11 April 2016 Animal Pharm · The country’s ruminants market, including sheep and goats, also...

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11 April 2016 © Informa 2016 1 of 13 ‘Not all parasiticides created equally’ says Zoetis as sales of Simparica begin in Europe BY JOSEPH HARVEY Zoetis has officially commercialized Simparica in Europe, thus adding to the company’s growing portfolio of products for dogs. Animal Pharm editor Joseph Harvey attended the product’s launch in Amsterdam, the Netherlands, to find out about the impact it would have on the European market. While there are vaccines available for the prevention of vector-borne diseases, therapies are limited in this area. One method of stopping the spread of disease vectors such as ticks is by clearing the environments they thrive in. However, this is not always an accurate and quick solution. Zoetis believes its new molecule of the isoxazoline class provides a quick, long-lasting solution to killing some of the most prevalent ticks in Europe. Simparica (sarolaner) is an oral tablet medication against a broad spectrum of ectoparasites in dogs beginning at eight weeks of age. Simparica kills Ctenocephalides canis, Ctenocephalides felis, Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes hexagonus and Sarcoptes scabiei. The once-monthly chewable tablets provide “immediate onset with peak performance against fleas and ticks lasting for full 35 days, without losing efficacy at the end of the month,” according to Zoetis. Simparica is also indicated for the treatment of sarcoptic mange and flea allergy dermatitis. It is a prescription-only product. Simparica was approved in Europe at the end of 2015, while US authorization came in February this year. Active substance Sarolaner was discovered and developed entirely by Zoetis scientists. The company said its research team designed a molecule providing optimized anti-parasite potency, pharmacokinetics and safety profile. Thomas Geurden, associate director of clinical research and development at Zoetis, explains to Animal Pharm in the video below how the firm selected sarolaner as its preferred molecule through in vitro screening. Calier reorganizes Latin American business with M&A BY JOSEPH HARVEY Spanish animal health firm Calier has recorded around 10% organic growth in 2015, despite divesting its Brazilian business. Barcelona-based Calier told Animal Pharm it posted sales of around €67.3 million ($76.3 million). The firm specializes in autogenous vaccines, antimicrobials, antiparasitics and premixes for a variety of species. In 2014, Calier said its annual revenues grew 3% to around approximately $125m. However, its Brazilian business – Hertape Calier – has been spun-out into a standalone entity in Juatuba. Hertape was established in 1943 and specializes in biologicals and pharmaceuticals for companion animals and livestock. Calier originally formed its Hertape Calier as part of a joint-venture agreement with Brazilian company Hertape in 2004. Whilst the Spanish firm saw a drop in sales from Brazil during fiscal 2015, Calier’s Latin American operations were boosted following the purchase of Colombian company Laverlam. www.animalpharmnews.com YOUR WEEKLY BRIEFING Animal Pharm Agribusiness intelligence | PRODUCTS COMPANIES

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11 April 2016

© Informa 2016 1 of 13

‘Not all parasiticides created equally’ says Zoetis as sales of Simparica begin in Europe

BY JOSEPH HARVEY

Zoetis has officially commercialized Simparica in Europe, thus adding to the company’s growing portfolio of products for dogs. Animal Pharm editor Joseph Harvey attended the product’s launch in Amsterdam, the Netherlands, to find out about the impact it would have on the European market.

While there are vaccines available for the prevention of vector-borne diseases, therapies are limited in this area.

One method of stopping the spread of disease vectors such as ticks is by clearing the environments they thrive in. However, this is not always an accurate and quick solution.

Zoetis believes its new molecule of the isoxazoline class provides a quick, long-lasting solution to killing some of the most prevalent ticks in Europe. Simparica (sarolaner) is an oral tablet medication against a broad spectrum of ectoparasites in dogs beginning at eight weeks of age.

Simparica kills Ctenocephalides canis, Ctenocephalides felis, Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes hexagonus and Sarcoptes scabiei.

The once-monthly chewable tablets provide “immediate onset with peak performance against fleas and ticks lasting for full 35 days, without losing efficacy at the end of the month,” according to Zoetis. Simparica is also indicated for the treatment of sarcoptic mange and flea allergy dermatitis. It is a prescription-only product.

Simparica was approved in Europe at the end of 2015, while US authorization came in February this year.

Active substanceSarolaner was discovered and developed entirely by Zoetis scientists. The company said its research team designed a molecule providing optimized anti-parasite potency, pharmacokinetics and safety profile.

Thomas Geurden, associate director of clinical research and development at Zoetis, explains to Animal Pharm in the video below how the firm selected sarolaner as its preferred molecule through in vitro screening.

Calier reorganizes Latin American business with M&A

BY JOSEPH HARVEY

Spanish animal health firm Calier has recorded around 10% organic growth in 2015, despite divesting its Brazilian business.

Barcelona-based Calier told Animal Pharm it posted sales of around €67.3 million ($76.3 million). The firm specializes in autogenous vaccines, antimicrobials, antiparasitics and premixes for a variety of species.

