may 31 corporate glenmark opens new manufacturing …€¦ · glenmark opens new manufacturing...

May 31 – June 7, 2014

CORPORATE

GLENMARK OPENS NEW MANUFACTURING FACILITY IN SWITZERLAND

Economic Times, 4 June, 2014

DELHI: Glenmark Pharmaceuticals today opened a new manufacturing facility in Switzerland for supply of

clinical trial material. Glenmark Pharmaceuticals S.A (GPSA), a wholly-owned subsidiary of the company

has opened its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de- Fonds,

Switzerland, Glenmark Pharma said in a statement. "This manufacturing facility supplements Glenmark's

existing in-house discovery and development capabilities and will supply material for clinical

development," it added. Glenmark Pharma Biologics-President Michael Buschle said: "We have been doing

cutting edge work in the area of novel monoclonal antibodies and have several monoclonal antibody

candidates & bispecific antibodies in the pipeline. The manufacturing facility would help us bring these

antibodies to the clinic faster..." An antibody is a protein produced by plasma cells that is used by the body's

immune system to identify and neutralise foreign particles such as bacteria and viruses. The focus for the

biologics R&D centre is to develop novel biologic entities for the treatment of pain, oncologic,

inflammatory and respiratory conditions, Glenmark Pharma said. Since its inception around 10 years back,

Glenmark's biologics research centre has filed several patents on novel biologic entities, it added. "GBR

500, its most advanced candidate has been licensed to Sanofi and is currently in Phase II development.

GBR 900, a first-in-class molecule for treatment of chronic pain is currently in Phase I and GBR 830, an

anti OX-40 antagonist, is scheduled to enter the clinic later this year," it said. The Glenmark Pharma scrip

was trading at Rs 539.90, down 0.03 per cent, on the BSE in the afternoon.

SUN PHARMA IN $400 M DEAL TO SUPPLY GENERICS AT DISCOUNT DNA, 31 May, 2014

Pharma major Sun Pharmaceutical Industries said it would supply generics at discounted costs to a third

party for an upfront $400 million in order to manage its cash flow and debt better. Sun Pharma founder and

managing director Dilip Shanghvi, in an earnings call, said, "We did this deal to manage our cash flow and

debt in a better manner. The $400 million comes to us offhand but this has nothing to do with our fiscal

2015 guidance." Shanghvi said the deal may see a drop in the topline. Margins will not be impacted, he

said. Under a settlement of a patent dispute case with Pfizer in the US last year over the latter's acid reflex

brand Pro-tonix, Sun had agreed to pay the multinational $550 million. According to analysts, though Sun

had made its provisions, the $400 million will help it to improve cash flow. "Sun will get $400 million

offhand for its supply of possibly a mixed portfolio of generics to the third party at discounted rates. This

will help in managing its cash flow and debt," said pharma analyst Bino Pathiparampil of IIFL. "The

contract is possibly for mixed generics as we do not see a point in selling generic version of Protonix to a

customer since it is unlikely to be launched in the US market anytime soon," said a pharma analyst.

Shanghvi also expressed concern over reduction in price negotiating ability in the US market. "Around 80

% business will be consolidated among 3-4 customers. It will reduce our negotiating capabilities."

DCGI SUSPENDS RANBAXY'S SUPPLY The Asian Age, 31 May, 2014

In a major development, the Drugs Controller General of India (DCGI) has suspended supplies from one of

Ranbaxy's manufacturing units to the European Union (EU). The DCGI inspects domestic manufacturing

facilities supplying to the European Union (EU), on behalf of its regulator. Based on the inspection of

Ranbaxy's Toansa plant in Punjab, the DCGI recently.suspended Ranbaxy from exporting pharmaceutical

products to European countries. "Due to the suspension of written confirmation to EU from Toansa plant,

ranbaxy cannot export to EU till they comply with the set standards," said a senior official in the health

ministry. Earlier, the the US FDA had put restriction on manufacturing and distributing pharmaceutical

ingredients after flaws were found at their drug manufacturing unit, after which the Indian drug regulators

woke up to review the ranbaxy plant. The Drug DCGI had asked for lifting samples of ranbaxy drugs for

independent testing.. While most of the samples have been found be found to be fit in its other facilities

which are under scrutiny. , "Non compliance was found in the Toansa plant after which its license of export

to EU was terminated," added the official.

EMA FINDS RANBAXY'S MANUFACTURING SITE IN TOANSA NO RISK TO PUBLIC

HEALTH

Pharmabiz, 6 June, 2014

European regulatory authorities have finalised their assessment of reported non-compliance with Good

Manufacturing Practice (GMP) at Ranbaxy Laboratories’ manufacturing site in Toansa, India that had led to

the suspension of the GMP certificate for the site in the European Union (EU). Although the assessment

showed that there were a number of GMP deficiencies at the concerned site, assessment of all available

information has reassured European regulators that there has been no risk to public health from these

deficiencies. Patients should continue to take their medicines as prescribed by their healthcare professional.

European regulators also considered the corrective measures put in place by the company and were satisfied

that the measures are sufficient to ensure GMP-compliant manufacture of products at the site. As a

consequence, the EU authorities will reinstate the GMP certificate which was suspended in January 2014.

The certificate will be re-entered into EudraGMDP, the EU database that contains GMP certificates. The

assessment followed an inspection by the US Food and Drug Administration (US FDA) which revealed

areas of non-compliance with GMP at the site. The European medicines regulatory network responded

quickly to the FDA’s findings, and sent a team of inspectors from Germany, Ireland and the UK, who were

joined by inspectors from Switzerland and Australia to undertake an unannounced international inspection

of the site. The GMP inspection concluded that appropriate corrective and preventive measures have been

put in place by the manufacturer.

CHRYSCAPITAL TO SELL 10% IN DRUG MAKER INTAS PHARMACEUTICALS TO

TEMASEK FOR OVER $160 MILLION


In what would be one of the most profitable recent exits in Indian private equity, ChrysCapital is selling its

stake in drug maker Intas Pharmaceuticals at nearly 20-fold returns. According to sources, Temasek has

emerged as frontrunner to pick up the stake valuing the Ahmedabad-based company at Rs 8,800 crore.

Others, such as Capital International and Goldman Sachs, were also in the fray for the deal finally clinched

by the Singapore sovereign wealth fund, which is expected to pick up over 10% stake in the company. The

deal size has been pegged at about $160-170 million, or Rs 950-100 crore. The transaction comes at a time

when PE industry is struggling with exits due to factors like a tepid IPO market and depreciating currency.

"It's a significant and great news for PE Industry, given emergence of secondary deals as a viable exit route

and the exit value," said Raja Lahiri, partner for transaction advisory services at Grant Thornton. The deal is

now awaiting clearance from Foreign Investment Promotion Board, the nodal body on clearing foreign

direct investments in India. Jayesh Shah, CFO at Intas Pharmaceuticals, confirmed talks with Temasek but

declined to comment on transaction details. "I cannot comment on valuation right now as the deal is not yet

signed. But we have filed with FIPB, and the process is going on," he said.

SUN MAY SHINE ON HEALTHY MARGIN, VALUATION MAKES CIPLA ATTRACTIVE Economic Times, 3 June, 2014

Drugmakers Sun Pharmaand Cipla have reported contrasting performance in the quarter to March. Sun

Pharma's rich profitability with an operating margin of 44 %, was its high point during the three months

while its topline growth of 32 % compared with the year-ago period was a tad disappointing. The

company's US sales grew 22 % in dollar terms, but its non-US international sales remained flat. Its unit

Taro's sales grew 13 %, lagging the growth rate posted by its US business. The company maintained its

edge in the domestic business though, with revenues growing strongly at 21%, faster than the industry

average. In the current fiscal, the company has targeted to file 25 ANDAs (abbreviated new drug

applications) in the USandhasguided for a conservative revenue growth of 13-15% that does not include

Ranbaxy's consolidation. On the other hand, Cipla's profitability continued to be afflicted by low-margin

antiretro-viral business and high staff costs and over-heads for the second consecutive quarter. While the

consolidated revenues grew at 27 %, driven by growth in export sales, the operating profit dropped 4% and

operating margin contracted 5.3 percentage points to 16.8%. The sales from the domestic business,

contributing 40 % of the revenues, grew strongly at 19 %, higher than the industry growth. Cipla has

increased its market share from 4.7% to 5.3% in the domestic market. Its management has guided for a

growth of 15 % in revenues and operating margin of 21% for the current fiscal. The second half of the fiscal

is likely to be better than the first due to the proposed launch of combination inhalers in Europe.

BIOCON ARM, BRISTOL-MYERS SQUIBB EXTEND DRUG DISCOVERY PARTNER Financial Express, 4 June, 2014

Syn-gene, the contract research arm of India's largest biotechnology firm Biocon, on Tuesday said its drug

discovery and development collaboration with US pharma company Bristol-Myers Squibb has been

extended by five years. The two firms had entered into a collaboration in 2007 with Syngene setting up the

Biocon Bristol-Myers Squibb Research Center (BBRC) that houses 500 scientists in Bangalore. The firms

did not reveal financial terms of the contract extension. So far, the collaboration has produced six drug

candidates for further study besides helping Bristol-Myers Squibb reduce the time and costs associated with

advancing new compounds to first-in-human studies, said a release from Biocon. "One drug candidate

currently in clinical trials was discovered at BBRC and early non-clinical development work done at BBRC

has enabled most of Bristol-Myers Squibb's small molecule assets to advance to later stages of development

over the last five years," it said. The Bangalore centre, currently Bristol-Myers Squibb's largest research and

development centre outside the US, is aimed at developing integrated capabilities in process chemistry,

biology, biotechnology, bio-markers, drug metabolism and pharmacokinetics, analytical research, and

pharmaceutical development. "We are delighted to extend our discovery and development partnership with

Bristol-Myers Squibb for another five years. This extension reflects the strength of our existing

collaboration which has delivered many successful outcomes," said Peter Bains, director, Syngene

International. "BBRC has supported the non-clinical development of a large proportion of our small-

molecule portfolio assets since its inception, and is a premier example of the high-quality innovative drug

hunting that is taking place in India today," said Francis Cuss, executive vice president and chief scientific

officer, Bristol-Myers Squibb.

ANOTHER US FIRM EYES INDIA BUY Business Standard, 4 June, 2014

US-based drug maker Amneal Pharmaceuticals LLC, headed by Chintu Patel and Chirag Patel, may be the

latest among multinationals eyeing India for expanding its manufacturing footprint. The company, it is

learnt, is in advanced talks to buy Hyderabad-based oncology products manufacturer Epsilon

Pharmaceuticals. According to an industry source, the deal is also likely to include sale of a manufacturing

facility that received approvals of the US Food and Drug Administration (US FDA). The transaction could

be valued at Rs.80-100 crore, he said. A detailed questionnaire e-mailed to Amneal Pharmaceuticals did not

elicit any response. Phone calls made to Epsilon's Hyderabad office remained unanswered. According to

Epsilon's website, the company is mainly engaged in manufacturing sterile injectibles for treatment of

cancer. Incorporated in November 1998, Epsilon Pharmaceuticals has a facility spanning over 20,000

square metres in Jedcherla special economic zone near Hyderabad. Exclusive for multi-product sterile

dosage form manufacturing, the facility has a capacity to make up to 5 million lyophilised vials and up to

10 million liquid filled sterile vials, it said. For Amneal, the buyout may make sense as it already has

presence in the generic drug manufacturing space. Moreover, oncology injectibles is seen as a high-growth

segment, which also allows higher margins compared with conventional generic products. Global injectible

market is pegged at over §15 billion. Recently, Mylan, another American generic drug maker, acquired

Strides Arco-lab's injectible manufacturing subsidiary, Agila Specialities in a $1.8-billion deal. Others such

as Hospira have also expanded their presence in the injectible manufacturing space in India. However,

Amneal Pharma already had presence in India through its R&D (research and development) facility in

Bavla near Ahmedabad. Amneal develops over a dozen generic products from this centre annually across all

dosage forms, all of which are to be filed from its US facilities. Industry officials say if the two companies

seal the deal, they may also need clearance from the Foreign Investment and Promotion Board.

FDA FINDS FLAWS AT WOCKHARDT'S US PLANT Mint, 4 June, 2014

Wockhardt Ltd, the gener-ics drug maker that has faced quality issues at two of its Indian plants, was cited

by the Food and Drug Administration (FDA) for testing lapses at a factory in Illinois. The FDA issued a

Form 483 listing possible violations of the Food Drug and Cosmetic Act after inspecting Wockhardt's drug

making facility in Morton Grove, Illinois, over seventeen days between January and March, according to a

document on the agency's website. Two of the Mumbai-based drug maker's local facilities are already

banned from exporting to the US after inspections where the FDA reported similar violations. If Wockhardt

fails to address the problems, the latest observations could hurt the company's supply to its biggest market.

The facility generated more than half of Wockhardt's US sales last quarter. Wockhardt's US business

dropped 26% in the year ended March 2014 following the import restriction on the two other factories. The

contribution from US sales dropped to 45% of total revenue from 51% the year before. The Form 483,

issued on 26 March and containing 12 observations, said the plant's quality unit doesn't have documented

procedures and some systems weren't followed. The Wockhardt factory in Illinois is the latest Indian facility

to come under FDA scrutiny. Four factories from India's Ranbaxy Laboratories Ltd are banned from selling

to the US and the FDA this year put import restrictions on a Sun Pharmaceutical Industries Ltd plant.

IPCA, ONCOBIOLOGICS IN PACT FOR BIOSIMILARS Mint, 3 June, 2014

Mumbai-based drug maker Ipca Laboratories Ltd has said on Monday that it has entered into an alliance

with Oncobiologics Inc., a US-based biological drug researcher, for the development, manufacture and

commercialization of biosimilar monoclonal antibody products. The biologies covered under this alliance

are among the most popular therapies in the world for immunology and cancer indications, c.h.

unnikrishnan

STRONG US SHOWING AIDS AUROBINDO'S EARNINGS Business Standard, 3 June, 2014

Expectations of a good performance and the Aurobindo Pharma stock's 28 per cent rise through the last

three months weren't unjustified, with the company posting better-than-expected results for the quarter

ended March. Largely led by its performance in the US, Aurobindo posted 48.4 per cent year-on-year

growth in consolidated revenue at Rs.2,330 crore; the company's net profit more-than-tripled to Rs.502

crore. Sale of US formulations rose 129 per cent, owing to strong sales of anti-depressant Cymbalta.

Increased sales of high-margin drugs such as Cymbalta helped Aurobindo post its highest ever earnings

before interest, tax, depreciation and amortisation margin of 31.9 per cent. What aided the company's

performance in the US market was gain in market share for key products. Bank of America Merrill Lynch

(BoAML) analysts estimate the company's market share in the US generics market increased from 1.6 per

cent in FY11 to four per cent in March 2014. The market share for Cymbalta, a drug with a market size of

§5 billion, launched about six months ago, is pegged at about 25 per cent. These gains have helped

Aurobindo more-than-triple its US revenue from §56 million in the first quarter of FY12 to $186 million in

the March quarter 2014. Analysts expect the company to sustain sales in the US due to its product pipeline

of injectables, antibiotics and controlled substances. BoAML analysts believe the pipeline will ensure 20

per cent annual revenue growth during FY14-16, in dollar terms.

PHARMA M & AS TO DRIVE INFOSYS' LIFE SCIENCES BIZ Business Standard, 5 June, 2014

Infosys, India's second largest software services company, expects the recent spate of mergers and

acquisitions (M&As) in the global pharmaceutical sector to boost its life sciences business over the next 12

months. "There is a lot of M&A activity happening in the life sciences space. When M&A is typically

initiated, budgets are tightly controlled, because companies are hoarding cash to ward off (rival bids) and to

make the sale happen," said Manish Tandon, senior vice-president and global segment head of life sciences.

