Zydus picks up brands and companies manufacturing divested ... · Zydus picks up brands and...

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© Informa 2015 1 of 25 Zydus picks up brands and manufacturing divested by Zoetis BY JOSEPH HARVEY Zoetis’ cost-cutting strategy has led to more divestments, this time in India. Zydus Animal Health has acquired select Zoetis generic brands and the firm’s manufacturing operations in Haridwar, India, for $29 million. Zydus gains medicated feed additives, anti-infectives, parasiticides and nutritionals, sold for livestock primarily in India. The firm said the acquired products have a combined turnover of INR171 crore ($26m). The assets will complement Zydus’ existing portfolio, which features products for livestock and poultry. The Ahmedabad-based company claims to be the Indian market leader for antibacterials, non-steroidal anti- inflammatory drugs, anti-mastitis products, tonics and poultry vaccines. Not only will the deal will help Zydus expand its domestic animal health business but the GMP-approved manufacturing operations have been catering to global markets, thus expanding the firm’s horizons via exports. The Haridwar facility is spread over 10,000 square meters and manufactures tablets, liquid oral solutions and injectables. The acquisition is expected to close during the first quarter of 2016. According to Animal Pharm estimates, Zydus recorded 2014 sales of around $48.5 million – the second-largest domestic animal health firm in India. This transaction would bring it much closer to Indian Immunologicals, India’s leader in animal health with sales of $83.6m last year. Zydus is a subsidiary of Cadila Healthcare – domestic market leaders in human pharmaceuticals, as well as consumer care and over-the-counter drugs. The deal is a continuation of Zoetis’ strategy to improve its margins and cut costs. The industry leader is aiming to improve its profit margins by cutting 5,000 product shelf-keeping units, 10 manufacturing sites and up to 2,500 employees. Two manufacturing sites have already been divested to Bulgarian firm Huvepharma for $40m. Review 2015: Megadeals help animal health to consecutive record M&A year BY JOSEPH HARVEY Records were broken in the animal health sector during 2015. Not only was the biggest animal health deal announced last year but also more money was spent on transactions than ever before. Animal Pharm editor Joseph Harvey takes a look at where this money was spent. With the frenzy of recent M&A activity in animal health, Elanco’s merger with Novartis Animal Health seems a long time ago. Last year, this coming together was the biggest the industry had ever seen. In fact, 2014 saw the most money ever spent on M&A in the veterinary medicines sector – mainly because of Elanco’s acquire and develop strategy. In 2015, records tumbled once more after four individual billion-dollar deals. The biggest trends were towards aquaculture, vaccines and veterinary products distribution, while Boehringer Ingelheim made a bold move for Merial – a new record biggest deal in animal health, pending closure. Animal Pharm tracked 49 acquisitions in the animal health space during 2015. This figure was about par for the course – last year there were 48 deals, while in 2013 there were 47 transactions. 11 January 2016 www.animalpharmnews.com YOUR WEEKLY BRIEFING COMPANIES COMPANIES

Transcript of Zydus picks up brands and companies manufacturing divested ... · Zydus picks up brands and...

Page 1: Zydus picks up brands and companies manufacturing divested ... · Zydus picks up brands and manufacturing divested by Zoetis by joseph harvey Zoetis’ cost-cutting strategy has led

© Informa 2015 1of 25

Zydus picks up brands and manufacturing divested by Zoetis

by joseph harvey

Zoetis’ cost-cutting strategy has led to more divestments, this time in India.

Zydus Animal Health has acquired select Zoetis generic brands and the firm’s manufacturing operations in Haridwar, India, for $29 million.

Zydus gains medicated feed additives, anti-infectives, parasiticides and nutritionals, sold for livestock primarily in India. The firm said the acquired products have a combined turnover of INR171 crore ($26m).

The assets will complement Zydus’ existing portfolio, which features products for livestock and poultry. The Ahmedabad-based company claims to be the Indian market leader for antibacterials, non-steroidal anti-inflammatory drugs, anti-mastitis products, tonics and poultry vaccines.

Not only will the deal will help Zydus expand its domestic animal health business but the GMP-approved manufacturing operations have been catering to global markets, thus expanding the firm’s horizons via exports. The Haridwar facility is spread over 10,000 square meters and manufactures tablets, liquid oral solutions and injectables.

The acquisition is expected to close during the first quarter of 2016.

According to Animal Pharm estimates, Zydus recorded 2014 sales of around $48.5 million – the second-largest domestic animal health firm in India. This transaction would bring it much closer to Indian Immunologicals, India’s leader in animal health with sales of $83.6m last year.

Zydus is a subsidiary of Cadila Healthcare – domestic market leaders in human pharmaceuticals, as well as consumer care and over-the-counter drugs.

The deal is a continuation of Zoetis’ strategy to improve its margins and cut costs. The industry leader is aiming to improve its profit margins by cutting 5,000 product shelf-keeping units, 10 manufacturing sites and up to 2,500 employees. Two manufacturing sites have already been divested to Bulgarian firm Huvepharma for $40m.

review 2015: Megadeals help animal health to consecutive record M&a year

by joseph harvey

records were broken in the animal health sector during 2015. Not only was the biggest animal health deal announced last year but also more money was spent on transactions than ever before. animal pharm editor joseph harvey takes a look at where this money was spent.

With the frenzy of recent M&A activity in animal health, Elanco’s merger with Novartis Animal Health seems a long time ago.

Last year, this coming together was the biggest the industry had ever seen. In fact, 2014 saw the most money ever spent on M&A in the veterinary medicines sector – mainly because of Elanco’s acquire and develop strategy.

In 2015, records tumbled once more after four individual billion-dollar deals. The biggest trends were towards aquaculture, vaccines and veterinary products distribution, while Boehringer Ingelheim made a bold move for Merial – a new record biggest deal in animal health, pending closure.

Animal Pharm tracked 49 acquisitions in the animal health space during 2015. This figure was about par for the course – last year there were 48 deals, while in 2013 there were 47 transactions.

11 January 2016

www.animalpharmnews.com

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

companies

companies

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The main difference in 2015 was the amount of money being spent on animal health assets. The total figure came to approximately $12.2billion compared to $6.2bn in 2014.

aquaculture boomAround $2.6bn was spent on assets in the aquaculture sector in 2015 – a sign of the growing importance of fish protein for a world faced with a growing demand for food.

While Zoetis’ $765m purchase of fish vaccine leader Pharmaq was hailed as the moment the business of aquaculture “really came of age”, it was Cargill that sealed the largest aquaculture-related purchase in 2015.

The US feed and food company entered the growing salmon feed market with a €1.3bn ($1.5bn) takeover of Norway’s largest aquaculture feed producer EWOS in August. US investment firm KKR and Alltech both made significant acquisitions in the fish feed sector.

UK firm Benchmark Holdings closed three deals in the aquaculture space – the largest of these deals came in December when it secured INVE Aquaculture for $342m.

The aquaculture industry is worth around $130bn. This value represents growth of approximately 10-12% since 2011.

Distributors in demandThe last 12 months has also seen the landscape for veterinary product distributors change markedly.

Officially, $3.6bn was spent on acquiring veterinary distributors in 2015. However, this figure should be a lot higher as many deals had undisclosed fees.

In February, US distributor MWI Veterinary Supply was acquired for around $2.5bn by US drug wholesale firm AmerisourceBergen.

MWI’s competitor Henry Schein continued to bulk up its international portfolio during the year. It bought: German firm Scil Animal Care in January; Nordic companion animal products supplier Jorgen Kruuse in June; and a 50% investment in Romanian business Maravet in July.

While MWI and Henry Schein executed acquisitions, the other leading vet products distributor Patterson Companies also made a head-turning move on the M&A scene. The US firm became a powerhouse in the distribution sector with the capture of Animal Health International in a $1.1bn transaction.

The deal will double the size of Patterson’s animal health business to around $2.7bn in annual sales and establish it in the production animal sector.

The transaction will also put Patterson just behind the two leading veterinary distributors – MWI and Henry Schein – in terms of sales.

Consolidation is nothing new for the veterinary distribution sector. In 2001, there were over 20 major distributors and now there are eight left in the US – Patterson, MWI, Henry Schein, Northeast Veterinary Supply Company, Penn Veterinary Supply, Midwest Veterinary Supply, Victor Medical Company and Merritt Veterinary Supplies.

vaccines a hot targetAs the race for antibiotic alternatives grows, vaccines will become an increasingly important part of animal health companies’ repertoire.

In January, Phibro Animal Health bolstered its vaccine offering with the acquisition of exclusive North American distribution rights for swine vaccines developed using MJ Biologics technology. Prior to this purchase, Phibro’s vaccine business was mainly focused on poultry applications.

Dechra Pharmaceuticals entered the veterinary vaccines market with a move for a stake in Croatia’s largest animal health company Genera – a share purchase deal valued at £19.4m ($30.3m). This transaction also augmented Dechra’s portfolio of products for food-producing animals and expanded its geographic horizons.

November saw a very interesting transaction when Merck Animal Health scooped up family-owned Harrisvaccines for an undisclosed fee.

Harrisvaccines hit the headlines over the last few years when the small, Iowa-based firm secured the first conditionally-licensed vaccine to help control porcine epidemic diarrhea virus in the US. In September 2015, Harrisvaccines received a conditional approval for a Eurasian H5 subtype avian influenza vaccine and was subsequently awarded a $6m contract by the US Department of Agriculture to produce the vaccine for the national stockpile.

This acquisition will aid Merck in developing and commercializing vaccines in a short period of time for production animals.

M&a analysisM&A 2014: Rumors and repercussions in record year for animal health

M&A 2013: Increases ahead of potential boom

Important Animal Health M&A 1995-2014

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While the deals listed above had a specific focus on vaccines, the Boehringer-Merial merger had a more wide-ranging rationale. Nevertheless, the deal will pool together a significant amount of vaccines from the portfolios on each side of the deal. This differs somewhat to the Elanco-Novartis Animal Health merger, which saw Elanco benefit from attracting Novartis’ vaccine expertise.

even more to come?According to Ernst and Young, 2015 was a record year for US deal-making because of so-called megadeals across several high-profile sectors. This trend “will continue into 2016 pointing to ongoing resilience for the M&A market”.

Ernst and Young added: “Across industries, companies are considering transformational deals and continued divestitures and spin-offs to stay ahead of changing consumer preferences and technological disruption.”