In 2014, Calier said its annual revenues grew 3% to around approximately $125m. However, its Brazilian business – Hertape Calier – has been spun-out into a standalone entity in Juatuba. Hertape was established in 1943 and specializes in biologicals and pharmaceuticals for companion animals and livestock.

Calier originally formed its Hertape Calier as part of a joint-venture agreement with Brazilian company Hertape in 2004.

Whilst the Spanish firm saw a drop in sales from Brazil during fiscal 2015, Calier’s Latin American operations were boosted following the purchase of Colombian company Laverlam.

www.animalpharmnews.com

YOUR WEEKLY BRIEFING

Animal PharmAgribusiness intelligence |

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Laverlam is headquartered in Cali and is focuses on developing biologicals and antibacterials for food-producing animals. The firm adds to Calier’s Latin American network and increases its portfolio of vaccines.

Calier also retains businesses in Venezuala, Uruguay, Argentina, the Dominican Republic and Mexico. In Europe, the firm also has a presence in Portugal, Italy, Poland and Germany, while the firm also has a base in Morocco.

Calier historyThe company has three pillars of R&D supporting its growth: veterinary biologics; MUMS (minor use, minor species) medicines; and generic products.

Formed in 1968, Calier was exporting its products to Latin America and North Africa by the 1970s. The firm formed its first subsidiary in 1978 – Calier Venezuala. In 1981, the company gained its first headquarters in Les Franqueses del Vallès in Catalonia, while in 1984 it bought all the rights to Novartis’ Tiamutin antibiotic.

In 1982, the firm began to grow its South American presence with a Colombian subsidiary. Then a Portuguese unit was established in 1988.

The company’s Les Franqueses del Valles site was certified with European GMP in 1993. The 1990s saw Calier build more subsidiaries in Argentina (1994), Brazil (1998) and the Philippines (1996).

In the 2000s, Calier begun the development and manufacturing of vaccines in a new plant in Leon, Spain, Uruguay (2001), Poland (2001), Italy (2008) and Mexico (2008) all saw Calier subsidiaries established locally.

Recently, Calier opened a new parasiticides plant in Uruguay and set up Calier Deutschland in 2013. The company also increased the capacity of its biologicals center in Leon.

The company is part of Grupo Indukern, a family-owned Spanish fine chemicals manufacturer founded in 1962.

Vaccine revenues propel Czech firm Bioveta to strong annual growth

BY MALCOLM FLANAGAN

Czech Republic-based animal health firm Bioveta recorded a healthy 25% sales growth in 2015.

Full-year sales for the company reached €50.7 million ($57.7 million). Between 2010 and 2015, Bioveta has achieved an average annual revenue growth rate of around 19%.

The growth was largely driven by sales of Bioveta products within Europe and Asia. The firm’s most succesful products have been: the Biocan and Biocan M Plus vaccines for Microsporum canis and distemper in dogs; APP (Actinobacillus pleuropneumoniae serovar) vaccines for pleuropneumonia in pigs (BioSuis and Hyobac); and BioBos vaccines for respiratory infections in cattle.

Bioveta’s research and development services for third parties attracted increased revenue and has become an important part of the company’s services.

In order cope with the increasing demand for its products and services, Bioveta is going to invest €15m ($17m) in new manufacturing and research premises within its facility situated at its Ivanovice na Hané headquarters. Construction will begin in June.

The new premises should enable Bioveta to increase its production capacities for vaccines, as well as to extend space to accommodate more research projects focused on vaccines for third parties. Another investment into capacity expansion is planned for 2017.

“We predict an 11% organic growth for 2016 that should result in €56.3m sales. The growth is expected especially in sales of Bioveta vaccines portfolio within Europe. For future growth, the company plans to enter the US market, where it has already introduced one of its Biocan canine vaccines,” said Bioveta.

Bioveta has a portfolio of around 150 products for the diagnosis, prevention and treatment of disease in farm and companion animals, particularly veterinary vaccines, hormones and pharmaceuticals. It exports to more than 70 countries around the world. This includes active collaborations with overseas companies that are market leaders in veterinary products.

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Turkish industry anticipates animal health export boom

BY JOSEPH HARVEY

The Turkish animal health sector could soon benefit in an export boom as domestic manufacturers begin to globalize.

The country’s burgeoning animal health industry is currently worth around $350 million, according to the Turkish veterinary pharmaceutical industry association (VISAD). This makes Turkey one of the largest animal health markets in its region of the world.

VISAD said the Turkish industry, whilst being established in the near- and far-East, is looking for new export markets including nations within the EU.

Turkey’s major animal health business driver is its highly integrated poultry sector. In fact, the nation produces around two million tons of poultry per year. This figure is second to only Iran in the Middle East.

The country’s ruminants market, including sheep and goats, also plays a relevant role to its economy, while Turkey’s companion animal market is comparably small but is “promising a bright future with new regulations that are similar to EU standards”. The Turkish aquaculture sector is also third in the region and produced 234,000 tons of fish in 2013.