"As these M&As are fructified in the next six months to a year, a lot of new work will be generated. We are

confident we will get a lot of business there." In April, Swiss drug maker Novartis announced a multi-

billion dollar revamp. As part of it, the company swapped assets with GlaxoSmithKline and sold its animal

health arm to simplify business and increase focus on high-margin cancer medicines. In India, Sun

Pharmaceutical Industries bought Ranbaxy Laboratories in a $4-billion transaction, making the combined

entity the world's fifth-largest generic drug maker by sales. Pfizer tried to buy the UK's second largest

pharmaceutical company, AstraZeneca, but the deal did not come through. Life sciences makes for nearly

five per cent of Infosys' revenue and till recently, it was part of the company's retail and life sciences

business segment that comprised retail and consumer packaged goods, transport and logistics, life sciences

and health care. The combined segment grew 3.4 per cent in October-December 2013 over the previous

quarter but shrank 3.5 per cent in January-March

SUN PHARMA NOT TO ALLOW RANBAXY MINORITY INVESTORS A MERGER VETO Mint, 5 June, 2014

Sun Pharmaceutical Industries Ltd will settle for nothing short of a full merger with Ranbaxy Laboratories

Ltd although some minority investors want to maintain Ranbaxy as a separate unit and nurse it back to

financial health before proceeding with the union. The drug maker, which on 6 April agreed to buy Ranbaxy

for $3.2 billion (around ^19,200 crore) in stock in addition to assuming $800 million of debt, will walk

away from the deal rather than keep Ranbaxy as a separate entity in case the merger, due to be completed by

end-2014, is nixed, said three people including a senior Sun Pharma executive. "The deal will cease to exist

if the merger doesn't happen," said the executive, who didn't want to be identified. The transaction, aimed at

creating India's largest drug maker and the world's fifth largest maker of generic, or off-patent drugs, has

come under scrutiny of the Securities and Exchange Board of India (Sebi) over allegations of insider trading

in Ranbaxy shares in the run-up to the announcement of the deal. "Any findings by Sebi that proves the

insider trading of Ranbaxy shares would directh' impact the merger," said a Mum-bai-based corporate

lawyer, who spoke on condition of anonymity- For Sun Pharma, a merger of Ranbaxy's operations with its

own is crucial. The acquisition will allow the company to expand in countries where it hasn't ventured so far

and give it access to Ranbaxy's product pipeline in the US and the large distribution network in India. It will

result in cost savings of $250 million for Sun Pharma. Maintaining Ranbaxy, which has been battling

regulatory issues with the US Food and Drug Administration (USFDA), as a separate entity would mean

large overlaps of business and overheads. "Given that the deal is beneficial for all shareholders of Sun as

well as Ranbaxy, we expect the deal to be approved," a Sun Pharma spokesperson wrote in response to Mint

queries. Japan's Daiichi Sankyo Co. Ltd agreed to sell its stake in Ranbaxy to Sun Pharma at f 457 per

share; it had bought the stake five years ago paying 61% more. Ranbaxy and Daiichi declined to comment

for this story. The transaction requires approvals from the audit committee, shareholders including minority

investors and the boards of directors. The transaction will need approval by a majority, representing 75% in

value of the shares present and voting at the shareholder meetings of Sun Pharma and Ranbaxy. The deal hit

a roadblock within days of it being signed after two minority shareholders challenged the merger in the

Andhra Pradesh high court, alleging insider trading in Ranbaxy shares. The shareholders cited a sharp rise

in the share price of Ranbaxy prior to the announcement of the acquisition. The high court first ordered an

interim stay on the merger, asking Sebi to withhold approval for the union, but later vacated the stay and

asked the market regulator to investigate the allegations. Experts say the merger process could face other

obstacles. The Companies Act, 2013 and listing norms of Sebi under the related-partv transaction clause

also makes a special resolution by minority shareholders mandatory for approving mergers and acquisition

deals between two companies. In the Sun-Ranbaxy case, according to experts, there are two grounds which

could probably be invoked to prove a relationship between the parties involved. First is the equity that

Silverstreet Developers Lip, a wholly owned subsidiary of Sun Pharma, holds in Ranbaxy.

GLENMARK OPENS NEW UNIT IN SWITZERLAND FOR CLINICAL MATERIAL Politicel Business Daily, 5 June, 2014

GLENMARK Pharmaceuticals today opened a n-ew manufacturing facility in Switzerland for supply of

clinical trial material. Glenmark Pharmaceuticals SA (GPSA), a wholly-owned subsidiary of the company

has opened its new GMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds,

Switzerland, Glenmark Pharma said in a statement. "This manufacturing facility supplements Glenmark's

existing in-house discovery and development capabilities and will supply material for clinical

development," it added. Glenmark Pharma Biologies-president Michael Buschle said: "We have been doing

cutting edge work in the area of novel monoclonal antibodies and have several monoclonal antibody

candidates & bispecific antibodies in the pipeline. The manufacturing facility would help us bring these

antibodies to the clinic faster..." An antibody is a protein produced by plasma cells that is used by the body's

immune system to identify and neutralise foreign particles .such as bacteria and viruses. The focus for the

biologics R&D centre is to develop novel biologic entities for the treatment of pain, oncologic,

inflammatory and respiratory conditions, Glenmark Pharma said. Since its inception around 10 years back,

Glenmark's biologies research centre has filed several patents on novel biologic entities, it added.

INTERNATIONAL

ADAPTIMMUNE INKS CANCER IMMUNOTHERAPY PACT WITH GSK TO DEVELOP &

COMMERCIALISE NOVEL CELL-BASED THERAPIES


Adaptimmune Limited, a leading biotechnology company developing TCR engineered T-cells to treat

cancer, has entered into a strategic collaboration and licensing agreement with GlaxoSmithKline (GSK) for

the development and commercialisation of its lead clinical cancer programme. Using its unique T-cell

receptor (TCR) engineering technology, Adaptimmune has created TCRs which are deployed to target the

cancer testis antigen, NY-ESO-1, and other targets. The company’s trials in the NY-ESO-1 programme in

multiple myeloma, melanoma, sarcoma and ovarian cancer in the US are generating encouraging results,

with European trials set to commence shortly, and it has a pipeline of follow-on programmes. Under the

terms of the agreement, Adaptimmune will co-develop its NY-ESO-1 clinical programme and associated

manufacturing optimisation work together with GSK. GSK will have an option on the NY-ESO-

programme through clinical proof of concept, anticipated during 2016, and, on exercise, will assume full

responsibility for the programme. The companies will also co-develop other TCR target programmes and

collaborate on further optimization of engineered TCR products. According to the agreed development plan,

the deal could yield payments in excess of $350 million to Adaptimmune over the next seven years, with

significant additional development and commercialisation payments becoming due in subsequent years if

GSK exercises all its options and milestones continue to be met.

GSK IN $350MDEAL TO DEVELOP CANCER DRUGS Financial Chronicle, 3 June, 2014

GlaxoSmithKline has agreed a deal worth more than $350 million with British biotech company

Adaptimmune to develop cancer drugs, based on novel cell-based therapies. Adaptimmune said on Monday

it would collaborate with GSK on its lead clinical program, which it said had already generated encouraging

results in multiple myeloma, melanoma, sarcoma and ovarian cancer in trials in the United States. The

privately-owned company said it could receive payments in excess of $350 million over the next seven

years from the tie-up, subject to development goals being met, and significant development and

commercialisation payments in subsequent years. Adaptimmune said it would also receive sales royalties,

ranging from single to double digits on net sales, on any products that reach market. The company's cancer

therapies work by re-engineering the patient's own t-cells, a type of white blood cell, to target and destroy

cancerous or infected cells. GSK manufactures drugs and vaccines for major disease areas such as asthma,

cancer, infections, diabetes, digestive and mental health conditions, the biggest selling of which were

Advair, Avodart, Flovent, Augmentin, Lo-vaza, and Lamictalin 2013. Many medicines were historically

discovered or developed at GSK and its legacy companies and are now sold as generics. Its drugs and

vaccines earned 21.3 million in 2013. Its consumer healthcare division, which earned 5.2 million in 2013,

sells oral healthcare and nutritional products, drinks and over-the-counter medicines, including Sensodyne,

Boost and Horlicks.

US FDA GRANTS FAST TRACK STATUS TO ASTRAZENECA’S NOVEL ANTIBIOTIC

CANDIDATE AZD0914


The US Food and Drug Administration (US FDA) has granted fast track status to AstraZeneca's novel

investigational drug AZD0914 as a Qualified Infectious Disease Product (QIDP) for the treatment of

uncomplicated gonorrhoea, which is increasingly resistant to existing antibiotics and poses a serious global

public health threat. AZD0914 is a novel oral antibiotic entering phase II clinical trials to investigate

efficacy in treating uncomplicated gonorrhoea and is the first of a novel class of molecules to be developed

for this indication. Uncomplicated gonorrhoea is becoming increasingly difficult to treat as the Neisseria

gonorrhoeae bacterium has developed resistance to successive classes of antibiotics. There are currently few

treatment options and the US Centers for Disease Control and Prevention has recently designated Neisseria

gonorrhoeae an immediate public health threat that requires urgent and aggressive action. The QIDP

designation was created by the US Generating Antibiotic Incentives Now (GAIN) Act, implemented in

2012 to encourage the development of treatments for antibiotic-resistant organisms known to cause serious

or life-threatening infections. Fast Track status is a process designed to facilitate and speed-up interactions

with the FDA on issues related to study design, safety data, the use of biomarkers and other critical issues in

the development and regulatory review of drugs. The QIDP and Fast Track designations mean that

AZD0914 is eligible for priority review by the FDA and a five-year extension of exclusivity under the US

Hatch-Waxman Act if approved. If untreated, gonorrhoea can lead to serious and permanent health

problems including pelvic inflammatory disease, first-trimester abortions, ectopic pregnancy and infertility.

The World Health Organisation estimates that in 2012, gonoccocal infections represented 106 million of the

estimated 498 million new cases of curable sexually transmitted infections that occur globally every year.

BAYER, ORION ENTER AGREEMENT TO DEVELOP & COMMERCIALISE NEW PROSTATE

CANCER TREATMENT


Bayer has entered into a global agreement with Orion Corporation, a pharmaceutical company based in

Espoo, for the development and commercialisation of the compound ODM-201, an investigational novel

oral androgen receptor inhibitor. ODM-201 is in clinical development for the treatment of patients with

prostate cancer. Bayer and Orion plan to start jointly the clinical phase III programme to further evaluate the

efficacy and safety of ODM-201 in patients with non-metastatic castration-resistant prostate cancer (nm-

CRPC) in 2014. These patients are at high risk of developing metastatic disease and can be identified due to

rapid Prostate Specific Antigen (PSA) increases. “We see in ODM-201 a potential new treatment for

patients with high risk non-metastatic castration-resistant prostate cancer and are looking forward to

developing this promising compound,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive

Committee and Head of Global Development. “Bayer’s oncology portfolio currently includes Xofigo which

has been shown to prolong life in patients with castrate resistant prostate cancer with symptomatic bone

metastases, and no known visceral metastases. From a clinical perspective, ODM-201 has the potential to

complement our portfolio in prostate cancer and enables us to deliver new treatment options for patients

who desperately need them.” "Joining forces with Bayer, I believe that we have again achieved a

collaboration that represents the best of all worlds," said Dr. Reijo Salonen, SVP R&D and chief medical

officer for Orion. “Bayer has recently committed to developing therapies in Oncology, particularly for

prostate cancer. At Orion, we continue our track record of inventing innovative molecules. And most

importantly, for patients with prostate cancer, this partnership will bring a medicine that will make an

important difference to their lives." Under the terms of the agreement, Bayer and Orion will jointly develop

ODM-201, with Bayer contributing a major share of the costs of future development.

PROVENCE TECHNOLOGIES GROUP BUYS SYNPROSIS


Provence Technologies Group, a specialist fine chemistry research group, has acquired Synprosis, a

company specialized in the chemical synthesis of peptides and proteins for therapeutic use. Synprosis is

based in Aix-en-Provence, France. The financial terms of the agreement were not disclosed. The deal opens

up new development opportunities for the Provence Technologies Group in the area of biologically active

pharmaceuticals. Synprosis has a ten-year history of producing active principles in the field of vaccines

under development (for malaria, cancer, and allergies, etc.), as well as in other therapeutic fields (for

neurogenerative diseases and the treatment of pain). The company was first recognised for its expertise in

creating synthetic vaccines for HIV and malaria. The technology developed by Synprosis offers

significantly increased peptide production yields with a cost reduction of 30 to 40 per cent. The Group’s

new entity has adopted the name Provepep. Synprosis will be the division specialized in pharmaceutical-

standard production, in keeping with good manufacturing practices. Jean-Pierre Salles, who founded

Synprosis, will remain in the Provepep executive management team.

PFIZER WALKS AWAY FROM $118 BN ASTRAZENECA BID Western Times, 2 June, 2014

Pfizer abandoned its attempt to buy AstraZeneca for nearly 70 billion pounds as a deadline approached

without a last minute change of heart by the British drugmaker. The decision ends a month long public fight

between two of the world's biggest Pharmaceuticals companies that sparked political concerns on both and

corporate tax maneuvers.Following the AstraZeneca board's rejection of the proposal, Pfizer announces that

it does not intend to make an offer for AstraZeneca, Pfizer said in a short news release.

TEVA TO BUY BIOTECHNOLOGY COMPANY, LABRYS BIOLOGICS FOR $825 MILLION

Pharmabiz, 5 June, 2014 Teva Pharmaceutical Industries Ltd., and Labrys Biologics, Inc., a privately-held development stage

biotechnology company focused on treatments for chronic migraine and episodic migraine, announced that

Teva has entered into a definitive agreement to acquire Labrys, broadening Teva’s array of biotechnology

assets and capabilities. Teva will acquire Labrys for $200 million in upfront payment in cash at closing as

well as up to $625 million in contingent payments upon achievement of certain pre-launch milestones.

Potential peak sales for LBR-101 are estimated to reach $2 to $3 billion. With the goal of becoming a global

leader in pain by 2020, the Labrys acquisition adds a significant migraine prophylaxis dimension to Teva’s

extensive pain care franchise, which includes a range of investigational, approved and marketed treatments

for migraine, cancer pain and chronic pain. Labrys is developing LBR-101, a fully humanized monoclonal

antibody that binds to calcitonin gene-related peptide (CGRP) currently in phase IIb clinical trials for

prevention of chronic and episodic migraine. Teva’s acquisition of the LBR-101 programme targeting high

frequency episodic and chronic migraine clearly complements the recent addition of Zecuity, an innovative

therapy for the acute treatment of migraine, obtained through the acquisition of NuPathe. This ability to

treat both acute and chronic migraine builds on Teva’s broader pain portfolio, which was recently further

strengthened by positive pivotal phase III results achieved by Teva’s potential abuse-deterrent extended

release hydrocodone. The results gave a clear indication, in a clinical setting, of the promise of Teva’s

proprietary technology with potential abuse-deterrent properties in a range of opioid medications.

CRB, KEY ORGANICS SIGN EXCLUSIVE GLOBAL SUPPLY & MARKETING AGREEMENT

FOR PEPTIDES


Cambridge Research Biochemicals (CRB), a leading independent producer of custom-made peptide and

antibody tools, and Key Organics Limited (Key Organics), a Tennant Group of Companies and a leading

supplier of R&D compounds and chemistry contract research services to the international life sciences

industries, have entered into a worldwide exclusive supply & marketing agreement that makes CRB’s

peptides available to Key Organics’ global life science customer base through its online BIONET catalogue.

