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Elanco M&A strategy yields forceful end to fiscal year

by JosEph hArvEy

Elanco’s sales climbed 28% in the fourth-quarter of 2015, rounding off a growth-heavy year.

The firm’s Q4 reached $811.7 million. Sales in the US grew 19% to $381.8m, while revenues outside the US leaped 38% to $429.9m. The transformational purchase of Novartis Animal Health was the key driver behind these increases.

However, a different picture is revealed if the Novartis Animal Health’s 2014 sales are included in the year-on-year comparison. In this case, fourth-quarter revenues declined by 11% (US sales fell 2% and non-US sales dropped 18%).

Elanco said the dip in US sales was due to “lower realized prices and volume in food animal products, partially offset by higher volume for companion animal products”. The decline in sales outside the US was related to the unfavorable impact of foreign exchange rates and decreased volume.

“Including the sales of Novartis Animal Health in 2014 and excluding the unfavorable impact of foreign exchange rates, worldwide animal health sales decreased 5%,” the company stated.

This suggests as Elanco’s M&A-driven growth wears off throughout fiscal 2016, it will look more towards organic growth to drive the business – recently-launched companion animal products should lead this strategy.

Full-year shows 36% growthElanco’s annual growth rate came to 36%, with sales coming to $3.181 billion.

US sales improved 21% to $1.541bn and non-US revenues were up 53% to $1.640bn. This highlights the international benefits behind the Novartis deal.

Including the sales of Novartis Animal Health in 2014, Elanco’s full-year revenues dropped 7%. US sales fell by 1% and revenues outside the US decreased 13%.

Again, the decline in the US was driven primarily by a decreased volume in food animal products, while the performance outside the US was impacted by the unfavorable influence of foreign exchange rates as well as decreased volume in pet products. These mitigating factors partially offset higher realized prices and volume for food animal products.

Including the sales of Novartis Animal Health in full-year 2014 and excluding the unfavorable impact of foreign exchange rates, Elanco’s sales dropped 1%.

Importance to Eli LillyElanco now contributes more sales to Eli Lilly than any of its individual human drug portfolios. Humalog is the group’s leading human pharma brand – it recorded sales of around $2.8bn in 2015.

The animal health division also showed a higher sales growth rate than any of Lilly’s human drug brands. Elanco represents 16% of the group’s annual sales. This contribution is significantly more than Elanco’s rivals in the animal health top five.

Moving up the rankingsThese annual sales figures will ensure Elanco is the third-largest animal health company globally. In fiscal 2014, it was the fourth-largest – the Novartis acquisition has helped it leapfrog Merial.

Last year was by far and away Elanco’s strongest in terms of overall growth sin the last nine years.

Previous growth has been driven by the purchase of firms such as Lohmann Animal Health and Janssen Animal Health, as well as a portfolio of products sold off by Pfizer/Fort Dodge.

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Y O U R W E E K LY B R I E F I N G

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Irish facility to closeElanco’s manufacturing facility in Sligo, Ireland is to close. The site has been operational since 1991 and will see the loss of 100 jobs, according to local press. The move comes despite redundancies at the site last year.As a result, Elanco’s parent company Eli Lilly expects to record a charge of approximately $100m (pre-tax) or approximately $0.09 per share (after tax) in the first-quarter of 2016.The closure comes as part of a review by Eli Lilly into its operations. This strategy will also lead to closure of its plant in Dundee, Scotland and the loss of 160 jobs. This site is a former Novartis facility. Elanco is seeking cost savings via facility closures. Four R&D facilities in Switzerland, Germany, Japan, Australia and Greensboro, North Carolina are set to close. The company is also closing manufacturing sites in Vacaville, California (vaccines) and Terre Haute, Indiana (enzymes).

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Elanco sales 2007-2015

year sales ($ million) Change

2007 996 13.7

2008 1,093 9.7

2009 1,207 10.4

2010 1,391 15.3

2011 1,678 20.6

2012 2,037 21.6

2013 2,151 5.4

2014 2,347 9.1

2015 3,181 35.5

Source: Eli Lilly

European approvals in 2015 highlight new active substances

by JosEph hArvEy

The European Medicines Agency (EMA) recommended marketing authorization for seven veterinary products containing a new active substance in 2015.

This represented half of the 14 veterinary medicines recommended for marketing authorization over the year.

These positive opinion recommendations included eight medicines for food-producing animals (five of which were vaccines), five for companion animals and one for minor use minor species (MUMS)/limited market.

Of the vaccines recommended for approval, four are biotechnology products (Porcilis PCV ID, Vectormune ND, Innovax-ILT and Suvaxyn Circo+MH RTU). The EMA said this reflects the current shift from manufacturing of veterinary vaccines using traditional methods towards biotechnology processes.

Two of the vaccines (Ceva Santé Animale’s Vectormune ND and MSD Animal Health’s innovax-ILT) use a single-vaccine organism to protect against two diseases. This method reduces the number of live organisms to which chickens are exposed through vaccination.

The MUMS recommendation was for Dechra Pharmaceuticals’ Zycortal to treat mineralocorticoid deficiency in dogs.

The EMA noted it recommended two medicines for approval that have the potential to reduce the need for antimicrobials in dairy cattle. Velactis and Imrestor are both intended for the prevention of mastitis – they are also the two products in the list still awaiting full approval in Europe.

MSD Animal health had three products recommended, while Elanco, Zoetis and Ceva Santé Animale each had two products recommended.

There were 15 products approved in Europe during 2015. These included: Zoetis’ Zulvas SBV vaccine used to protect cattle and sheep against Schmallenberg virus; Zoetis’ Suvaxyn CSF Marker recombinant veterinary vaccine to protect pigs against outbreaks of classical swine fever; and Merial’s Nexgard Spectra chewable flea and tick tablets.

These products received their positive opinion recommendations in 2014.

positive opinions down from 2014In 2014, the EMA passed 20 positive opinions on veterinary products – the highest annual total in its history. In over 20 years of its existence, the EMA has recommend authorization of around 200 veterinary medicines.

Important procedures on safety in 2015The EMA noted two significant safety procedures that began in 2015.