Jeff Greene, Ernst and Young’s global life sciences leader for its Transaction Advisory Services, said: “Pharmaceutical companies are being rewarded for narrowing their strategic focus to fewer businesses and therapeutic areas.

“Deal activity in the animal health space will likely pick up in 2016 and we’ll continue to see more divestitures in medical devices.”

animal health mergers and acquisitions in 2015The table below displays all of the animal health acquisitions tracked by Animal Pharm during 2015.

Deals announced in 2014 are not included.

acquiror Target Company sector Fee Date closed

AmerisourceBergen (US)

MWI Veterinary Supply (US)

Distributor $2.5bn February

Henry Schein (US) Scil Animal Care (Germany)

Distributor Undisclosed April

Phibro Animal Health (US)

Distribution rights for MJ Biologics (US) technology

Swine vaccines Undisclosed January

Vaxin (US) Immune Targeting Systems (US)

Vaccines Undisclosed February

Alivira Animal Health stakeholders (India)

Shasun Pharmaceuticals' stake in Alivira Animal Health (India)

Veterinary medicines $1.2m February

Aratana Therapeutics (US)

Elanco's rights to a canine cancer drug (US)

Rights to AT-004 $3m February

VCA (US) Abaxis Veterinary Reference Laboratory (US)

Veterinary reference laboratory

$21m March

Lallemand Animal Nutrition (Canada)

75% stake in Bussan Biotech (Japan)

Distributor Undisclosed March

Consortium led by Eurozeo (France)

InVivo's animal health business (France)

Feed and veterinary medicine

€215m ($253m) equity stake

March

Alltech (US) Ridley (US) Animal feed and nutrition

Can$521m ($429m) June

Patterson Companies (US)

Animal Health International (US)

Distributor $1.1bn June

Ecuphar (Belgium) Esteve's animal health business (Spain)

Veterinary pharmaceuticals

Undisclosed May

Cargill (US) 51% stake in Ekol Gida (Turkey)

Feed additives Undisclosed May

Henry Schein (US) Jorgen Kruuse (Denmark)

Distributor Undisclosed September

SeQuent Scientific (India)

Acent Capital's stake in Alivira Animal Health (India)

Veterinary pharmaceuticals

INR240 crore ($37.8m)

July

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Alltech (US) Produs and Produs Aqua (Norway)

Feed Undisclosed July

Henry Schein (US) 50% investment in Maravet (Romania)

Distributor Undisclosed July

Benchmark Holdings (UK)

Akvaforsk Genetics Center (Norway)

Aquaculture genetics NOK140m ($17m) combined amount

July

Benchmark Holdings (UK)

Spring Genetics (US) Aquaculture genetics NOK140m ($17m) combined amount

July

De Heus Animal Nutrition (the Netherlands)

Proteinka (Serbia) Animal feed Undisclosed July

Avista Pharma Solutions (US)

Scynexis' animal health business (US)

Contract drug development

Undisclosed July

Zoetis (US) KL Products (Canada) Hatchery automation technology

Undisclosed July

Dechra Pharmaceuticals (UK)

63.3% in Genera (Croatia)

Veterinary vaccines £19.4m ($30m) October

Altor Fund IV and Goldman Sachs (Sweden and US)

Hamlet Protein (Denmark)

Animal feed Undisclosed August

Cargill (US) EWOS (Norway) Fish feed €1.3 billion ($1.5 billion)

August

IDT Biologika (Germany)

Gallant Custom Laboratories (Canada)

Vaccine manufacturing

Undisclosed August

Simcro (New Zealand) ISL Animal Health (New Zealand)

Distributor Undisclosed September

Simcro (New Zealand) NJ Phillips (Australia) Distributor Undisclosed September

Cinven (UK) Synlab (Germany) Portion of business focused on veterinary lab diagnostics

Undisclosed June

Alivira Animal Health (India)

Lyka Animal Health Care (India)

Animal health pharmaceuticals

Undisclosed October

Novozymes (Denmark)

Pacific Vet Group-USA (US)

Probiotics Undisclosed October

AB Neo (UK) Bodit Tachov (Czech Republic)

Animal feed Undisclosed October

GHO Capital (UK) DNA Diagnostics Center (US)

Portfolio of veterinary DNA diagnostics

€104m ($118.15m) October

Guangdong Wen's Food Group (China)

Guangdong Dahua Animal Health Products (China)

Pharmaceuticals and vaccines

Undisclosed November

Henry Schein (US) Majority stake in VCA's Vetstreet (US)

Veterinary client marketing software

Undisclosed Pending

Zoetis (US) Pharmaq (Norway) Aquaculture medicines

$765m November

InVivo (France) Welgro (Indonesia) Poultry feed Undisclosed November

Heska (US) Cuattro Veterinary (US)

Veterinary imaging technology

$6m in stock for remaining stake

Jan-16

Alltech (US) Masterfeeds (Canada) Animal feed Undisclosed November

Merck Animal Health (US)

Harrisvaccines (US) Veterinary vaccines Undisclosed Q4 2015

KKR (US) Yuehai Feed Group (China)

Aquaculture feed $100m stake November

Alivira Animal Health (India)

TOPKiM (Turkey) Veterinary pharmaceuticals and feed additives

20.7 million Turkish Lira ($7m)

Pending

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De Heus Animal Nutrition (the Netherlands)

Nuter (Spain-Portugal) Animal nutrition Undisclosed December

Nutreco (the Netherlands)

Micronutrients (US) Trace minerals Undisclosed December

Boehringer Ingelheim Animal Health (Germany)

Merial (France) Pharma and vaccines

Merger + €4.7bn ($5.1bn)

Q4 2016

Benchmark Holdings (US)

INVE Aquaculture (the Netherlands)

Fish health and nutrition

$342m Pending

Cargill (US) Format International (UK)

Feed formulation software

Undisclosed December

Huvepharma (Bulgaria)

Zoetis (US) Products and manufacturing facilities

$40m plus additional considerations

Q1 2016

Sumitomo (Japan) 25% stake Shandong Sinder Technology (China)

Drugs and vaccines Undisclosed December

review 2015: New companion animal approvals aiding topline progress

by joseph harvey

a wide array of products was approved for companion animals in 2015, with firms beginning to reap financial benefits before the year had closed. animal pharm editor joseph harvey investigates the growing significance of pet products as well as the stand-out authorizations for food animals.

If the latest set of financial results is anything to go by, companion animal products are stimulating healthy sales growth amongst the leading companies.

In many cases pet products are outshining the sales growth made by food animal portfolios. This is due to a greater amount of brand new products being launched in the pet space. However, it should be noted companion animal portfolios have more room for growth compared to more mature and established food animal businesses.

At the nine-month stage, Zoetis, Merial, Virbac and Vétoquinol all said their pet divisions were outperforming sales growth from products for food-producing animals. Other leaders such as Merck Animal Health, Elanco and Bayer Animal Health also praised growth from pet products but did not specify their division’s growth rate.

Zoetis seals pet approvalsZoetis’ big boon was canine dermatological treatment Apoquel, which was launched at the beginning of 2014 and rolled out in 2015 in further markets including Japan. Zoetis said Apoquel will continue to fuel future growth as it is launched in more international markets throughout 2016. Some analysts believe Apoquel sales could reach up to $300 million this year.

In addition to this top-selling product, Zoetis gained a US conditional license for its canine atopic dermatitis immunotherapeutic – its first approval for a monoclonal antibody – in August.

The firm also added Simparica (sarolaner) to its EU pet portfolio in November. Zoetis aims to launch the canine flea and tick treatment in Europe during the first quarter of 2016, while US approval is expected this year too. The product’s active substance, sarolaner, is a new ectoparasiticide in the isoxazoline class, developed in-house by Zoetis.

Zoetis’ Australian branch achieved full registration for its Hendra virus vaccine, following multiple horse and human deaths related to Hendra over the last 20 years.

The food animal side of Zoetis was boosted by the acquisition of Pharmaq, which gained several approvals for fish vaccines this year in Latin America – a key area for the aquaculture industry.

Canine flu addressedIn November, Zoetis also gained a conditional license for the first vaccine to help control disease associated with canine influenza virus H3N2. Merck Animal Health’s own conditional US license for a vaccine against H3N2 canine influenza followed soon after.

analysis

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This strain of canine influenza was first detected in March 2015 and since being discovered in Chicago, it was reported in 25 states as the outbreak spread.

bayer and piedmont work pays offWhile Bayer Animal Health’s key companion animal brands Seresto and Advantage have helped it prosper in 2015, the firm aims to continue momentum in the pet sector following two recent approvals.

In September, Bayer secured US approval for its first single-dose therapy to treat susceptible strains of common pathogens found in canine otitis externa. Claro (15.0 mg/mL florfenicol, 13.3 mg/mL terbinafine, 2.0 mg/mL mometasone furoate) Otic Solution is indicated for the treatment of canine otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Claro was developed as part of an agreement with North Carolina company Piedmont Animal Health. The two firms also combined to secure US approval of advantus (imidacloprid), an antiparasitic soft chewable tablet for dogs, in February.

Outside of the Piedmont partnership, Bayer received US approval for a topical canine heartworm disease solution in July.

Coraxis (Moxidectin) is indicated for the prevention of heartworm disease caused by Dirofilaria immitis, as well as for the treatment and control of Ancylostoma caninum, Uncinaria stenocephala, Toxocara canis, Toxascaris leonina and Trichuris vulpis.

elanco gains pet tractionElanco’s merger with Novartis Animal Health enabled the firm to immediately boost its offering in the companion animal area. In addition, Elanco was also able to roll out Novartis-developed products in the US, such as the Onsior feline pain reliever and Osurnia, a two-dose treatment for canine otitis externa. Osurnia was also launched in Europe.

Elanco also benefited by bringing back the Interceptor brand of heartworm tablets to the US, which had been off-market since 2011. The product had previously been manufactured at Novartis Animal Health’s Lincoln, Nebraska plant – a site which was temporarily closed due to packaging problems.

One brand Elanco was not able to benefit from was Sentinel, which was offloaded to Virbac to comply with anti-trust regulations. The range of parasiticides for dogs recorded sales of around $72m by the end of September. Excluding Sentinel, Virbac’s nine-month sales fell 4%.