VISAD recently celebrated its 25th anniversary in Antalya. Nearly 200 participants from industry, academia and the Turkish Ministry of Food, Agriculture and Livestock attended the anniversary.

The attendees – including guest speaker Dr Klaus Hellmann of German veterinary contract research organization Klifovet – discussed the most prominent topics in Turkish animal health, namely GMP compliance and antimicrobial resistance.

Established in 1991, VISAD has 30 member companies including leading multinationals as well as many domestic companies. VISAD represents more than 80% of the total animal health sector in Turkey.

GMP targets being metSince 2011, Turkish manufacturers of veterinary medicines have been obliged to comply with Good Manufacturing Practices (GMP). According to VISAD, this process is ongoing with both manufacturers and inspectors collaborating to implement these best practices.

The president of VISAD, Burcak Zorlu (pictured right), said the industry has already achieved GMP standards set by Turkey’s Pharmaceutical Inspection Committee. He added that this should allow the Turkish industry to be even more competitive.

The need for increased GMP compliance was echoed by Dr Semra Yılmaz (pictured right), head of the country’s Veterinary Medicinal Product and Public Health Directorate in the Ministry of Food, Agriculture and Livestock. There are currently 40 veterinary pharmaceutical and biological manufacturing sites in Turkey – as well as several exporting countries – that have been audited and GMP-certified by the Ankara-based Ministry.

Other veterinary concerns in TurkeyVISAD said: “The Turkish veterinary market is facing very similar challenges as the veterinary industry in Europe and worldwide. While there is a highly integrated poultry industry, veterinarians are fearing for their influence regarding keeping animal health at the required level, while also maintaining the right for prescription and dispensing of veterinary medicinal products.

“At the same time, we see the topic of antimicrobial resistance growing, with disproportionate attacks of some individuals against the industry in general. As in many other areas of the world, it is difficult to argue against this in the absence of sound scientific data for Turkey on these topics.”

Europe launches new species-focused antimicrobial surveillance plan

BY JOSEPH HARVEY

European authorities will be monitoring the use of antibiotics in different animal species for the first time, as part of an official surveillance scheme.

The European Medicines Agency (EMA) has published its latest European Surveillance Veterinary Antimicrobial Consumption (ESVAC) draft strategy for 2016-2020.

policy & regulation

Burcak Zorlu, president VISAD

Dr Semra Yılmaz, Ministry of Food, Agriculture & Livestock, Turkey

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ESVAC said the strategy aims “to enable the analysis of European-level trends in antimicrobial consumption per animal species using data that is standardized between countries”. The data collection will have a specific focus on pigs, poultry and cattle.

“For a more accurate estimate of the exposure to antimicrobials by animal species, ESVAC will publish defined daily doses and defined course doses in 2016 to provide standardized units of measurement,” the draft strategy states.

Industry body IFAH-Europe welcomed ESVAC’s new species-specific focus, saying it “should enable policy-makers to develop better targeted and refined policies to fight antimicrobial resistance effectively”.

The strategy is open for consultation until June 30, 2016. The full draft strategy can be read here.

ESVAC’s missionEstablished in 2009, ESVAC’s mission is to “develop a harmonized approach for the collection and reporting of data based on national sales figures combined with estimations of usage in at least major groups of species”.

To date, ESVAC has published sales data from 26 European countries, while the upcoming 2016 report will feature data from 29 countries.

Currently, the data is submitted voluntarily by countries. However, a proposal for new regulations governing veterinary medicinal products was adopted by the European Commission in September 2014 including a requirement for European Union/European Economic Area nations to collect and supply data regarding sales and use of antimicrobials to the EMA.

“In the period 2016-2020, a major driver for ESVAC activities will therefore be to put in place the systems and procedures necessary to manage this anticipated future legal requirement for both national competent authorities and the EMA,” ESVAC stated.

“It is currently envisaged that the regulation will be adopted in 2017 to come into force two years later. Whilst the detailed provisions of the regulation cannot be predicted in advance of the outcome of the co-decision procedure, there is widespread consensus that the collection of data on sales and use of veterinary antimicrobials will form an important part of the new legislation.”

ESVAC recently noted sales of antibiotics for food-producing animals in Europe dropped by around 8% between 2011 and 2013.

Centrexion to explore use of Boehringer analgesics in pets

BY JOSEPH HARVEY

US firm Centrexion Therapeutics has acquired three analgesic candidates from Boehringer Ingelheim for an undisclosed fee.

Centrexion specializes in developing new pain treatments for both humans and companion animals, with a particular focus on new non-opioid and non-surgical therapies.

The company’s chief veterinary officer, Dr Peter Hanson, told Animal Pharm: “In keeping with our combined vet and human development strategy we will explore potential animal health applications as well.

“The need for pain drugs based on new mechanisms of action applies to animals as much as it does for humans. Further, non-addictive, non-opioid drugs are also important to reduce the risk for potential diversion and human abuse of such products.”