Emily Humphrys, commercial director at CRB commented: “Our partnership with Key Organics will allow

us to expand the reach of our growing peptide product portfolio to a global market. We will continue to

focus on our core peptide activities, serving our key customers with bespoke custom-made peptides, whilst

Key Organics sells our new catalogue peptide range.” Joe Carey, managing director at Key Organics added:

“We have been seeking to extend our product range in the peptide area so are delighted to enter into this

agreement with CRB. The Company has established itself as a world leader in peptide chemistry with an

excellent quality and service record that conforms to the standards we have established for our BIONET

portfolio." Since CRB was established in 1980, the company quickly became a global leader in the supply

of custom–made peptides and has recently expanded its premises in Billingham, UK. CRB continues to

develop the range of products and services offered and can supply all flavours of peptides. This

encompasses simple to heavily modified targets and various labels can be incorporated, including stable-

isotopes, radio-isotopes and fluorescent dyes. Milligram to gram-scale quantities are offered, at the highest

levels of purity. Within its BIONET brand, Key Organics offers an extensive range of over 74,000 screening

compounds, intermediates, building blocks and biochemicals to the international pharmaceutical,

biotechnology and agrochemical industries. With new premises near Boston, USA, Key Organics is able to

supply its BIONET products to the North American market.

ARGEN-X INKS ALLIANCE WITH SHIRE PHARMA IN THERAPEUTIC ANTIBODIES


arGEN-X, a clinical-stage biopharmaceutical company focussed on creating and developing differentiated

therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, has entered into a long-

term strategic alliance with Shire Pharmaceuticals. Under the agreement, arGEN-X will bring its entire suite

of human antibody discovery technologies to a partnership focussed on multiple targets aligned with Shire's

therapeutic focus. The multi-year initiative aimed at helping augment the Shire development pipeline

follows an initial research and development collaboration undertaken in March 2012. "Our partnering

philosophy at arGEN-X is to create alliances for the long term with select, top tier companies. We have

certainly upheld this principle by repeatedly expanding our collaboration with Shire, with today's

announcement marking our most ambitious and exciting venture with them to date," said Tim Van

Hauwermeiren, chief executive officer, of arGEN-X. "We have enjoyed consistent success in our

collaboration, recognising important synergies in combining our strengths and capabilities.

ENDO COMPLETES SALE OF BRANDED PHARMACEUTICAL DRUG DISCOVERY

PLATFORM TO ASANABIOSCIENCES


Endo International announced that its Endo Pharmaceuticals subsidiary has completed the sale of its

branded pharmaceutical drug discovery platform to AsanaBioSciences, LLC, an independent member of the

Amneal Alliance of Companies. The deal includes an upfront payment as well as milestones on the

achievement of certain development objectives. Endo initiated the exploration of strategic alternatives for

the portfolio of early stage drug discovery assets in 2013 as part of the company's portfolio optimisation

process. The sale includes multiple early-stage drug discovery and development candidates in a variety of

therapeutic areas, including oncology, pain and inflammation, among others. "The sale of the early stage

discovery platform is another step in the transformation of Endo," said Rajiv De Silva, president and chief

executive officer, of Endo. "We continue to make progress against the strategic objectives we set forth in

2013 and remain enthusiastic about what lies ahead for Endo. We are committed to supporting the organic

growth of our existing business segments as we search for attractive acquisition targets to enhance our

portfolio of pharmaceutical products." Endo International plc is a global specialty healthcare company

focused on improving patients' lives while creating shareholder value. Endo develops, manufactures,

markets, and distributes quality branded pharmaceutical, generic and device products through its operating

companies.

MERCK SERONO INTRODUCES UPDATED ELECTRONIC INJECTION REBISMART FOR

SELF-ADMINISTRATION OF REBIF


Merck Serono, the biopharmaceutical division of Merck, has introduced its updated electronic injection

RebiSmart for self-administration of Rebif (interferon beta-1a). Rebif is the disease-modifying treatment of

the company, which is used as basic therapy for the treatment of relapsing-remitting form of multiple

sclerosis (MS). The new RebiSmart allows patients to inject Rebif themselves, and may also collect

information about injection times, dates and doses administered and store and wirelessly send the safe

MSdialog server. But only the new RebiSmart must be inserted into a corresponding transmitter and then a

button to be pressed. Together with the new RebiSmart, Merck Serono also conducts a the new, web-based

software system MSdialog. This allows people with MS to become actively involved in the management of

their disease by being regularly called upon to fill abstracts of health-related questionnaires that are based

on established procedures and standardized scales - such as the MSQLI (Multiple Sclerosis Quality of Life

Inventory) - and the MusiQoL (Multiple Sclerosis International Quality of Life) questionnaire. In addition,

doctors and MS nurses can monitor patient compliance as well as the course of their health on the basis of

regular questionnaires. "To encourage patients through knowledge and technologies and to enable, may

have the potential to improve patient outcomes, as it allows the patient, even to contribute to document their

disease," said Dr. Gavin Giovannoni, Professor of Neurology at the Barts and The London School of

Medicine and Dentistry. "This new RebiSmart and MSdialog platform can provide physicians access to

certain therapy data of their patients in real time, so that the time can be used during the doctor visit to

discuss important patient-specific topics and issues. Moreover, these technologies enable the patient to more

indepth knowledge of their own disease. " Patients who use MSdialog, have the choice between E-mail and

SMS reminders for the self-application of their medication.

DCC VITAL ACQUIRES WILLIAMS MEDICAL HOLDINGS


DCC plc, the international sales, marketing, distribution and business support services group, announces

that DCC Healthcare's subsidiary DCC Vital has acquired Williams Medical Holdings (Williams), the

market leader in the supply of medical and pharmaceutical products and related services to general

practitioners in Britain. The consideration was paid in cash at completion, based on an enterprise value of

£45 million. Williams supplies a wide range of own and third party branded products medical equipment,

consumables and pharmaceuticals to a very broad customer base of c.10,000 GP practices, as well as

healthcare providers in the community care and domiciliary care sectors. The business also provides a range

of services including field based testing & calibration and repair & maintenance of equipment. The

Williams business model, similar to that in DCC Technology, is based on telesales, e-commerce, product

catalogues and key account management, supported by high quality IT systems and cost effective logistics.

Williams has 165 employees and operates from a modern, purpose built facility in Rhymney, SouthWales.

In its last financial year ended 31 July 2013, Williams recorded an adjusted operating profit of £6.0 million.

DCC Vital is building a substantial business focussed on sales and distribution of own and third party

pharmaceuticals and medical devices across all channels to the healthcare market.

US FDA ACCEPTS GENZYME'S LEMTRADA RESUBMISSION FOR REVIEW

Pharmabiz, 31 May, 2014

The US Food and Drug Administration (FDA) has accepted for review the Genzyme's resubmission of

supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the

treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the

Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter. This resubmission is

based on data from the same clinical studies included in the original sBLA, and provides supplemental

analyses and additional information to specifically address issues previously noted by the FDA in its

December 27, 2013 Complete Response Letter. The company resubmitted the sBLA earlier this month

following constructive discussions with the agency. Genzyme has pioneered the development and delivery

of transformative therapies for patients affected by rare and debilitating diseases for over 30 years.

QIAGEN COLLABORATES WITH LILLY TO CO-DEVELOP COMPANION DIAGNOSTICS

FOR SIMULTANEOUS ANALYSIS OF DNA & RNA BIOMARKERS IN COMMON CANCERS


Qiagen N.V., a Netherlands-based leading global provider of sample & assay technologies, has entered into

a collaboration with Eli Lilly and Company to co-develop universal and modular assay panels for the

simultaneous analysis of DNA and RNA biomarkers targeting multiple cellular pathways involved in

common cancer types. The agreement includes the development of tests that will be based on Qiagen’s

multi-modal, multi-analyte Modaplex analysis platform, which can process multiple sample types and

biomarkers in a single test. “We are excited to add a new stage to our successful collaboration with Lilly,

this time co-developing a broad panel of molecular assays covering a range of biomarkers with diverse

nucleic acid analytes and modalities to guide the use of tailored therapies. We believe our technology can

enhance Lilly’s development of innovative therapies for the benefit of cancer patients,” said Peer M Schatz,

chief executive officer of Qiagen. “In addition to a broad portfolio of PCR-based assays targeting more than

25 biomarkers, Qiagen’s personalized healthcare offering has expanded to include universal solutions using

next-generation sequencing (NGS) and now also a unique and proprietary multi-modal, multi-analyte

testing technology. Our collaborations with Lilly are among more than 20 co-development and co-

commercialization projects underway with leading pharmaceutical and biotechnology companies.” Richard

B Gaynor, senior vice president, oncology-clinical product development and medical affairs, of Lilly, said:

“Certain applications in biomarker development for tailoring oncology therapeutics require the combined

analysis of DNA and RNA, and this collaboration provides a multi-modal, multi-analyte solution that can

process multiple sample types and biomarkers in a single test. We are pleased to work with Qiagen on this

novel platform to support our development programmes.” The new collaboration is the fourth project in the

two companies’ long-standing partnership.

MISSION PHARMACAL STARTS PROMOTION OF ELESTRIN IN US MARKET


Mission Pharmacal Company, a privately held pharmaceutical company based in San Antonio, has begun

exclusive promotion of Elestrin (estradiol gel) 0.06 per cent in the United States through an agreement with

Meda AB. Elestrin is a prescription medicine approved by the Food and Drug Administration (FDA) for use

as a topical hormone replacement gel to treat moderate-to-severe hot flashes due to menopause. Using

estrogen-alone may increase your chance of getting cancer of the uterus (womb). The addition of Elestrin

complements and expands Mission Pharmacal's existing line of branded products for women. Established in

1946 in San Antonio, Texas, the company has a long history of service and expansion in the women's health

sector. Mission Pharmacal therapies for women include a premier line of prescription prenatal vitamins, an

innovative bone health product, anti-infectives, an iron supplement, a urinary analgesic, and now Elestrin.

"Mission Pharmacal's commitment to women's health has never been stronger," says Dan Kibbe, senior vice

president, Pharmaceutical Division, Mission Pharmacal. "The addition of Elestrin further enhances our

position as one of the most valuable partners in providing healthcare solutions for obstetricians and

gynaecologists (OB/GYNs) and their patients in the women's healthcare community." Elestrin also directly

supports Mission's vision to offer innovative, science-based products that meet the nutritional and

healthcare needs of people at every life stage.

CELL THERAPEUTICS RENAMES AS CTI BIOPHARMA CORP


Cell Therapeutics, Inc. (CTI or the Company), a biopharmaceutical company focussed on acquiring,

developing and bringing to market novel targeted therapies for blood-related cancers, announced that it will

change its corporate name to CTI BioPharma Corp. effective May 30, 2014. The company's common stock

will continue to trade under its current ticker symbol: "CTIC." "The rebranding from Cell Therapeutics to

CTI BioPharma comes at a defining moment in our company's history and better reflects who we are today

and our aspirations for becoming a leader in developing therapies for patients with blood-related cancers,"

said James A Bianco, managing director, president and chief executive officer of CTI BioPharma. "From the

beginning, CTI has looked at potential therapies from the patient's perspective to address both the clinical

need and the impact treatment can have on a patient's life. This inspires everything we do and is evident in

the drug candidates we are currently pursuing and those we'll look to acquire. Currently, we have a growing

commercial presence in Europe for Pixuvri (pixantrone) for patients with relapsed aggressive B-cell non-

Hodgkin lymphoma, and a promising late-stage pipeline that includes a phase 3 programme for pacritinib, a

novel JAK2/FLT3 inhibitor, for patients with myelofibrosis."

ROCHE BUYS CALIFORNIA-BASED DNA SEQUENCING FIRM, GENIA TECHNOLOGIES

FOR US$ 350 MN


Roche, a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics,

announced the acquisition of Genia Technologies, Inc. (Genia), a privately held company, based in

Mountain View, California, USA. Genia is developing a single-molecule, semiconductor based, DNA

sequencing platform using nanopore technology. Under the terms of the agreement, Roche will pay Genia’s

shareholders USD 125 million in cash. In addition to this payment from Roche, Genia’s shareholders may

receive up to USD 225 million in contingent payments depending on the achievement of certain milestones.

Genia’s proprietary technology is expected to reduce the price of sequencing while increasing speed and

sensitivity. “The acquisition of Genia is a further step for Roche to introduce a potentially disruptive

technology to the market,” said Roland Diggelmann, COO of Roche Diagnostics. “The addition of Genia’s

single molecule semiconductor DNA sequencing platform using nanopore technology strengthens our next

generation sequencing pipeline.” “We are very excited about continuing our successful development as part

of the Roche Group and bringing our technology to researchers on a global scale,” said Stefan Roever, CEO

of Genia. Once the transaction is complete, Genia will be integrated into Roche Sequencing Unit and will

continue to focus on the development of this innovative system.

NEWRON PHARMA SUBMITS SAFINAMIDE NDA TO US FDA


Newron Pharmaceuticals S.p.A. (Newron), a research and development company, and its partner Zambon

S.p.A., an international pharmaceutical company, have announced that the New Drug Application (NDA)

for safinamide was submitted to the US Food and Drug Administration (FDA). The submission covers the

indications "safinamide as add-on therapy to a stable dose of a single dopamine agonist" in early

Parkinson's disease patients and "safinamide as add-on therapy to levodopa alone or in combination with

other Parkinson's disease treatments" in mid-to late stage Parkinson's disease patients. The submission was

based on completion of activities agreed upon during meetings with the FDA. The submission was made by

Newron, which is the NDA holder until completion of the sublicense process for the US rights to

safinamide, by Zambon. Stefan Weber, Newron's CEO, commented: "We are both proud and excited to be

submitting the company's first ever NDA, for safinamide. Parkinson's disease is a debilitating condition and

this brings us one crucial step closer to providing an innovative treatment to improve the quality of life for

these patients." Ravi Anand, Newron's CMO, commented: "Following the usual review periods, we are

optimistic that safinamide will receive approval within Europe by end of this year, and in the US within 12

months.

POLYPLUS-TRANSFECTION LAUNCHES LATEST OPTIMISED TRANSFECTION REAGENT

FECTOPRO


Polyplus-transfection SA, a privately-held company specialising in the development of innovative solutions

for transfection, announces the launch of FectoPRO, the latest optimised transfection reagent in their

product portfolio. FectoPRO has been designed for high yields in medium and large-scale production of

proteins and antibodies in mammalian cells. Polyplus has designed FectoPRO to deliver very high protein

yields in CHO and HEK cell line systems, the current industry standard systems and most commonly used

by bio-production scientists. FectoPRO will also produce up to three times more protein using half the DNA

required by other leading commercial transfection reagents. In addition, scientists working with transient

gene expression (TGE) systems using FectoPRO will be able to benefit from reproducibility experiment-to-

experiment and between reagent batches. “The bio-production markets, specifically those using larger scale

transient transfection systems, have continued to increase their need for higher protein yields whilst

decreasing costs and reducing the time to develop viable lead molecules. In our communication with

customers, across all sections of this market, these were the consistent and clear messages coming back to

us time and time again,” said Mark Bloomfield, cief executive officer, of Polyplus-transfection.