Merial builds NexGard offeringIn Q3, Merial said its NexGard flea and tick treatment fueled sales growth and more than offset a decline in sales of the generics-embattled Frontline products family. NexGard received a US supplemental approval in March that allows it to be used to treat and control the brown dog tick (Rhipicephalus sanguineus). NexGard Spectra was also approved in Europe and Japan during 2015.

Merial also received a significant approval in the pet cancer field. In March, the firm was granted a US conditional license for Feline interleukin-2 immunomodulator. The product received conditional approval based on demonstrated efficacy and safety, and will be available to veterinary oncologists. Merial said additional potency and efficacy studies are in progress.

other notable pet products approvedFinnish business Orion Animal Health boosted its global standing by gaining approval for Sileo (dexmedetomidine hydrochloride) in the US and Europe during 2015. The product is an oromucosal gel therapy indicated for the treatment of noise aversion in dogs.

Australian firm Jurox launched a new opioid analgesic for dogs and cats in its domestic market. Bupredyne is the latest in the company’s growing family of analgesic products, and contains buprenorphine, a commonly-used agent for providing pain relief and sedation in canine and feline surgeries.

Dechra Pharmaceuticals received EU approval for Zycortal treatment for dogs with Addison’s disease, while Vétoquinol launched Upcard for congestive heart failure in dogs in Europe.

Last year also saw US veterinary generics specialist Putney receive three domestic approvals for its products. Putney gained US authorization for: a generic of Merial’s Tresaderm, a treatment for skin disorders in cats and dogs; a generic version of Zoetis’ anesthesia drug Telazol for dogs and cats; and a generic of Bayer’s Baytril Antibacterial Injectable Solution for dogs.

Merck strengthens vaccine offeringIn 2015, Merck Animal Health gained approval for two significant vaccines. Under its MSD guise in Europe, the firm commercialized Innovax-ILT, a single-shot vaccine that protects poultry against infectious laryngotracheitis (ILT) and Marek’s disease. This marked the firm’s first vector vaccine launched in the EU. Innovax-ILT is also the only vector vaccine available in the EU to protect against ILT.

product approvals DirectoryIn 2016, Animal Pharm will be tracking product approvals with its new product approval Directory.This will combine new product authorizations from across the world and will be back-dated to January 2015.This new service will be launched in January 2016.

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Canigen L4 also received EU approval following a positive opinion in May. The product is a vaccine for the active immunization of dogs against leptospira.

MSD was also able to bolster its already established Porcilis brand throughout 2015. The firm launched the first ready-to-use single-injection combination vaccine in Europe – Porcilis PCV M Hyo – that protects piglets against both porcine circovirus type 2 and mycoplasma hyopneumoniae infections during the finishing period.

The company also received EU authorization for an inactivated PCV vaccine developed for use in finishing pigs. Porcilis PCV ID is intended for the active immunization of pigs from three weeks of age to reduce viremia, virus load in lungs and lymphoid tissues and virus shedding caused by PVC type 2 infection. The vaccine is also designed to reduce loss of daily weight gain and mortality associated with PCV2 infection.

In the US, Merck launched the first injectable ileitis vaccine for finishing pigs in the US. The business said its Porcilis Ileitis injectable vaccine offers 20-week immunity for control of ileitis. The disease affects the smaller intestine and is caused by caused by Lawsonia intracellularis.

bird flu vaccines on the stockpileMuch like Zoetis’ acquisition of Pharmaq, Merck was also able to purchase a company with recent product approvals.

Harrisvaccines was given a conditional license for a vaccine against highly pathogenic avian flu only a few months before it was bought by Merck. The firm’s avian flu vaccine RNA was the first to secure a conditional license from US authorities following an outbreak that killed almost 50 million chickens and turkeys in the first half of the year.

In November, Ceva Santé Animale and Harrisvaccines were granted contracts by the US Department of Agriculture to supply avian influenza vaccines to the national stockpile.

Ceva was also able to grow its Vectormune brand following the EU approval for its vaccine against Newcastle disease. Vectormune ND was developed by the firm’s Phylaxia Veterinary Biologicals laboratory in Hungary and is for the active immunization of 18-day-old embryonated chicken eggs or day-old broiler chickens.

boehringer grows european strengthIn March, Boehringer Ingelheim Animal Health launched its new Bovela vaccine against bovine viral diarrhea (BVD) in Europe. The company said it was the first vaccine to be marketed in the EU for the active immunization of cattle against both genotypes of the virus (BVDV-1 and BVDV-2). Boehringer said sales of Bovela exceeded €1m ($1.1m) in the UK alone by the end of October.

Boehringer’s Ingelvac CircoFlex gained European authorization to be used in pregnant and lactating sows in September. The vaccine is for protection against PCV2-related diseases. It was the first PCV2 vaccine licensed in the EU to protect piglets as well as sows.

other notable food animal approvalsNebraska-based firm VaxLiant gained US safety approval for three of its ENABL vaccine adjuvants in June. These were the first poultry adjuvants the company has received approval for – in March, the company received the green light for four ready-to-use ENABL adjuvants that can be added to vaccines to help improve the resulting immune response in cattle and swine.

Also in March, Canadian firm Prevtec Microbia secured European marketing authorization for an oral live vaccine against E coli in piglets. The Coliprotec F4 vaccine is specifically designed to immunize piglets against enterotoxigenic F4-positive E coli, which is associated with post-weaning diarrhea. The product will be distributed in the EU by Elanco.

review 2015: elanco-Novartis merger sparks upsurge of appointments

by MalColM FlaNaGaN

While little changed at the very top for global animal health companies in 2015, there was considerable executive impact and recruitment fallout from elanco’s acquisition of the swiss giant Novartis animal health. restructuring at Zoetis in May also added to executive upheavals as several former Zoetis employees took up roles elsewhere in the industry. animal pharm’s asia editor Malcolm Flanagan investigates.

A major figure in the changes at Elanco and Novartis Animal Health was the former chief executive of the latter, Dr George Gunn, who found his managerial and scientific expertise in considerable demand by veterinary firms around the world.

analysis

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His career has spanned 30 years within the animal health industry including roles at the Wellcome Foundation, Janssen Pharmaceuticals, Pharmacia and finally Novartis Animal Health, where he worked since 2003.

The first company to persuade Dr Gunn to join its board was UK veterinary firm Animalcare which lured Dr Gunn to join as a non-executive director in February.

A non-executive chairman position was offered to Dr Gunn by rising Irish company Nexvet Biopharma in April and duly accepted. In May, US animal health company Phibro Animal Health appointed Dr Gunn as a director. In August, Norwegian aquaculture company Pharmaq added Dr Gunn to its growing board of directors.

In the same month, US genomic data analyst firm Diversigen added Dr Gunn to its board of directors. The Houston, Texas-based business provides microbiome and metagenomic services to the human and animal health industries, as well as the agricultural sector. Its services include customized and complex data analysis.

Nexvet gains another Novartis execA second former Novartis executive has join Nexvet in May, as the firm sought to expand in global animal health markets.

Dublin-headquartered Nexvet added Dr Juergen Horn as its new chief product development officer following his departure from the combined Elanco/Novartis company.

UK veterinary pharmaceutical company Norbrook Laboratories was also keen on former Novartis expertise in 2015 and recruited an ex-Novartis marketing expert.

The Newry-headquartered company recruited former Novartis marketing executive Richard Palmer to be its new global head of sales and marketing in February.

Norbrook said Mr Palmer had a long and distinguished career at Novartis, most recently as chief marketing officer for its animal health business. Mr Palmer has lived and worked extensively in the UK, US and Europe, and has held a broad number of leadership roles in both the veterinary and human pharmaceutical sectors, including sales, marketing and general management.

In June, Norbrook also appointed Dr Simon Wheeler as its global head of commercial strategy and portfolio development.

Dr Wheeler previously held roles in companies such as Pharmacia, Merial and Novartis Animal Health. He has particular expertise regarding investment in animal health, after working for several years as the managing director of Novartis Venture Funds.

His previous roles have seen him work across a range of divisions including technical services, business development and marketing in both farm and companion animal sectors.

In December, Norbrook also boosted its international business by appointing a new vice president for Latin America and US companion animals.

Dr Oscar Romero will be responsible for managing and growing the firm’s existing business in Latin America. He will also be aiming to grow Norbrook’s market share in the US companion animal sector.

Dr Romero joined Norbrook from Zoetis, where he held the role of global director of new products marketing. In this position, he held responsibility for strategy and lifecycle management of the company’s swine vaccines. Before Zoetis, Dr Romero held senior roles at Pfizer Animal Health and Pharmacia Animal Health.

jaguar lures Novartis strategistUS veterinary gastrointestinal treatment specialist Jaguar Animal Health added former Novartis Animal Health strategist Folkert Kamphuis to its board of directors.

The San Francisco-based business said in June the appointment deepens its global animal health business development and its strategic commercialization expertise, as it aims to achieve clinical and corporate milestones.

Mr Kamphuis’ most recent position was global head of strategic planning at Novartis. In this role he oversaw business development, licensing, portfolio improvement and salesforce development. He also served as Novartis’ general manager in North America.

Before joining Novartis in 2009, Mr Kamphuis worked in business development and global marketing roles at Pfizer Animal Health/Pharmacia and Merial. He has more than 20 years of experience in the animal health sector.

New US porcine vaccine firm Aptimmune Biologics hired a former Novartis Animal Health manager to become its new chief executive in July. The company said Aaron Gilbertie would lead the company through pipeline development, product registration and commercialization of its vaccines.

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Mr Gilbertie is a former territory manager for Novartis and was also a market researcher for global swine and poultry at Elanco. Before joining Aptimmune, he was chief executive for Four Star Animal Health based in Chickasaw, Ohio.

At Four-Star his focus was on autogenous vaccine supply optimization and management of development projects for PRRS including the porcine epidemic diarrhea virus and porcine deltacoronavirus.

Nutriad adds to Iberian teamIn April, Belgian feed additive manufacturer Nutriad added to its Iberian team by hiring a former Novartis Animal Health Spanish area manager as a new executive.

The Hoogveld-headquartered company said Antonio Vila will be its new key account manager for Western Spain and Portugal.

Mr Vila joins Nutriad after over 20 years of experience in the animal feed pharmaceutical and additives business with Novartis, Virbac and Pharmacia Animal Health. Whilst with Novartis, Mr Vila was responsible for the Galicia, Castilla y León, Asturias, Cantabria and País Vasco regions in Spain.