The Baltimore, Maryland-based business has purchased CNTX-6970, a cytokine CCR2 antagonist. The firm said this small molecule agent has shown “promising efficacy in multiple animal models of inflammatory pain and has recently demonstrated safety and binding to its target in a single ascending dose Phase 1 clinical study”. Centrexion will take over the finalization of the Phase 1 program from Boehringer.

The company has also acquired CNTX-6016, which it describes as the first in a new generation of potent and super-selective cannabinoid CB2 agonists. Centrexion said CNTX-6016 is “20,000 times more selective for the CB2 receptor than for the CB1 receptor and thereby able to achieve pain relief without the euphoric and other side effects seen with less selective agonists”.

For CNTX-6016, efficacy has been shown in multiple neuropathic pain models with no central nervous system side effects.

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The third candidate is CNTX-0290, a selective somatostatin SSTR4 agonist. Centrexion said this analgesic has “demonstrated very broad efficacy in multiple animal models of chronic pain and has the potential to treat inflammatory, nociceptive, neuropathic and mixed chronic pain states”.

Both CNTX-6016 and CNTX-0290 are ready for investigational new drug applications in the US.

Founded in 2013, Centrexion has raised $58 million to date. Centrexion is developing a product for the animal health market in parallel with its human knee joint osteoarthritis treatment, with the programs providing synergies to each other.

Japanese market boosted by new veterinary biologicals

BY DR ATSUO HATA

The Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF) approved 18 new animal drugs in 2015 – two more than the previous year.

Of the products approved in 2015, seven were pharmaceuticals, six were biologicals, four were antiparasitics and one was a diagnostic product. The two extra authorizations were for biologicals.

The increase in biologicals relates to a growing amount of pet products being authorized by the JMAFF. Companion animals were the most common target species for the new products – 12 drugs were for dogs, cats or horses.

International firms secured 10 approvals in Japan, with Merial gaining three authorizations. The JMAFF also approved an additional indication of four existing animal drugs for 2015 (see second table).

New animal drugs approved in Japan for 2015Company Brand Ingredient IndicationBayer Animal Health Japan

Avodocate for dogs Imidacloprid + moxidectin

Prevention of heartworm disease, elimination of fleas, deworming roundworm and hookworm in/on dogs

Boehringer Ingelheim Vetmedica Japan

Pexion Tablets 50mg, 100mg, 400mg

Imepitoin Improvement of generalized seizures associated with idiopathic epilepsy in dogs

Ingelvac 3 FLEX Porcine trivalent vaccine

Prevention of porcine circovirus type 2 infection, porcine mycoplasmal pneumonia and porcine reproductive and respiratory syndrome (PRRS) in pigs

DS Pharma Animal Health

Pronamid E Powder 1%

Mosapride citrate monohydrate

Improvement of hypokinetic digestive tract associated with constipation in horses

Intervet (MSD Animal Health Japan)

Bravecto Chewable tablets 112.5mg, 250mg, 500mg, 1000mg, 1400mg

Fluralaner Elimination of fleas and ticks on dogs

Kaketsuken (Chemo-Sera Therapeutic Research Institute)

Swimgen ART2 Porcine bivalent vaccine produced by recombinant E.coli

Prevention of atrophic rhinitis in pigs

Awimgen ART2-ER Porcine trivalent vaccine produced by recombinant E.coli

Prevention of atrophic rhinitis and erysipelas in pigs

Kyoritsu Seiyaku Epiless Tablets 10mg, 20mg, 40mg, 80mg

Zonisamide Improvement of seizures caused by idiopathic epilepsy in dogs

Meiji Seika Pharma Animal Health

Vetorphal 2mg, 5mg

Butorphanol tartrate Alleviation of pain associated with surgical operation in dogs and cats

Merial Japan Broadline Fipronil, (S)-methopren, praziquantel, eprinomectin

Prevention of heartworm disease, elimination of fleas and ticks, prevention and control of flea infestation, deworming of roundworm, hookworm and tapeworm in/on cats

NexGard Spectra 11.3, 22.5, 45, 90, 180

Afoxolaner + milbemycin oxime

Prevention of heartworm disease, elimination of fleas and ticks, deworming of roundworm, hookworm whipworm in/on dogs

Purevax RCP-FeLV Feline tetravalent vaccine

Prevention of feline viral rhinotrachitis, feline calicivirus, feline panleucopenia and feline leukemia in cats

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Nippon Zenyaku Kogyo Mediderm Piroctone olamate Treatment of dermatitis caused by Malassezia in dogs

Nisseiken Swinetect APX-ME Porcine trivalent vaccine produced by recombinant E.coli

