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Ceva reinforces vaccine capabilities with Biovac purchase

BY JOSEPH HARVEY

Ceva Santé Animale has acquired Biovac Laboratories, a French firm specializing in autogenous vaccines, allergy treatments and reagents.

The move not only strengthens Ceva’s vaccine portfolio but furthers its strategy to build its offering of antibiotic alternatives. Financial terms of the acquisition were not disclosed.

According to Ceva, Biovac has experienced double-digit growth for several years due to increased demand from veterinarians for alternatives to control bacterial conditions. Biovac’s particular area of expertise is microbiology, which allows it to provide custom-made solutions for vets.

Biovac develops autogenous vaccines for pigs, poultry, fish, horses, rabbits and dogs. The company, which is headquartered in Angers, said around 15% of its revenues is allocated to R&D through in vitro and in vivo research.

Autogenous vaccines are produced with pathogenic micro-organisms isolated from sick animals. These micro-organisms are then re-administered to this animal or other animals from the same herd.

Libourne-based Ceva already offers this type of customized vaccine approach to the poultry and swine industries. The company said its custom vaccines can be produced and prescribed by the veterinarian in four to five weeks, “creating an extremely reactive and precise service for livestock producers”.

The firm’s chairman and chief executive, Dr Marc Prikazsky, said: “As a veterinarian, I know how disappointing it can be to make a diagnosis and then not have the precise tool necessary to control the disease. Biovac provides an extraordinary service to the veterinarians in France.

“Through this partnership, we will share all our expertise in vaccine production and new technologies, so that together we can provide veterinarians in new markets with an even better service.”

Ceva building core businessThis is Ceva’s third acquisition of 2016. In February, the company entered exclusive negotiations to merge its hatchery automation business with French firm iD Projects. A month later, Ceva broke into the Indian market after purchasing Indian business Polchem.

The company is building on its expertise in the vaccine space, as well as its know-how in developing nations, to continue its recent strong sales growth. Ceva’s goal is to become a global top five player in the animal health sector by 2020 – an aspiration it intends to achieve by harnessing next-generation vaccine technology and providing viable antibiotic alternatives.

Earlier this year, Dr Yannick Gardin, the company’s director of science and innovation, told Animal Pharm innovation in vet vaccines will come on a molecular level.

Autogenous vaccines is a hot spaceThis is the third acquisition of a company specializing in autogenous vaccines during the last six months – a clear sign of the value custom vaccines bring to already-established veterinary vaccine players.

In January, Phibro Animal Health bolstered its core offering of vaccines by purchasing fellow US company MVP Laboratories, which produces the MJPRRS autogenous swine vaccine for porcine reproductive and respiratory syndrome.

Last year, German firm IDT Biologika agreed to acquire Gallant Custom Laboratories, a Canadian manufacturer of autogenous viral and bacterial vaccines.

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Aratana’s commercialization plan: ‘It’s not about big versus small’

BY JOSEPH HARVEY

It has already been a noteworthy year for Aratana Therapeutics – the firm now has two US product approvals from the FDA and a major licensing deal under its belt. Animal Pharm editor Joseph Harvey spoke with the company to find out what else lies ahead for the firm in terms of commercialization.

Aratana Therapeutics’ first two US product authorizations were for new chemical entities – something unheard of in animal health.

“In the last five years, there have only been four new chemical entities approved in the US for companion animals, excluding antiparasitics,” explained Steven St. Peter, president and chief executive of Aratana.

Not only were the recently-approved products entirely new innovations but they also passed through the US FDA’s chemistry, manufacturing and controls technical section process in a single cycle for the first and after an abbreviated 60-day second cycle for the second – an achievement Dr St. Peter called “unprecedented”.

He said the company’s success so far in 2016 “reflects the Aratana team’s knowledge of the industry and the regulatory framework”.

“Working with the FDA was really positive. It’s good to have clear guidelines, feedback and articulated timelines,” he noted.

Elanco deal part of wider Aratana strategyEarlier this year, Kansas City-based Aratana sealed a licensing deal with Elanco for Galliprant – a treatment focused on the control of pain and inflammation associated with osteoarthritis in dogs. However, this type of collaboration will not necessarily be Aratana’s blueprint going forward.

Dr St. Peter explained: “We look at our portfolio and we ask ‘Is it a specialist product?’ or ‘Does it have relevance to the primary care vet?’ – then we choose the market strategy. For Galliprant, it is perfect to work with Elanco.”

He said Galliprant will have high relevance to primary care vets and lower significance to specialists. In order to reach the thousands of primary care vets in the US and to effectively deal with the competition, Aratana needed Elanco’s helping hand with a co-promotion and distribution deal.

When explaining Aratana’s relationship with Elanco and the larger animal health firms, Dr St. Peter commented: “It’s not about big versus small. We are different companies. We all work in the same ecosystem. Under the right scenarios, we will work with the larger companies.”

He noted Elanco’s parent Eli Lilly has a history of partnering with biotechnology companies in the human health sector and praised the group’s ability to adopt this in the animal health space.