SANGAMO & CITY OF HOPE GET $5.6 MN GRANT FROM CIRM TO SUPPORT TRIAL OF

STEM-CELL BASED ZFP THERAPEUTIC FOR HIV/AIDS


The California Institute for Regenerative Medicine (CIRM) has granted a $5.6 million Strategic Partnership

Award to Sangamo BioSciences, Inc. to fund clinical studies at City of Hope to develop a potentially

curative ZFP Therapeutic for HIV/AIDS based on the application of Sangamo's zinc finger nuclease (ZFN)

genome-editing technology in hematopoietic stem/progenitor cells (HSPCs). "Sangamo's powerful and

precise ZFN-mediated genome editing technology allows us to modify a patient's own stem cells and

perform 'autologous' transplants, with the potential to replicate the functional cure obtained for the 'Berlin

Patient' in any HIV-infected individual," said John A. Zaia, M.D., Professor & Chair, Department of

Virology, Beckman Research Institute of City of Hope and a member of the clinical team that will be

conducting the pilot clinical trial of this ZFP Therapeutic. "We are very pleased to be working with

Sangamo to test this important immunologic approach in the clinic." The four-year grant provides matching

funds to support evaluation of Sangamo's stem cell-based ZFP Therapeutic in HIV-infected individuals in a

clinical trial conducted at City of Hope. The grant application entitled, "A Phase 1, Open-Label Study to

Assess the Safety, Feasibility and Engraftment of Zinc Finger Nucleases (ZFN) CCR5-Modified

Autologous CD34+ Hematopoietic Stem/Progenitor Cells (SB-728mR-HSPC) with Escalating Doses of

Busulfan in HIV-1 (R5) Infected Subjects with Suboptimal CD4 Levels on cART" tied for the highest

scientific score and was one of two applications recommended for funding in this round of CIRM's

Strategic Partnership Awards. CCR5 encodes a critical co-receptor for HIV infection of immune cells. A

naturally occurring mutation of the CCR5 gene, CCR5 delta-32, results in the loss of expression of the

CCR5 protein on the surface of immune cells. Individuals who carry the CCR5 delta-32 mutation on both

copies of their CCR5 gene (CCR5 delta-32 homozygotes) are not susceptible to the most common strain of

HIV. One HIV-infected individual, known as the 'Berlin Patient,' underwent stem cell transplantation with

HSPCs from a CCR5 delta-32 homozygote achieving what is considered to be a "functional cure" of his

HIV and enabling him to remain off antiretroviral medication for more than six years. As stem cell

transplantation is limited by the availability of HLA-matched, homozygous CCR5 delta-32 donors,

Sangamo's approach is designed to make HIV-infected individuals their own donor using ZFN technology

to disrupt the CCR5 gene in their HSPCs.

WIRB-COPERNICUS FORMS NEW CANCER-FOCUSED INSTITUTIONAL REVIEW BOARD,

WCG ONCOLOGY


The WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services

for clinical research, announced the formation of a new cancer-focused institutional review board, WCG

Oncology. The company also unveiled the members of its prestigious WCG Oncology Expert Advisory

Board. This Board will provide strategic counsel to WCG regarding the changing oncology research

landscape, covering cutting-edge theory, scientific methods, technologies, and study designs. WCG

Oncology Board members include James E. Rothman, Ph.D., chairman of cell biology at Yale Medical

School, and recipient of The Nobel Prize in Physiology or Medicine in 2013; John E. Niederhuber, M.D.,

CEO of Inova Translational Medicine Institute and former director of the National Cancer Institute; and

Arnold J. Levine, Ph.D., professor at the Institute for Advanced Study at the School of Natural Sciences,

and professor in the Departments of Pediatrics and Biochemistry at the Robert Wood Johnson Medical

Center. They are joined by Howard I. Scher, M.D., chief of the Genitourinary Oncology Service at the

Sidney Kimmel Center for Urologic and Prostate Cancers at Memorial Sloan Kettering; John M. Falletta,

M.D., pediatric oncologist and IRB chair at Duke University Medical Center, and former vice chair of the

Copernicus Group IRB; and George D. Demetri, M.D., director of the Ludwig Center at Harvard and senior

vice president for Experimental Therapeutics at the Dana-Farber Cancer Institute. Donald A. Deieso, Ph.D.,

WCG’s Chairman and CEO, commented, “Advancing science has created exciting and very promising new

approaches to cancer treatment. To assure the proper risk-benefit assessment of these new approaches, the

IRB members must possess a deep understanding of the underlying science and clinical aspects of the

associated treatments. WCG Oncology will provide our clients with the confidence that reviews will be

conducted with therapeutic focus.” “Oncology is one of the fastest-evolving medical fields,” added WCG

Chief Clinical Research Officer Lindsay McNair, M.D., M.P.H., M.S.B.

NOVOZYMES INKS PACT TO CONDUCT RESEARCH ON NOVEL SUBUNIT VACCINE

COMPLEX BASED ON ALBUMIN FUSION TECHNOLOGY


Novozymes Biopharma has entered a new collaborative research agreement with one of the world’s top

vaccine companies. The partnership will enable the company to evaluate Novozymes Biopharma's modified

recombinant human albumin (rAlbumin) Veltis technology, to assess the dosing and performance of a novel

subunit antigen vaccine candidate. “This collaborative research agreement with one of the leading vaccine

companies showcases the potential application of Novozymes’ proven albumin-based half-life extension

technology in the vaccine space”, says Svend Licht, Global Head of Sales & Business Development,

Novozymes Biopharma. He continues, “The Veltis technology could overcome many of the limitations of

current subunit vaccines, resulting in both improved healthcare and economic outcomes.” The human

immune system's capability to respond effectively to replicating viruses means that some live attenuated

vaccines are effective with a single dose. Subunit vaccines are regarded as a safer and more specific

alternative to live attenuated vaccines; however, they are often limited by the requirement for multiple

dosing and the need for adjuvants to improve the immune response. Novozymes Biopharma’s Albumin

vaccine complex technology, based on the genetic fusion or conjugation of a subunit antigen to Novozymes’

sequence modified albumin variants, has been specifically designed to overcome these limitations by

allowing the fused or conjugated antigenic species to remain in circulation for a longer period of time than

the uncomplexed antigen. Veltis’ long half-life is due to a receptor mediated recycling process in the cells

lining blood vessels. In specific immune cells, this receptor has been shown to facilitate presentation of

antigens when bound to antibodies as a complex. The Albumin vaccine complex technology should

similarly be presented in these immune cells, potentially eliciting a powerful and protective immune

response. The agreement covers a feasibility study between the parties and is not expected to have any

impact on Novozymes’ financial results in 2014. Recently Novozymes has also announced that its half-life

extension technology is being used by Janssen and GlaxoSmithKline.

THE BUTTERFLY TREE GETS LICENSE TO IMPORT PRODUCTS FOR MALARIA

PREVENTION & OTHER VECTOR-BORNE DISEASES


The Butterfly Tree, a UK charity and NGO in Zambia to support rural communities decimated by the HIV

pandemic in Zambia, has been given a licence to import two safe new products to use in the prevention of

malaria and other vector-borne diseases. Globally malaria is the biggest killer of man. 75 per cent of people

who die from malaria are children under five, mostly in Sub-Saharan Africa. The products could potentially

save the lives of thousands of children and also help to prevent Onchocerciasis, commonly known as river

blindness, caused by the black fly. In areas of the Northern and Western Provinces one in ten people suffer

from this condition and currently there are no preventative methods available in Zambia. The Ministry of

Health and the Malaria Control Centre in Zambia have welcomed the products. They have been tested by

the London School of Hygiene and Tropical Medicine in the UK and the active ingredients used have been

approved by the World Health Organisation. The Butterfly Tree is to be given licenses to import and

distribute throughout Zambia. Besides using it for our humanitarian projects we are contacting all

corporates operating in the nation as this could be hugely beneficial to the mining, agriculture and tourist

industries. Many productive hours are lost as a result of malaria. By selling it to corporates we will be able

to create sustainability for our water, health, education and community projects in addition to extensively

distributing the products to vulnerable communities. The first product, MozziMort, is an insecticidal coating

used on any hard surface that lasts for two years and could replace the normal method of insecticide

spraying, which only lasts for six months. The second product, MozziMort Larvicide granules, prevents

mosquito larvae reaching adult stage.

DRUG FIRMS ACCUSED OF CREATING PAINKILLER ADDICTS The Rakyat Post, 2 June, 2014

Chicago, the third-biggest US city, sued Johnson & Johnson and four other drug companies for allegedly

pushing consumer use of opioid painkillers, creating addicts and driving up its costs. More than 12 million

people abuse prescription painkillers annually, according to a study published March 3 in JAMA Internal

Medicine. Misuse of those drugs in 2008 killed more people than heroin and cocaine combined, according

to the U.S. Centers for Disease Control and Prevention. “Since 2007, the city has paid for nearly 400,000

claims for opioid prescription fills, costing nearly US$9.5 million (RM30.66 million) and suffered

additional damages for the costs of providing and using opiates long-term to treat chronic non-cancer pain,”

lawyers for the municipality alleged in a state court complaint filed in Chicago. Lawyers for the city of 2.7

million accused the drug companies of deceiving the public about the risks associated with the use of pain-

killers including Duragesic, made by Johnson & Johnson’s Janssen Pharmaceuticals unit, while overstating

their benefits. In May, two California counties made similar accusations in a lawsuit against the same

drugmakers. Johnson & Johnson, based in New Brunswick, New Jersey, is the world’s biggest health-care

products maker. Accusing the companies of civil conspiracy, fraud and violations of city laws, Chicago is

seeking unspecified money damages including coverage of the costs associated with its lawsuit. Other

drugmakers being sued by the city are Purdue Pharma Inc, maker of OxyContin, Endo Health Solutions Inc,

which makes Percoset and Percodan, Teva Pharmaceutical Industries Ltd and Actavis plc. The companies

and related entities engaged in a long-term campaign to alter public perceptions of the narcotics, which are

classified by the US as controlled substances, resulting in their increased use, increased instances of

addiction and users migrating to heroin because it is less expensive and sometimes easier to obtain,

according to the complaint. In the California case, Santa Clara and Orange counties sued the companies in

state court, claiming they marketed the drugs as rarely addictive, trivialised serious side effects and falsely

assured consumers that opioids were safer than over-the-counter drugs.

ROCHE ACQUIRES US GENE SEQUENCING FIRM GENTIA Pharmatimes, 2 June, 2014

As part of its plans to expand in gene sequencing, Roche is acquiring Genia Technologies in a deal that

could be worth up to $350 million to the US firm. The Swiss major will pay privately-held Genia’s

shareholders $125 million in cash upfront and up to $225 million in contingent payments depending on the

achievement of certain milestones. The Mountain View, California-based company is developing a single-

molecule, semiconductor based, DNA sequencing platform using nanopore technology. Genia’s technology

“is expected to reduce the price of sequencing while increasing speed and sensitivity”, Roche noted. Roland

Diggelmann, chief operating officer of its diagnostics arm, said that getting hold of this technology

“strengthens our next-generation sequencing pipeline”. A couple of years ago, Roche finally walked away

from a proposed $6.60 billion bid to buy the gene sequencing market leader Illumina after the US firm

fought off an attempt to take control of its board.

TEVA READY TO SHELL OUT $825M ON LABRYS Pharmatimes, 3 June, 2014

Teva Pharmaceutical Industries is snapping up private California-based biotech Labrys Biologics in a deal

worth up to $825 million. The Israeli drugmaker is particularly attracted to Labrys' experimental migraine

drug LBR-101 - a fully humanised monoclonal antibody that binds to the well-known target calcitonin

gene-related peptide (CGRP) - which is currently in Phase IIb clinical trials. According to the companies,

potential peak sakes for LBR-101 are an impressive $2 billion-$3 billion, and Teva says its addition

complements the recent acquisition of acute migraine drug Zecuity (obtained through its purchase of

NuPathe in January). "With its long half-life, target specificity and favourable pharmacokinetic profile

allowing for infrequent, and convenient, subcutaneous administration, LBR-101 represents a very exciting

biologic product candidate, and much needed option, for the management of this truly debilitating

condition," said Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer, further

explaining the interest. Under the terms of the deal, Teva will acquire Labrys for $200 million in upfront

payment in cash as well as up to $625 million in contingent payments upon achievement of certain pre-

launch milestones.News of Teva's latest acquisition comes hot on the heels of an internal reshuffle via a

suite of organisational changes, including the appointment of Sigurdur Olafsson as President and CEO of a

newly established Global Generic Medicines Group, which will take on responsibility for all global

commercial activity from July 1.

APPLE PLAN TO REVOLUTIONISE MOBILE HEALTHCARE Pharmatimes, 3 June, 2014

Apple has unveiled HealthKit, a platform to centralise data from different types of devices, like fitness

trackers, heart rate and blood pressure monitors. Launching iOS 8 for iPhones and iPads, which it describes

as the biggest release since the launch of the App Store, Apple gave much prominence to HealthKit, which

“gathers the information you choose from your various health apps and fitness devices, and provides you

with a clear and current overview in one place”. The new operating system offers developers the ability for

these apps “to communicate with each other”, the company said, and with permission of the user, each app

can use specific information from other apps “to provide a more comprehensive way to manage your health

and fitness”. Apple gave the example of the Nike+ apps using NikeFuel which “will be able to pull in other

key HealthKit metrics such as sleep and nutrition to build a custom user profile”. It has also teamed up with

Mayo Clinic in a move which will see the world-famous medical group launch a new app in September

offering its patients and consumers easy-access personalised health information, guidance and care when

they need it. Mayo chief executive John Noseworthy said that “we believe Apple’s HealthKit will

revolutionize how the health industry interacts with people”. Apple is also collaborating with the electronic

health records major Epic Systems so that HealthKit can be used by healthcare professionals to monitor

specific patient data. Craig Federighi, Apple’s head of software engineering, said the scheme is giving

developers “amazing new tools” to make managing health from devices “an integrated, simple and secure

experience”.

WELLNESS

HUL EXPANDS DISTRIBUTION NETWORK BY 50% IN TWO YEARS Livemint, 2 June, 2014

Mumbai: Hindustan Unilever Ltd (HUL), India’s largest consumer packaged goods company, undertook its

most aggressive expansion drive by increasing its distribution network by 50% over the last two years. The

company also relaunched nearly two-third of its products portfolio, it said in its annual report for the year

2013-14 released on Monday. The company had said in its 2011-2012 annual report that it had reached 2

million stores across urban and rural India. Hindustan Unilever also increased the number of perfect stores

from 80,000 in 2010 to one million in 2013, the company said. A perfect store ensures that the right

products are available on the shelves and are marketed clearly. “Pilot studies in India and Argentina show

that outlets enrolled for the ‘perfect stores’ programme grow on average 4% more than other outlets,” said a

2012 Hindustan Unilever annual report. The Indian subsidiary of Unilever also added more than 17,000

Shakti entrepreneurs in 2013, taking the total count to 65,000. Shakti entrepreneurs are a network of rural

women reaching out and selling the company’s goods in villages where it has limited reach. Hindustan

Unilever has also developed a low-cost distribution model based on the mobile phone. “The company has

increased penetration in the interiors substantially,” said Arvind Singhal, chairman of Technopak Advisors

Pvt Ltd. According to the latest census, India has 7-8 million small stores selling consumer packaged goods

across 600,000 villages and 5,500 towns. Hindustan Unilever also relaunched 60% of its portfolio in one

year—making it one of the highest number of relaunches taking place in a single year.