Prevetion of Actinobacillus pleuropneumoniae type 1, 2 and 5 infection in pigs

Riken Genesis CoCoMo-BLV detection kit

Diagnostic kit for cattle

Detection of bovine leucosis provirus in genome extracted from blood in cattle

Vaxxinova Japan Vaxon AE Pox Liquid Avian bivalent vaccine

Prevention of avian encephalomyelitis and fowl pox in chickens

Zoetis Japan Trocoxil Chewable 6, 20, 30, 75, 95

Mavacoxib Relief of inflammation and pain caused by degenerative arthritis in dogs

Apoquel Tablets 3.6, 5.4, 16

Oclacitinib Relief of symptoms caused by atopic dermatitis and pruritus associated with allergic dermatitis in dogs

Source: JMAFF

Additional indications for existing animal drugs in Japan for 2015Company Brand Ingredient IndicationASKA Animal Health Benesal for fish Praziquantel Elimination of Benedenia seriolae and Cardicola

opisthorchis on Sea bass and Bluefin tuna

Bayer Animal Health Advocate for cats Imidacloprid + moxidectin

Prevention of heartworm disease, elimination of fleas and ear mites, deworming of roundworm, hookworm in/on cats

Hadaclean Praziquantel Elimination of Benedenia seliolae and Cardicola opisthorchis on Sea bass and Bluefin tuna

Zoetis Japan Cerenia Injection Maropitant citrate Prevention and control of vomiting in dogs Control of vomiting in cats

Source: JMAFF

South Korean vaccine firm to open new factory

BY MALCOLM FLANAGAN

One of South Korea’s leading domestic animal health firms is planning to open a new factory and laboratory near the capital Seoul, in order to increase capacity and raise standards of research.

The Green Cross Veterinary Company was present at the recent VETME 2016 exhibition in Dubai and told Animal Pharm that it has been planning the move for some time. It is intending to increase its present 160 staff to over 200 once the move is complete. Most of the new staff will be scientists.

The company was founded in Seoul in 1970 to produce poultry vaccines. Ten years later it also moved into swine and bovine vaccines. It claims to currently be the top South Korean producer of animal vaccines.

Green Cross’s director of strategy Dr Byung Ho said his company is producing 15 poultry vaccines and 30 swine vaccines. It also has 10 bovine and dairy vaccines. Whilst primarily aimed at the domestic livestock market, which has been hit by many animal diseases in recent years, the company began to export its products in 2013.

“In the last few years we have started to increase our production plus exports have become more relevant and that is why we are building a new factory and laboratory complex at Yong In, which is quite near Seoul. The opening date for our new complex is not known yet,” said Dr Ho.

“We will be modernizing the company and increasing production at the same time. We have partnerships with overseas universities and the South Korean government. We currently export to Thailand, Bangladesh and Indonesia. We would like to export to China also.

“We are looking for distributors in the Middle East and Arabian Gulf states. We believe our poultry vaccines are of high quality and competitive in price in the Middle East. I am confident we can make inroads in the region quite soon.”

Dr Ho said the company had spent around $10 million on the new factory and the Level Three laboratory complex. He said the company also produces chemical treatments and feed additives intended for the control of diseases in animals.

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In total, Green Cross products include vaccines, antimicrobials, coccidiostats, antibiotics, feed and feed additives, insecticides, disinfectants and milk replacers. The company also has a small number of companion animal products.

Green Cross has a partnership agreement with French company Merial in place and is keen to find other foreign partners for research and product distribution.

Age-old skills spur Pakistan’s vet instruments sector

BY MALCOLM FLANAGAN

Pakistan’s thriving north eastern city of Sialkot has a centuries’ old tradition of metal and steel working, which it now also applies to sophisticated veterinary instruments.

Five Sialkot veterinary instrument companies were present at the recent VETME 2016 exhibition in Dubai to show off their animal health surgical and diagnostic instruments to would-be distributors in the Middle East and Arabian Gulf states.

One of the Pakistani companies, Saqalain International, has been in existence since 1957 and is growing rapidly in the country’s veterinary market. In addition, it is also increasing its export markets.

Saqalain’s export director Sultan Haider Shabbir said the company has been utilizing the traditional steel making skills of the local population to adapt to the production of veterinary instruments.

Sialkot companies in the past have used their steelmaking skills to produce cutlery, human surgical instruments and weapons.

“The skills the steel workers have are often inherited in families and they do not find it difficult to move from one steel sector to the veterinary sector. We import our high quality steel from Japan, China and Germany. This is then crafted in surgical instruments and diagnostic equipment for livestock and companion animals,” said Mr Shabbir.

“We have a turnover of several million dollars and currently employ more than 200 workers in our factory. Our exports are going to Europe, the US and Japan. It is our first time in Dubai and we would like to find distributors for the Middle East region. Companies from the Lebanon and Saudi Arabia have shown interest.”

Mr Shabbir said some 30% of the company’s products were diagnostic in nature while the rest were surgical.

Price competitiveAnother Pakistani veterinary instrument company exhibiting at the recent VETME event was TA Walthem which is also headquartered in Sialkot.

The firm’s sales director Imtinan Tariq said he believed the company was competitive on price and quality with the rest of the world. The company employs 130 staff and produces mainly steel livestock instruments.