The organization started a review of Closamectin Pour-On Solution and associated names (closantel and ivermectin) following suspension of marketing authorization in France. The EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) recommended the medicine should remain available but changes should be made to the product information, conditions concerning risk mitigation and surveillance measures.

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Additionally, the CVMP reviewed the risk to consumers from the use of lidocaine in food-producing animals. It subsequently issued regulatory recommendations to ensure a negligible risk to consumers from residues that may occur in milk following off-label use in cattle.

The agency also recommended communication with veterinarians to ensure an adequate interval of time is allowed to elapse between the administration of lidocaine and the collecting of milk for human consumption.

veterinary medicines recommended for marketing authorization in 2015

product New active substance?

species Manufacturer Launched?

Canigen L4 No Dogs MSD Animal Health Yes

Fortekor Plus No Dogs Elanco Yes

Sileo No Dogs Orion Animal Health Yes

Simparica Yes (sarolaner) Dogs Zoetis Yes

UpCard Yes (Torasemide anhydrous)

Dogs Vétoquinol Yes

Zycortal Yes (desoxycortone pivalate)

Dogs Dechra Pharmaceuticals

Yes

Imrestor Yes (pegbovigrastim)

Dairy cattle Elanco Pending

Velactis No Dairy cattle Ceva Santé Animale

Pending

Novaquin No Horses Le Vet Pharma Yes

Innovax-ILT Yes (cell-associated live recombinant turkey herpesvirus)

Chickens MSD Animal Health Yes

Vectormune ND Yes (live recombinant turkey herpes virus with ND insert)

Chickens Ceva Santé Animale

Yes

Coliprotec F4 Yes (live non-pathogenic Escherichia coli O8:K87)

Pigs Prevtec Microbia Yes

Porcilis PCV ID No Pigs MSD Animal Health Yes

Suvaxyn Circo+MH RTU

No Pigs Zoetis Yes

Source: EMA

boehringer expert explains bvDv vaccine strategy

by MALCoLM FLANAgAN

A Boehringer Ingelheim virology expert recently explained how the company successfully produced a vaccine against bovine viral diarrhea virus (BVDV).

Dr Konrad Stadler, of Boehringer Ingelheim’s Veterinary Research Center, said the Bovela vaccine launch came about as a result of a lengthy partnership between academia and the Ingelheim-based company.

Dr Stadler told delegates to the recent Veterinary Vaccinology Network Conference 2016 in Manchester, UK, that setting clear targets and defining a product profile at an early project stage was a key component in company’s strategy.

In addition, the successful collaboration required various experts to get involved in processing and marketing at an initial stage. Throughout, clear communication was essential as was patience and persistence. Finally, knowing when to end the project and release the completed vaccine was strategically important.

The projected BVDV vaccine had a defined profile for the Boehringer team to work on. It included: clinical protection; good stimulation of the immune system; easy application; protection against BVDV genotype 1

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and type 2; protection against fetal transmission; protection from virus shedding; and a marker vaccine which combined the safety profile of killed vaccines with the efficacy profile of a live vaccine.

Dr Stadler said: “In general, a vaccine should be safe and efficient. In the BVDV system, efficacy not only means the prevention of clinical symptoms after the challenge of vaccinated animals but also the absence of transmission of the challenge virus to the fetus. The effects of BVDV infections of cattle can range from inapparent to lethal disease. It is endemic in most countries of the world.”

BVDV economically impacts cattle farmers due to decreased weight gain, decreased milk production, reproductive losses or even the death of the infected animals. Most of the animals show symptoms that can be confused with other ailments. This makes the detection and control of the disease even more complicated. Up to 60% of EU cattle can be infected with the disease, explained Dr Stadler.

Boehringer’s Bovela was the first vaccine to be launched in the EU for the active immunization of cattle against both genotypes of the virus. It received its marketing authorization by the European Medicines Agency in December 2014.

Bird flu in Asia: The situation ahead of festival season

by Dr WILLIAM rILEy

Traditions die hard and in the case of bird-to-human transmission of highly pathogenic avian influenza, the preference of many Chinese to purchase live birds to slaughter during the holiday season puts them at a particular risk for airborne contact with the virus from infected animals. Dr William Riley, an animal health and nutrition consultant based in Hong Kong and Guangzhou, China, provides an avian flu profile in Asia, with a particular focus on the up-coming Chinese New Year holiday.

The start of 2016 brought little reprieve from the avian flu threat across Asia and the Chinese New Year – celebrated this year on February 8, – will bring with it the increased risk of bird-to-human avian influenza transmission that has accompanied the Spring Festival in the past.

The long-standing Chinese cultural tradition of purchasing live poultry to slaughter puts those involved at risk of contracting the virus from infected birds via the respiratory route. This was quite evident in China upon the first outbreak of the H7N9 strain in April 2013, despite repeated warnings from the government and health authorities.

These same warnings will be necessary with the forthcoming holiday season in China and in other countries where the festival is celebrated where bird flu is evident (i.e. Vietnam, Taiwan, Indonesia, South Korea, Malaysia and Singapore).

philippinesFirst the good news: the Philippines continues to be avian influenza-free. Since immunization against is not allowed in the Philippines (for fear of reversion), the success of the country in preventing outbreaks can be attributed to effective biosecurity measures and favorable avian migratory routes.

One might also suggest that there is some benefit to all the typhoons that target the islands each year, with winds blowing in a northerly and westerly direction. Unfortunately, that included blowing most of the resident livestock out to sea when Super Typhoon Yolanda hit Tacloban in 2013.

Elsewhere in Asia, the situation has remained relatively stable over the last several months, meaning avian flu remains troublesome but essentially controlled through targeted immunization programs.

vietnamAs Animal Pharm reported in mid-2015 and as documented by the World Organisation for Animal Health (OIE), there were some isolated ‘outbreaks’ of highly pathogenic avian flu (HPAI) in Vietnam last year, including the H5N6 strain and the H5N1 strain.

These outbreaks, which involved the deaths of hundreds of chickens, were countered by vaccination strategies.

Perhaps the number of affected animals is significant, as Animal Pharm also reported there were several additional outbreaks of bird flu in Vietnam in 2015.