Also in April, Scottish animal health charity, the Global Alliance for Livestock Veterinary Medicines (GALVmed), made two new senior appointments to its head office team in Edinburgh.

Brigitte Schiessl joined GALVMed as portfolio director. Ms Schiessl previously worked with Novartis where she headed the European clinical operations team in Basel, France and the UK.

Rosie Stewart, joined GALVmed as its new finance manager. Ms Stewart will run the finance department on a day-to-day basis. She is a chartered accountant and previously worked as the head of finance at a Scottish mental health charity.

parnell adds ex-Zoetis directorIn October, US animal health firm Parnell Pharmaceuticals appointed Karen Greenwood to the role of vice president of R&D.

Ms Greenwood’s previous position was director of Zoetis’ companion animal internal medicine research unit, where she recently worked on the successful Apoquel canine dermatological treatment.

She joined Pfizer Animal Health in the UK during 1988 and transferred to Kalamazoo, Michigan, in 2006 to focus solely on companion animals. Ms Greenwood has a biochemistry degree from the University of Southampton.

In December, a former senior Zoetis executive was recruited by US animal pathogens specialist Anitox to lead its sales teams in North America.

Lawrenceville, Georgia-headquartered Anitox said Jim Brewer has been appointed as national sales manager for North America. He will oversee the day-to-day activities of the key account managers and feed mill technicians in the US and Canada.

Mr Brewer has over 30 years of experience in sales, marketing and training roles in the livestock industry, most recently as global director of training and development in the poultry division of Zoetis.

Chad Terrell, commercial director for the Americas region for Anitox, said: “Anitox is growing its presence in the Americas in two key areas, milling efficiency – preventing shrink that impacts feed volume and nutrient values – and in the control of pathogens in feed.”

virbac appoints new r&D directorFrench animal health firm Virbac made a significant appointment as the firm looks to drive its vaccine business. It appointed Jules Minke to the role of group biological research and development director in November.

Mr Minke is now responsible for coordinating and supervising all R&D and global teams involved with Virbac’s biological projects, as well as monitoring related regulatory activities.

His goals include optimizing the management, quality and compliance of Virbac’s biological projects in line with its strategic priorities, based on the pooling of the firm’s R&D facilities.

In addition, Mr Minke will also become a member of the company’s executive committee for France, reporting to Virbac’s director of product innovation Jean-Pascal Marc.

In September, Swedish animal health company Premune appointed a former Dechra Pharmaceuticals executive Ed Torr to be its head of business develelopment and commercial operations.

Mr Torr is based in the UK and will oversee Premune’s commercialization and business development efforts as the company prepares for its initial product launches. He will also broaden its product portfolio with strategic in-licensing opportunities and proprietary innovations.

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Stockholm-headquartered Premune is a research and development-stage animal health company focused on new therapeutics for companion animals. Recently it became a commercial entity when it agreed to market a pet skin product for Italian veterinary company Innovet in Europe.

Mr Torr brings more than 30 years of experience in animal health with senior leadership roles in animal health companies in Europe including ICI, Coopers Animal Health, Alfa Laval Agri and Dechra Pharmaceuticals.

He was an executive director of Dechra Pharmaceuticals from 2000 to 2014, during which time he had responsibility for business development, manufacturing, product development and geographical expansion.

Merck’s new aquaculture chiefIn February, Merck Animal Health appointed a new leader to the firm’s aquaculture division.

Dr Chris Beattie now leads lead the aquaculture unit of Merck – known as MSD Animal Health outside the US and Canada – by overseeing the strategic direction of the division, product introductions, life-cycle management and the firm’s expansion to markets in developing regions.

Merck’s aquaculture division provides products for fish health such as: vaccines; anti-infectives; a parasiticide for the prevention of sea lice, Slice; and a reproductive performance drug, Chorulon. The unit caters to salmonids, marine fish and warm water fish.

Dr Beattie joins Merck from his role as general manager at Skretting North America, a firm specializing in aquaculture feed and feeding expertise.

Gary Eaton was appointed vice president of sales and marketing at US pet generics developer Putney in July.

Mr Eaton is responsible for leading Putney’s commercial team and driving revenue growth related to the firm’s upcoming and recent product launches.

Portland, Maine-based Putney has launched six veterinary generics in the last nine months,

Mr Eaton previously worked at veterinary diagnostics company IDEXX Laboratories, where for over 16 years he held various senior leadership roles and broadened his expertise in marketing, sales and commercializing new products.

pharmaq selects new asia managerNorway’s leading producer of aquaculture pharmaceutical products, Pharmaq, selected a new general manager for Asia in February

Danish national Andreas von Scholten was appointed to the position of general manager Pharmaq Asia and is based at the company’s Asia headquarters in Vietnam. He replaces Alistair Brown who was in the job for one year. Pharmaq is globally headquartered in Oslo.

Mr von Scholten was previously manager for Asian emerging markets at Danish medical equipment company Coloplast. He has a master’s degree in economics from the University of Copenhagen.

Morten Nordstad, Pharmaq chief executive, said: “Mr von Scholten’s business drive, knowledge about the markets in Asia and formal background will be a strong contributor to drive Pharmaq’s ambitions in Asia.”

In May, Pharmaq has also expanded its presence in the western Mediterranean with the opening of a new sales and technical office in the Spanish capital Madrid.

At the same time, the company appointed Roberto Guijarro to general manager of Pharmaq Spain. Mr Guijarro will work closely with all departments within Pharmaq and particularly throughout the Mediterranean region where the company is increasing its activities in all the major fish farming countries.

Pharmaq has been present in Spain during the past five years but without an office. Mr Guijarro is a veterinarian and has previously worked as general manager of Santamix Ibérica (Spain) and Qalian (Portugal), the two animal health branches of InVivo for the Iberian area.

agrilabs appoints executive vpUS animal health distributor AgriLabs appointed Sean O’Hare to the role of executive vice president in March.

The Missouri-based company said Mr O’Hare will be leading its marketing, sales and technical service businesses. AgriLabs also said he will play a key role in the business development process and management of the company.

Mr O’Hare has over 18 years of experience in the animal health, agricultural sciences and the biotechnology sectors. His previous companies include the Pig Improvement Company, InVentiv Health, Novartis and most recently Boehringer Ingelheim.

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During this time he led sales and marketing initiatives to widen brand awareness for swine and poultry. He has a bachelor of science degree from Nebraska Wesleyan University and a master of business administration degree from Bellevue University, which is also in Nebraska.

Non-commercial appointmentsThe Institute for Infectious Animal Diseases (IIAD), a US Department of Homeland Security Science and Technology Center of Excellence, selected a new program director in October.

Dr Matt Cochran will be working with the College Station, Texas-based Institute’s AgConnect suite of data tools. He will provide AgConnect with strategic vision and management. AgConnect is a suite of customizable data integration and analysis products designed to enhance situational awareness of disease outbreaks.

He will also work closely with the IIAD leadership team to manage day-to-day operations, support strategic planning and direct logistical activities to promote program success and strategic vision.

Dr Cochran previously worked for the Texas A&M Veterinary Medical Diagnostic Laboratory, where he served as assistant agency director since 2012. Prior to that, he held multiple roles at the Texas Animal Health Commission and worked in large and small animal private practice.

Finally, in March Boehringer Ingelheim Animal Health’s global head George Heidgerken became the president of the Brussels-based global animal health industry body HealthforAnimals.

Mr Heidgerken was appointed to a two-year term in the role. His predecessor was Jeff Simmons, Elanco’s president.

Review 2015: Worst avian flu crisis in Us history dominates headlines

by MalColM FlaNaGaN

In 2015, avian flu was by far the predominant livestock disease to hit the headlines internationally, with outbreaks erupting on different continents but with the Us suffering the most economic damage as a result. animal pharm’s asia editor Malcolm Flanagan investigates the avian flu conundrum.

In previous years, the devastating effects of avian flu and its different strains had been most keenly felt in China, South East Asia and parts of the Middle East. This year, the US Midwest felt the impact of its worst ever highly pathogenic avian influenza (HPAI) outbreaks with commercial poultry flocks of different species being devastated by infection from migratory birds and initially weak biosecurity strategies.

The US Department of Agriculture (USDA) estimated the avian flu cull in the country cost more than $500 million and presented real challenges in terms of finding sufficient landfill sites to accommodate the huge volume of infected carcasses, presenting additional issues in working with local communities.

HPAI detections began in December 2014 and continued into mid-June 2015. During that time H5 bird flu virus detections were reported in 21 US states (15 states with outbreaks in domestic poultry or captive birds and six states with H5 detections in wild birds only).

Other regions did suffer sporadically from avian flu including North Africa, West Africa, Central America and late in the year northern Europe, particularly France and Germany.

Novel avian flu strains emergeIn March, perhaps as a precursor of poultry disease incidents to come, the World Health Organisation (WHO) said avian influenza viruses are spreading and mutating more extensively than ever before.

The WHO said virologists see the recent proliferation of emerging viruses as a sign that co-circulating avian influenza viruses are rapidly exchanging genetic material to form novel strains.

The organization explained that this means flu viruses can constantly reinvent themselves in a “dazzling array of possible combinations”, adding this appears to now be happening at an accelerated pace.

As the avian flu virus gene pool becomes more diverse, the Geneva-headquartered organization warned the consequences for animal and human health are “unpredictable yet potentially ominous”.

Later in October, a leading poultry expert at French company Ceva Santé Animale, Dr Marcelo Paniago, said dramatic changes in the prevalence of avian flu are posing an increasing threat to animal health, animal welfare, the global economy and human health.

analysis

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Dr Paniago said: “Avian flu has changed dramatically in the last few years. To date, 2015 has seen 309 individual outbreaks of avian flu reported to the World Organisation for Animal Health (OIE), which is a staggering 147% increase on outbreaks reported in 2014. Some 75% of emerging human infectious diseases, of which avian flu is one, come from animals.”

avian flu to remain a threatA UK avian flu expert Professor Ian Brown, director of the EU/FAO/OIE Reference Library for Avian Influenza in Surrey, said in July that avian flu was set to remain a threat to global food security and human health for many years to come.

He said strains of H5 highly pathogenic avian flu had become “truly panzootic” affecting poultry and wild birds globally.