On the other hand, Aratana’s second approved product will take a different commercial path to the US market. Entyce, an appetite stimulant in dogs, has immediate relevance to veterinary specialists in addition to the high adoption that Aratana expects from primary care veterinarians.

Aratana will adopt its own direct sales route and work with independent distributors for this product. The firm believes that because inappetence is not a competitive therapeutics category, it can succeed with Entyce without the early involvement of a larger player.

Dr St. Peter said this is why the company has decided to commercially launch Entyce in conjunction with the North American Veterinary Conference in February 2017. This nine-month period will allow Aratana the time to ramp up supply chain, manufacturing, packaging and other necessary processes.

“We’ve had a plan since we started the company and now we are just executing the plan,” he told Animal Pharm. “We are moving from a central organization to one with representatives all around the country.”

More licenses and studies in 2016The next product approval for Aratana will be its Nocita (bupivacaine liposome injectable suspension) long-acting local anesthetic, designed to provide up to 72 hours of post-operative pain control in dogs. The product candidate was licensed from Pacira Pharmaceuticals in December 2012.

Aratana expects to receive its technical section complete letter for CMC from the FDA for Nocita this month, which will allow Aratana to submit Nocita for approval. If approved, Nocita’s launch is expected in late 2016. Under Aratana’s commercialization strategy, Nocita represents more of an opportunity for veterinary specialists, rather than those in primary care. Therefore, the company will adopt direct sales tactics.

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The company is also hoping to secure US conditional licensure from the USDA for AT-014 – a canine osteosarcoma vaccine licensed from Advaxis. Last month, Advaxis received an FDA Fast Track Designation for its human cancer immunotherapy candidate.

Another product in Aratana’s pipeline is AT-016 – an adipose-derived, allogeneic stem cell product exclusively licensed from VetStem Biopharma, for the treatment of osteoarthritis pain in dogs. Dr St. Peter said the candidate should enter a pivotal efficacy study this year. In 2015, VetStem garnered positive results from a dose confirmation study of AT-016.

Additionally, Aratana will be carrying out feline inappetance studies for AT-002 (which became Entyce for dogs) this year.

In 2017, the company will work on establishing its commercialized brands. “We expect to have high visibility in vet clinics during 2017,” Dr St. Peter noted.

He previously told Animal Pharm that Aratana’s success should be measured against its profitability. However, Dr St. Peter also suggested there will be a lack of investor interest in the companion animal therapeutics space until commercial success is proved by one of the sector’s trailblazers.

“We want to carry the torch for the smaller animal health companies,” he said, adding: “Our goal is to remain an independent leader in pet therapeutics.”

Europe becomes Alivira’s biggest market as M&A trail leads to Spain

BY JOSEPH HARVEY

Indian firm Alivira Animal Health is to acquire a majority stake in the Karizoo Group, a Spanish family-owned developer and distributor of food animal products.

Not only does the deal make the European market Alivria’s biggest sector but it also strengthens the company’s presence in Latin America by providing it with entry into Mexico.

This acquisition also grows Alivira’s annual revenues up to $120 million – enough to put it in the top 30 rankings of global animal health businesses.

Under the terms of the purchase, Alivira will own a 60% stake in Vila Vina Particpacions, which owns Karizoo as well as feed additive specialist Phytosolutions Spain, Covivet Spain and Karizoo Mexico. The deal will be made through Alivira Ireland, a wholly-owned subsidiary, and is expected to close in July 2016.

Karizoo was founded by the Vila family in 1983 near Barcelona. The company is focused on antibiotic products for livestock and in fiscal 2015 recorded sales of €29.1m ($32.5m). Karizoo sells products in 14 countries including Spain, Poland, Belgium, the Netherlands, Sweden, Germany, the UK, Mexico and Iran.

The firm has 12 marketing authorizations in Spain, 65 in rest of EU, 25 in Mexico and 15 in the Middle East/North Africa region. These products are all produced at Karizoo’s EU-GMP manufacturing facility near Barcelona.

Alivira claims Karizoo also has a pipeline of three products under registration in the EU, while 25 products are under development in the areas of anesthetic gas, oral solutions, oral powders, oral suspensions and drug premixes.

Strides’ grand plan unfoldingMumbai-based Alivira is owned by SeQuent Scientific, which itself is part of the Strides Group.

Strides has previously said it aims to develop a leading veterinary medicine business by 2020 through the acquisition of animal health firms in the US, Brazil and Australia. So far deals have been secured in Europe, Brazil, India and Turkey. Alivira is set to become the world’s first truly global Indian animal health firm.

The firm said: “Alivira now has a strong formulation business in the key veterinary markets of Europe, India, Turkey, Latin America, Africa and South East Asia.

“The recently established, state-of-the-art active pharmaceutical ingredients facility at Vizag makes Alivira one of the few integrated players in the global animal health space. The facility has already commenced supplies to Europe and the first filings for the US market have also been completed.”

Vizag, also known as Visakhapatnam, is the largest city in the Indian state of Andhra Pradesh.

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Bayer signs Canadian R&D deal for mastitis vaccine

BY SIAN LAZELL

Bayer Animal Health and Canada’s Université de Sherbrooke have agreed a strategic licensing deal for the development of a novel vaccine candidate for mastitis.