However, when government officials in Vietnam were questioned as to whether there were any outbreaks in 2015, the response was negative. This likely indicates a semantic difference between ‘outbreaks’ and ‘cases’ depending upon the number of birds involved and thus the definition of the two terms.

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Dr William riley

Dr William Riley is a professor at the International School at Jinan University, Guangzhou, China, where he teaches courses in clinical medicine, food safety and quality, and pharmacy programs. He also owns and operates WWR and Associates, a Hong Kong-based animal health and nutrition company that specializes in technical consulting, product distribution, research trial management and product registration.Dr Riley manages a distribution and research network across the Asia-Pacific Region and in Europe, and he provides logistical support and product registration assistance for veterinary (including companion animal) and human health products, nutritional feed, diagnostics and food additives.His current clients include companies from Canada, Italy, Germany, South Korea and China, and his distribution and research partners represent five continents.

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IndonesiaIndonesia has long been a focal point for avian influenza in Southeast Asia. There were a number of reported cases of bird flu across the country during 2015; however, there were no human cases reported recently. H5N1 is still the most prevalent strain in Indonesia.

Although the subclass 2.1.2 had previously been most evident, subclass 2.3.2 is now more commonly reported. Some cases of strain H7N9 have also been reported recently but it has not been considered to be as significant as the H5N1 strain.

TaiwanWithout doubt, the most problematic recent news concerning avian flu in Asia has emanated from Taiwan and South China.

A number of outbreaks of the highly pathogenic H5N8 strain were reported early in January this year in southern Taiwan on several duck, geese and chicken farms, and H5N2 outbreaks were reported in other counties stretching to the north of Taiwan, as far as Taipei, affecting ducks, geese, chickens and turkeys.

In these combined instances, thousands of birds were affected, either directly or through culling as preventative a measure.

south ChinaAt approximately the same time, the H5N6 bird flu strain was discovered in a wild egret in the Diamond Hill section of Kowloon, Hong Kong. This is primarily a residential section of Kowloon and not in close proximity to any poultry production area.

However, the public and all commercial establishments that deal with avian species of any type were warned to take the proper precautionary measures to protect themselves and to prevent the possible spread of the virus.

This news was followed by a report that no one wished to hear so close to the Chinese New Year. Local media in Guangdong Province reported the outbreak of the highly pathogenic H5N6 virus and its contraction by six people in southern China, resulting in one death.

Three of these cases were in Guangdong Province and the other three were in Sichuan and Yunnan Provinces. The media reports confirmed that the three Guangdong victims had directly contacted poultry.

Not only does the public still seek to purchase live birds but despite well publicized warnings from authorities, many poultry markets still offer live birds for sale, in violation of the laws that have been implemented to prevent this practice. When there is little tradition for abiding by the ‘rule of law,’ there can at times be deadly consequences.

Adisseo, Novozymes pact yields first poultry probiotic

by JosEph hArvEy

French animal feed additives specialist Adisseo and Danish biotechnology company Novozymes have launched a poultry probiotic in several global markets.

Alterion has been introduced to the US, a number of countries in the Middle East and South East Asia.

The probiotic was developed by both firms from a strain of Bacillus subtilis, a naturally-occurring bacterium found in soil.

When added to poultry feed, Alterion provides gut health control. It also limits development of unwanted bacteria in the digestive tract, as well as optimizing feed conversion by 2-2.5%.

The two partners collaborated in May 2015 to develop an alternative to antibiotic growth promoters. Novozymes performed in vitro testing and is currently responsible for the product’s development and production. Adisseo provided in vivo testing and now manages Alterion’s marketing and sales.

Jean-Marc Dublanc, the chief executive of Adisseo, said: “Global trials have validated the performance and mode of action of Alterion and trial customers are very excited about the results. This confirms the product is ready for market and it will be gradually rolled out on a global scale.”

probiotics market valueAdisseo and Novozymes estimate the value of the probiotics market to be at €200-300 million ($216-325 million) with 8-10% annual growth.

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In October last year, Novozymes acquired poultry probiotics developer Pacific Vet Group-USA. Last week, fellow Danish company Chr. Hansen agreed to purchase US livestock probiotics firm Nutritional Physiology Company for $185m.

Chr. Hansen said demand for natural products that advance health and productivity in livestock is rising and the expected growth for microbial solutions in the industry is 7-9%.

According to a French expert in animal nutrition, there are a number of strong drivers (including probiotics) in the global feed additives market. These will ensure annual growth in the sector of up to 7% for the foreseeable future.

Additionally, in August 2015, one US trade analyst predicted the probiotics global feed additives market to rise as high as $4.4 billion by 2019.

Merial, Georgia Tech to work on internet-connected technology

by JosEph hArvEy

Merial has joined a multi-year academic partnership to explore the use of connected technologies in homes, cars, veterinary clinics or farms.

The US branch of the French firm has partnered with the Georgia Institute of Technology’s Center for the Development and Application of Internet-of-Things Technologies (CDAIT). The two partners are aiming to understand the potential for use of connected networks such as the internet, radio frequencies and other forms of transmission in the animal health sector.

While telemedicine and wearable technologies are already part of a new era of remote health management and monitoring capabilities in human medicine, the potential for connected networks in animal health is yet to be realized.

Merial said links between animals, their owners and veterinarians – as well as the analysis of the data being transmitted from animals – will not only demand more sophisticated technology but also provide opportunities for increased efficiencies and the potential to significantly improve the healthcare of animals.

The collaboration will encompass the health of food-producing animals, as well as companion animals. Merial joins the founding members of the CDAIT, which include: telecommunications specialist AT&T; mobile technology expert AirWatch by VMware; technology leaders Cisco, IBM and Flex; electronics group Samsung; tools and electronics company Stanley Black and Decker; and information technology business Wipro.

The Internet-of-Things and the incorporation of Big Data is a fledging trend in the animal health industry. However, the importance of connected technologies is beginning to emerge and could be a major animal health market within the next 10 years.

Earlier this month, US sensor technology company AGL entered into a strategic marketing alliance with Hill’s Pet Nutrition to share information on its new smart canine analytics system Vetrax.