Prof Brown told delegates to the GARAD 2015 avian diseases conference in London this has produced significant long lasting evolutionary trends combined with epidemiology, creating new threats to poultry production as demonstrated by the recent incursion into North America.

As a result, there is endemicity in some regions and re-incursions in others, with little prospect for immediate disease control in either.

Prof Brown said repeated re-incursions generate a status approaching endemic but with reduced levels in countries such as Vietnam and Cambodia. There has also been successful eradication but occasional subsequent re-introductions of H5 strains in Japan, EU countries, South Korea and Nigeria.

Turkeys hit first in UsUS authorities confirmed the country’s first case of HPAI in a commercial poultry flock in January 2015.

The US Department of Agriculture (USDA) said laboratory tests identified the H5N8 strain in a commercial turkey flock in Stanislaus County, California.

The finding added to a December 2014 detection of H5N8 influenza in wild birds and in a backyard flock of guinea hens and chickens in Oregon, along with separate H5N2 HPAI detections in wild birds in California and Washington State.

In March 2015, USDA confirmed an outbreak of highly-pathogenic H5N2 in a backyard flock in Kansas.

The strain was detected in a chicken and duck flock in Leavenworth County and was the first finding of HPAI in the ‘central flyway’ of wild birds in the US. This is a bird migration route that generally follows the Great Plains in the US and Canada.

After the flock experienced increased mortality, state officials quarantined the affected premises. The birds on the property were culled to prevent the spread of the disease.

Chicken farm hit in WisconsinIn April, there was an HPAI outbreak in the US Midwest, at a large chicken farm in Wisconsin. It was the first outbreak in chickens in the Midwest.

Madison, Wisconsin reported previous H5N2 outbreaks had been discovered on turkey farms in the Midwest but this had spread to chickens for the first time.

The H5N2 outbreak affected a flock of about 200,000 layer chickens in Jefferson County, in south eastern Wisconsin. About 20,000 chickens had already died from the disease and the remaining 180,000 were killed to help prevent the disease from spreading.

Migratory waterfowl suspectedUSDA scientists suspected HPAI was being spread by migratory waterfowl. They also tried to determine how the disease has been getting inside Midwest poultry barns despite biosecurity measures designed to keep it out.

Some veterinary experts believed turkeys were more predisposed to H5N2 than chickens. The Center for Infectious Disease Research and Policy at the University of Minnesota (CIDRAP) said the H5N2 virus had been found in a few wild birds in the Midwest, which can carry it without appearing sick.

“Officials believe wild waterfowl have been spreading H5N2 across the country. Infected birds shed the virus in their feces, leading to the suspicion that the recent outbreaks have been sparked by feces somehow carried into poultry barns by vehicles or people,” said CIDRAP.

“But in Minnesota, at least, investigators have not been able to confirm or rule out that suspicion, nor have they found the virus in fresh fecal samples collected from wild ducks near virus.”

Indiana halted poultry tradingIn May, the Indiana State Board of Animal Health halted poultry movements in the state in an effort to tackle the spreading epidemic.

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Previously, in April, Wisconsin declared a state of emergency concerning the avian flu H5N2 outbreak and enlisted the help of the National Guard.

Wisconsin Governor, Scott Walker, signed an executive order on April 20, authorizing Wisconsin National Guard to assist authorities in tackling and containing the avian flu outbreak, and assist in site clean-ups in Jefferson, Juneau and Barron counties. The National Guard’s call to action was due to a scarcity in federal resources due to outbreaks of the disease in other states.

In October, Both Ceva Santé Animale and Harrisvaccines were granted contracts by USDA to supply avian influenza vaccines to the National Veterinary Stockpile.

USDA’s Animal and Plant Health Inspection Service said it would expand its National Veterinary Stockpile with several hundred million doses of Ceva’s Vectormune AI vaccine and Harrisvaccines’ Avian Influenza H5 vaccine.

New theories on virus spreadWild birds may not have been solely responsible for the spread of HPAI in the US. Virus particles may have also been carried by wind, rodents, people and vehicles moving between farms, according to the US Animal and Public Health Information System (APHIS) in June.

Since HPAI first reached commercial poultry facilities at the start of 2015 more than 47 million birds were lost to the disease, causing serious disruption to US egg and turkey markets by the end of June.

While APHIS scientists said they believed wild birds were responsible for first introducing HPAI into US poultry flocks, they suggested strong winds may have played a part in its subsequent spread.

Some in the industry suggested the reason avian flu had hit turkey and egg farms rather than broiler chicken facilities was linked to different standards of biosecurity in each of those poultry sector segments. For its part, the USDA stepped up collaborative efforts to promote stricter biosecurity since the outbreaks began in early 2015.

latin america agrees avian flu strategyIn September, poultry producing countries in Latin America agreed a joint strategy to control avian flu in order to enhance food security in the region.

The initiatives included a number of actions such as the creation of funds and avian flu contingency plans in all states in the region, and the establishment of a series of biosecurity measures. A working group was created in order to propose specific preventive actions for each important poultry production area in different countries.

West african avian flu fightIn July, The Food and Agriculture Organization (FAO) asked the international community for $20 million to fight avian flu which was breaking out across West Africa and threatening food security in the region.

The Rome-based FAO said fears were growing that without timely intervention to stem outbreaks of the highly virulent strain HPAI H5N1, it was likely it would spread further across the region. To this end, the FAO called for the $20m for prevention and response activities.

The appeal followed outbreaks of the virus in poultry farms, markets and family holdings in Nigeria, Burkina Faso, Niger, Cote d’Ivoire and Ghana.

While the first incursion of the H5N1 in West Africa occurred in 2006 it was eliminated by 2008. In late 2014, however, the virus was re-introduced in Nigeria, where it spread rapidly in the following three months.

egypt a cause for concernIn May, the OIE said the levels of H5N1 avian flu circulating in poultry flocks in Egypt remained “a cause for considerable concern”.

The Paris-based OIE said there indications that H5N1 was circulating in all sectors of Egyptian poultry production and in every part of the country.

As regards human infections of H5N1, the OIE said Egypt ha experienced more human infections and deaths in the first five months of 2015 than had previously been recorded by any country. The OIE said there has been a total of 165 human cases totaled 165, including 48 deaths, in the period from November 2014 to April this year.

The Egyptian H5N1 upsurge was not related to avian flu virus mutations but rather to more people being exposed to infected poultry than ever before, according to the OIE’s most recent research.

First outbreak in France for eight yearsLate in December 2015, there were several outbreaks of avian flu reported by the French agriculture ministry, adding to recent cases in a number of other EU member states. This marked the first time in eight years avian flu cases had been reported in France.

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Three of the cases in France were detected in the Dordogne region, while the other was in Haute Vienne. The total number of HPAI flu cases in France since the virus resurfaced in late November stands at 30.

Elsewhere in the EU, a low pathogenic H5N2 case was detected on a poultry farm in Germany in December, while the same subtype was detected in northern Italy.

The OIE said the German H5N2 outbreak took place at a poultry farm near the town of Roding in Bavaria and resulted in 13,100 layer hens, ducks and turkeys being destroyed. The area was quarantined and premises disinfected. A vaccination strategy was not implemented.

review 2015: europe threatened by encroaching livestock diseases

by MalColM FlaNaGaN

Whilst avian flu dominated the global headlines on veterinary diseases, with the Us mainly in the firing line of different strains, a new focus developed on the threats to european livestock from encroaching animal diseases on the eU’s borders. lumpy skin disease (lsD), african swine fever (asF), foot and mouth disease (FMD) and peste des petits ruminants (ppr) were prominent threats. animal pharm’s asia editor Malcolm Flanagan examines the last 12 months of outbreaks.

Simon More, chair of the European Food Safety Authority’s (EFSA) Animal Health and Welfare Panel, said at the very beginning of the year in January 2015 that LSD, ASF and PPR are prevalent in areas bordering the EU.

Mr More also pointed out that resurgent FMD was also reported in a number of northern African countries in the previous year, describing it as a “major threat to agriculture in the EU” in future years.

“There are many reasons for the ongoing spread of dangerous animal diseases in neighboring countries, with areas of conflict being of particular concern,” he said. The EFSA expert said the most likely pathway for livestock diseases to reach EU territory is the uncontrolled movement across borders of people and animal products.

Mr More also stressed better knowledge of legal and illegal livestock and animal product movements should be sought, while farmers and veterinarians should be trained to recognize animal diseases under field conditions, especially those in border regions considered most at risk from disease incursions.

lumpy skin disease concerns growIn October 2015, the Food and Agriculture Organization (FAO) of the United Nations expressed its immediate concern at the spread of LSD among cattle in Southern Europe, Russia and the Middle East.

LSD is a disease that results in substantial economic losses in terms of dairy and meat production, and can also cause severe damage to valuable animal hides. The disease can lead to restrictions or a total ban of international trade of live animals and animal products. In August last year, Greece reported two outbreaks of LSD in the Evros region along the border with Turkey.

The Rome-based FAO said the source of the disease is likely to have originated from vectors spread from LSD outbreaks reported in Turkey in the Edirne region earlier in June. In September, the disease was also reported in the Russian Federation in Dagestan, not far from the border with Azerbaijan where previous outbreaks had occurred.

Additionally, collapse of important veterinary services in conflict zones in parts of the Middle East in the past few years, together with uncontrolled animal movement, have been major factors in LSD spreading in the Mediterranean region.

“An urgent risk assessment for at-risk regions is required to help decision makers understand the LSD situation and plan response actions,” said the FAO.

“The assessment should focus primarily on the pathways for LSD introduction, such as movements of cattle, regulations, weak authority and weather conditions that could favor the survival of the vectors. Specific risk-management options exist for at-risk countries, including sanitary assistance.”

african swine fever creeps towards Western europeIn 2015, ASF established itself in Russia, Ukraine and parts of Eastern Europe, continuing to creep towards Western Europe.

In a report to the World Organisation for Animal Health (OIE) in July, the Estonian Veterinary and Food Board said the disease was detected on two commercial pig farms in Viljandi and another in Valga.

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ASF first appeared in Estonia in September last year after spreading to the Baltic region from Russia and Belarus. Until the two most recent cases, ASF had been limited to wild boar, although the number of cases has been steadily increasing.