Bayer signed the global license agreement with TransferTech Sherbrooke – the corporate body responsible for commercializing innovations from the university and its affiliated institutions – for the development of the vaccine to treat mastitis caused by Staphylococcus aureus in dairy cows.

The license agreement will see Bayer develop and commercialize the vaccine from technology and intellectual property from TransferTech Sherbrooke.

Mastitis is the most common disease affecting dairy farms globally. Around 10-15% of clinical mastitis infections are caused by S aureus. In addition to affecting cow health and welfare, mastitis can also prove costly to producers and is associated with milk loss, lower milk quality and productivity, and increased veterinary care and labour.

The FAO previously estimated up to 895 million people directly depend on dairy farming.

Professor Jacques Beauvais, vice president of research, innovation and entrepreneurship at the Université de Sherbrooke, said: “In North America, it is estimated that the economic losses related to mastitis can reach $2.4 billion annually, representing about 11% of the total milk production from more than 10 million cows. An effective vaccine that could help protect dairy cattle from S aureus mastitis would make a welcomed difference to dairy farmers around the world.”

There are two commercially available S aureus bovine mastitis vaccines, including Lysigin from Boehringer Ingelheim Vetmedica in the US. Spanish firm Hipra sells Startvac in Europe and Canada – an inactivated vaccine against bovine mastitis.

Bayer firming up animal health positionIn recent weeks, there has been talk of Bayer selling its animal health business to back its proposed acquisition of Monsanto.

However, the German firm has revealed it is committed to keeping and growing its animal health branch, something which is evidenced by its agreements with both TransferTech Sherbrooke and biotech specialist BioNTech.

Elanco’s onsior pain therapeutic approved for US dogs

BY JOSEPH HARVEY

Elanco has gained the first US approval for the use of onsior to control post-operative pain and inflammation associated with soft tissue surgery in dogs.

The oral therapeutic’s active ingredient is robenacoxib and comes in tablet form. The tablets contain 10mg, 20mg or 40mg of robenacoxib, depending on the dog’s body weight, and are indicated for the treatment of dogs over 2.5 kg in weight and over four months of age, for up to a maximum of three days.

Elanco launched an injectable version of onsior for cats in the US last year. This was for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats up to four months old. The injectable version of onsior is not available for dogs in the US.

Prior to its merger with Elanco, Novartis Animal Health received US authorization of the tablet version of onsior for cats during 2012.

In Europe, onsior was launched by Novartis for dogs and cats in 2009. At the time, it was the first coxib non-steroidal anti-inflammatory drug for pets. Both tablet and injectable versions are available in Europe.

Pain market bloomingCompanion animal pain is becoming an area of great interest in the animal health space.

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According to US firm Aratana Therapeutics: “There is no single protocol for the use of pain medications in veterinary surgeries, and pain management practices have traditionally been based on the veterinarian’s perception of the level of pain associated with a specific surgical procedure and the perceived pain tolerance of the pets.”

There is currently a need for new, longer-acting local anesthetics for pets that have undergone painful surgery. Animal Pharm previously analyzed the market opportunity for new pet pain therapeutics, while a survey of US-based veterinarians by investment firm William Blair has previously stated feline pain was one of the largest unmet needs in animal health.

Earlier this week, Aratana completed the technical section for the chemistry, manufacturing and controls of Nocita, which is being developed to provide local post-operative analgesia for cranial cruciate ligament surgery in dogs.

Earlier this year, Aratana sealed a licensing deal with Elanco for Galliprant – a treatment focused on the control of pain and inflammation associated with osteoarthritis in dogs. Another product in Aratana’s pipeline is AT-016 – an adipose-derived, allogeneic stem cell product exclusively licensed from VetStem Biopharma, for the treatment of osteoarthritis pain in dogs.

In May, Nexvet Biopharma said it aims to commence a pivotal efficacy and field safety study this year for NV-02, a candidate therapy to control pain associated with feline osteoarthritis.

Earlier this year, US firm Centrexion Therapeutics acquired three analgesic candidates from Boehringer Ingelheim. The company’s chief veterinary officer, Dr Peter Hanson, told Animal Pharm: “The need for pain drugs based on new mechanisms of action applies to animals as much as it does for humans. Further, non-addictive, non-opioid drugs are also important to reduce the risk for potential diversion and human abuse of such products.”

Zoetis data backs canine dermatology treatment efficacy

BY SIAN LAZELL

Zoetis has presented data at the 8th World Congress of Veterinary Dermatology (WCVD) that supports the efficacy and safety of its interleukin-31 (IL-31) canine atopic dermatitis immunotherapeutic.

The firm carried out a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of Lokivetmab, which inhibits the canine cytokine interleukin-31, in relieving clinical signs of pruritus (itching) and other clinical signs associated with atopic dermatitis in dogs.

Veterinary experts at 15 clinics enrolled 245 client-owned dogs with chronic atopic dermatitis. Dogs were treated with Lokivetmab or a placebo, administered by subcutaneous injection on day 0, and evaluated periodically over 56 days.

