy. The study was published in the journal

Clinical Infectious Diseases. Researchers examined the electronic health records of more than 21,000

Kaiser Permanente patients in Southern California who were 60 years of age and older and received

chemotherapy between January 2007 and December 2012. Researchers found that those patients who were

previously vaccinated with zoster vaccine were 42 per cent less likely to develop shingles following

chemotherapy. In addition, no vaccinated patients underwent hospitalization for shingles, while six

unvaccinated patients were hospitalized with the disease, according to the study. "The zoster vaccine has

been shown to be safe and effective in elderly adults with healthy immune systems but until now, there has

been a lack of data on whether the vaccine remains safe and effective for individuals who might have

compromised immune systems resulting from treatments like chemotherapy," said study lead author Hung

Fu Tseng, PhD, MPH, of the Kaiser Permanente Southern California Department of Research & Evaluation.

"Our study demonstrates that older patients who had previously been vaccinated against shingles have a

lower chance of developing this painful and often debilitating disease after chemotherapy." Shingles is

caused by the varicella zoster virus and can affect anyone who has had chickenpox. Symptoms of shingles

include a painful rash and blisters that develop on one side of the face or body as well as fever, headache

and chills. According to the Centers for Disease Control and Prevention, before the zoster vaccine was

available, almost one out of every three people in the United States would develop shingles at some point in

their lifetime, which translated into more than 1 million cases of shingles expected each year in the US.

FIRST MALARIA VACCINE MAY BE READY NEXT YEAR


The world's first malaria vaccine will be available in the market by next year. Pharma company GSK has

submitted a regulatory application to the European Medicines Agency (EMA)forits malaria

vaccinecandidate,RTS,S. It will be exclusively for use against the Plas-modium falciparum malaria parasite,

which is most prevalent in sub-Saharan Africa (SSA). Around 90% of estimated deaths from malaria occur

in SSA, and 77 % of these are children under the age of 5. Data from the phase IE vaccine trial programme

conducted at 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya,

Malawi, Mozambique, Nigeria, and Tanzania) including over 16,000 infants and young children have also

been included to support the filing. Results from a large-scale Phase HI trial showed that over 18 months of

follow-up, children aged 5-17 months at first vaccination with RTS.S experienced 46% fewer cases of

clinical malaria, compared to children immunized with a control vaccine. An average of 941 cases of

clinical malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated in this age

group. Severe malaria cases were reduced by 36%; 21 cases of severe malaria were prevented over 18

months of follow-up for every 1,000 children vaccinated. Malaria hospitalizations were reduced by 42 %.

Trials showed that the vaccine effectively protected young children and infants from clinical malaria up to

18 months after vaccination.

NEW TECHNIQUE TO REGENERATE INSULIN IN TYPE-1 DIABETICS

Deccan Herald, 2 August, 2014

Scientists at Sanford-Burnham Medical Research Institute (Sanford-Burnham) have revealed that they have

found a promising way for type 1 diabetics to restore the body's ability to produce insulin. The researchers

have found that a peptide called caerulein can convert existing cells in the pancreas into those cells

destroyed in type 1 diabetes-insulin-producing beta cells. Fred Levine, of the Sanford Children's Health

Research Center at Sanford-Burnham, said that they were able to generate new beta cells, the cells that

produce insulin, by introducing caerulein to the pancreas and have potentially freed patients from daily

doses of insulin to manage their blood-sugar levels. The study first examined how mice in which almost all

beta cells were destroyed—similar to humans with type 1 diabetes—responded to injections of caerulein. In

those mice, but not in normal mice, they found that caerulein caused existing alpha cells in the pancreas to

differentiate into insulin-producing beta cells. Alpha cells and beta cells are both endocrine cells meaning

they synthesize and secret hormones—and they exist right next to one another in the pancreas in structures

called islets. However, alpha cells do not normally become beta cells.