INDUSTRY AND ECONOMY

PHARMA DEPT TO BAT FOR REVIVAL OF BULK DRUG INDUSTRY Economic Times, 31 May, 2014

The Department of Pharmaceuticals in a presentation, it is preparing to brief Prime Minister Narendra

Modi, may pitch for the revival of the domestic bulk drug industry, which has lost much of its sheen over

the past decade. Citing instances of depending too much for drug raw materials from China, which has built

an immense competitive edge in API (Active Pharma Ingredients, main raw materials) and intermediates,

the pharma department could bat for measures to boost the domestic bulk drug sector, government officials

told ET. "In our presentation, we would focus on steps to reboot the bulk drug industry and overall

measures to improve the compe-tiveness of the pharma sector," an official told ET. India's API imports have

grown at a C AGR of 18 % in the last decade from a base of $801 million in 2004 to $3.4 billion in 2013,

ac-cordingto EXIM (Export-Import) database. An estimate of Indian Pharma Alliance, a grouping of

leading domestic drugmakers, reckoned earlier this year that for the API of many common drugs, India is

close to 90% dependent on China for imports. The top Indian drugmakers cite the case of APIs needed to

manufacture Vitamin C, antibiotics—Metronidazole, Ofloxacin, Livoflox-acin—to buttress their argument

on high dependence on Chinese imports of bulk drugs. The dependence is much higher in intermediates,

raw material other than APIs used in finished drugs. This exposes the pharma sector to price volatility and

supply side shocks like the one during Beijing Olympics of 2008, when China decided to shut down many

of its API plants due to pollution they were causing, which led to sharp spike in prices of many bulk drugs

at that time.

DESPITE EFFORTS, NEW MOLECULES ELUDE INDIAN PHARMA Financial Express, 2 June, 2014

INDIAN pharma firms have tried for more than a decade now to develop new molecules but they've had

little luck so far. Over the last 15 years or so, several of them, including Glen-mark, Biocon Cadila

Healthcare, Dr Reddy's Laboratories, have put in the time and resources to try and discover some

blockbuster drug or other but their efforts haven't paid off. At least four of Glenmark's experimental drugs

were returned or abandoned by partners, according HSBC analysts. Apart from Crofelemer—a treatment for

HI V-related diarrhoea and in-licensed from San Francisco-based Napo Pharmaceuticals — none of its

pipeline drugs has fructified into marketable products. Oglemilast, a drug meant to target asthma and

chronic obstructive pulmonary disorder (COPD), for which Glenmark partnered with Teij in Pharma for

marketing rights in Japan and Forest Laboratories for US rights, was abandoned after the drug failed to

meet the main goals of a mid-stage study in 2009. Similarly, other out-licensed molecules such as

melogliptin, an anti-diabetic licensed to Merck, and GRC6211, a potential painkiller with Eli Lilly as the

licensing partner, were also junked after statistically insignificant results. Others too have met with little

success. Dr Reddy's Laboratories scrapped its promising anti-diabetic experimental drug, Balagli-tazone,

around 2011 after the drug failed to yield the requisite results. It had an out-licensing agreement with

Swedish drug-maker Novo Nordisk. Earlier in 2002, Ranbaxy had licensed out a prostate research molecule

to Schwarz Pharma. Yet, the deal hit a roadblock in November 2004, after the German company terminated

clinical trials due to unclear pre-clinical findings. Sujay Shetty ED and leader -pharma life sciences,

Pricewater-house Coopers, notes that NCE-styled research can be very difficult and takes years to be

perfected. "So there is no shame with some molecules being junked," he says. Nevertheles, out-licensing

products guarantees milestone-based payments, a revenue model which yields returns even if the product

does not materialise in the end.

GENERIC PHARMA COS SET EYES ON NEW GROWTH PILL Economic Times, 4 June, 2014

Indian generic drug producers are devising fresh strategies to continue benefiting from the world's largest

pharmaceutical market, the United States, because exclusive marketing rights for off-patent drugs are not so

exclusive anymore. The US Food and Drug Administration (USFDA) has been clearing applications to

make generic drugs that are going off patent at a faster pace, which is resulting in increased competition.

Moreover, the FDA has been granting joint 'first to file' (FTF) status for several gener-ics, diluting the value

of the exclusive marketing right that comes with such a status. FTF refers to drugs whose generic, or low-

cost, versions, can be launched by a drug-maker who enjoys a 180-day exclusive marketing period during

which no other generic versions can be sold. FTFs are the main growth drivers for most leading Indian

companies that make generic versions of expensive drugs that have gone off patent. Industry experts and

analysts point out that many domestic pharmaceutical companies that once enjoyed windfall gains

frequently through 180-day market exclusivity are realising that they cannot remain the sole players to reap

benefits of market exclusivi-. ty after the FDA amended guidelines to allow joint firsts to copycat

drugmakers. Out of India's $15 billion global pharmaceutical exports, domestic drugmakers depend on the

US market for at least $4 billion in sales. Abhijit Mukherjee, COO of India's second-largest drugmaker Dr

Reddy's Laboratories said the era of windfall gains from FTF is over.

CPHI WORLDWIDE ANNOUNCES FINDINGS OF PHARMA INSIGHTS REPORT ON TURKEY

Pharmabiz, 2 June, 2014 CPhI Worldwide, part of UBM Live’s Pharmaceutical Portfolio, has announced the findings of its Pharma

Insights report on Turkey ahead of an in-depth study to be published free of charge at CPhI Istanbul (June

4-6). The comprehensive analysis of the Turkish pharma market was conducted amongst all major Turkish

manufacturers, evaluating conditions for both foreign and domestic companies, and was compiled with the

help of research partner Global Business Reports. Overall the report concludes that pricing challenges

domestically have had a parallel effect of increasing the dynamism in the market and improving overall

competitiveness of the sector. As a result, the country now boasts a highly price efficient manufacturing

industry far cheaper than those in the West, coupled with a comparable regulatory standards, providing an

ideal mix of factors to establish Turkey as the key regional pharma economy. If reimbursement conditions

improve, this should provide the right environment for a burgeoning healthcare industry, with Turkey

having seen GDP per capita triple in the last 10-years alone. However, beyond the domestic reimbursement

market, niche products and export led growth is also providing a significant avenue for greater revenues.

Investment in new facilities is now taking place across the market, which CPhI concludes will see Turkey

establish itself as the definitive player and supplier of drugs across the MENA and CIS regions, with

exports even as far reaching as the Baltic states. Ultimately, the country’s manufacturers are now aiming to

begin supplying directly into Europe and even the US..

IPA-KARNATAKA BRANCH DELIBERATES ON SOLUTIONS TO REGULATORY

CHALLENGES IN PHARMA MANUFACTURING


The Indian Pharmaceutical Association (IPA), Karnataka branch has highlighted regulatory roadblocks

faced by pharmaceutical manufacturers in terms of compliance. The recent global regulatory charges

against a few Indian companies have further pressed the need to relook at the manufacturing processes and

devise mechanisms to put in place systems. In order to place impending issues in perspective, IPA-

Karnataka branch organised a seminar on ‘Current Regulatory challenges in pharmaceutical manufacturing’

which is the first in the series after its parent body Indian Pharmaceutical Association commemorates its

Platinum Jubilee in December 2013. The half day event with 175 participants was held in Bengaluru at the

Atria Hotel on May 31,2014 which set the tone to highlight the issues and paved a roadmap for the future.

The event was inaugurated by Karnataka Health and Family Welfare principal secretary, Sivasailam N who

recommended scheduled inspections of pharma production facilities by the state drug control department

inspectorate team for which total support would be extended. In his opening remarks, Dr. BR Jagashetty,

president, IPA Karnataka branch and the former drugs controller, government of Karnataka pointed out that

the state pharma industry was known for its high standards of quality as was known for its total compliant

Schedule M certified companies after Gujarat and Maharashtra, besides being second in electronic

issuances of licenses after Gujarat. The state was the first to announce Karnataka pharmaceutical a policy

focusing on industry development among others. Further, the meets ensured industry, trade and academia an

opportunity to review and interact with experts. It provided a comprehensive overview and insights into the

regulatory challenges faced by Indian companies including those from Karnataka in the global

pharmaceutical market.

OVERWHELMING RESPONSE FOR PHARMA PRO&PACK 2014

Pharmabiz, 2 June, 2014 second edition of IPMMA initiative, PHARMA Pro&Pack Expo 2014 received a good response from

exhibitors and visitors with a huge flow of pharma professionals. PHARMA Pro&Pack Expo 2014 was

supported by more than 14 national and international associations. There were more than 480 pharma

manufacturing companies from 18 countries and more than 20,000 potential buyers including more than

1400 buyers from 140 countries at the PHARMA Pro&Pack Expo 2014 and iPHEX 2014. Member of

Parliament, Gopal Shetty, Dr G N Singh, Drug Controller General of India, Sudhanshu Pandey, Joint

Secretary, Dr P V Appaji, director general, Raghuveer Kini, executive director, Ashutosh Gupta, chairman,

Madan Mohan and vice chairman – Pharmexcil, Bhavin Mehta, chairman – iPHEX 2014, and Nipun Jain

were present at the inaugural of the twin events. The Indian pharmaceutical industry has been witnessing

phenomenal growth in recent years, driven by rising consumption levels in the country and strong demand

from export markets thanks to the large pool of talented young and experienced pharma professionals. In

the earlier days, Indian pharmaceutical industry was not so advanced as there were only a few pharmacy

colleges and emphasis was not given to the technological research and developments in the field of

pharmacy. But now the scenario has completely changed. Along with the development of pharmaceutical

companies, pharmaceutical machinery manufacturers are also advancing to meet the challenges of

pharmaceutical industries. Most of the leaders in the field are looking towards advanced markets like the

US and Europe for their pharma products.

IIHMR IN TALKS WITH THE AFGHANISTAN GOVT TO RE-BUILD HEALTH SERVICES IN

THE REGION


The Indian Institute of Health Management Research (IIHMR) is in dialogue with the government of

Afghanistan to bid for another round of the project after the success of the Afghanistan Mortality Survey.

The institute is keen to monitor and evaluate the health system and chip in its expertise to rebuild the health

services and improving health status of the people in the country. The institute has signed an MoU with the

Afghanistan Center for Training and Development to strengthen research, training and consultancy services

in health management areas in Afghanistan. The Afghanistan Morality Survey conducted by IIHMR is a

unique model of large scale nationwide survey that provides the latest and the most authentic health

information about Afghanistan. IIHMR has also conducted program evaluations of TB Prevention and

control, HIV/AIDS, Leprosy, Malaria, and Blindness and has made significant contributions in strategies,

reorganisation of programme implementation mechanism design and monitoring systems. IIHMR has made

significant contributions in health systems research, capacity building and creating a critical mass of

professionally trained managers for health systems, stated Dr. SD Gupta, president, IIHMR University.

According to ML Mehta, chairman of IIHMR University “we have been designated as a WHO

Collaborating Centre for district health system based on primary health care. It has created a wide network

of research and academic institutes interested in public health research and management”. The Global

Alliance for Improved Nutrition (GAIN), Geneva has selected IIHMR as the only Project Management Unit

in the State of Rajasthan to implement the Food Fortification Project. Under the project IIHMR has signed

MoUs with various dairy companies, edible oil brands and wheat flour brands which have extensively

benefited more than 8.5 million individuals on a monthly basis through milk fortification and more than

80,000 individuals through wheat flour fortification. To generate awareness on Food Fortification and its

benefits, IIHMR has conducted sensitisation program for over 250 doctors. Further, the Union government

has also identified us as a collaborating institute for conducting 10 weeks Professional Development Course

(PDC) in Management, Public Health and Health Sector Reforms for District Medical Officers and more

than 235 doctors of Rajasthan have been trained under this course. Recently, with support from WHO, the

Ministry of Health and Family Welfare, Government of India nominated 92 officials to undergo one-month

training on “Public Private Partnership in Health” at IIHMR Jaipur. Apart from this, we have conducted

management research for improving maternal and child health programmes, adolescent health programmes,

reproductive health programmes and other National Health Programmes, said Professor Sodani, Dean,

IIHMR University.

FINANCIALS

SHASUN PROFIT DIPS 21% The Hindu Business Line, 31 May, 2014

Chennai-based Shasun Pharmaceuticals has reported a 21 per cent drop in net profit at Rs 10.4 crore during

the quarter ended March 31. The company's top-line grew 31.4 per cent to Rs.363.2 crore against Rs 276.3

crore during the corresponding quarter last fiscal. During the fourth quarter, finance costs more than

doubled to Rs 13.7 crore from Rs 5.2 crore. The company had allotted 35 lakh shares and 71 lakh

convertible warrants to SeQuent Scientific Ltd, with which it has begun a joint venture to manufacture and

export veterinary products to the US. Posting an annual revenue of Rs 1,212.6 crore, the company also

missed its annual revenue growth forecast of a 30 per cent jump to Rs 1,410 crore during fiscal 2013-14.

Last fiscal, its revenue stood at Rs 1,084.7 crore. The company's share ended marginally lower at Rs 139 on

the BSE on Friday.

WOCKHARDT NET PLUNGES 77% FN Q4 ON IMPORT BANS Western Times, 2 June, 2014

Drugmaker Wockhardt reported a 77 per cent drop in its net profit to Rs 74.45 crore during the quarter

ended March 2014, on the back of import alerts received from the international regulators. The company

reported a net profit of Rs 334.76 crore during the corresponding period of the previous year. Total income

form operations during the period under review declined to Rs 1038.67 crore form Rs 1485.50 crore, a drop

of 30%. Net profit for the year 2013-14, decreased by forty seven per cent to rs 840.71 crore form Rs

1594.12 crore during the previous year. The company received import bans from both USFDA and the

United Klingdom Medicines and Healthcare products Regulatory Agency on the Aurangabad and Daman

facilities. In may last year, the company's Waluj facility at Aurangabad received import ban over non

compliance to good manufacturing practices. Its Chikaithana facilities at Aurangabad and Kadaiya facility

at Daman also came under regulatory scanner. According to a pharma analysts with a Mumbai based

brokering company, the drop in net profit was expected. Three of its units are under ban and which are

selling to the US and UK markets. The few products which have bene given a respective by the foreign

regulators comprises a very small amount/There is a double whammy for the company. While the overall

sales i the US market is affected, thee is remedial costs which is adding to its woe. The company during the

quarter, increased its research spend significantly which stood at 9.7% of total slash at Rs 101 crore.

Including capital expenditure total. R&D spend accounted for 10.7% of sales during the quarter Wockhardt

field ten new product applications with the United States food and Drug Administration USFDA during the

quarter taking cumulative filings pending approval to 62. The company also field for 134 patens during the

quarter taking the cumulative filings to-2001 and has bene granted seventeen patens during the quarter

taking the cumulative patents granted to 259The company's international business contributed seventy nine

per cent of the total revenues during 2013-14.Wockhardt's US business declined by 26 percent durr ing the

fiscal and contrib-uted forty five per cent of' the global revenues.

PATENTS

'INDIAN PATENT LAW MATCHES GLOBAL STANDARDS' Indian Express, 4 June, 2014

AFTER three major US companies — Boeing, Abbott and Honeywell — auto major Maruti Suzuki has

now come in support of India's intellectual property rights (IPR) regime, saying the 'Very strong" domestic

laws are on par with international standards. American pharma sector had alleged that Indian IPR laws

discriminate against US companies and violate global norms. "Maruti Suzuki India firmly believes that the

patent law in India is very strong; especially the changes that happened after the TRIPS agreement have

made Indian Patent law at par with the international standards," the company said in its views submitted to

the commerce and industry ministry. MSI said: "Many recent judgments have proved that strong patent law

not only secures the rights of patentee, but also ensures genuine public need. The IPR law in India provides

transparent system of securing and enforcing the patent rights." It also said that the Indian government

grants patents to encourage inventions. "We have not observed any violation of our IP rights and our rights

are fully secured under Indian IP laws," it added. The company, however, said that "further betterment in the

processes would always help stakeholders and the awareness to enforcement agencies for proper execution

of laws". MSI has one of the biggest automobile R&D set-ups in India, where it develops technologies and

files IPR for them.