Owners assessed their dog’s pruritus using a visual analog scale (VAS) and investigators assessed associated skin lesions using Canine Atopic Dermatitis Extent and Severity Index-03 (CADESI-03) scores.

In both owner and clinician assessments, one subcutaneous injection of Lokivetmab demonstrated improvement in pruritus for four to six weeks in dogs with atopic dermatitis.

Safety resultsZoetis also assessed the safety of Lokivetmab at a dose of 1-3.3 mg/kg in the treatment of canine atopic dermatitis.

Veterinarians evaluated 245 client-owned dogs with chronic, naturally-occurring atopic dermatitis. Dogs were randomized at a 2:1 ratio to receive two monthly injections of Lokivetmab (162 dogs) or a placebo on days 0 and 28.

Data showed no immediate hypersensitivity reactions were observed and there were no clinically important differences in clinical pathology results. Reported adverse reactions to the product were similar to those of a placebo.

In addition, no apparent adverse drug interactions were reported. The dogs involved were taking a wide variety of medications, which Zoetis noted as important because multimodal therapy is commonly prescribed for dogs with atopic dermatitis.

Interleukin insightZoetis also presented data at the WCVD (held in Bordeaux, France) that it said provided new insight into the role of IL-31 in pruritus in dogs.

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Researchers identified the IL-31 receptor protein in skin and nerve tissues in dogs. They said demonstrating the presence of IL-31 receptor in both skin and nerve tissue offers a greater understanding into how this cytokine induces pruritus in dogs. Zoetis added that the finding further supports the blockade of IL-31 as a viable therapeutic approach for the treatment of pruritic skin conditions such as atopic dermatitis.

Itching is one of the most common problems affecting dogs. It can be triggered by factors such as infections, otitis, parasites and allergies. Around 15-20% of all itchy dogs are diagnosed with atopic dermatitis.

Zoetis already markets its Apoquel treatment for atopic dermatitis in the US, which was initially launched in 2014. However, Lokivetmab, which was awarded a conditional license in the US in August 2015, is the firm’s first approval for a monoclonal antibody.

Dr Douglas DeBoer, one of the presenting researchers at WCVD and professor of dermatology at the University of Wisconsin-Madison, said: “Therapeutic monoclonal antibodies are going to become important for the future. They have already been revolutionary in some human treatments.

“Around 70-80% of dogs with atopic dermatitis may benefit from Lokivetmab treatment. Monoclonal antibody therapy is a cutting-edge, unique, exciting, potentially exceptionally useful treatment in veterinary medicine.”

Earlier this year, Animal Pharm editor Joseph Harvey spoke to Zoetis about the background to its recent success in dermatology and its aspirations in this burgeoning market space.

Parnell, Merial partner for long-term contract manufacturing pact

BY JOSEPH HARVEY

US animal health company Parnell Pharmaceuticals has sealed a 10-year contract manufacturing deal with Merial for sterile injectable products.

Under the terms of the agreement, Merial will exclusively purchase certain sterile injectable products from Parnell with minimum annual purchase commitments. Merial will pay an upfront fee in return for an immediate supply of product.

Overland Park, Kansas-based Parnell estimates the total value of the arrangement to be between $7 million and $20m, depending on the volume of products purchased by Merial over the deal’s term.

This is Parnell’s first contract manufacturing deal, with more expected this year.

Robert Joseph, president and chief executive of Parnell, said: “Our business development team has been pursuing contract manufacturing opportunities to leverage the 75% available capacity we have in our facility, and this agreement with Merial generates cash flows that will contribute to our goal of seeing our manufacturing division become a profit center for us in the future. We hope to announce further contract manufacturing deals in 2016.”

Mr Joseph previously said the Merial deal will “bring in millions of dollars of revenue over several years”.

Phibro makes promotion as former CEO retires

BY JOSEPH HARVEY

US firm Phibro Animal Health has promoted Larry Miller to the position of chief operating officer (COO), as Gerald Carlson retires from the role.

Mr Miller joined the Teaneck, New Jersey-based company in 2008 from Schering-Plough, where he was vice president of the Intervet/SPAH global ruminant business. His current role at Phibro is president of animal health.

“During his eight years as president of animal health, Larry has built a strong global organization,” said Jack Bendheim, the firm’s chairman, president and chief executive.

“His leadership has been key to the success of Phibro’s sales growth worldwide. He has also been a driver of the vaccine acquisitions which are a part of Phibro’s strategic platform to bring animal health solutions to our customers.”

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Phibro has recently been offsetting a loss in revenues from medically-important antibacterials by bolstering its vaccine assets with deals for firms such as MVP Laboratories.

Carlson retiringGerald Carlson will retire after 14 years with Phibro. Mr Carlson will leave the position on July 1, 2016, but will remain as a member of the board of directors.

“During his tenure, Jerry played a critical role in Phibro’s business success,” commented Mr Bendheim. “He was instrumental to Phibro’s strategic direction and the growth of our business, programs and people. We greatly appreciate his contributions to shaping the organization.”

Mr Carlson joined Phibro as chief executive in May 2002 and was appointed COO in March 2014. He has also been a director at the company since 2008. Before joining Phibro, Mr Carlson served as the commissioner of trade and development for the State of Minnesota from 1999 to 2001.