MORE PEOPLE GROWING RESISTANT TO ANTIBIOTICS A CAUSE FOR CONCERN

DNA, 3 August, 2014

The rampant use of antibiotics for the last 10 years by doctors as well as due to over-the-counter sales, has

led to a serious health care crisis across the country According to health experts, treating gram-negative

infections — which affects hospitalised patients mostly — is getting difficult because the category of

bacteria is evolving and becoming more immune to existing antibiotics. The bacteria, classified as gram-

negative because of their reaction to the so-called gram stain test, can cause severe pneumonia and

infections of the urinary tract, bloodstream and other parts of the body. Their cell structure makes them

more difficult to attack with antibiotics than gram-positive organisms, like MRSA. Dr Om Shrivastava,

infectious disease expert at Jaslok Hospital, said, "Presently, the gram-negative infections are the biggest

concern when it comes to antibiotic resistance problem. This not only leads to prolonged hospital stay but

also leads to treatment cost going up, along with recurrent hospital stay" It is a known fact that doctors often

prescribe broad spectrum antibiotics to patients as they have to act quickly on imperfect information. These

methods put selective pressure on microbes to evolve resistance to antibiotics. In the recent past, data has

revealed a six-fold increase in the number of antibiotics being popped by Indians. Last April, the World

Health Organization (WHO), in its first global report on antibiotic resistance, said it is a serious and

worldwide threat to public health. Even the US's Centre for Disease Control and Prevention ranked

resistance to antibiot-ics in these categories: urgent, serious, and concerning. To stop the rampant use of

antibiotics by doctors, Indian Medical Association, the umbrella body of doctors practising allopathy, has

started a campaign on rational use of antibiotics under which it is going to educate its own doctors. It is

found that many doctors don't justifiably prescribe antibiotics, which has led to people developing

resistance to antibiotics.

ISA NATIONAL SURVEY SEES BENGALURU TOPPING WITH OVER 60 PER CENT

AWARENESS ON STROKE


The Indian Stroke Association (ISA) research survey conducted by IPSOS, a leading market research

agency, reveals that Bengaluru reported to have the highest levels of awareness of 60 per cent on stroke.

This was attributed to the right education on the causes, symptoms and the immediate treatment required for

stroke. Almost 68 per cent of people in the city were aware about the fact that a stroke could occur without

pain and often go undiagnosed. The survey was conducted across men and women aged between 25-50

years from the city. It mainly captured the respondents’ awareness & understanding of the term “Stroke”, its

symptoms, perceived causes, the prevailing knowledge about treatment options and their experiences with

stroke sufferers. The primary symptoms of a stroke are sudden onset of facial weakness, arm drift and

abnormal speech. According to a World Stroke Association survey in 2011, only 6.2 per cent of people

recognised stroke symptoms. The citizens in the city were aware of the stroke symptoms. They knew about

the immediate measures to be taken when a person suffered from a stroke. Rushing to the nearest hospital is

the measure that 86 per cent of the respondents suggest, however not many knew about the Stroke

Excellence Centres that are operational across hospitals in Bengaluru. “Based on IPSOS survey, 68 per cent

associated stroke with the brain, followed by Kolkata, Chennai and Mumbai. Hyderabad and Delhi had the

lowest levels of awareness.

NEW WEARABLE VAPOUR SENSOR FOR DISEASE MONITORING


Researchers, including one of Indian-origin, are developing a new wearable vapour sensor that could offer

continuous disease monitoring for patients with diabetes, high blood pressure, anemia or lung disease. The

new sensor, being developed at the University of Michigan, can detect airborne chemicals either exhaled or

released through the skin. It would likely be the first wearable to pick up a broad array of chemical, rather

than physical, attributes, researchers said. "Each of the diseases has its own biomarkers that the device

would be able to sense. For diabetes, acetone is a marker, for example," said Sherman Fan, a professor of

biomedical engineering. Other chemicals it could detect include nitric oxide and oxygen, abnormal levels of

which can point to conditions such as high blood pressure, anemia or lung disease. Fan is developing the

sensor with Zhaohui Zhong, an associate professor of electrical and computer engineering, and Girish

Kulkarni, a doctoral candidate in electrical engineering. The researchers said their device is faster, smaller

and more reliable than its counterparts, which today are much too big to be wearable. Beyond disease

monitoring, the sensor has other applications. It would be able to register the presence of hazardous

chemical leaks in a lab, or elsewhere, or provide data about air quality.