“We are keen to expand in the Middle East and are looking for distributors. Saudi Arabia and Iran are of particular interest to us at this time. We have completion but we believe our quality if attractive to local suppliers,” said Mr Tariq.

“We already have customers in Europe and have thousands of products available. We can also make products which can be tailor-made specifically for customers. We source our high quality steel from overseas as well as locally in Pakistan.”

Sialkot has a Metal Industries Development Center which has further information on its veterinary steel products sector and individual local companies. The Sialkot veterinary instruments industry is said to have a turnover of around $10 million.

Scientists identify killer tilapia virus in Israel, Latin America

BY JOSEPH HARVEY

International researchers have identified and characterized the virus behind considerable farmed tilapia deaths in Israel and Ecuador.

The virus, which poses a serious threat to the $7.5 billion global tilapia industry, has been pinpointed by a team led by researchers at Columbia University’s Mailman School of Public Health in the US and Tel Aviv University in Israel.

asia

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The team’s paper in the journal mBio describes tilapia lake virus (TiLV) and provides an insight into how the outbreak can be dealt with.

According to the research paper, Israel has seen a swift decline in tilapia production since 2009. The country’s annual yields have plummeted by as much as 85%. This is “highly unusual considering the fish is known to be relatively resistant to viral infections”, suggests the research team. Similar die-offs have been observed in Ecuador and Colombia.

Columbia University said: “The scientists used high-throughput sequencing to determine the genetic code of the virus from tissue taken from diseased fish in Israel and Ecuador. This process would normally be sufficient to identify the culprit, but in this case, the resulting DNA sequences didn’t match any known virus, with the exception of a small genetic segment, that only remotely resembled a virus associated with the reproduction of influenza C.”

The researchers then used mass spectroscopy tools to characterize the proteins located in cells growing the virus. These proteins matched those the team expected to see based on the genetic sequence.

“By analyzing the structure of viral DNA, they went on to observe 10 gene clusters with complementary endpoints, suggesting a circular form associated with a common type of viral reproduction involving a protein called a polymerase,” the university said.

“Finally and conclusively, healthy fish were exposed to TiLV cultured in a laboratory, resulting in disease that matched with what was seen in those countries: in Israel, the fish had swollen brains; in Ecuador, liver disease.”

Enabling vaccine productionThe team’s discoveries provide the genomic and protein sequences necessary for TiLV detection and containment, as well as opening up the possibility of vaccine development.

In the next few weeks, the researchers aim to publish research regarding the link between TiLV and an outbreak of disease among tilapia in Colombia. Longer-term, the researchers are shifting their focus to implementing diagnostic tests for containment of infection and to developing vaccines.

Eran Bacharach, a molecular virologist at Tel Aviv University and one of the research’s authors, commented: “The TiLV sequence has only minimal similarity in a small region of its genome to other viruses. Thus, the methods we typically use to identify and characterize viruses through sequencing alone were insufficient.”

Nischay Mishra, associate research scientist at the Center for Infection and Immunity at Columbia’s Mailman School, added: “It appears to be most closely related to a family of influenza viruses called orthomyxoviruses. However, we still don’t understand much about its biology.”

The research was aided by the Center for Infection and Immunity and the New York Genome Center in the US, Kimron Veterinary Institute in Israel, the University of Edinburgh in Scotland and St. George’s University in Grenada, West Indies.

Importance of tilapiaNative to the Middle East, tilapia is the world’s second most farmed fish after carp. The research paper also noted that tilapia is “the basis of aquaculture employment in developing countries in Asia, Latin America and the Middle East”, while “the US is the leading tilapia importer globally”.

Currently, there are there are six major virus diseases, 15 bacterial diseases and five fungal diseases affecting species of tilapia.

Last year, an Asian aquaculture expert from MSD Animal Health said disease is the biggest limiting factor in the sustainable production of the popular freshwater fish tilapia. He urged the development of more vaccines focused on tilapia.

Nevertheless, most of the so-called ‘easy vaccines’ for treating fish diseases have already been developed, leaving preventative remedies for more difficult aquaculture pathogens and disorders to be resolved. The next-generation technologies required by the aquaculture industry – especially for tilapia producers include virus-like particle vaccines, chimera vaccines, molecular decoys, molecular sponges and fish-derived anti-microbial peptides.

Top UK executive to become Dechra chairman

BY MALCOLM FLANAGAN

Expanding UK animal health company Dehra Pharmaceuticals is to appoint a new board chairman with considerable executive experience at major British companies.

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The Northwich, Cheshire-based firm said Tony Rice will be made chairman in October after serving six-months with Dechra as a non-executive director. He will be confirmed as chairman following the firm’s annual AGM in the same month. Dechra’s current chairman Mike Redmond will step down from the board at the conclusion of the AGM.

The appointment of Mr Rice as chairman follows a comprehensive search process which was led by Ishbel Macpherson, senior independent director.