He was previously senior vice president of corporate planning and development at Ecolab, a global provider of cleaning and sanitation products. Mr Carlson was at Ecolab for 32 years and also held several senior vice president roles.

EU approval for leishmaniasis vaccineBY JOSEPH HARVEY

Spanish firm Laboratorios Leti’s vaccine for active immunization against the canine parasitic disease leishmaniasis has gained European approval.

The vaccine protects dogs against leishmaniasis caused by the parasite Leishmania infantum. According to the European Medicines Agency (EMA), L infantum is widespread in countries bordering the Mediterranean Sea and is transmitted by the bites of sand flies.

Leti claims between 6% and 30% of dogs in the Mediterranean region have antibodies against the leishmaniasis parasite and “expected disease prevalence may reach 10% in endemic regions”.

A recent EU report indicated sandflies infected with potentially fatal canine leishmaniasis are moving up from the Mediterranean region into northern Europe.

Letifend contains protein Q as its active substance, which is made of different fragments of proteins from L infantum. The vaccine is available as a freeze-dried powder and solvent, which are both made into an injectable solution. It is a prescription-only product.

The EMA said Letifend is given to dogs from six months of age as a single injection under the skin with a booster injection recommended every year. The vaccine received a positive opinion ruling in February.

The agency added: “In a field study in France and Spain, 275 dogs were vaccinated with Letifend and 274 dogs received placebo. The dogs were exposed to natural infection with L infantum. Over a two-year period, there were eight confirmed cases of leishmaniasis in the vaccinated group compared with 19 cases in the placebo group, showing Letifend was effective in reducing the occurrence of the disease.”

Barcelona-based Leti has a veterinary medicines division that focuses on immunology and dermatology for companion animals.

Forthcoming European approvals?Other products to have received European positive opinion rulings this year but are yet to be approved include: a canine anesthetic from Chanelle; Elanco’s Clynav, a DNA vaccine to protect Atlantic salmon against salmon pancreas disease; and Eco Animal Health’s Aivlosin antimicrobial for use in chickens laying eggs for human consumption.

Aratana’s Nocita moves closer to approval

BY JOSEPH HARVEY

Aratana Therapeutics has completed the technical section for the chemistry, manufacturing and controls (CMC) of Nocita.

The product is being developed as a therapeutic option to provide local post-operative analgesia for cranial cruciate ligament surgery in dogs.

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Aratana claims Nocita (bupivacaine liposome injectable suspension) works as a long-acting local anesthetic designed to provide up to 72 hours of post-operative pain control. The product candidate was licensed from Pacira Pharmaceuticals in December 2012.

Kansas City-based Aratana pointed out that the technical section complete letter for CMC is the last of three major hurdles required to file an administrative new animal drug application for approval with the US FDA.

The firm will now finalize the product label, complete the other minor technical sections and submit the administrative new animal drug application “in the coming weeks”.

If Nocita receives the green light from the FDA, Aratana will begin commercialization in late 2016. Under the company’s commercialization strategy, Nocita represents more of an opportunity for veterinary specialists, rather than those in primary care. Therefore, the company will adopt direct sales tactics.

Cargill continues Vietnamese feed expansion

BY JOSEPH HARVEY

US agricultural leader Cargill has increased its number of animal feed mills in Vietnam to 11 as part of heightened expansion plans in the country.

The firm recently opened an $8.5 million animal nutrition plant in the Nam Cam Industrial Zone. The facility, which is based in the Nghi Lôc district of Nghê An province, will have a total capacity of 66,000 metric tons per year for livestock feed.

Cargill said Vietnam is one of its best performing animal nutrition markets and plans to build another feed mill in the country are underway. The company is constructing a $30m animal feed mill in Bình Du’o’ng province, which is expected to be completed in the second half of 2017. This site will have a total capacity of 260,000 metric tons per year.

The firm also recently spent $8m on expanding its mill in Đông Tháp province, which allowed it to increase production of specialty aquatic feed. In 2014, Cargill completed a $20m animal feed mill expansion in Bình Đįnh province. At the time, the company said it had invested more than $110m in Vietnam’s livestock and aquaculture industry over the previous last 10 years.

Jorge Becerra, country representative and managing director of Cargill’s feed and nutrition business in Vietnam, said: “In the face of a general slowdown in the Southeast Asia region, Vietnam’s economy continues to perform very well and foreign investments along with exports are on the rise. The agricultural sector is currently suffering from a terrible drought but in the long run, we see good growth potential in the industry.

“We will continue to invest in our animal nutrition business and the opening of our plant in Nghê An is testament of our commitment.”

Canadian swine association warns of border control threat

BY SIAN LAZELL

Canadian pig producer association Manitoba Pork has suggested the country’s swine industry is at risk due to dated legislation.

The organization said it is “extremely disappointed and concerned” that the Canadian government is again forcing livestock transporters to “comply with a decades-old border regulation which threatens the health of Canada’s swine herd”.

Porcine epidemic diarrhea virus (PEDV) is a disease which is nearly always fatal to piglets and has killed approximately eight million newborn pigs in the US since it first emerged there in 2013.