VENUS REMEDIES GRANTED PATENT Mint, 4 June, 2014

Venus Medicine Research Center, the discovery research arm of drug maker Venus Remedies Ltd, has been

granted a product patent by the European Union Patent Office (EPO) for a novel antibiotic product, code

named VRP008, to treat drug-resistant bacterial infection. VRP008 is a combination of anti-bacterial drug

carbapenem and a novel amino glycoside-a new chemical entity. It is the outcome of eight years of research

by Venus, which has been focusing on anti-microbial resistance.

MYLAN SETTLES GENERIC CELEBREX PATENT LITIGATION WITH PFIZER

Pharmabiz, 3 June, 2014 Mylan Inc., a global pharmaceutical company, has entered into a settlement and license agreement with

Pfizer Inc. relating to Mylan's Abbreviated New Drug Application (ANDA) filed with the US Food and

Drug Administration (FDA) for Celecoxib capsules, 50 mg, 100 mg, 200 mg and 400 mg. This product is

the generic version of Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis,

rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Under the

terms of the agreement, Mylan will begin selling product at the earliest market formation, however in any

case not later than December 2014. All other terms and conditions of the settlement and license agreement

are confidential, and the agreement itself is subject to review by the US Department of Justice and the

Federal Trade Commission. Additionally, Mylan has appealed the decision by the United States District

Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against

the FDA. Mylan continues to believe that FDA seriously erred in its decision awarding one party eligibility

for 180 days of exclusivity on Celecoxib, and will continue with this suit independent of the

aforementioned settlement. For the 12 months ending March 31, 2014, Celebrex had US sales of

approximately $2.34 billion, according to IMS Health.

VENUS REMEDIES GETS EUROPEAN PATENT FOR ANTIBIOTIC DRUG

Economic Times, 3 June, 2014 Drug major Venus Remedies today said its research arm Venus Medicine Research Centre has received

patent for its antibiotic product 'VRP008' from European Patent Office (EPO). The product is designed for

mixed multi-drug infections for pediatric, geriatric and adult immuno-compromised patients where the risk

of adverse events is high and very low amount of doses are required, Panchkula-based company said in a

statement issued here today. "Once launched, VRP008 (research code for this Antibiotic Adjuvant Entity)

will be one of the best solutions for ICU infections," said Manu Chaudhary, Joint Managing Director cum

Director Research, Venus Remedies Limited. This product, which consists of a carbapenem and a novel

amino glycoside, is the outcome of the eight years of research and it is developed by following stringent

international guidelines defined for developing a new drug and has undergone for pre-clinical studies such

as Acute Toxicity, Sub Acute toxicity, Intravenous, para venous toxicities as per OECD guidelines, the

statement said. At present, at least 25,000 people die each year in the European Union from infections due

to 'Eskape' pathogens which are multi-drug-resistant organisms. Infections caused by these antibiotic-

resistant bacteria resulted in approximately 2.5 million extra hospital days annually in Europe. Venus has

already received EU patent for its product Elores, Potentox, Vancoplus and Achnil.

COURT ALLOWS TEVA MOVE AGAINST NATCO Mint, 31 May, 2014

The Delhi high court on Friday set aside a decision by a single judge of the same court dismissing a civil

suit by Israeli drug maker Teva Pharmaceutical Industries Ltd for an injunction against Natco Pharma Ltd

on grounds of lack of jurisdiction. Allowing an appeal to Teva, the two-judge bench of chief justice G.

Rohini and Rajiv Sahai Endlaw declared that the high courts jurisdiction could extend to those cases where

there was an apprehension of marketing products manufactured through a patented process in the territory

of Delhi. Shreeja Seh

ACTAVIS SIGNS AGREEMENT WITH CEPHALON TO SETTLE NUVIGIL PATENT

LITIGATION

Pharmabiz, 3 June, 2014 Actavis has entered into an agreement with Cephalon, Inc. to settle all outstanding patent litigation related

to Actavis' generic version of Nuvigil (armodafinil tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg).

Nuvigil is a prescription medicine indicated to improve wakefulness in adult patients with excessive

sleepiness associated with obstructive sleep apnea (OSA), shift work disorder (SWD) or narcolepsy. Under

the terms of the agreement, Cephalon will grant Actavis a license to market generic versions of 100 mg and

200 mg Nuvigil beginning on June 1, 2016, or earlier under certain circumstances. Cephalon will also grant

Actavis a license to market generic versions of 50 mg, 150 mg and 250 mg Nuvigil beginning 180 days

after the initial launch of generic versions of those dosage strengths. Other details of the settlement were not

disclosed. Based on available information, Actavis believes it is a "first applicant" to file an ANDA for the

generic versions of 100 mg and 200 mg Nuvigil and expects to be entitled to 180 days of generic market

exclusivity. For the 12 months ending February 28, 2014, Nuvigil had total US sales of approximately $437

million, according to IMS Health data.

VENUS REMEDIES GETS EUROPEAN PATENT FOR THE DRUG VRP008 TO FIGHT MULTI-

DRUG RESISTANT BACTERIA

Pharmabiz, 3 June, 2014 Venus Remedies Limited has received another patent grant for a novel antibiotic product VRP008

consisting of a carbapenem and a novel amino glycoside (NCE entity) from EPO. This product is the

outcome of the eight years of research put in by Venus Medicine Research Centre, pioneering into

antimicrobial resistance research. “We have been working dedicatedly to provide effective and affordable

solution to the compounding problem of anti-microbial resistance ever since we recognized this problem

more than 10 years ago. . We have received from all over the globe for our novel antibiotic entities such as

Elores, Potentox, Vancoplus and VRP008 (the research code for this AAE). Once launched, VRP008 will be

one of the best solutions for ICU infections,” informed Dr Manu Chaudhary, joint managing director cum

director Research, Venus Remedies Limited. The product is designed for mixed multi-drug infections for

pediatric, geriatric and adult immuno-compromised patients where the risk of adverse events is high and

very low amount of doses are required. It is expected to capture a wide range of market sector which is

upheaval with antibiotics for wide indications. Presently, at least 25,000 people die each year in the

European Union from infections due to ESKAPE pathogens which are multi-drug-resistant organisms. The

economic impact is estimated at € 1.5 billion per year. Infections caused by these antibiotic-resistant

bacteria resulted in approximately 2.5 million extra hospital days annually in Europe. Product is developed

by following the stringent international guidelines defined for developing a new drug and has undergone for

pre-clinical studies such as acute toxicity, sub acute toxicity, intravenous, para venous toxicities as per

OECD guidelines, efficacy and safety studies established through a series of microbiological studies carried

out as per CLSI guidelines. Apart from these, stringent stability studies on all four zone conditions

including reconstitution stability have been carried out. In 2009, the global anti-infectives market generated

revenues of $79.12 bn for 12 months to second-quarter, 2009. Over this period, the systemic antibacterial

market accounted for 46.9 per cent of this market segment reaching $37.14 bn in revenues. The total

worldwide revenues for the systemic antibacterials drugs for 12 months to the Q2 were $37.14 bn. Overall

growth for the forecast period from 2009 to 2024 is estimated to be 6.76 per cent (CAGR) rising to a figure

of $99.13 bn.

POLICY AND REGULATIONS

NPPA SEEKS STATES' PARTICIPATION TO KEEP DRUG PRICES UNDER CONTROL


The drug pricing regulator has urged state governments to identify expensive and most commonly used

drugs for diseases prevalent in their regions, which they think should be brought under price control in

public interest. This comes close on the heels of National Pharma Pricing Authority's (NPPA) plans to lower

prices of expensive medicines used for select therapeutic categories such as cancer, HIV, diabetes,

cardiovascular diseases, malaria and tuberculosis, as reported by ET last month. The NPPA has also sought

feedback from state drug controllers and state health secretaries on its plans to cut prices of these therapies.

"There are some diseases which are concentrated in a few regions; for instance, Japanese encephalitis in UP,

Bihar and the North-Eastern states. Considering India's size and diversity, some drugs which may be very

important in one part of the country may not be so relevant in another part and, therefore, it becomes

essential for states to participate in this process," said an NPPA official. However, this issue could prove to

be a flashpoint between the drug pricing regulator and pharma industry, which believes that NPPA is going

beyond its brief of regulating prices of 652 drugs enlisted in the National List of Essential Medicines

(NLEM) of 2011. The regulator, on the other hand, says that the new law allows NPPA to fix and revise

price caps of drugs in public interest and this clause applies to both drugs which are part of the NLEM and

those outside of it. Last month, in an internal meeting, NPPA approved a proposal to monitor prices of all

drug brands in these therapeutic categories and fix prices of those which are being marketed or launched at

significantly higher prices. To begin with, the plan involves tracking retail prices of single ingredient drug

brands.

GOVERNMENT TO DISTRIBUTE FREE MEDICINES THROUGH PUBLIC HOSPITALS

Economic Times, 31 May, 2014

The government will soon start work on distributing free medicines through public hospitals across the

country, health minister Harsh Vardhan said on Friday, reviving a plan that former prime minister

Manmohan Singh had promised in his Independence Day speech in 2012 but did not implement due to

apparent lack of resources. Vardhan plans to revive the central council of health (CCH), a body that

comprises health ministers of all states in the country as well as experts, to take the discussion forward on

firming up the model to implement the programme. The minister decided this in a meeting he had held with

senior health ministry officials on the previous day. "I am sure my colleague health ministers in the states

are keen to ensure the success of this programme," Vardhan said, adding despite the Union Cabinet's formal

clearance in May 2013, the implementation of the programme remained restricted to a few hospitals in big

cities because the infrastructure for procurement and distribution was not put in place. Health economists

have lauded the new government's move to prioritise the programme. "The plan has been in the making for

the last three years. If implemented effectively, it will significantly reduce out-ofpocket expenditure in the

country. The Tamil Nadu and Rajasthan model should be replicated in the other states," said public health

expert Sakthivel Selvaraj. According to Planning Commission's estimate, a countrywide free generic drug

programme will cost Rs 28,560 crore during the 12th Five-Year Plan period.

INJETI SRINIVAS APPOINTED AS NPPA CHAIRMAN

Economic Times, 3 June, 2014 Government has appointed Injeti Srinivas as the new Chairman of National Pharmaceuticals Pricing

Authority (NPPA). The Appointments Committee of the Cabinet has approved the appointment of Injeti

Srinivas as NPPA Chairman, the Ministry of Personnel, Public Grievances and Pensions said in a statement.

Srinivas will replace the current Chairman CP Singh. NPPA fixes, revises the prices of controlled bulk

drugs and formulations in the country. It also enforces prices and availability of the medicines in the

country. Besides, it recovers amounts overcharged from consumers by manufacturers for the controlled

drugs.

PRODUCT APPROVALS

US FDA APPROVES TRIMEL PHARMA'S NATESTO NASAL GEL TO TO TREAT MEN WITH

LOW TESTOSTERONE


The United States Food and Drug Administration (US FDA) has approved Trimel Pharmaceuticals

Corporation's Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for

replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous

testosterone. Natesto is self-administered via a nasal applicator thereby minimising the risk of secondary

exposure to testosterone of women or children. “In my practice I regularly encounter men demonstrating

symptoms of hypogonadism and physicians will increasingly see this as the North American population

ages,” said Dr. Jeffrey Rosen, the medical director and founder of Clinical Research of South Florida

(CRSA). “For these patients seeking to restore their testosterone levels, Natesto will offer an alternative

delivery system that is safer and more convenient than the other options currently available on the market.”

It is conservatively estimated that nearly 13 million American men may have low testosterone levels.

Current treatment guidelines focus on the restoration of the physiological testosterone level through the use

of exogenous testosterone preparations, which include topical gels applied by the hands, subcutaneous

pellets, transdermal patches, intramuscular injections, oral tablets, as well as a buccal patch.

AUROBINDO GETS USFDA NOD FOR BIPOLAR DISORDER DRUG The Hindu Business Line, 4 June, 2014

Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to

manufacture and market Divalproex sodium extended-release tablets. The product is ready for launch. The

drug is the generic equivalent of AbbVie Inc's Depakote ER extended-release tablets and indicated for the

treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic

features. The product has a market size of approximately $ 690 million for the twelve months ending March

2014 according to IMS. "This ANDA has been approved out of Unit VII (SEZ) formulation facility in

Hyderabad," the company said in a release issued here. Aurobindo now has a total of 194 ANDA approvals

(168 final approvals, including 7 from Au-rolife Pharma LLC and 26 tentative approvals) from USFDA

STRIDES ARCOLAB RECEIVES US FDA APPROVAL FOR METHOXSALEN CAPSULES


Strides Arcolab has received the approval from the United States Food & Drug Administration (US FDA)

for Methoxsalen capsules USP, 10 mg (soft gelatin capsules). According to IMS data, the US market for

generic Methoxsalen capsule is approximately USD 13.6 million, with no generic player. The product will

be manufactured at the company’s US FDA approved oral dosage facility at Bengaluru and marketed

directly by Strides in the US market. Methoxsalen is a drug used to treat psoriasis, eczema, vitiligo and

some cutaneous lymphomas in conjunction with exposing the skin to UVA light from lamps or sunlight.

Methoxsalen modifies the way skin cells receive the UVA radiation, clearing up the disease. Strides Arcolab

develops and manufactures a wide range of IP-led niche pharmaceutical products. The company has five

manufacturing facilities presence in more than 75 countries in developed and emerging markets.

CLINICAL TRIALS

GSK'S PHASE III STUDY OF ANTI-HER2 AGENTS LAPATINIB & TRASTUZUMAB FAILS TO

MEET PRIMARY ENDPOINT


GlaxoSmithKline plc (GSK) announced that the phase III study of two anti-HER2 agents, lapatinib

(Tykerb/Tyverb) and trastuzumab, did not meet the primary endpoint of improved disease free survival

(DFS) compared to single agent therapy with trastuzumab as adjuvant treatment for HER2 positive early

breast cancer. The safety profile was consistent with the established safety profile of the study drugs, with

no new safety signals observed. These results were presented at the 50th Annual Meeting of the American

Society of Clinical Oncology (ASCO) in Chicago, Illinois. “While it is disappointing that ALTTO did not

meet its primary endpoint, we now have a tremendous amount of information that will help to further our

knowledge of the biology of this disease and inform future studies in HER2 positive breast cancer in the

adjuvant setting. Further analysis of these data will continue over the coming months,” said Dr. Rafael

Amado, senior vice president Oncology R&D at GSK. “We are most grateful to the more than 8,000

patients across the world who participated in ALTTO—their generous contribution to the scientific

community will facilitate a greater understanding of this aggressive disease.” The primary analysis of the

study tested for superiority (p=0.025) between the combination arm and trastuzumab alone with respect to

DFS; the trastuzumab followed by lapatinib arm was tested for non-inferiority (p=0.025). The results

showed that at four years, 88 per cent of women lived without their disease returning (4-year DFS) in the

lapatinib plus trastuzumab arm and 86 per cent in the trastuzumab arm . The 4-year DFS rate for the

trastuzumab followed by lapatinib arm was 87 per cent compared to 86 per cent in the trastuzumab arm

Adverse events (AEs) more frequently reported in the lapatinib plus trastuzumab arm compared to the

trastuzumab arm were diarrhoea (75per cent vs. 20 per cent ), rash (55 per cent vs. 20 per cent ) and

hepatobiliary (23 per cent vs. 16 per cent). Diarrhoea, grade 3 or higher, was increased in all lapatinib

containing treatment arms (5-15 per cent ), compared to trastuzumab alone (1per cent ).