Latvia and Poland had already seen the disease reach backyard pig holdings, although wild boar accounted for the bulk of cases. In May, the Lithuanian authorities also reported an outbreak of ASF on a large commercial holding of 20,000 pigs, close to the border with Belarus and Latvia.

Food safety and veterinary officials from Estonia, Latvia, Lithuania and Poland met in November through the auspices of the EFSA to discuss improvements to the collection of epidemiological data on ASF.

The officials met with European ASF experts in a three-day EFSA workshop to ensure that ASF information complies with the highest quality standards.

Ieva Rodze from the Institute of Food Safety, Animal Health and Environment in Latvia, said after the meeting in Parma: “We are already collecting data but we are not yet using it for deep epidemiological analysis.”

During 2015, Finland expressed concerns that ASF was a serious threat to its swine population. Finland is recommending no wild boar meat or related food products should be brought into the Scandinavian country from neighboring Baltic countries, Russia or Poland due to ASF.

The Finnish Food Safety Authority (FFSA) said ASF has already spread into neighboring Estonia, Latvia, Lithuania and Poland. The Helsinki-based FFSA said ASF is a highly contagious virus which could endanger Finnish pork production and survives extremely well in meat products.

The organization added that ASF is very resistant to various methods of meat product manufacture and capable of spreading in long-life sausages, as well as smoked or air-dried meat products.

“Bringing a gift of wild boar meat from the neighboring areas can also pose a risk. Therefore, the FFSA recommends that travelers do not bring in wild boar meat or foodstuffs from the Baltic countries or Poland, where the disease is present,” warned the FFSA.

Foot and mouth remains a threatIn July, a major animal disease conference in Brussels heard that FMD poses the most significant threat of re-emergence in Europe, according to Dr Bognar Lajos, of the Hungarian Ministry for Agriculture.

Dr Lajos said FMD is present on the fringes of Eastern Europe and the Mediterranean basin – it is currently endemic in Turkey, while Bulgaria suffered an outbreak in 2013 and North African countries have experienced outbreaks this year.

Dr Lajos told delegates to the IFAH-Europe Sustainability Conference the re-emergence of FMD is just one of three key threats to European livestock, the others being emerging diseases and bioterrorism.

An outbreak of FMD was confirmed in Israel in December 2015, the first in the country since February last year. The outbreak occurred on a pig farm in Hazafon in Israel’s Northern District. The Paris-based OIE recorded 172 cases of FMD out of a susceptible 2,300. It reported 120 deaths from the disease.

Earlier in November, Spain announced a raft of new measures to guard against FMD following recent outbreaks in Morocco. Existing restrictions on the import of live animals are being tightened, including a ban on imports of animal products other than those derived from fishing and aquaculture. The measures apply not only to Morocco but also Algeria, Libya and Tunisia.

The Spanish agriculture ministry said it was also banning the import of live animals and animal products from its own North African enclaves – Ceuta and Melilla.

“The sanitary situation in relation to foot and mouth disease in North African countries puts our country and the EU in a position of imminent risk of the disease spreading,” the ministry said in a statement.

peste des petits ruminants outbreaks on eU bordersOutbreaks of PPR on Europe’s borders have also been cited as a cause for concern as regards the potential of the virus spreading to European livestock.

In April 2015, there was an outbreak of PPR in the northern region of Israel, according to the OIE.

The Paris-based OIE said the PPR outbreak took place in Hazafon and affected two farms where 10 goats died out of a susceptible herd of 1,495. A quarantine zone was been implemented and premises disinfected. A vaccination strategy was employed.

As conflict in Syria drives hundreds of thousands of refugees into neighboring countries, the FAO warned there could also be serious consequences for PPR in the region.

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Syria’s neighbors are at risk as some of the 1.5 million Syrian refugees bring with them large numbers of unvaccinated sheep, goats, cattle and other animals.

In July there was a large outbreak of PPR in north-west Morocco in three locations affecting a susceptible herd of 11,000 sheep. Quarantine restrictions were imposed and a vaccine strategy employed. The cause remains unknown and blood samples were sent to the Casablanca Regional Laboratory for Analysis and Research.

Two years ago, international animal health bodies held a meeting in Ryadh, Saudi Arabia, to look at ways of controlling PPR in the Arabian Peninsula and the Middle East.

A global program to control and eradicate PPR disease among livestock has been costed at between $7.6 billion and $9.1 billion over a 15-year period.

Dr Jonathan Rushton, professor of animal health economics at the UK’s Royal Veterinary College, calculated the figures after analyzing the cost to 99 countries involved in the program, which was agreed at the FAO/OIE International Conference for the Control and Eradication of PPR in Abidjan, Cote D’Ivoire, in early April 2015.

review 2015: biotech shares tumble as firms await crucial year

by sIaN laZell

The next 12 months will be critical for animal health’s group of biotechnology firms. last year, their share prices tumbled as pipelines neared fruition. animal pharm analyst sian lazell looks at the highs and lows of the listed animal health businesses.

The majority of listed animal health companies experienced a decline in their share prices in 2015. However, in the case of the biotechnology firms, first-time commercialization is on the horizon – as is the realization of their first significant revenues.

Aratana Therapeutics share price high point of the year came in March when it hit $19.98, soon after a positive fourth-quarter performance and advancements in its canine product pipeline.

By May, the company’s stock price had steadily declined to $12.92, before climbing back up to $19.68 in July – a month which saw the Kansas City-based company gain positive results from a pivotal field effectiveness study of a drug candidate for treating post-surgical pain in dogs.

After a dip, shares returned to $19.73 on September 17. This coincided with US investment bank William Blair describing Aratana’s feline ostesoarthritis drug candidate as verging on “blockbuster territory” just a week earlier.

However, Aratana’s stock price then dropped drastically to $7.83 by the end of the month. In September, Aratana revealed post-licensure marketing studies of its canine lymphoma products AT-004 and AT-005 did not fully capture the market opportunity.

The firm’s share price continued to decline until the end of the year, with it listing at $5.58 on December 31, 2015.

This tumble coincided with the firm’s decision in November to halt the development of one product candidate and its plan to out-license another. Aratana’s lowest share price in 2015 came in at $5.38 earlier in December.

Nevertheless, 2016 could be the year Aratana starts to reel in its first significant revenues as its lead products – Galliprant, Entyce and Nocita – could all be on sale within the next 12 months.

Kindredbio shares decline tooKindred Biosciences experienced a similar share price situation to Aratana in 2015. Throughout the first six months of the year, its share price held relatively steady, only experiencing a slight dip to $6.22 on June 1 before increasing to its highest price of the year at $7.83 on June 23.

Following this peak, KindredBio’s stock price showed a generally continuous decrease throughout the remaining six months of 2015. By August, the Californian company’s shares had dropped to $5.52 and by November, they had dropped further to $4.07. The company’s lowest share price was $3.25 on December 10. It showed little improvement by the end of the month, sitting at $3.40 on December 31.

In November, KindredBio revealed a pivotal field study of one of its lead drug candidates SentiKind –a treatment for post-operative pain in dogs – had missed its primary endpoint.

Following the announcement, the firm added it would turn its attention to developing its equine and biologics franchises over the next five years.

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This coming year will prove important for KindredBio as it completes the rolling new drug application filings for its KIND-010 and KIND-012 candidates.

Nexvet also awaits approvalsLike its biotechnology counterparts, Nexvet Biopharma’s share value also saw a general decrease over the year as it awaits product approvals.

The company’s highest share price of the year was recorded on March 3 at $10.57.

It then dropped to $7.35 by March 26 before improving slightly to reach $9.34 in April, then declining to $4.40 in June.

Over the next six months the firm’s share price steadily decreased, reaching $3.41 on December 31. During this time, the company experienced two slight spikes, with a share price of $6.26 in September and $5.62 in November. Nexvet’s lowest share price recorded in 2015 was $2.95 on December 14.

In 2015, Dublin-based Nexvet gained pivotal safety and efficacy study for its NV-01 candidate and proof-of-concept studies for NV-02.

During November, the firm achieved a crucial goal on its way to commercialization as it secured positive results from a pivotal safety and efficacy study.

jaguar and parnellJaguar Animal Health is another firm which, throughout 2015, was largely focused on R&D. The company’s share price saw a general decline since listing on the Nasdaq stock exchange earlier in the year.

On May 13, shares were at $6.78. The company’s highest share price was recorded on May 15 at $7.01. By the beginning of August this figure had fallen to $3.

Jaguar’s lowest share price was $1.96 on October 26 but by the end of the month, this spiked to $3.85 before trailing off again in the last two months of the year. This spike followed the signing of a drug formulation contract for the active ingredient in the firm’s lead drug candidate.

Although Jaguar saw its stock price gradually fall during 2015, this could change in 2016, with the expected launch of new products and the firm’s recent publication of various positive trial results.

Parnell Pharmaceuticals on the other hand hardly saw any variation in its share prices last year. The company started 2015 with a share price of $4.76 and ended the year at $3.88. Its highest stock value was $5.75 on March 20 and its lowest was $3.26 on September 29.

In October, Parnell said it was close to securing a contract manufacturing deal following recent product introductions.

Zoetis shares driven by takeover rumours?Industry leader Zoetis had a more varied year.

Between January and June the firm’s stock price gradually increased. It took a slight dip at the end of April, dropping to a share price of $44.42 but then continued to improve following its cost-cutting announcement in May, experiencing a spike from $49.71 on June 24 to $55.38 on June 25.

This was Zoetis’ highest pricing throughout the year and it followed rumours at the time of a takeover by Valeant Pharmaceuticals.

The company’s share price then dropped off again, reaching a low of $39.65 by the end of September. However, its share price steadily increased throughout the last three months of the year (particularly after its acquisition of Pharmaq in November) reaching $47.92 by December 31.

Phibro Animal Health’s highest share price in 2015 was $40.04, recorded on August 11. This was an improvement from its lowest share price of 2015 which was $27.33 on January 30.

The firm’s stock value climbed considerably throughout February, going from $27.88 at the beginning of the month to $37.30 by the beginning of March. Phibro ended the year at $30.13.

Mixed year for diagnostics firmsIDEXX Laboratories shares started January with a valuation of $147.33, which remained relatively steady until the end of April when it dipped to $125.37. The firm then saw an even steeper drop in its share price, which went from $132.17 on June 3 to $65.60 on June 5. This followed flat sales results from the company, released at the end of April.