When PEDV first appeared in the US, Manitoba Pork and the Canadian Food Inspection Agency (CFIA) agreed to suspend Section 106(5) of the Health of Animals Regulation and launch a trailer wash pilot project, to prevent the disease spreading to Canada.

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Under an emergency protocol, the pilot project meant pig transporters returning to Canada from deliveries to US farms could have their trailers washed and disinfected in disease-free, certified Canadian facilities, instead of US facilities in regions where PEDV was “rampant”.

Manitoba Pork said the project has been extremely successful in keeping Western Canada free of PEDV. Only five on-farm cases have been detected in Manitoba since the project’s launch and all have been contained. Combined with other strict biosecurity measures, the washing protocol has proved to be an effective barrier against PEDV, despite the fact Manitoba ships around three million weanlings to US finishing farms each year.

However, the federal government is now ending the emergency protocol – something which Manitoba Pork said will remove a critical biosecurity measure from the Canadian hog industry.

As of May 2, 2016, the government demanded that livestock trailers should be washed at US facilities before crossing the border into Canada. According to Manitoba Pork, there is no evidence that such facilities will not contaminate disease-free Canadian transporters.

Prior to the government scrapping the emergency protocol introduced in 2013, Manitoba Pork said: “The government continues to ignore professional advice from practicing veterinarians, all the major swine producer groups, the chief veterinary officers of the three Prairie Provinces and swine health researchers.

“This is a crisis moment for the Canadian swine industry. Manitoba Pork is advising all swine producers in Western Canada to insist that any trailer returning from the US be properly washed and disinfected in a certified Canadian facility. Producers should assume that trailers washed only at US facilities are almost certainly contaminated with PEDV.”

It added: “On behalf of all Canadian swine producers, Manitoba Pork calls upon the federal minister of agriculture and agri-food, Lawrence MacAulay, to intervene and have CFIA commit in the next four weeks to working collaboratively with industry representatives to reduce the risk of this fatal virus devastating Canada’s swine herd. Manitoba Pork is confident that working with CFIA will result in effective resolution of this issue. Let’s work together to keep Western Canada PEDV-free.”

Manitoba Pork told Animal Pharm that since then, there has been little progress on the issue and Minister MacAulay’s response was not encouraging.

When the matter was raised in parliament, Minister MacAulay said: “It is because of the disease in the US that we are always committed to protecting animal health in Canada. That is exactly why CFIA is ensuring that trucks are washed before they come across the border into Canada. We want to ensure that we can keep the diseases out of this country, with every measure possible, as long as we can.”

Benchmark upgrades Scottish aquaculture research facility

BY MALCOLM FLANAGAN

New state-of-the-art aquaculture research facilities have been unveiled at the Ardtoe Marine Research Facility (AMRF) on the west coast of Scotland.

The enlarged research center was purchased by UK animal health company Benchmark in 2013 to complement its growing interest in aquaculture and supply knowledge to its businesses in different parts of the world.

Sheffield, Yorkshire-headquartered Benchmark said AMRF houses the latest leading-edge technology in aquaculture research and fish health. It will operate 24-hours a day, year round. The company has spent £4 million ($5.9 million) on the upgrade of the site.

Trial activities will involve a wide variety of marine and freshwater species including finfish (salmon, wrasse and lumpfish), shellfish and microalgae.

The facility will also offer training courses and complete support services to fish farmers and producers to help improve health, welfare and husbandry protocols plus production practices for key farmed species.

The site will provide in-house development services to the fish health, breeding, genetics and advanced animal nutrition divisions within the Benchmark group. It will also undertake a range of contract research and production services for industry, government and academia.

Ruth Layton, Benchmark co-founder and director, said: “With the Scottish industry’s ambitious 2020 sustainable production targets, aquaculture is poised to increase its contribution to the Scottish economy and its role in providing jobs in remote communities.

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“Since Benchmark purchased the site three years ago we have invested heavily to transform it into a state-of-the-art facility equipped to support a modern and rapidly growing aquaculture industry here, and further afield, to get to grips with the challenge of sustainability and fish health.”

In March this year, Benchmark through its subsidiary the Fish Vet Group, also opened a state-of-the-art diagnostic laboratory in Chile. Benchmark said the 13,500-square-feet facility is equipped with robotic quantitative polymerase chain reaction (qPCR) and digital histology equipment. The facility is based at Puerto Montt, southern Chile, where the country’s large salmon industry is located.

The company said the laboratory is currently the only aquaculture health facility in Latin America with the latest qPCR diagnostic capability. The new laboratory utilizes the diagnostic technology to form a highly automated process from receipt of samples to the reading of the results.

Quality control in developing countries feed labs urged

BY MALCOLM FLANAGAN

Research from the FAO and the International Analytic Group (IAG) suggests feed laboratories in developing countries have to improve their animal nutrition sample testing if feed quality is to catch up with the developed world.

A 2015 FAO review of developing country feed laboratories said without a robust quality control system in place, feed laboratory personnel in these regions are unable to properly evaluate the quality of animal nutrition sampled.