LILLY'S CYRAMZA IMPROVES OVERALL SURVIVAL IN PHASE III NSCLC STUDY


Eli Lilly and Company announced detailed results from REVEL, a global phase III study of Cyramza

(ramucirumab) in combination with chemotherapy in patients with second-line non-small cell lung cancer

(NSCLC). Data from the trial were published in The Lancet and also presented at the American Society of

Clinical Oncology (ASCO) Annual Meeting. REVEL is the first positive Phase III study of a biologic in

combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone

in second-line NSCLC. Lung cancer is the leading cause of cancer death in the US and most other

countries, and non-small cell lung cancer accounts for 85 per cent of all lung cancer cases. It is estimated

that approximately half of NSCLC patients are receiving treatment in the second-line setting. Despite

currently available therapies, there continues to be a need for new second-line treatment options for patients

with NSCLC. "While there have been other recent Phase III studies that have evaluated the addition of a

cytotoxic or targeted agent in previously-treated NSCLC patient populations, none have demonstrated

improved overall survival in the total patient population," said Richard Gaynor, managing director, senior

vice president, product development and medical affairs for Lilly Oncology. "We are pleased that Cyramza

demonstrated a significant survival improvement in a difficult-to-treat patient population where there

continues to be a major unmet medical need in both nonsquamous and squamous NSCLC patients. These

data build on Lilly's continued commitment to discovering potential new treatment options for the large

numbers of people fighting lung cancer. They also add to our growing clinical data set for Cyramza, which

is being studied in multiple tumour types." The global, randomised, double-blind REVEL trial compared

Cyramza plus docetaxel to placebo plus docetaxel in NSCLC patients with progression after platinum-based

chemotherapy for locally-advanced or metastatic disease. The international study included a total of 1,253

nonsquamous and squamous NSCLC patients from 26 countries on six continents

NOVARTIS' PHASE II TRIAL OF INVESTIGATIONAL COMPOUND LDE225 SHOW MARKED

TUMOR RESPONSES IN ADVANCED BASAL CELL CARCINOMA


Novartis announced the results of a pivotal phase II trial demonstrating that patients with locally advanced

(laBCC) or metastatic basal cell carcinoma (mBCC) taking the investigational oral compound LDE225

(sonidegib) had marked and sustained tumour shrinkage after a median follow-up of 13.9 months. The data

were revealed for the first time today in an oral presentation at the 50th Annual Meeting of the American

Society of Clinical Oncology (ASCO) in Chicago "These results represent an important milestone in the

clinical development of LDE225, as well as in our research strategy to develop new therapies for patients

with unmet needs," said Alessandro Riva, managing director, Global Head, Novartis Oncology

Development and Medical Affairs. "These data will form the basis for the filing of another important new

medicine for a skin-related disease in which Novartis is building a leading position." The trial assessed the

efficacy and safety of two oral doses of LDE225, 200 mg and 800 mg, in patients with laBCC or mBCC.

The primary endpoint was the objective response rate (ORR), defined as the proportion of patients with

complete or partial tumor response, or shrinkage, as measured by a central review committee. The study

met the primary endpoint in both treatment arms with ORRs of 41.8 per cent (95 per cent) confidence

interval in the 200 mg arm and 32.5 per cent (95 per cent CI: 25.1, 40.5) in the 800 mg arm. More

specifically, 47.0 per cent of patients with laBCC and 15.4 per cent of patients with mBCC, in the 200 mg

arm, and 35.2 per cent of patients with laBCC and 17.4 per cent of patients with mBCC in the 800 mg arm,

achieved an objective response.

PHASE 3 STUDY OF VELCADE-BASED THERAPY SIGNIFICANTLY IMPROVES

PROGRESSION-FREE SURVIVAL COMPARED TO STANDARD THERAPY AS FRONTLINE

TREATMENT OF PATIENTS WITH MCL


Millennium: The Takeda Oncology Company announced results from the primary analysis of an

international, randomized phase 3 study that showed treatment with a Velcade (bortezomib)-based

combination therapy demonstrated a 59 per cent relative improvement in the study’s primary endpoint of

progression-free survival (24.7 vs. 14.4 months; Hazard Ratio among previously untreated patients with

mantle cell lymphoma (MCL) compared to treatment with a standard therapy. These data were presented at

the annual meeting of the American Society of Clinical Oncology (ASCO). After a median follow up of 40

months, median overall survival (OS), a key secondary endpoint, had not been reached for patients who

received the Velcade-based therapy (Velcade, rituximab, cyclophosphamide, doxorubicin, and prednisone,

while a median OS of 56.3 months was observed in patients treated with the standard regimen (rituximab,

cyclophosphamide, doxorubicin, vincristine, and prednisone Overall, among patients receiving VcR-CAP

compared to R-CHOP, serious adverse events (SAEs) were reported in 38 per cent vs. 30 per cent of

patients, and grade =3 adverse events were reported in 93 per cent vs. 85 per cent of patients. "This is one

of the largest studies ever conducted in newly diagnosed MCL. The substantial improvement seen in

progression-free survival and in secondary endpoints, including complete response, time to next therapy

and time to progression with the Velcade-based regimen in newly diagnosed mantle cell lymphoma patients,

expands our understanding of Velcade’s contribution to patients with MCL," said Franco Cavalli, managing

director, director of the Oncology Institute of Southern Switzerland. "The 59 per cent relative improvement

in progression-free survival, along with the trend suggesting improved OS with the Velcade-based regimen,

has the potential to represent a significant advance in the frontline treatment of mantle cell lymphoma for

some patients," said Michael Vasconcelles, MD, Global Head, Takeda Oncology Therapeutic Area Unit.

"Patients with relapsed MCL have benefited from access to Velcade therapy since 2006. We look forward to

working with regulatory authorities to bring this new information to physicians and patients in the near

future." The open-label, multicenter, prospective study evaluated the efficacy and safety of VcR-CAP vs. R-

CHOP in 487 patients with newly diagnosed Stage II, III or IV MCL who were ineligible or not considered

for a bone marrow transplant. An Independent Radiology Review Committee (IRC) assessed the primary

efficacy endpoint. Key secondary endpoints for patients receiving VcR-CAP vs. R-CHOP included: 30.5 vs.

16.1 months median time to progression (HR 0.58; P<0.001) 44.5 vs. 24.8 months median time to

subsequent anti-lymphoma treatment (HR 0.50; P<0.001) 53 per cent vs. 42 per cent CR+CRu rate

(P=0.007).

AMGEN ANNOUNCES POSITIVE RESULTS FROM PHASE 2 PEAK STUDY OF

PANITUMUMAB VS BEVACIZUMAB IN COMBO WITH FOLFOX TO TREAT PATIENTS

WITH WILD-TYPE RAS MCRC

Pharmabiz, 3 June, 2014 announced results from the phase 2 PEAK study that reinforce the improved overall survival (OS) benefit

of panitumumab (Vectibix) when used in combination with Folfox, an oxaliplatin-based chemotherapy

regimen, compared to bevacizumab (Avastin) plus Folfox as first-line treatment in patients with wild-type

RAS metastatic colorectal cancer (mCRC). The data was presented at the 50th Annual Meeting of the

American Society of Clinical Oncology (ASCO) in Chicago The data presented at ASCO was an extended

analysis of the PEAK study that supports the use of panitumumab in combination with Folfox for patients

with wild-type RAS (absence of exons 2, 3, or 4 KRAS or NRAS mutations) mCRC. In this exploratory

analysis, patients who received panitumumab plus Folfox and were then treated with a VEGF inhibitor-

based treatment (including bevacizumab) had a median OS improvement of 41.3 months. By comparison,

patients who received bevacizumab plus Folfox and were then treated with an anti-EGFR inhibitor-based

treatment (including panitumumab/cetuximab), had a median OS improvement of 29.0 months. For both

arms, outcomes were similar to those observed in the overall treated population with wild-type RAS

mCRC. "The initial PEAK data reinforce the potential importance of panitumumab for select patients, but

we wanted to evaluate whether this benefit was dependent on administration with Folfox and if other

subsequent treatments might impact survival outcomes," said Fernando Rivera, managing director, Medical

Oncology Department, Hospital Universitario Marques de Valdecilla, Santander, Spain, and a lead

investigator in the study.

ELI LILLY BEGINS SHARING OF CLINICAL TRIAL DATA WITH SCIENTIFIC

RESEARCHERS THROUGH WEBSITE


Eli Lilly and Company announced it will begin sharing its clinical trial data with scientific researchers

through www.clinicalstudydatarequest.com. This website, which houses data from several clinical trial

sponsors, was created in support of ongoing efforts by the Pharmaceutical Research and Manufacturers of

America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to

increase access to and transparency of clinical trial results with researchers around the world. "Scientific

advancements to improve patient care require the collaboration and creative thinking of researchers around

the world. Since our early partnership with academic researchers brought about the first commercial insulin,

we've continued to seek new ways to bring our internal expertise together with the high-quality research

being done beyond our walls," said Tim Garnett, managing director, senior vice president and chief medical

officer, Eli Lilly and Company. "By joining others in our industry to share clinical trial data with qualified

researchers, we can quicken the pace of scientific advances needed to make life better." The new portal,

www.clinicalstudydatarequest.com, differs from previous Lilly data-sharing sites in that access will only be

granted after approval of a research proposal by an independent scientific review panel. Lilly will not be

involved in the decisions made by the independent scientific review panel. The multi-sponsor portal will

include Lilly-sponsored interventional clinical studies from approved medicines and indications in the US

and EU in the following categories: Phase 2, 3 or 4 studies used as part of a regulatory approval submitted

to the U.S. Food and Drug Administration (FDA) on or after 1999; hase 2, 3 or 4 global studies with a first

patient visit after January 1, 2007; and Phase 2, 3 or 4 global or regional/local studies in indications

approved in both the US and EU with a first patient visit after January 1, 2014. All shared data on the

website are anonymised to safeguard patients' privacy.

IMMUNOVACCINE PRESENTS POSITIVE RESULTS FROM PHASE I/IB STUDY OF LEAD

CANCER VACCINE CANDIDATE, DPX-SURVIVAC AT ASCO 2014


Immunovaccine Inc. (IMV), a clinical stage vaccine company, presented positive results from a phase I/Ib

clinical study of the company’s lead cancer vaccine candidate, DPX-Survivac, at the American Society of

Clinical Oncology (ASCO) 2014 Annual Meeting. In a poster presentation at the conference,

Immunovaccine highlighted promising early evidence of clinical activity for DPX-Survivac in ovarian

cancer patients. One patient, who experienced a 43 per cent reduction in tumour size, was classified as a

partial response (PR) as measured by Response Evaluation Criteria In Solid Tumours (RECIST 1.1). The

PR, which persisted following discontinuation of treatment, was accompanied by reduction in levels of a

commonly used ovarian cancer biomarker (CA125) and a significant increase in vaccine-induced immune

responses. The patient’s tumour and CA125 levels remain stable eight months following initiation of the

DPX-Survivac therapy demonstrating a potentially durable effect of the therapy. Additionally, patients

across all vaccine doses exhibited evidence of desired polyfunctional T cell responses against survivin, a

protein that is over-expressed in ovarian cancer and several other tumor types. Statistically significant

increases in immune response were achieved with higher doses of DPX-Survivac (p=0.013) and when

DPX-Survivac was combined with low dose oral cyclophosphamide (CPA) (p=0.015). A modified

vaccination schedule, reducing the dose for the first two vaccinations then boosting with a lower dose every

eight weeks, resulted in a lower frequency of local injection related adverse events. Importantly, robust

immune responses were produced with the modified immunization schedule, demonstrating the potency and

flexibility of DPX-Survivac. Finally, DPX-Survivac was well tolerated with no significant vaccine related

systemic adverse events reported

RESEARCH

ANTI-DIABETIC DRUG MAY SLOW AGING Times of India, 4 June, 2014

Metformin, the world's most widely used anti-diabetic drug, may slow aging and increase lifespan, a new

study suggests. Researchers at the University of Leuven, Belgium decoded the mechanism behind

metformin's age-slowing effects:' the drug causes an increase in the number of toxic oxygen molecules

released in the cell and this, surprisingly, increas-' es cell robustness and longevity in the long term. 'As long

as the amount of harmful oxygen molecules released in the cell remains small, it has a positive long-term

effect on the cell. Cells use the reactive oxygen particles to their advantage before they can do any damage,"

said doctoral researcher Wou-terDeHaes. "Metformin causes a slight increase in the number of harmful

oxygen molecules. We found that this makes cells stronger and extends their healthy lifespan," he added.

The researchers studied metformin's mechanism in the tiny roundworm Caenorhabdi-tis elegans, an ideal

species for studying aging because it has a lifespan of only three weeks, pti

EXPOSURE TO LIGHT WHILE SLEEPING CAN MAKE YOU FAT: STUDY


Exposure to greater levels of light while sleeping can make you pile on the pounds, a new study has

claimed. Scientists at The Institute of Cancer Research, London, found that body mass index, waist-hip

ratio, waist-height ratio and waist circumference in women increased with increasing exposure to light at

night. These associations were still seen after adjustments were made for confounding factors that could be

associated with light exposure levels and weight in the study participants, such as physical activity, having

young children and sleep duration. The findings come from cross-sectional analyses of data from the

Breakthrough Generations Study, the largest study of its kind, following more than 113,000 women from

across the UK for 40 years in a bid to find the root causes of breast cancer. "Metabolism is affected by

cyclical rhythms within the body that relate to sleeping, waking and light exposure," said Anthony

Swerdlow, Professor of Epidemiology at The Institute of Cancer Research, and co-leader of the study. "The

associations we saw in our study between light exposure at night and obesity are very intriguing. We cannot

yet tell at this stage what the reason for the associations is, but the results open up an interesting direction

for research," Swerdlow said. The findings were published in the American Journal of Epidemiology.

ICE CREAM OR CHOCOLATE WON'T BOOST YOUR MOOD

Times of India, 31 May, 2014

Rushing to gulp that chocolate ice cream may not actually boost your mood. In fact, we may simply feel

better after some time regardless of what food we eat, researchers say. "Whether it is your comfort food, or

it is a granola bar, or if you eat nothing at all, you will eventually feel better. Basically, comfort food can not

speed up that healing process," explained Heather Scherschel Wagner, a doctorate candidate from

University of Minnesota. During the study, participants were asked to pick foods that they thought would

make them feel better if they were in a bad mood. They were also asked to pick foods that they liked but

that they did not think would boost their mood. The participants then watched a 20-minute video intended

to elicit feelings of sadness, anger and fear. As expected, participants were in a bad mood immediately after

watching the video. Three minutes later, their mood improved, regardless of whether they had their comfort

food, another food, or no food at all. According to Wagner, it makes sense that people would attribute an

improvement in mood to something they ate, without realising that the food was not necessarily responsible

for the mood change. People like to find explanations for things, Wagner noted, adding that if people find

that they do actually feel better without eating comfort foods, that might stop the unhealthy pattern of

eating.

SLEEPING WITH LIGHTS ON CAN MAKE YOU FAT

Times of India, 2 June, 2014

A new study has revealed that sleeping with too much light in the room increases the risk of obesity in

women. Greater exposure to light at night raised both Body Mass Index (BMI) and waist size in more than

113,000 women taking part in the British study, scientists found. The Breakthrough Generations Study

followed the women for 40 years in an attempt to identify root causes of breast cancer. Obesity is a known

risk factor for the disease, News.com.au reported. Professor Anthony Swerdlow, from The Institute of

Cancer Research in London, said that metabolism is affected by cyclical rhythms within the body that relate

to sleeping, waking and light exposure.