Mr Rice has extensive board level experience across a range of sectors. He is currently the senior independent non-executive director at UK health and safety firm Halma.

He was previously chief executive at Cable & Wireless Communications and Tunstall Holdings. Previously, he held various roles at BAE Systems including managing director of commercial aircraft and group managing director of business development.

Ian Page, Dechra’s chief executive, said: “Mr Rice has gained extensive knowledge of international businesses and has a solid understanding of key strategic drivers. These skills will further enhance Dechra’s capabilities.”

In mid-March, Dechra purchased US companion animal generics specialist Putney in what it called “the most complementary US acquisition opportunity identified”.

The deal saw Dechra pay $200 million and will potentially double its business in the US. The move is in sync with the firm’s long-term plans to significantly expand its presence in North America, the world’s largest companion animal market.

In October 2015, Dechra closed its purchase of Genera, Croatia’s largest veterinary medicines business. The aggregate cost of acquiring the controlling interest in Genera was £36.6m ($56.6m) which was funded from Dechra’s existing cash and debt facilities.

Jaguar adds venture fund expert as director

BY JOSEPH HARVEY

San Francisco-based Jaguar Animal Health has added John Micek to its board of directors.

Mr Micek has also joined the firm’s three standing committees, as well as becoming the chair of Jaguar’s audit committee.

Mr Micek’s background is in the venture capital industry. From 2000 to 2010, he was managing director of Silicon Prairie Partners – a Californian family-owned venture fund. Since then, he has been managing partner at merchant bank Verdant Ventures.

Amongst his other positions, Mr Micek serves on the board of Armanino Foods of Distinction, Innovaro and JAL/Universal Assurors. He is also a board member, chief executive and chief financial officer of Enova Systems, a firm that specializes in electric and hybrid electric drive systems.

Mr Micek is a practicing California attorney specializing in financial services.

Jaguar is currently taking through several gastrointestinal product candidates through the R&D process – it recently reported a net loss of $16.3 million in fiscal 2015.

Anatara sends Detach to Zoetis for testing

BY MALCOLM FLANAGAN

Australian animal health company Anatara Lifesciences has sent a shipment of its piglet diarrhea treatment Detach to Zoetis as part of an evaluation program to test the efficacy of the product.

Brisbane-based Anatara said the shipment was part of a partnership deal agreed with Zoetis in early January this year.

The deal will allow Zoetis to explore the potential use of Detach as a non-antibiotic anti-infective product for use in food-producing animals.

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Detach is Anatara’s lead product. It recently gained positive results from an Australian field trial focused on preventing and treating diarrhea in piglets.

Detach is a modified release formulation of BromelainRx, which is a natural extract from pineapple stems. The product is formulated with various ingredients to allow oral administration and its efficient delivery to the small intestine.

The agreement between the two companies provides Zoetis with an exclusive option to license Detach for development and marketing worldwide, while Anatara retains the rights for the product in Australia and New Zealand. The companies will research the utility of Detach in multiple livestock species.

Anatara expects its lead product to be approved in Australia at the beginning of 2017. The firm has also met with regulatory authorities in Europe and the US regarding authorization of Detach. The company said an invoice has been issued to Zoetis for the first upfront payment due following signing of the agreement.

Anatara managing director and chief executive Dr Paul Schober said: “The Detach consignment was manufactured under strict GMP compliance and labelled to conform to US standards.

“We now have in place the ability to manufacture and supply large quantities of Detach which are sufficient to meet global demand. The shipment of product to the US marks a significant milestone for Anatara.”

Canine flu virus found in Midwest US cats

BY SIAN LAZELL

The canine influenza virus which affected a large number of dogs in the Midwest in 2015 has now been detected in a group of cats in the region.

Experts at the Wisconsin Veterinary Diagnostic Laboratory (WVDL) – based at the University of Wisconsin-Madison – recently tested a number of cats at an animal shelter in Northwest Indiana, finding the animals positive for the H3N2 canine influenza virus.

Preliminary work to study the genetic signature of the virus shows it is identical to the H3N2 virus that infects dogs. Researchers at the WVDL are currently completing a full genetic analysis and study of the virus.

Dr Sandra Newbury, clinical assistant professor and director of the Shelter Medicine Program at the university’s School of Veterinary Medicine, said: “Suspicions of an outbreak in the cats were initially raised when a group of them displayed unusual signs of respiratory disease.

“While this first confirmed report of multiple cats testing positive for canine influenza in the US shows the virus can affect cats, we hope that infections and illness in felines will continue to be quite rare.”

Transmission among catsH3N2 was not seen in the US until 2015. Although past cases reported in South Korea suggested the virus could leap from dogs to cats, only one cat tested positive for H3N2 on a single occasion during the outbreak in the US last year. No repeated sampling was done because the sample was only found to be positive long after the cat’s symptoms had resolved.

However, experts at the WVDL said it now appears the virus can also replicate and spread from cat to cat.