In June 2015, Kansas City start-up FitBark said it secured a deal with US retailer Target to sell its FitBark activity monitor for dogs.

While later in August of the same year, US companion animal diagnostics company PetPace launched its dog and cat health monitoring collar which showed the device could accurately record a pet’s changing temperature to inform vets what treatment would be required.

Aratana debut approval set for March

by JosEph hArvEy

Aratana Therapeutics expects to receive its first US approval on March 25.

The Kansas City-based companion animal therapy specialist has filed an administrative new animal drug application with the US Food and Drug Administration’s Center for Veterinary Medicine for Galliprant, a product for the control of pain and inflammation in dogs with osteoarthritis.

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Should Aratana gain approval for Galliprant, the product will become commercially available to veterinarians in the fall of 2016. The candidate was formerly known as AT-001.

Galliprant is a new chemical entity and according to Aratana, is highly targeted – it works by binding to the EP4 prostaglandin receptor antagonist on the PGE2 pathway to block pain and inflammation.

It is over five years since Aratana was formed. In this half a decade, the firm has built a significant pipeline of pet products. While last year was a rocky time for the company’s share price, 2016 is set to be an important year for Aratana. Two more of its lead candidates – Entyce and Nocita – could also be on sale within the next 12 months.

Should all regulatory hurdles be achieved on time, then Aratana could be bringing in its first significant revenues during the fourth quarter of fiscal 2016.

Us livestock producers unaware of label changes

by JoAN MUrphy

There is a low level of awareness among US livestock producers about the country’s judicious use policies regarding medically important antibiotics, according to a new report by the Farm Foundation.

The report focuses on the findings of 12 regional workshops, held in the US by the Farm Foundation, on federal efforts to stem rising antibiotic resistance. It found livestock producers and veterinarians may not be aware of legal changes, while less than half of workshop participants were clear about changes to Veterinary Feed Directive (VFD) policies.

The US Food and Drug Administration’s (FDA) new guidelines mean some drugs will see label changes allowing only therapeutic uses and some drugs administered in feed or water will require veterinary oversight, in the form of a veterinarian’s prescription or direct administration by a veterinarian.

“Despite months of work by organizations, agencies and media outlets, many stakeholders lack a full understanding of the policies,” and this knowledge gap is “a critical barrier to successful implementation of the policies, which take full effect at the end of 2016,” said Farm Foundation president Neil Conklin.

The Farm Foundation sponsored a two-day summit in Washington, DC, to talk about the need for collaboration in promoting antibiotic stewardship with speakers from the federal government and industry.

Industry concernsBetween the antibiotic changes and the Food Safety Modernization Act, “there’s a lot hitting at the same time,” said Paul Keppy, legislative and regulatory specialist with the American Feed Industry Association. “There’s concern about exhausting currently labeled feed products before the changes come into effect and about the increased paperwork,” he said.

However, Bernadette Dunham, the FDA’s Center for Veterinary Medicine director, said she is “totally confident this will be a success story,” referring to label changes that come into effect December 31, 2016, and the revised VFD changes that become effective January 1, 2017. She said the FDA’s biggest challenge is deciding which metric to use to gauge the program’s success.

“Judging the program’s success will depend on surveillance and research but those items cost money and the US Department of Agriculture (USDA) failed to receive the $10 million requested from Congress in this year’s budget,” said Larry Granger, senior leader of the Antimicrobial Resistance Program at the USDA’s Animal and Plant Health Inspection Service.

“The USDA will be asking for another $10m in the full year 2017 budget to begin a long-term surveillance project but it is up to Congress to approve it,” he said.

“Long-term studies that chart progress in antibiotic use will be complex and cannot focus on changes in quantity of these drugs alone,” said the FDA’s William Flynn. “It will take a long time to chart these trends and that’s going to cost money,” Mr Flynn added.

In response to concerns raised during the regional workshops, Mr Flynn explained, “The FDA is likely to give a warning when it finds violations before pursuing enforcement action, unless there is a particularly egregious situation. The three-year implementation timetable is because the agency recognized the enormous task of educating producers and veterinarians on the adjustments.”

Joan Murphy is a senior editor with Food Chemical News, a sister publication of Animal Pharm.

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New global research consortium on animal health launched

By PAul HuTcHinson

A new International Research Consortium for Animal Health (IRC) has been created to coordinate global research and ultimately lead to new methods of controlling animal diseases.

The IRC builds on an existing global network on animal disease research, STAR-IDAZ, and aims to instigate new strategies on over 30 priority diseases and challenges, such as vaccine development and antimicrobial resistance.

Over €1 billion ($1.09 billion) has been initially pledged by participants – governments, research institutes, global organizations and veterinary pharmaceutical industry representatives – while the World Organisation for Animal Health (OIE) is involved as a strategic partner.

The IRC, formally launched in Brussels this week, was proposed by the European Commission following the success of STAR-IDAZ, created with just €1m of EU co-funds in 2011 and run by the UK Department for Environment, Food and Rural Affairs (Defra).

The IRC is effectively the next phase of STAR-IDAZ and is a first in the realm of animal health, with similar global research consortia in place for human health issues such as rare diseases, those behind the initiative explained to Animal Pharm’s sister publication, Agra Europe.

Comprising research funders from all continents, the IRC’s mandate is to “deliver measurable advancements in the control of animal diseases through the alignment of both public and privately funded animal health research programs around the world”.

The delivery targets are to facilitate new or improved strategies in a host of areas, including candidate vaccines, diagnostics, therapeutics and other animal health products and procedures, in addition to scientific information/tools to support risk analysis as well as disease control.

The diseases identified for initial collaboration include animal influenza, bovine TB, foot and mouth disease, brucellosis and African swine fever. Priority issues include food-borne pathogens, antimicrobial resistance (AMR) and advances in animal genetics/genomics.

IrC crucial to food securityOIE director general Monique Eloit told Agra Europe the IRC has an important role not only for food safety but also for food security, with the livelihoods and economic survival of many farmers in Africa and South East Asia dependent on keeping their livestock.

Despite the eradication of diseases such as Rinderpest, other diseases such as foot and mouth and bovine tuberculosis are still a big threat, while the growing problem of antimicrobial resistance means alternatives to antibiotics must be sought – something which Dr Eloit warned is a huge task.