LOW LEVELS OF VITAMIN D CAN DOUBLE DEMENTIA RISK


Low levels of vitamin D in elderly people can double the risk of developing dementia and Alzheimer's,

according to a largest study of its kind. An international team, led by Dr David Llewellyn at the University

of Exeter Medical School, found that study participants who were severely Vitamin D deficient were more

than twice as likely to develop dementia and Alzheimer's disease. The researchers studied elderly

Americans who took part in the Cardiovascular Health Study. They discovered that adults who were

moderately deficient in vitamin D had a 53 per cent increased risk of developing dementia of any kind, and

the risk increased to 125 per cent in those who were severely deficient. Similar results were recorded for

Alzheimer's disease, with the moderately deficient group 69 per cent more likely to develop this type of

dementia, jumping to a 122 per cent increased risk for those severely deficient. The study looked at 1,658

adults aged 65 and over, who were able to walk unaided and were free from dementia, cardiovascular

disease and stroke at the start of the study. The participants were then followed for six years to investigate

who went on to develop Alzheimer's disease and other forms of dementia. "We expected to find an

association between low Vitamin D levels and the risk of dementia and Alzheimer's disease, but the results

were surprising - we actually found that the association was twice as strong as we anticipated," Llewellyn

said.

NEW GENE THAT INCREASES RISK OF BREAST CANCER IDENTIFIED


Women with mutations in a certain gene have on average a 35 per cent chance of developing breast cancer

by the age of 70, scientists have found. A team of researchers from 17 centres in eight countries led by the

University of Cambridge analysed data from 154 families without BRCA1 or BRCA2 mutations, which

included 362 family members with PALB2 gene mutations. Women who carried rare mutations in PALB2

were found to have on average a one in three chance of developing breast cancer by the age of 70. However,

the risks were highly dependent on family history of breast cancer where carriers with more relatives

affected by breast cancer, were at higher risk. Only a very small proportion of women worldwide carry such

mutations and the researchers pointed out that additional studies are required to obtain precise estimates of

mutation carrier frequency in the population. PALB2 is known to interact with both the BRCA1 and

BRCA2 and was first linked with breast cancer in 2007. As is the case for women who carry mutations in

BRCA1 or BRCA2, women with PALB2 mutations who were born more recently tended to be at a higher

risk of developing breast cancer than those born earlier. The reason why is unclear, but the researchers

speculated that it may be related to factors such as later age at first childbirth, smaller families and better

surveillance leading to earlier age of diagnosis.

DEPRESSION INCREASES DEMENTIA RISK


The secret of preventing memory loss in old age may lie in treating depression and causes of stress early as

researchers have confirmed that depression indeed increases the risk of dementia. Having a higher level of

depression symptoms was associated with a more rapid decline in thinking and memory skills, the findings

showed. "These findings are exciting because they suggest depression truly is a risk factor for dementia,"

said Robert Wilson from Rush University Medical Centre in the US. "If we can target and prevent or treat

depression and causes of stress we may have the potential to help people maintain their thinking and

memory abilities into old age," Wilson explained. The study involved 1,764 people with an average age of

77 who had no thinking or memory problems at the start of the study. Participants were screened every year

for symptoms of depression, such as loneliness and lack of appetite, and took tests on their thinking and

memory skills for an average of eight years. During the study, 922 people, or 52 percent of the participants,

developed mild cognitive impairment (MCI) and a total of 315 people, or 18 percent, developed dementia.

People who developed mild cognitive impairment and dementia were more likely to have a higher level of

symptoms of depression before they were diagnosed.

VEGGIES EVERY DAY KEEP HEART DISEASE AT BAY Financial Chronicle, 8 August, 2014

TODAY, I am writing about heart disease and how it is controllable and reversible; with just a healthy diet.