IDEXX’s stock price then remained largely level throughout the remaining six months of 2015, finishing the year at $72.92.

Fellow US veterinary diagnostics specialist Heska started January with a share price of $18.03, which continuously increased throughout the year, reaching a high of $39.76 on December 29. This only dropped off slightly to $38.68 by December 31.

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Heska’s share price growth could be attributed to a number of deals throughout 2015, such as its Canadian distribution agreement with a Henry Schein affiliate, new product launches and its acquisition of Cuattro Veterinary, a veterinary imaging developer – a purchase which it said boosted third-quarter sales.

VCA Antech’s share price steadily increased from $48.58 at the beginning of January to $55.71 by April 23. Its share price then dipped slightly to $50.91 on May 1 before climbing to its highest value of $61.53 on July 31. This followed VCA’s acquisition of the Abaxis Reference Laboratory in March.

VCA’s share price then remained relatively steady around the $55 mark for the rest of the year, finishing 2015 with a value of $55 exactly.

ImmuCell share price up and downBetween April and July, ImmuCell’s share prices showed a general increase. Its share price first climbed from a low of $5.65 on May 12 to $8.49 by May 19, coinciding with positive first quarter sales.

This figure then increased to a high of $11.05 on July 30 – earlier in the month, the company raised its sales forecast for the second quarter of 2015.

However, ImmuCell’s stock price then fell steeply throughout August, sitting at $6.71 on September 1. This price only increased slightly throughout the remainder of the year to $7.54 by the end of December.

In November, the Portland, Maine-based company reported a surge in Q3 sales.

review 2015: The antibiotic resistance debate escalates

by joseph harvey

In 2015, the movement to reduce the amount of antibiotics used in food animals gathered pace. New legislation was approved across many nations, major retailers committed to cut their use of antibiotics and leading animal health companies took their own strategies to the White house. however, the issue attracts a wide range of opposing opinions. These quotes from the last 12 months explore this hot topic.

“People are not interested in ‘no antibiotics’, they are interested in what is on their plate. It is hard to describe what ‘no medically-important antibiotics’ actually means.”

rob Freeman, director of quality systems for McDonald’s Canada, in June

“Antibiotics are fed mostly to healthy animals as a means to compensate for unsanitary and overcrowded conditions on the farm and to make the animals grow larger and faster. This unnecessary antibiotic treatment causes routine bacteria to mutate into untreatable superbugs, and can cause antibiotic-resistant infections in humans either through consumption of tainted food products, by transfer in soil or water runoff, or other means.”

louise M slaughter, a democratic representative for New York’s 25th congressional district, in March

“We need a stronger and more unified voice. Then we can educate, share the benefits and reduce sensationalism.”richard Deluca jr, executive vice president and president of animal health for Merck, said in June

“Policies to tackle antibiotic resistance require a multi-disciplinary approach based on science and reliable facts. In the interest of animal welfare, the main objective should be to reduce resistance to antibiotics, not simply to reduce antibiotic use. A sick animal must be treated with the appropriate medicine when necessary.”

roxane Feller, IFAH-Europe secretary general, in December

“They just don’t have anything in the pipeline. The market is so small it’s not worth it.”Sanderson Farms chief executive joe sanderson talking to the Wall Street Journal

about animal health companies’ alternatives to antibiotics in May

“We have many potential alternatives, so do we actually need new antibiotics? The answer is still ‘yes’. There will always be a need for veterinary antibiotics as long as there is no effective replacement for the treatment of disease.”

Dr erik de ridder, head of regulatory affairs strategy and policy at Elanco, speaking in March

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“In our view, there seems to be a developing consensus that antibiotics will continue to have a role, although perhaps more limited.”

richard johnson, Phibro Animal Health’s chief financial officer in May

“We need to take a strong stance against antimicrobial resistance and the increasing problem of leakage into soil and water, while at the same time avoiding creating red tape that hampers the development of new medicines.”

EU Parliament rapporteur Marit paulsen in July

“It is our industry’s responsibility to keep animals healthy and treat the ones that get sick while safeguarding antibiotics for future generations through responsible use. Ultimately, this is about One Health – not just animal health, but this work creates healthy food, ensures the health of people and protects the planet.”

jeff simmons, Elanco’s president, at the White House in June

“Drug makers regularly exploit this [US legislation] loophole by advertising the growth benefits that can result from using antibiotics for disease prevention and the FDA has failed to crack down on this practice.”

steven roach, senior analyst for the Keep Antibiotics Working collation

“Antibiotic resistance has given birth to new technology but I believe there is still a place for antibiotics in animal health.”

Clint lewis, executive vice president and president of international operations at Zoetis, in June

“There is a need to agree on successful strategies to keep existing antibiotics working to the benefit of all, and we can only achieve that through cross-cooperation between the two medical sectors together with all stakeholders involved.”

HealthforAnimals’ executive director, Carel du Marchie sarvaas, talking about One Health collaboration in June

Finnish firm provides virtual approach to companion animal r&D

by joseph harvey

Solani Therapeutics is seeking early-stage collaborations or licensing deals for two pain relief products it is developing for companion animals.

The Finnish company is aiming to tackle administration problems of oral non-steroidal anti-inflammatory drugs (NSAIDs) with an alternative product solution.

Solani is developing ST14D – a controlled-release formulation of the NSAID meloxicam for dogs suffering from osteoarthritis. The candidate utilizes silica-based drug delivery technology licensed from fellow Finnish business DelSiTech.

According to Solani, ST14D is subcutaneously injectable hydrogel depot with target release time of 30 days that will free dog-owners from the daily administration of oral meloxicam products. A proof-of-concept study for ST14D was completed in January 2015. Further in vivo studies began in the fall.

The company’s second meloxicam-based project is ST15C for post-operative pain in cats. This product uses the DelSiTech technology and aims to provide a subcutaneously injectable meloxicam hydrogel with a release time of 3-5 days. For this candidate, proof-of-concept study results will be available this month.

The company was able to fund 50% of its meloxicam projects with funding from TEKES, a Finnish state funding tool for domestic innovation.

virtual advantageEstablished in March 2014, Solani is the brainchild of three co-founders with backgrounds in the contract research organization (CRO) industry.

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One of these co-founders, Elina Niskanen, told Animal Pharm that while the co-founders have more expertise in human health, they also garnered some animal health research know-how.

Ms Niskanen, who is also the chief executive of Solani, said the co-founders “we saw an opportunity and wanted to see if the grass is greener on the other side” by using their CRO knowledge to create a drug development company in the animal health space.

She said the company aims to use its research background to approach a wide range of R&D projects. It also buys or licenses all of its technology, analytics and animal study data from third parties.

“Biotechnology companies tend to be founded around the founders’ core competence in science and technology,” Ms Niskanen said.

“We, however, wanted to have more market oriented approach. Before we chose the meloxicam project we surveyed the market needs and asked what vets and pet owners would like to have. As we are virtual and new, the ease in building the needed collaboration network and how quickly we could reach proof-of-concept were of great importance for us.”

Further research workWhile the meloxicam work is Solani’s key focus, the firm is also working on other R&D projects. Ms Niskanen said the company is collaborating with an unnamed animal health partner on a research assignment. She did not disclose full details of the partnership but said Solani would receive a fee should proof-of-concept be achieved.

“We are a virtual company, so the overheads are small, which is an advantage,” Ms Niskanen explained. “We think our business model is attractive to our partners. We take the risk and cover the cost up until proof-of-concept. We are flexible and we go where the market goes.”

She said Solani is also in discussions concerning another potential research project with another unnamed animal health partner.

oulu backgroundWhile Solani is a virtual company and does not have any research facility, its office and roots are in the Finnish city of Oulu.

The co-founders all graduated from the University of Oulu’s department of Chemistry. Their careers took them to several research-focused businesses in and around Oulu, which has a reputation as being a leading hub for scientific work in Northern Europe.

Former senior Merial executive joins patterson

by MalColM FlaNaGaN

Former Merial senior executive Doug Jones has joined Patterson Animal Health as president of the company’s companion animal group.

Patterson Animal Health, which is part of the St Paul’s, Minnesota-headquartered Patterson Companies, said Mr Jones joins the company after previously being president of Merial North America.

Mr Jones spent a total of six years with Merial North America. Other positions held with Merial included being head of Merial’s US pets sales and national accounts teams. Mr Jones was also a key member of the company’s regional strategic management committee.

French company Merial is to be merged with Germany’s Boehringer Ingelheim to form the world’s second largest animal health company and biggest in Europe.

Earlier in his career, Mr Jones was a business consultant for accountants PricewaterhouseCoopers and The North Highland Company. He holds an undergraduate degree from Vanderbilt University and an MBA from the University of Texas at Austin.

Scott Anderson, chairman and chief executive of Patterson Companies, said: “Our commitment to our customers begins with hiring exceptional talent who can effectively lead our ability to deliver customized solutions. I am confident Mr Jones’ industry experience and vision will drive business growth in our companion animal business.”

Patterson Animal Health, formerly Patterson Veterinary, is a leading, full-line distributor in North America and the UK of animal health products, services and technologies to both the production-animal and companion animal markets.

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Zoetis adds aquaculture- focused patents

by joseph harvey

Zoetis boosted its portfolio of patents focused on technology for aquaculture in December.

As of December 31, the industry leader had gained eight new patents for the month. These included patents covering subunit immersion vaccines for fish, as well as selamectin for treatment of sea lice infestations.

In November, Zoetis made a significant move in the aquaculture market by purchasing Pharmaq in a $765m deal.

Boehringer Ingelheim Vetmedica secured the largest amount of patents in December, with four of these focused on porcine diseases. The patents covered: novel European PRRSV strain; commercial-scale process for production of PRRSV; use of a PCV2 immunogenic composition for lessening clinical symptoms in pigs; and porcine parvovirus 5B, methods of use and vaccine.

Merial, which is set to merge with Boehringer’s animal health business over the next few months gained two patents related to parasiticidal compositions, amongst others.

According to Animal Pharm’s Patent Archive, other firms to gain animal health-related patents in December included Bayer Animal Health, Merck Animal Health, Elanco-owned Novartis Animal Health, Virbac, Ceva Santé Animale, Norbrook Laboratories, Ouro Fino Saúde Animal, Biogénesis Bagó and Aratana Therapeutics.