Professor Ian Boyd, chief scientific advisor for Defra, added that the IRC can contribute to turning the tide in a global “arms race” with pathogens.

However, participants also acknowledged the huge research and development costs for pharmaceutical companies and the fact that new vaccines will only be developed if they foresee a return on investment.

EU Agriculture Commissioner Phil Hogan praised the IRC and said the Commission’s agriculture department (DG Agri) intends to become a participant and contribute funds.

The initial €1bn has been pledged for the period 2016-2021, with participants agreeing to coordinate research programs to address common needs and share results, based on the most up-to-date scientific knowledge. Ahead of the launch there were 14 IRC signatories from 12 countries* but this has since risen to 16 and more are expected in the coming months – with US company Zoetis having just decided to join, Agra Europe was told.

Working groupsIRC working groups of researchers will be established for each of the 30+ priority topics, to be guided by an IRC scientific committee.

These working groups will carry out research gap analyses, while the scientific committee, to be made up of independent experts, will present the gap analyses to IRC partners and advise them on how their programs could be aligned accordingly.

A scientific secretariat will also be set up to provide the working groups with literature reviews and support them in the gap analyses, as well as supporting the scientific committee and an IRC executive committee.

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*IRC signatories so far: HealthforAnimals, the global animal medicines agency; Danish National Veterinary Institute; French Agency for Food, Environmental and Occupational Health & Safety; France’s National Institute of Agricultural Research; Italy’s Ministry of Health; UK Biotechnology and Biological Science Research Council (UK); UK Department for Environment, Food and Rural Affairs; Argentina’s National Institute of Agriculture Technology; Argentina’s Ministry of Science and Technology; Canadian Food Inspection Agency (CFIA); US Department of Agriculture’s agriculture research services; Japan’s National Institute of Animal Health, National Agriculture and Food Research; International Livestock Research Institute (based in Kenya); Israel’s Kimron Veterinary Institute; and the Tanzania Veterinary Laboratory Agency.

Paul Hutchinson is a Brussels correspondent for Agra Europe, a sister publication of Animal Pharm.

plague-riddled prairie dogs offer zoonotic clues

by MALCoLM FLANAgAN

The common ground-dwelling US rodent, the prairie dog, is pointing the way to new discoveries in infectious zoonotic disease research.

Millions of prairie dogs inhabit the western states of the US and periodically suffer from the once-feared bubonic plague and are often wiped out in different grassland and desert regions.

However, recent studies by Colorado State University (CSU) researchers show prairie dogs have an amazing ability to re-populate areas where the deadly plague has struck. The researchers said the plague deaths are part of an unending cycle of disease and recovery.

As a result, scientists have concluded that the millions of plague-riddled prairie dogs are an excellent research tool for infectious animal disease spread. CSU biologists said in a recently published essay the sporadic ebb and flow of prairie dog plague is also an ideal model for the study of zoonotic diseases such as Ebola and Middle East Respiratory Syndrome.

Plague, in its virulent and fatal forms, is caused by the Yersinia pestis bacterium, which is usually spread through flea bites. Last year in Colorado, there were also a handful of human cases, including at least two deaths.

The multi-year CSU study involved trapping and testing thousands of prairie dogs across Colorado’s Pawnee National Grassland, and tens of thousands of their plague-carrying fleas.

Diseases smolderThrough their analysis of plague in prairie dogs, the CSU researchers concluded that such diseases may ‘smolder’ unnoticed in an animal population for years, rather than jump from species to species immediately before an outbreak. They also found that investigations occurring after outbreaks can be too shallow or yield false information about which host was chiefly responsible.

In essence, the research claims there is no simple transmission model for fatal zoonotic diseases like Ebola and bubonic plague. It also discovered grasshopper mice and coyotes that scavenge plague-killed prairie dogs can speed transmission of the disease by spreading the disease-carrying fleas.

A plague outbreak in a prairie dog colony might go unnoticed for years because the animals are dying underground. Furthermore, the mechanism that drives the spread of plague during the ‘smoldering, unnoticed period’ might be different than during a full-blown epidemic.

Ecological conditionsEcological conditions come in bursts too. As regards the bubonic plague, a cool wet season is best for the pathogen to proliferate. The CSU researchers said Ebola became a pandemic due to a combination of factors, including exposure of the virus in densely populated urban centers with little access to health care and sanitation. Similarly, the plague in medieval Europe spread due to things like concentrations of people living with animals. In other words, the pathogen was given a pathway to persist.

In the case of Ebola, the CSU scientists argue that the sampling of fruit bats after human outbreaks may have resulted in biased subsequent investigations towards bat-Ebola virus ecology and other possible host species may have been overlooked.

The researchers hope their study leads to better measures for modeling and predicting infectious disease transmission but there are still open questions about the human-wildlife interface of disease.

CSU researcher Dr Daniel Salkeld said: “The swirl of ecological factors driving plague outbreaks in prairie dogs can lend key insights into the study of zoonotic diseases. Such diseases, among them Ebola, which swept

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through West Africa in 2014, are notoriously hard to study. Their outbursts are sporadic at best, making their spread trajectories elusive.

“Bubonic plague is deadly – it’s not like the common cold. It kills its host. It affects different hosts, including rats, prairie dogs and grasshopper mice. It is reasonably rare to watch an outbreak, and doing so can give us insight into other zoonotic diseases.”

IDEXX saves best for last with bumper Q4

by JosEph hArvEy

US diagnostics firm IDEXX Laboratories reported a 15% year-on-year uplift for its animal health division in the fourth quarter of 2015.

The Westbrook, Maine-based business posted Q4 sales of around $369.4 million for its companion animal and food animal segments.

The firm’s core companion animal business saw sales grow 18% to $336m in Q4, while food animal diagnostics saw a 9% decline to $33.4m.

IDEXX said organic companion animal growth for the quarter was 13%. This was driven by 12.5% growth in recurring diagnostic sales – largely due to IDEXX VetLab consumables – as well as a 28% increase in revenues from instruments. The company also benefitted from an 11% hike in revenues from its reference laboratory and consulting services, particularly in the US.