SURGERY ON WEEKENDS UPS DEATH RISK


In a first that shows cyclic influences on hospital mortality in patients after surgery, a new research says that

the risk of death is the highest following surgery conducted on weekends, in the afternoon or in February.

During the analysis of the data from 218,758 patients, researchers found that surgery conducted in the

afternoon was associated with 21 percent increased risk of death compared with surgery conducted at other

times of the day. Surgery at the weekend was associated with a 22 percent increased risk of death compared

to surgery on weekdays. February was the highest risk month, with surgery in February associated with a 16

percent increased risk of death compared to surgery in all other months. Several factors may have

influenced this outcome. "For example, it may be that standard of care differs throughout the day and

between weekdays and weekends," said Felix Kork from Charite-University Medicine Berlin, Germany.

"Although we controlled for risk factors including emergency surgery in our study, it may very well be that

the patients treated in the afternoon and on the weekends were more severely ill," he explained. "We need

more data to draw conclusions regarding seasonal variation in postoperative outcome," Kork added.

USE ANTI-DIABETIC DRUG TO SLOW AGEING


Metformin, which is the world's most extensively used anti-diabetic drug, decreases ageing and increases

lifespan, says new evidence found by Belgian doctoral researcher Wouter De Haes (KU Leuven). The

researchers teased out the mechanism behind metformin's age-slowing effects: the drug causes an increase

in the number of toxic oxygen molecules released in the cell and this, surprisingly, increases cell robustness

and longevity in the long term. Mitochondria - the energy factories in cells - generate tiny electric currents

to provide the body's cells with energy. Highly reactive oxygen molecules are produced as a by-product of

this process. Wouter De Haes explained that as long as the amount of harmful oxygen molecules released in

the cell remains small, it has a positive long-term effect on the cell. Cells use the reactive oxygen particles

to their advantage before they can do any damage. Metformin causes a slight increase in the number of

harmful oxygen molecules. We found that this makes cells stronger and extends their healthy lifespan, he

added. The researchers studied the drug's mechanism in the tiny roundworm Caenorhabditis elegans, a

species which has a lifespan of only three weeks, and found that as the worms age, they get smaller, wrinkle

up and become less mobile. But worms which were treated with metformin showed very limited size loss

and no wrinkling, said Wouter De Haes.

EXERCISE SCORES OVER DIET IN LOWERING CANCER RISK


Are you on a strict diet to reduce body fat that may also help lower breast cancer risk? Better take up

exercise as researchers have found that physical activity offers additional benefit, beyond the effect of

weight loss in reducing cancer risk. Both exercising and eating better are thought to reduce women's risk of

breast cancer by decreasing body fat and levels of the sex hormones related to breast cancer. "Exercise has a

stronger effect on breast cancers fuelled by hormones, compared to dieting, and also offers additional

benefits such as preserving lean body mass," said Anne Maria May from University Medical Center Utrecht

in the Netherlands. "Exercise is the preferred weight loss strategy to decrease breast cancer risk," May

added. The study involved about 240 overweight women, aged 50 to 69, and they were set a goal to lose

five to six kgs over 16 weeks. By the end of the study, women in both the exercising and dieting groups

achieved their weight-loss goals, but the exercising participants preserved their lean body mass (which

includes muscles and bones), and reduced more of their body fat, compared with the dieting participants.

Those who exercised also reduced their levels of estrogen (a potential risk factor for breast cancer) more

than dieting participants did and the exercising women showed decreases in all types of estrogen in the

body, whereas women in the diet group showed a decrease in only one type of estrogen.

SMOKERS WITH GENE DEFECT HAVE LUNG CANCER


25 percent of smokers who carry a defect in the BRCA2 gene would be developing lung cancer at some

point in their lifetime, a large-scale, international study reveals. The defect in BRCA2 - best known for its

role in breast cancer - increases the risk of developing lung cancer by about 1.8 times. The researchers, led

by a team at The Institute of Cancer Research, London, compared the DNA of 11,348 Europeans with lung

cancer and 15,861 without the disease, looking for differences at specific points in their DNA. The team

was mainly funded by the US National Institute of Health, with additional support from Cancer Research

UK. The link between lung cancer and defective BRCA2 - known to increase the risk of breast, ovarian and

other cancers - was particularly strong in patients with the most common lung cancer sub-type, called

squamous cell lung cancer. The researchers also found an association between squamous cell lung cancer

and a defect in a second gene, CHEK2, which normally prevents cells from dividing when they have

suffered damage to their DNA. The results suggest that in the future, patients with squamous cell lung

cancer could benefit from drugs specifically designed to be effective in cancers with BRCA mutations. A

family of drugs called PARP inhibitors have shown success in clinical trials in breast and ovarian cancer

patients with BRCA mutations, although it is not known whether they could be effective in lung cancer.

SUGAR-HEAVY DRINKS UP FATTY LIVER DISEASE RISK


The key to preventing fatty liver disease, the most common cause of chronic liver disease worldwide, may

lie in avoiding sugar-sweetened drinks. Researchers have found that blocking a path that delivers dietary

fructose (fruit sugar) to the liver prevented mice from developing the condition. A molecule called GLUT8

carries large amounts of fructose, which is present naturally in fruit and is added to soft drinks and myriad

other products, into liver cells. Blocking or eliminating GLUT8 in mice reduced the amount of fructose

entering the organ and appeared to prevent the development of fatty liver. Mice with GLUT8 deficiency

also appeared to burn liver fat at a faster rate. "We showed that GLUT8 is required for fructose to get into

the liver," said Brian DeBosch from Washington University School of Medicine in St Louis, US. "If you

take away or block this transporter in mice, they no longer get diet-induced fatty liver disease," he added.

"If the fructose does not go into the liver, it may go to peripheral tissues," DeBosch noted.

AVG AGE OF PATIENTS WITH ORAL CANCER CAUSED BY TOBACCO DOWN TO 20-35 DNA, 31 May, 2014

Analysing the number of patients coming in with oral cancer caused by tobacco use, specialists at the head

and neck cancer department of Narayana Health City have concluded that there is a diminishing trend in the

age group of patients diagnosed with the ailment. Traditionally, it used to be people in the age group of 50-

60 years who were affected with oral cancer caused by tobacco use, but of recent, this has dropped to 20-35

years. Dr Vikram Kekatpure, senior consultant, head and neck surgery department, Narayana Health, said:

"About 30% of oral cancer cases we get today are in the age group of 25-35 years old and about 80% of the

cases detected are in stage 3 and stage 4, which is irreversible in most cases. Strangely, we are getting lot of

women with oral cancer from the lower socio-ecomic group comprising almost about 50%. All these people

might have got into the habit of tobacco use in the form of ghutka around 1990-2000." Easy access to

tobacco products is a major reason for youngsters picking up the habit and becoming early prey to oral

cancer. Hence, raising taxes on tobacco is the only way out to curtail consumption of tobacco, he asserted.

Meanwhile, a World Health Organization study have proven that increasing the price of tobacco through

higher taxes is the single most effective way to encourage tobacco users to quit and prevent children from

starting to smoke. The study has shown 10% increase in taxes on beedi would reduce the'consumption by

9.2% in rural India and 8.5 % in urban India. Hence, internationally it has been recommended to have a

uniform increase in taxes on all tobacco products to prevent users to switch from one product to another.

The World Bank recommends a 65% to 80% tax on tobacco products. Compared to the neighbouring states,

Karnataka has the lowest tax levied on tobacco products. Kerala, Andhra Pradesh and Tamil Nadu levy 20

% on cigarettes and in Maharashtra it is 25%. [email protected]

DRUG COMBINATION MAY BE HIGHLY EFFECTIVE IN RECURRENT OVARIAN CANCER:

STUDY

Pharmabiz, 5 June, 2014 Significant improvement with the use of a combination drug therapy for recurrent ovarian cancer was

reported at the annual meeting of the American Society of Clinical Oncology meeting in Chicago. This is

the first ovarian cancer study to use a combination of drugs that could be taken orally. The drugs were

tested in a phase I combination study followed by a randomised phase 2 trial sponsored by the National

Cancer Institute (NCI), part of the National Institutes of Health. The trial compared the activity of a

combination of the drug olaparib (which blocks DNA repair) and the blood vessel inhibitor drug cediranib,

vs. olaparib alone. Trial results showed a near doubling of progression-free survival benefit (the length of

time during and after treatment that the cancer did not get worse) for the combination therapy over use of

the single drug alone. “The findings of this study are exciting because they support the idea that combining

these two targeted oral therapies results in significant activity in ovarian cancer, more so than olaparib

alone,” said Joyce Liu, managing director, M.P.H., the lead investigator and medical oncologist at the Susan

F. Smith Center for Women's Cancers External Web Site Policy at Dana-Farber Cancer Institute External

Web Site Policy, Boston. “We are looking forward to further exploring this combination in ovarian cancer

and potentially increasing effective treatment options for our patients with this cancer.” Over 22,000 cases

of ovarian cancer are diagnosed annually in the United States. Seventy-five percent of the cancers are

classified as high-grade serous type, the women have more advanced disease at diagnosis, and their tumours

are more aggressive. Of this high-grade type, about three-quarters of patients respond to initial treatment

but nearly all will recur and need follow-up treatment. That treatment will be based on how the cancers

have responded to previous therapies and are broken down into two categories based on patients’ responses

to chemotherapy regimens that include platinum: Platinum-Sensitive these are patients most likely to

benefit from Poly ADP-Ribose Polymerase (PARP) inhibition. PARP inhibitors, such as olaparib, are

targeted drugs that block an enzyme involved in many functions in the cell, including the repair of DNA

damage. Platinum-Resistant these are patients whose disease recurred within six months of completion of

conventional chemotherapy (using the drugs cisplatin or carboplatin) and are generally less responsive to

subsequent treatments and have not responded as well to PARP inhibitors.

NEW AND GENERIC DRUG APPROVALS

US FDA site

Drug Name Strength Dosage Form /

Route

Marketing

Status

Company

Methadose 10mg/Ml Concentrate;Oral Prescription Mallinckrodt

Ms Contin 30mg; 60mg;

15mg; 100mg;

200mg

Tablet, Extended

Release;Oral

Prescription Purdue Pharma Lp

Reyataz Eq 100mg Base;

Eq 150mg Base;

Eq 200mg Base;

Eq 300mg Base

Capsule;Oral Prescription Bristol Myers Squibb

Mefenamic Acid 250mg Capsule;Oral Prescription Vintage Pharms Llc

Oxycodone

Hydrochloride

5mg Capsule;Oral Prescription Lehigh Valley

Oxycodone

Hydrochloride

5mg/5ml Solution;Oral Prescription Vistapharm

Dymista Eq 0.125mg

Base/Spray;

0.05mg/Spray

Spray,

Metered;Nasal

Prescription Meda Pharms

Divalproex

Sodium

Eq 250mg

Valproic Acid;

Eq 500mg

Valproic Acid

Tablet, Extended

Release;Oral

Prescription Aurobindo Pharma Ltd

Kyprolis 60mg/Vial Powder;Intravenou

s

Prescription Onyx Pharms

Reyataz 50mg Powder;Oral Prescription Bristol Myers Squibb

Vistaril Eq 25mg Hcl;

Eq 50mg Hcl

Capsule;Oral Prescription Pfizer

Vistaril Eq 100mg Hcl Capsule;Oral Discontinued Pfizer

Vistaril Eq 25mg

Hcl/5ml

Suspension;Oral Discontinued Pfizer

Cortenema 100mg/60ml Enema;Rectal Prescription Ani Pharms

K-Tab 10meq; 20meq Tablet, Extended

Release;Oral

Prescription Abbvie

Potassium

Chloride

8meq Tablet, Extended

Release;Oral

Discontinued Abbvie

Increlex 40mg/4ml

(10mg/Ml)

Injectable;Subcuta

neous

Prescription Ipsen Inc

Votrient Eq 200mg Base;

Eq 400mg Base

Tablet;Oral Prescription Glaxosmithkline

Prolia 60mg/Ml Injectable;

Subcutaneous

Prescription Amgen

Xgeva 70mg/Ml Injectable;

Subcutaneous

Prescription Amgen

Nithiodote 300mg/10ml(30

mg/Ml),N/A;

N/A,12.5gm/50

ml(250mg/Ml)

Solution,

Solution;Intraveno

us, Intravenous

Prescription Hope Pharms

Pramipexole

Dihydrochloride

0.125mg;

0.25mg; 0.5mg;

0.75mg; 1mg;

1.5mg

Tablet;Oral Prescription Strides Arcolab Ltd

Oxycodone

Hydrochloride

5mg; 10mg;

15mg; 20mg;

30mg

Tablet;Oral Prescription Amneal Pharms

Humulin N 100 Units/Ml Injectable;Injection Over-The-

Counter

Lilly

Humulin 70/30 30 Units/Ml; 70

Units/Ml

Injectable;Injection Over-The-

Counter

Lilly

Humulin 70/30

Pen

30 Units/Ml; 70

Units/Ml

Injectable;Injection Over-The-

Counter

Lilly

Humalog 100 Units/Ml Injectable;Injection Prescription Lilly

Humalog

Kwikpen

100 Units/Ml Injectable;Injection Prescription Lilly

Humalog Pen 100 Units/Ml Injectable;Injection Discontinued Lilly

Humalog Mix

75/25

75 Units/Ml; 25

Units/Ml

Injectable;Injection Prescription Lilly

Humalog Mix

75/25 Kwikpen

75 Units/Ml; 25

Units/Ml


Humalog Mix

75/25 Pen

75 Units/Ml; 25

Units/Ml

Injectable;Injection Discontinued Lilly

Humalog Mix

50/50

50 Units/Ml; 50

Units/Ml


Humalog Mix

50/50 Kwikpen

50 Units/Ml; 50

Units/Ml


Humalog Mix

50/50 Pen

50 Units/Ml; 50

Units/Ml

Injectable;Injection Discontinued Lilly

Elidel 1.00% Cream;Topical Prescription Valeant Bermuda

Fortesta 10mg/0.5gm

Actuation

Gel,

Metered;Transder

mal

Prescription Endo Pharms

Byetta 300mcg/1.2ml Injectable;Subcuta Prescription Astrazeneca Ab

(250mcg/Ml);

600mcg/2.4ml

(250mcg/Ml)

neous

Vimpat 50mg; 100mg;

150mg; 200mg

Tablet;Oral Prescription Ucb Inc

Prandimet 500mg; 1mg;

500mg; 2mg

Tablet;Oral Prescription Novo Nordisk Inc

Cefepime In

Plastic Container

Eq 1gm

Base/50ml (Eq

20mg Base/Ml);

Eq 2gm

Base/100ml (Eq

20mg Base/Ml)

Injectable;Injection Prescription Baxter Hlthcare

Prolia 60mg/Ml Injectable;

Subcutaneous

Prescription Amgen

Xgeva 70mg/Ml Injectable;

Subcutaneous

Prescription Amgen

Levothyroxine

Sodium

100mcg/Vial;

200mcg/Vial;

500mcg/Vial;

500mcg

Powder;Intravenou

s

Prescription Fresenius Kabi Usa

Amitriptyline

Hydrochoride

10mg; 25mg;

50mg; 75mg;

100mg; 150mg

Tablet;Oral Prescription Accord Hlthcare

Vogelxo 50mg Gel; Transdermal Prescription Upsher Smith Labs

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