Merck, elanco secure Us supplemental approvals

by joseph harvey

Merck Animal Health’s Zilmax feed supplement and Elanco’s Pulmotil bovine respiratory disease treatment have had their US approvals slightly changed.

In the case of Zilmax (Zilpaterol hydrochloride), the US Food and Drug Administration’s approval provides for the replacement of previously-approved determinative and confirmatory procedures for cattle liver with new liquid chromatography–mass spectrometry methods.

The new approval also covers the addition of determinative and confirmatory procedures for cattle muscle, as well as the inclusion of a 10 parts per billion tolerance for zilpaterol in cattle muscle.

Several versions of Zilmax gained supplementary approval in May 2015. The product was first approved in the US in 2006 as part of the Intervet business.

Elanco’s Pulmotil AC (Tilmicosin phosphate) gained a new indication as part of the supplementary approval. It is now indicated for the control of swine respiratory disease (SRD) associated with Mycoplasma hyopneumoniae in the presence of porcine reproductive and respiratory syndrome virus in groups of swine within buildings where a respiratory disease outbreak has been diagnosed.

Pulmotil originally received US authorization as a treatment for bovine respiratory disease in December 2011.

sumitomo invests in Chinese animal drug company

by Dr aTsUo haTa

Japanese trading business Sumitomo will acquire 25% of shares in Chinese animal health firm Shandong Sinder Technology.

r&d

products

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Located in Shandong province, Shandong Sinder is a manufacturer of vaccine and antibiotic products for poultry and pigs, at its own four factories which employ 1,100 people. Shandong Sinder had sales of CNY350 million ($54 million) in fiscal 2014.

Tokyo-based Sumitomo intends to negotiate with Shandong Sinder about a license agreement for vaccine manufacture and import business of animal drugs on behalf of certain Japanese companies.

Sumitomo is growing its involvement in the animal drug space. The company already manufactures animal feed additives through its chemicals arm.

argenta begins Us manufacturing operations

by joseph harvey

New Zealand animal health firm Argenta has commenced manufacturing operations in the US.

The company purchased the AML Riverside facility in Fort Dodge, Iowa, last year from Boehringer Ingelheim Vetmedica. Argenta aims to hire 43 staff in the first year of the site’s operation, with the first 20 starting work this week.

The facility is 145,000-square-feet within a 15.3 acre site. It consists of production spaces as well as support laboratories.

While this is the first Argenta manufacturing site in the US, it is the company’s third business situated stateside. In 2008, Argenta gained a presence in the US when it bought New Jersey-based clinical contract research provider AlcheraBio. The Auckland-headquartered company also opened a drug product research laboratory in Lawrence, Kansas, in 2011.

Doug Cleverly, Argenta’s managing director and co-founder, said: “The Fort Dodge facility is world-class and the advanced manufacturing technologies we’ve acquired means the facility produces some of the most high-tech products available in animal health today.

“Interest from existing and potential clients has been stronger than we expected, meaning a far more aggressive hiring plan has been adopted already. Originally, we committed to creating 30 jobs within three years, but we will exceed this within the first year.”

He also said the facility will provide the firm with the additional capacity it needs to meet increasing demand for “quality animal health technologies and products in the US”.

Argenta was founded in 2006 and specializes in drug development, drug delivery technologies and contract manufacturing services for the animal health industry. The firm currently employs around 300 staff globally and “works with nine of the top 10 global animal health pharmaceutical companies, as well as several startups”. It also exports products and services to over 40 countries including US, Canada and Japan as well as many European nations.

boehringer japan gains Ingelvac approval

by Dr aTsUo haTa

Tokyo-based Boehringer Ingelheim Vetmedica Japan obtained market approval of its Ingelvac 3 FLEX (trivalent porcine vaccine) in December.

The vaccine is designed to protect swine against porcine circovirus virus type 2 (PCV2), porcine mycoplasmal pneumoniae (PMP) and porcine reproductive and respiratory syndrome (PRRS).

Boehringer previously launched Ingelvac FLEX Combo Mix in Japan during 2013. The product is indicated for the prevention of PCV2 and PMP.

companies

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The Ingelvac brand – which the company continues to build on – is key to Boehringer’s global swine portfolio. Its PRRS vaccine records annual sales of around €74 million ($81 million). In Europe last year, the company launched Ingelvac PRRSFLEX EU for piglets and ReproCyc PRRS EU for breeding gilts and sows.

Wsava updates global vaccination guidelines

by MalColM FlaNaGaN

The World Small Animal Veterinary Association (WSAVA) has updated its canine and feline vaccination guidelines which it offers to veterinarians worldwide.

The Ontario, Canada-based WSAVA said its vaccination guidelines aim to provide globally applicable recommendations on best practice for the vaccination of pets to help veterinarians undertake the practice in a standard and scientifically-justified fashion.

The WSAVA has also updated the vaccination guidelines it offers to pet owners and breeders, as well as fact sheets it has created on key global vaccine-preventable diseases of dogs and cats.

The organization’s original vaccination guidelines were published in 2007 as WSAVA’s initial response to the need for globally applicable recommendations on vaccination best practice.

The late 2015 release of the guidelines is based on a new evidence-based classification system for vaccinology. It also includes a number of additional FAQs (110 in total). The guidelines for both veterinarians and owners/breeders are available for free. Currently available in English, they are being translated into a number of languages.

Professor Michael Day, chair of the VGG, said: “The vaccination guidelines are one of the most frequently downloaded resources on the WSAVA’s website and are gradually driving a change in vaccination practice throughout the world.

“We hope they will prove even more helpful and ensure that more small animals are vaccinated in a more scientifically-based, robust and safer fashion.”

The guidelines were last updated in 2010 and since then the WSAVA’s Veterinary Vaccines Group (VVG), which is supported exclusively by MSD Animal Health, has been focusing on issues relating to small companion animal infectious disease and veterinary education in Asia.

WSAVA is an umbrella organization representing 158,000 veterinarians globally through 96 regional and country member associations. The VVG was established in 2006.

Merial cattle pour-on approved in australia

by sIaN laZell

Merial’s generic Tixfix pour-on tick development inhibitor was approved by the Australian Pesticide and Veterinary Medicines Authority (APVMA) in December.

Tixfix is a topical solution indicated for the treatment and prevention of cattle ticks in beef cattle after weaning. The product’s active ingredient is the widely-used insecticide fluazuron and it is available in 2.5L, 5L, 10L, 20L and 25L sizes.

Other pour-on parasiticides for cattle developed by Merial that are already approved in Australia include Maximus (moxidectin) and Avomec (abamectin).

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Galvmed working on molecules for nagana

by joseph harvey

Animal health charity the Global Alliance for Livestock Veterinary Medicines (GALVmed) is hoping to attract commercial partners to work on a treatment for Animal African Trypanosomosis (AAT).

AAT, also known as nagana, is a deadly livestock disease. According to GALVmed, AAT kills around three million cattle each year, as well as many sheep and goats. It is spread by tsetse flies bites and causes fever, severe anemia and ultimately death if not treated.

The disease impacts 40 countries across Africa and is responsible for up to 50% loss in milk and meat production in affected cattle.

While there are available treatments for AAT, their efficacy is limited as some were introduced more than 40 years ago. Safety is also a key issue, particularly in terms of residues of treatments in products from food-producing animals.

GALVmed has tested a range of trypanocidal drugs to identify which ones are effective against T congolense and T vivax, the most important parasites species that cause AAT. The development work has been funded by the Bill & Melinda Gates Foundation and the UK’s Department for International Development.

GALVmed explained: “The search for new trypanocides has unearthed several potential candidates that fit the bill; their development has been de-risked to the point where they are near to handover to a commercial partner to develop further and market.

“The results on candidate molecules were shared with a number of potential commercial partners in Franschhoek, South Africa during a meeting in November 2015. Those who are interested in taking the potential candidates through full development have been asked to submit their Expressions of Interest to GALVmed by January 2016.”

The charity is also looking for veterinary company partners to commercialize a live LaSota strain Newcastle disease vaccine.

UK to improve bio-containment capabilities

by joseph harvey

The UK is to bolster its resilience to animal diseases by investing around £65 million ($95 million) in new defenses.

UK Environment Secretary Elizabeth Truss outlined plans for Department for the Environment, Food and Rural Affairs (Defra) to create state-of-the-art laboratories and fund the upgrade of the country’s bio-containment facilities in Weybridge.

She said these measures would help in “securing our ability to fight diseases like swine fever and avian flu”.

This investment comes following last year’s announcement that Defra’s budget will be cut by 15% over the next four years. Defra’s move to strengthen the UK’s animal disease control measures may go some way to appeasing critics of the cuts.

In a speech to delegates at the annual Oxford Farming Conference, Ms Truss also highlighted the threat poised to the UK from bovine tuberculosis (bTB).

She said: “We are making good progress against what is the gravest animal disease threat facing Britain, with half of England due to be declared bTB-free by 2020. Our approach of tackling the disease both in cattle and wildlife has worked in Australia and is working in Ireland and New Zealand.

Thanks to the efforts and dedication of local farmers, all three areas – Somerset, Gloucestershire and Dorset – hit their target in 2015. The chief veterinary officer is clear this policy needs to be followed over a wider area to secure full disease control benefits. That’s why I announced, in line with his advice, I want to see culling in more areas this year.”

New cases of bTB in the UK are levelling off. However, the country still has the highest rate in Europe. The country’s government is currently working on a 25-year strategy to eradicate bTB.

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Iran suffers first foot-and-mouth outbreak

by joseph harvey

A case of foot-and-mouth disease (FMD) has been confirmed in the Iranian village of Asgarlou – the first ever in the country.

The outbreak occurred in August 2015 but was only confirmed in December by the UK’s Pirbright Institute. According to the laboratory tests, this is a new strain of FMD.

The outbreak happened in a population of 1,250 fattening cattle. There were 15 confirmed cases of FMD and two deaths.

Dr Mehdi Khalaj, the head of the Iran Veterinary Organization, informed the World Organisation for Animal Health (OIE) of the outbreak, which was attributed to illegal movement of animals.

The OIE report said: “Samples were collected from fattening calves illegally introduced in a big fattening complex. The origin of these calves was traced to Miyandoab live animal market located in West Azarbijan province.

Vaccination (using a Merial vaccine), disinfection and movement control measures have all been applied.

middle east

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