The food animal division suffered from lower livestock services revenue in Australia and lower Europe bovine sales.

Full-year strengthAt the nine-month stage of 2015, IDEXX’s sales growth was 7%.

The strong fourth quarter has helped the company record a full-year increase in animal health revenues of 9% to $1.48 billion. This will maintain IDEXX’s position as the seventh-largest company in the animal health industry.

Over the 12 months, the firm’s companion animal business grew approximately 11% to $1.36bn. Its food animal segment saw sales drop 10% to $127.1m.

sedivue set for success?Jonathan Ayers, IDEXX chairman and chief executive, pinpointed the company’s new SediVue analyzer as a potential driver of growth in 2016.

“SediVue is a breakthrough innovation that helps improve accuracy and streamlines workflows of a historically challenging manual process involving microscopic interpretation,” he said. “SediVue presents veterinarians with a huge opportunity to enhance the quality of patient care while simultaneously helping to drive practice revenue growth and staff efficiency.

“Working in concert with chemistry and hematology, urinalysis forms the essential third pillar of the minimum diagnostic database in pet care.”

Abaxis sales drop 6% in third quarterby sIAN LAzELL

US diagnostics specialist Abaxis has reported revenues of $40.9 million for its veterinary division in the third quarter of its fiscal 2016, down 6% from $43.4m in Q3 2015.

The firm suffered from a change in distributor to the veterinary market. However, sales in the nine months ended December 31, 2015, looked considerably better, totalling $131.08m. The figure represents growth of around 8% from the $121.45m recorded during the nine months ended December 31, 2014.

Abaxis’ performance in Q3 2016 is a deterioration from its second quarter, when it saw an 11% hike in veterinary sales. However, over the next few months the Californian firm could be set to benefit from its distribution deal with Banfield Pet Hospital, which claims to be the largest general veterinary practice in the world.

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Clint Severson, chairman and chief executive of Abaxis, said: “Unit sales of our higher margin medical and veterinary reagent discs increased by 12% over last year’s third quarter. These results reflect continued strength in our portfolio of consumable products.

“We also expanded our growth opportunities in the veterinary market. In the third quarter of fiscal 2016, we entered into a five-year supply agreement with Banfield Pet Hospitals to provide our VetScan hematology analyzers and associated consumables to all of Banfield’s more than 900 pet hospital locations, with installation and training to begin late in our fourth quarter of fiscal 2016.

“ Our solid earnings results reflect continued strength in our operating margins and were also supported by a lower effective tax rate for the third quarter of fiscal 2016 due to the reinstatement of the federal research and development tax credit.”

Mr Severson added: “ While the results for last year’s comparable quarter was very strong due to the Ebola crisis and the impact of our new distributor partners in the veterinary market, we remain focused on continuing to grow our business in a cost efficient manner.”

Kindredbio gains positive cat weight data

by JosEph hArvEy

US pet therapeutics specialist Kindred Biosciences has received positive results from a pilot field study of its drug candidate for weight loss in cats.

The randomized, single-blind, placebo-controlled trial enrolled 32 cats. During the study, 16 cats received KindredBio’s KIND-010, while 16 cats received a placebo. The objective was to demonstrate the effectiveness and safety of KIND-010 for the stimulation of weight gain in cats under clinical conditions.

After two weeks, the mean weight of cats in the KIND-010 group was 4.32kg. This represented an increase from day one of 3.25%. The mean weight of the cats in the placebo group was 3.98kg after two weeks – a 1.65% decrease in weight compared to day one.

A pivotal effectiveness study for KIND-010 for the management of weight loss in cats is over halfway enrolled, which puts it ahead of schedule. This will be a randomized, double-blind, placebo-controlled study. It will enroll a minimum of 200 cats (100 KIND-010/100 placebo) to assess the mean percentage change in body weight from day one to week two.

San Francisco-based KindredBio conducted a pre-specified, interim sample-size reassessment after more than 100 cats were enrolled and it determined the original sample size does not need to be increased.

After shifting its pipeline strategy in November 2015 to focus on biologics and equine products, KindredBio has realigned its workforce accordingly, introduced new scaffold technology and also moved a step closer to the approval of KIND-012, which is designed for the control of pyrexia in horses.

hester poultry vaccines drive 10% growth

by sIAN LAzELL

Indian animal health firm Hester Biosciences has reported 10% year-on-year growth in the third quarter of its fiscal 2016.

Third-quarter sales totalled INR241.77 million ($3.57 million), driven primarily by the company’s poultry vaccines portfolio. In Q3 2015, Hester recorded sales of INR218.83m.

Hester’s net profit totalled INR47.58m in Q3 2016, compared to the INR33.71m recorded during the same time last year, representing growth of 41%.

For the nine months ended December 31, 2015, Hester reported net sales of INR727.11m – a 9% increase from the INR666.76m posted in the corresponding period of fiscal 2015.

Net profit for the nine months totalled INR137.18m – up 31% from the INR104.55m recorded for the nine months ended in 2014.

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Hester said: “With poultry vaccines still being the primary contributor towards sales, the recent slump in the poultry industry impacted the sales of poultry vaccines and health products.

“Poultry meat and egg producers were unable to recover their production costs thereby resulting into decrease in the poultry population across the country. The situation has considerably improved since mid-December 2015 and the industry is back on an upswing.

“Large animal vaccines and health products together have grown by 33% cumulatively in nine months as compared to last year. Exports are growing faster than the forecasts. Our current imperative is to increase the sales contribution of the large animal divisions, thereby having a balanced top line.”

The company launched its large animal vaccines division in September 2015. The large animal vaccines opportunity in India is estimated to have a growth rate of 15-20%.

global feed output close to one billion tons

by MAX grEEN

Global production of animal feed narrowly missed out on breaking the one billion-ton mark in 2015, as a slowdown in China offset some of the gains seen in other parts in the world.

Results from Alltech’s latest Global Feed Tonnage Survey revealed production edged up by around 1.5% last year to reach an estimated 995.5 million tons.

Alltech said global production has risen by 14% since 2011, although the company’s chief innovation officer Aidan Connolly said estimates are now far more accurate than when the first survey was published five years ago.