Dr Caldwell Esselstyn Jr, author of Prevent and Reverse Heart Disease, is one of the most major proponents

of how diets can reverse and prevent heart diseases. Coronary artery heart disease is a leading killer across

the world. Experts agree that the primary cause is food borne. At this point, the logic of present day

treatment fails. For, doctors treat people with heart diseases by the use of a pill that compromises normal

liver function. Or, they mechanically pry open and bypass blocked arteries. But what they don't do is treat

the disease causation. Plant-based nutrition provides us with a pathway to escape the coronary artery

disease epidemic. Caldwell says that even today in the Papua highlands, rural China, central Africa and for

the Tarahumara Indians of northern Mexico, coronary artery heart disease is virtually non-, existent. That's

because these cultures thrive on plant-based nutrition. However, when they are exposed to the western diet

of oil, meat and dairy, they promptly develop western illnesses like heart diseases, cancer, diabetes, obesity

and hypertension. Why not simply stop eating animal foods that cause such deadly diseases? The

mechanical approaches of stents and bypass surgery may be lifesaving in the middle of a heart attack, but in

the majority of elective cases, they are merely a stop-gap patch job. They are fraught with significant

mortality, and morbidity through complications such as heart attacks, strokes, bleeding, infections, and can

have side effects such as kidney injuries, loss of memory, decreased cognition, and depression.

MAJOR DRUG BREAKTHROUGH ACHIEVED FOR ALZHEIMER'S The Free Press Journal, 8 August, 2014

taken a major step forward, as new drug compound has been found that turns the cognitive discrepancies of

the disease. Researchers from Yale School of Medicine have identified the compound TC-2153, which

inhibits the negative effects of a protein called STriatal-Enriched tyrosine Phos-phatase (STEP), which is

key to regulating learning and memory. The protein, STriatal-Enriched protein tyrosine Phosphatase, or

STEP, is present in the brain. Those with Alzheimer's disease have elevated levels of STEP in their brains.

Lead author Paul Lombroso and the co-authors studied thousands of small molecules in mice, searching for

those that would inhibit STEP activity and found a reversal of deficits in several cognitive exercises that

gauged the animals' ability to remember previously seen objects. Lombroso said that the small molecule

inhibitor was the result of a five-year collaborative effort to search for STEP inhibitors. A single dose of the

drug resulted in improved cognitive function in mice. Animals treated with TC compound were

indistinguishable from a control group in several cognitive tasks. Yale researchers are duplicating the

research to see if they get the same results with rats and non-human primates. The hope is that they will one

day come up with a drug that could be used to help treat people with Alzheimer's disease, according to

vnews.com.

NEW AND GENERIC DRUG APPROVALS

US FDA

Drug Name Strength Dosage Form /

Route

Marketing

Status

Company

Miralax 17gm/Scoopful For Solution;Oral Over-The-

Counter

Schering

Plough

Myfortic 180mg; 360mg Tablet, Delayed

Release;Oral

Prescription Novartis

Ketorolac

Tromethamine

15mg/Ml; 30mg/Ml Injectable;Injection Prescription Agila Speclts

Sirturo Eq 100mg Base Tablet;Oral Prescription Janssen Therap

Loestrin Fe

1.5/30

0.03mg; 1.5mg Tablet;Oral-28 Discontinued Warner

Chilcott Llc

Zosyn Eq 2gm Base/Vial; Eq

250mg Base/Vial;

Eq 3gm Base/Vial; Eq

375mg Base/Vial;


500mg Base/Vial;


4.5gm Base/Vial

Injectable;Injection Prescription Wyeth Pharms

Inc

Vincristine

Sulfate Pfs

1mg/Ml Injectable;Injection Prescription Hospira

Bimatoprost 0.01% Solution; Ophthalmic None (Tentative

Approval)

Sandoz Inc

Tenofovir

Disoproxil

Fumarate

300mg Tablet;Oral None (Tentative

Approval)

Macleods

Pharma

Phentermine

Hydrochloride

37.5mg Tablet;Oral Prescription Aurolife

Pharma Llc

Fludeoxyglucos

e F18

20-300mci/Ml Injectable;Injection Prescription Univ Iowa

Hosps

Orbactiv 1200 Mg. Powder, For Injection

Solution, Lyophilized

Powder

Prescription Medicines Co

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