The FAO said unreliable feed analysis data could adversely impact exports from developing countries and increase wastage of feed and food items for not meeting international quality and safety standards. Without high-quality data on chemical composition, precision feeding or balanced feeding approaches that demand meeting nutrients as per the animal requirements cannot be used.

“Unbalanced feeding results in production below the genetic potential of animals, reproductive problems for example longer age of first calving and longer calving interval and animal being more prone to metabolic diseases, and lower profit to farmers,” said the FAO.

“Also, animals have a shorter productive life, poor health and welfare, and excessive amounts of pollutants are released into the environment. Feed industries are neither able to resource good quality ingredients nor prepare balanced feeds without having sound chemical and nutritional value data on feed resources.”

The Rome-based FAO and the IAG stressed that for sustainable development of the livestock sector, generation of reliable chemical composition data of feed ingredients and mixed or compounded feed is a vital component. The IAG is based in Vienna, Austria.

US firm gains approval for canine ear generic

BY JOSEPH HARVEY

Californian firm Med-Pharmex has gained domestic authorization for Mometavet, a treatment of otitis externa in dogs.

The product is a generic version of Merck Animal Health’s Mometamax. The active ingredients are Gentamicin sulfate, mometasone furoate anhydrous and clotrimazole.

Med-Pharmex’s topical therapeutic is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp, coagulase- positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci).

The company also sells Betagen (gentamicin sulfate with betamethasone valerate) in the US. This is an otic solution and topical spray for dogs.

Med-Pharmex specializes in generic products for livestock, poultry and companion animals. The firm was established in 1983 and has three manufacturing facilities specializing in oral and externally-applied products.

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Ceva highlights environmental impact on pet skin

BY SIAN LAZELL

French firm Ceva Santé Animale believes environmental changes are having a negative impact on the skin of pets.

Speaking at the recent World Congress of Veterinary Dermatology in Bordeaux, the company said small changes to the environment, including temperature and pH levels combined with bacteria and allergens, can massively impact the sensitive skin of animals.

Ceva explained a need for a greater understanding of the multiple elements that protect skin from these harmful factors is necessary to future animal health.

It said using the appropriate products to protect against parasites or allergens that can break the skin barrier is critical, so accuracy in choosing the right product to suit pet owners is important.

Research by Ceva has shown 77% of pet owners fail to apply shampoos prescribed to them correctly. The company said its Duoxo range of dermatopicals, for example, provides a solution to this problem. The range consists of a dry mousse and micro-emulsion spray, enabling owners to easily and appropriately apply treatments to their pet’s skin without any problems.

In March, global investment banking firm Jefferies suggested dermatology is still a key opportunity in the pet health space, despite a number of firms working on alternatives to non-steroidal anti-inflammatory drugs in this area.

MSD signs UK trout vaccine agreementBY JOSEPH HARVEY

MSD Animal Health has signed up Europharma UK as the exclusive wholesaler of its trout vaccines.

Europharma will assume UK distribution responsibilities for MSD’s Aquavac ERM and Aquavac ERM Oral, which are inactivated vaccines against enteric redmouth disease caused by Yersinia ruckeri (Hagerman strain) in rainbow trout.

The deal also covers MSD’s Aquavac Relera – an inactivated vaccine against enteric redmouth disease caused by Yersinia ruckeri biotype 1 and biotype 2 (Hagerman type 1 and EX5 biogroup) in rainbow trout.

MSD and Europharma have already carried out customer workshops across the UK, in order to provide veterinarians and producers with the opportunity to discuss the products and the new distribution set-up.

Clydebank, Scotland-based Europharma offers customers a complete fish health program via its veterinary and biologicals services teams, which offer dedicated advice concerning nutrition, water quality, recirculation, breeding and fish biology. The firm also sells anesthetics, antibiotics, antifungals and diagnostics.

MSD is the market leader in aquaculture welfare and also sells a host of products such as vaccines and in-feed antibiotics for tilapia, salmon, yellow tails, amberjack, barramundi, sea bass and sea bream.

Japanese antibiotic feed additive production declines

BY DR ATSUO HATA

The production of antibiotic animal feed additives fell by 15.5% in Japan during 2015, according to the Japanese Fertilizer and Feed Inspection Service (JFFS).

The JFFS reported antibiotic feed additive production for fiscal 2015 ended March 31, 2016. Total production of antibiotic feed additive declined by 15.5% to 88,500kg potency compared to fiscal 2014.

Although polyether, tetracycline and macrolide feed additive production increased, polyether and avilamycin feed additive declined.