While China remained the world’s top producer with output of 179.93mt, this marked a 2% on drop on the previous year. The decline continues the trend reported in last year’s Alltech survey, when Chinese output fell 4% year-on-year.

“We are continuing to see a growth in meat consumption in China but this is not necessarily being reflected in feed production,” said Mr Connolly, who headed up the initiative to conduct the survey.

Meanwhile, a 2.5% rise in US production saw the country produce 172.73mt, closing the gap on China.

Expansion in IndiaBrazil saw production rise by 2% to reach 68.7mt, while Mr Connolly said one of the biggest stories of the survey was the rapid growth seen in India – up over 7% this year on the back of a 10% increase in the previous survey.

While the figures showed production in Europe up by an impressive 22%, most of this increase came from Russia, Turkey and Belarus – while Poland was the standout performer among EU member states.

Production in the Middle East was up 17% at 21.44mt, while gains in Africa and Latin America stood at 5% and 3% respectively. Despite the downturn in China, production for the Asia Pacific as a whole was 4% higher than the previous year while North America remained flat.

poultry leads the wayBroken down by species, the survey shows growth was once again driven by the poultry sector. At 463.69mt, poultry feed production was up by almost 6% when compared to 2014. As a result, feed for broilers, egg layers, turkeys and other fowl now accounts for 46% of all the feed manufactured globally.

In contrast, pig feed production was down 2% on year at 235.5mt, partly due to losses caused by animal diseases. Production of feed for ruminants gained 3% to reach 201.3mt driven by growth in dairy.

Aqua feed output surprisingly shrank by 5% on year, although Mr Connolly said this was largely due to developments in China where more than half of all aquaculture is concentrated. Outside of China, the figure seems to relate to more accurate data collection and not a specific decline. Equine feed, at 8.22mt, declined 2% compared to 2014, while pet food was up 4% on year at 22.59mt.

Consolidation continuesThe report also notes continued consolidation in the industry as production is concentrated into a smaller number of large production facilities. This is partly led by the drive for economies of scale but in countries such as China, it also reflects the government concerns over feed and food safety.

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“We do still see mills that produce two or three thousand tons a year but are increasingly seeing feed mills in places like Brazil and the US that produce hundreds of thousands of tons of feed or even a million tons coming through a single feed mill,” he noted. In these large mills, he said the cost of transforming raw materials into feed could be as low as $5 to $6 dollars a ton.

Alltech said the overall value of feed production in 2015 fell slightly to around €450 billion ($486 billion) due to lower raw material prices.

Max Green is Meat and Livestock editor for Agra Europe, a sister publication of Animal Pharm.

Coalition to support new fish products

by MALCoLM FLANAgAN

A new European organization has been established to support the creation of more veterinary products in the growing global aquaculture sector.

The FishMedPlus Coalition is composed of organizations and institutions active in the aquaculture sector. It was established in December 2015 with the aim of increasing the availability of authorized veterinary medicinal products for aquaculture within the EU and European Free Trade Association countries.

The organization believes a lack of medicinal products, including vaccines for aquaculture, is a serious constraint on the prevention and treatment of disease. This dearth in medicines will also lead to welfare problems as well as hamper the growth of the European aquaculture sector.

The coalition has been formed for a three-year period and will apply a three-step working approach.

First it will carry out gap analysis to investigate which products are needed on the market now and in the future. Secondly, the coalition will investigate the barriers and solutions to the availability of new products, including environmental risk assessment.

Lastly, FishMedPlus will explore ways to stimulate availability of further treatments for aquaculture animal diseases.

The coalition is chaired by Dr Peter Jones on behalf of the Federation of Veterinarians of Europe and consists of 10 experts from the aquaculture industry, academia, regulatory authorities, legislators, the animal health industry and the veterinary profession.

“Innovation in medicines for minor species such as fish is of great importance to IFAH-Europe. The animal health industry has called for extension to the periods allowed for the protection of technical documentation of veterinary medicines in new EU regulations,” said IFAH-Europe, one of the partners involved in the coalition.

“This is essential for companies developing such products to have the necessary incentives to expand the range of medicines available and develop better protection against aquaculture diseases.”

The organizations involved in FishMedPlus so far are: the FVE; the Federation of European Aquaculture Producers; the University of Stirling; the World Aquatic Veterinary Medical Association; IFAH-Europe; the University of South Bohemia Faculty of fisheries and protection of waters; the European Association of Fish Pathologists; the Ludwig Maximilian University of Munich (Fish Diseases and Fishing Biology Dept); and the Institute for State Control of Veterinary Biologicals and Medicines (Czech Republic).

One of the most notable events in the animal health industry last year was the acquisition of leading Norwegian aquaculture veterinary products specialist Pharmaq by market leader Zoetis. The event was described as a ‘coming of age’ for the aquaculture veterinary products industry. In fact, deals involving aquaculture targets were key to a boom year for animal health M&A.

bbrsC sets out its vision for the future

by MALCoLM FLANAgAN

Leading UK veterinary science research funder, the Biotechnology and Biological Sciences Research Council (BBSRC), has published its strategy for domestic animal and plant health research to 2020 and beyond.

This research strategy ‘A Vision and high-level Strategy for UK Animal and Plant Health Research To 2020 and Beyond’ has been developed with input from government, academia and industry.

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The Swindon-based BBSRC said by 2020 the UK will have created and harnessed new research knowledge and technology that will transform our ability to systematically predict, detect and understand key current UK animal and plant health problems and emerging threats in real-time.

At the same time, it will direct sophisticated and rapid responses to effectively and efficiently prevent and mitigate impacts on agri-environment and wider ecosystems and landscapes.

In parallel, the BBSRC said it will have created the optimal innovation environment for developing and trialing new interventions, stimulating inward investment and the development of new products and services through small and medium-sized enterprises and large national and multinational companies.

The BBSRC said there are compelling economic, social and environmental drivers for a more robust and concerted UK response to animal and plant health challenges, which are of critical importance to protecting and enhancing the UK’s prosperity and wellbeing. An integrated, whole-system approach to animal and plant health science is needed, and the research strategy details key opportunities to develop such an approach.

Professor Jackie Hunter, BBSRC chief executive, said: “There are urgent challenges posed by animal and plant health problems and new threats to the UK’s agriculture and wider environment, which have major implications for UK society and beyond.

“This vision and high level research strategy gives the key UK public research funders and policy makers, for the first time, a much needed framework within which to work together in partnership, and with our wider stakeholders, to nurture and direct the UK’s research capabilities to tackle these issues more effectively and efficiently.”

The full BBSRC report can be read here. The BBSRC budget for 2014-2015 was £509 million ($727 million). Some £459m was spent on research and capital grants with £50.5m allocated for training and fellowships.

vICh speeding up New zealand vet approvals

by MALCoLM FLANAgAN

New Zealand’s veterinary products body Agcarm is urging its members to take a greater interest in speeding up approvals for animal health products through its observer membership to the Veterinary International Conference on Harmonization (VICH).

Agcarm chief executive Mark Ross recently said bringing a veterinary medicine product to market in New Zealand is expensive and time-consuming. He said veterinary research and development programs in the country can cost millions of dollars and take between five to 11 years to complete.

Mr Ross said to be efficient, the veterinary regulatory process needs greater transparency as well as an increase of internationally accepted standards amongst New Zealand’s regulators. One way of doing this is by simplifying the regulatory process to create a universal framework for researchers and developers, allowing faster, more efficient approval of beneficial animal medicines.

To do this New Zealand is being encouraged to utilize its membership to the VICH. The trilateral VICH was conceived in 1996 as a fall out from the human medicines forum, the International Council of Harmonization, and is a program of collaboration between governments and animal health industry groups.

observer roleFull VICH members include the US, the EU and Japan, with secretarial support provided by the Brussels-based industry body HealthforAnimals.

New Zealand has an observer role at the VICH via the country’s Ministry for Primary Industries, along with Canada, South Africa and Australia. Due to the significance of regulatory harmonization VICH is also reaching out to a number of developing countries.

“Agcarm’s role on VICH should be to represent our industries views at the global decision table. With greater emphasis on the quality, safety and efficacy of veterinary medicines, VICH is becoming more important today than ever before as a coordinated means to facilitate the global registration of veterinary medicinal products, while establishing and maintaining consumer confidence,” said Mr Ross.

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“There are few industries in New Zealand that have the opportunity to engage with and influence global regulators, and meet with fellow international industry groups. With the current strong drive for greater cooperation when it comes to animal health, playing our part is more important than ever. Although complex, the VICH framework is allowing this to happen, with global coordination driving the way forward.”

The VICH recently met in Tokyo, Japan, and set out a number of priorities in the run up to 2020. Through its steering committee, the VICH delegates from 23 countries stressed the importance of global regulatory convergence for the animal health sector for the next five years. Some 189 participants took part. It was the 32nd meeting of the organization.

Jaguar secures equine proof-of-concept results

by JosEph hArvEy

US firm Jaguar Animal Health has gained largely positive results from a proof-of-concept study to evaluate safety and effectiveness of its new drug candidate.

SB-300 is for the treatment of gastrointestinal ulcers in horses. In a prospective, blinded, randomized, negative controlled study, both standardbred and thoroughbred racehorses were randomized to one of three groups (with 10 horses in each group). The horses were treated for 28 days.

Horses in the placebo group received water-filled syringes every six hours and horses in the TRT5 group received five grams of SB-300 divided into two doses per day. The horses in the TRT40 group received 40 grams of SB-300 divided into four doses per day.

San Francisco-based Jaguar said strict enrollment criteria required patients to have both squamous and glandular gastric ulcerations. All of the horses were examined prior to treatment, day 14 (mid-way through the study), day 28 (last day of treatment) and day 35 (seven days after the last treatment).

The company noted: “With respect to glandular ulcerations, a statistically significantly greater number of horses in both the TRT40 (89%) and the TRT5 (78%) group had an improvement or a resolution of glandular ulcerations, compared with the placebo (25%) group as soon as day 14.

By day 35, all of the SB-300 treated horses had experienced improvement or resolution. However, 75% of horses in the placebo group had also shown improvement.

For squamous ulcerations, “a non-statistically significant dose-dependent effect was observed with 40% and 33% of horses achieving an improvement or a resolution by day 14 in the TRT40 and TRT5 groups, respectively, compared with 11% of placebo horses”. By day 35, more horses in the TRT40 (60%) and TRT5 (55%) groups witnessed an improvement or a resolution compared with 33% of placebo horses.

The firm will release additional findings from the study after further analysis.

Jaguar is currently in the process of raising funds to support its ongoing R&D projects.

Cargill opens feed technology center in Turkey

by MALCoLM FLANAgAN

US animal nutrition specialist Cargill has expanded its operations in Turkey with the opening of a feed technology center in Izmir.

The Minnesota-headquartered company said the $2 million investment in the technology application center (TAC) will help customers in Turkey, the Middle East and Africa leverage and apply the latest global feed technology.

The new TAC further strengthens Cargill’s presence in the region following a 2015 deal in which the firm acquired a majority stake in Ekol Gida, a leading company operating in premix and feed additives markets in Turkey.

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The new Izmir TAC was created through a partnership with an existing commercial dairy farm owned by the Egesay Animal Agriculture Food Industry and Trade Company. The project will first concentrate on customized solutions relating to ruminants. A poultry center is scheduled to be constructed and operational by the end of 2017.

Scott Ainslie, global strategic marketing and technology director for Cargill’s animal nutrition business, said: “Severe climate and the availability of raw materials are significant challenges for dairy and poultry customers in Turkey, the Middle East and Africa.

“This new TAC will enable Cargill Animal Nutrition R&D and applications teams to evaluate and test Cargill global technology under local conditions, such as heat stress. Ultimately, our TACs allow us to more quickly deliver new products and services in the region, marketed under the Provimi brand, that meet the specific requirements of our customers for their locations.”

In November 2015, Cargill opened its largest overseas animal nutrition plant in the north-east of South Korea. In September 2015, the company announced it had tripled its feed capacity in Mexico. In August of the same year, Cargill bought into the salmon feed market with the purchase of Norway’s largest aqua feed specialist EWOS.

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