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Antibiotic feed additive production in Japan for fiscal 2015 (kg potency)Antibiotic feed additive Fiscal 2015 Fiscal 2014 % changePolypeptides 24,509.6 20,209.4 +21.3Zinc Bacitracin 950.0 3,727.0 -74.5

Enramycin 297.6 190.4 +56.3

Nociheptide 880.0 480.0 +83.3

Virginiamycin 0 0 0

Colistin sulfate 22,382.0 15,812.0 +41.6

Tetracyclines 2,600.0 2,240.0 +16.1Oxytetracycline 1,200.0 800.0 +50.0

Chlortetracycline 1,400.0 1,440.0 -2.8

Macrolides 5,498.0 5,326.8 +3.2Tylosin phosphate 5,498.0 5,326.8 +3.2

Polyethers 43,256.5 58,693.0 -26.3Narasin 13,162.5 31,777.5 -58.6

Salinomycin sodium 28,878.0 24,487.5 +17.9

Monensin sodium 1,216.0 2,428.0 -50

Lasalocid sodium 0 0 0

Others 12,635.0 18,315.0 -31Avilamycin 12,535.0 18,315.0 -31.6

Flavophsphlipol 100.0 0 N/A

Total 88,499.5 104,784.2 -15.5Source: JFFS

UK university develops new bTB blood test

BY SIAN LAZELL

Researchers from the UK’s University of Nottingham have developed a new blood test for the detection of bovine tuberculosis (bTB).

The diagnostic uses a bacteriophage-based technique to detect mycobacteria in blood, even at very low levels. The researchers used the test to demonstrate that cattle diagnosed with bTB have detectable levels of the causal bacterium of the disease, Mycobacterium bovis.

The university said its research group has now patented an improved version of the method that delivers results in just six hours. It also claims that proof-of-principal experiments have shown the improved version to be even more sensitive.

Routine testing for bTB involves all healthy cattle being regularly tested with the single intradermal comparative cervical tuberculin (SICCT) skin test for M bovis. However, the university said the SICCT test is only 90% sensitive at best and can miss many infected animals.

It added that the SICCT test presents difficulties in detecting, growing cultures and achieving sensitive detection, causing a “major barrier to understanding and diagnosing bTB infection”. Data collected by the research team has shown M bovis can be detected before the animal becomes SICCT-positive.

Dr Cath Rees, lead investigator and an expert in microbiology at the university’s School of Biosciences, said: “In our paper we show that when blood samples from skin test negative cattle were tested for M bovis cells, all the samples proved negative.

“However, using just a 2ml blood sample, viable mycobacterium tuberculosis complex (MTC) bacteria were detected in 66% of samples from skin test positive animals. When the carcasses were inspected, it was found that the highest number of bacteria were detected in the animals with visible TB lesions and 85% of these animals were M bovis positive.

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“Using our new more sensitive six-hour method, this figure is even higher – all animals with visible lesions were MTC positive, and even 26 out of 28 animals where the lesions were not yet visible were also positive, suggesting that M bovis is commonly found in the circulating blood of infected animals.

“Using our bacteriophage-based test, the hope is that we can help improve herd control by finding animals at the early stages of infection and helping farmers control outbreaks of bTB more rapidly.”

In the past, bTB has proven hard to eradicate. In February, UK authorities awarded £7 million ($10.1 million) to nine research projects aimed at tackling the disease. In addition, the New Zealand government recently revealed it will invest NZ$69.8m ($48m) over the next four years in efforts to eradicate bTB in its beef, dairy and deer herds.

Dr Rees concluded: “The test also offers the potential for new, better tests for other farm animals. We are directly detecting the bacteria and so the method will work using blood samples from any animal species – so far we have detected mycobacteria in the blood of cattle, sheep and horses, but it could also be used for deer, goats or llamas.

“Not only that, we can detect any type of mycobacteria – we have used the same method to detect other diseases, such as Johne’s disease, not just bTB.”

New Zealand invests in bTB eradicationBY MALCOLM FLANAGAN

The New Zealand government is to invest NZ$69.8 million ($48 million) over the next four years in a continuing attempt to eradicate bovine tuberculosis (bTB) in its beef, dairy and deer herds.

The management agency for the bTB strategy is TB Free NZ, which carries out the work around the country. New Zealand’s livestock sectors also contribute funding to the established national bovine tuberculosis pest management plan.

The country has made considerable progress in the past two decades in reducing the incidence of bTB in livestock and wildlife. Primary Industries minister Nathan Guy said since 2002, the number of infected cattle herds has been reduced by 90% and infected deer herds are down by 95%.

In addition, bTB has been cleared from wild animals in more than 1.2 million hectares of New Zealand’s forest since 2011. Possums are considered to be the main carriers of bTB in the wild and poisoned baits are dropped in a number of forest areas to reduce their numbers to manageable levels.

Mr Guy said: “We’ve made great progress in tackling this destructive disease. This new funding will help achieve our goals of eradicating bTB from cattle and deer by 2026, and from bTB-infected wildlife in New Zealand by 2055.

“The amended bTB Plan is a fundamental shift in approach, from containing the disease to active eradication in livestock and wildlife. This success means we can take a more targeted, scientific risk-based approach to both bTB testing for cattle and deer, plus wildlife control.

“This work is important because the ability of our beef, dairy and deer industries to compete in global markets hinges on the successful management of bTB.”

In September 2015, New Zealand reported the incidence of bTB in cattle and deer herds in the country has dropped to its lowest point since a government disease control strategy was introduced four years previously.

New Zealand organization Operational Solutions for Primary Industries said the number of bTB infected herds has dropped below 40 for the first time since the bTB-free strategy came into effect in 2011.

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