“Sequential sampling of these individual cats has shown repeated positives and an increase in viral loads over time,” said Dr Kathy Toohey-Kurth, virology section head at the WVDL, said.

Infected cats at the shelter have exhibited symptoms such as a runny nose, congestion, general malaise, lip smacking and excessive salivation. However, the cats’ symptoms have resolved quickly and so far, the virus has not been fatal.

Some dogs at the shelter also tested positive for H3N2. Infected dogs may develop a persistent cough, runny nose and fever. Whilst some dogs will show no symptoms, others will exhibit more severe signs of illness. Although the virus has been associated with some deaths in dogs, the majority of dogs will recover with supportive care.

A Shelter Medicine Program team are currently working with the shelter to manage the outbreak. Dr Newbury said: “At this time, all of the infected cats have been quarantined and no infected cats or dogs have left this shelter. We will continue to watch carefully for instances of the disease.”

Last year, Zoetis gained the first US conditional license for a vaccine against canine influenza H3N2 virus. Shortly after, Merck Animal Health also gained a conditional licence for its own vaccine.

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Japan targets pigmented keratitis in dogs

BY DR ATSUO HATA

Japanese researchers are undertaking studies of regenerative medical treatment for pigmented keratitis (inflammation of the eye’s cornea) in dogs.

A research group at Kyoto Prefectural University of Medicine and the University of Tottori took autogenous cells from dogs’ oral mucous membranes and cultured them in vitro. This allowed the researchers to implant the cells into the removed lesion from the canine cornea.

The researchers expect to conduct a clinical study using several dogs by the end of 2016. Dr Norihiko Ito, a veterinary ophthalmologist, associate professor of Tottori University Veterinary Medical Center, said there are about 10,000 dogs with pigmented keratitis in Japan, especially the Shih Tzu and Pug breeds.

Malaysia’s InQpharm expands into the US

BY MALCOLM FLANAGAN

Malaysian animal health company InQpharm has increased its global reach by securing a licensing arrangement for livestock gut health products developed by US firm LiveLeaf.

Kuala Lumpur-headquartered InQpharm said the deal was a strategic move which would help it expand into the US market. The license for LiveLeaf’s phytobiologics portfolio would help extend InQpharm into production livestock and equine markets.

Currently InQpharm produces veterinary products for dairy cows and dogs. California-based LiveLeaf brands its phytobiologics portfolio as LiveXtract in the US market. The patented technology contains two highly bioactive botanical complexes with a “documented history of safe use”.

InQpharm said LiveXtract improves the gastrointestinal health of young food-producing animals and helps to keep them on the optimal natural growth curve. “Academic studies and extensive experience from field trials have already demonstrated the highly significant benefit of the phytobiologics technology as part of an antibiotic-free program,” said InQpharm.

InQpharm’s existing Vetrinol, Vetrinol Plus and Vetrinol Neo product lines have already been introduced in Europe for the prevention and treatment of reducing somatic cell count, sub-clinical mastitis and calf diarrhea. The firm also sells nutritional dog supplements under the AlphaSci brand.

Thomas Hafner, chief executive of Zaluvida, InQpharm’s parent company, said: “This agreement is evidence of our continued commitment to seek out novel solutions to the challenges of sustainable food production. These products are perfectly aligned with our focus on natural alternatives to reduce antimicrobial overuse in livestock growth promotion.”

Alex Huang, chief executive of LiveLeaf, added: “We are delighted to have found a like-minded partner to extend our reach in deploying this important breakthrough worldwide. Our LiveXtract phytobiologics provide production farmed animals the powerful immune benefits of a natural field grazing diet, but through a practical controlled delivery.”

InQpharm has offices in Germany, the Netherlands, the UK and US. The firm will also open an office in Switzerland by mid-2016. InQpharm is fully owned by Singaporean life science investment company Zaluvida. LiveLeaf is based in Silicon Valley, California.

Vietnam to create ASEAN zoonoses center

BY MALCOLM FLANAGAN

The Vietnamese government has agreed to establish an Asian regional research center for animal and zoonotic diseases, according to local media.

The official government Vietnam News Agency (VNA) said the center would be created with financial and material support from the Association of Southeast Asian Nations (ASEAN).

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The Hanoi-based VNA said the facility will be called the Coordinating Centre for Animal Health and Zoonoses (ACCAHZ). The research center will be constructed in the Vietnamese capital Hanoi. The concept for a regional center for zoonotic research was first endorsed at an ASEAN agriculture ministers meeting in Jakarta, Indonesia, in 2011.

Vietnam is in the process of forming several national bodies to potentially prevent an avian influenza epidemic or other zoonotic outbreaks. The VNA said the country’s Emergency Operations Center, the Ministry of Health, the Ministry of Agriculture and Rural Development and some relevant international organizations have agreed to participate in the ACCAHZ project.

“Vietnam with its role of a leading country in the ASEAN region has already coordinated with member states to build the ASEAN rabies elimination strategy, aiming to eradicate the deadly disease in neighboring countries by 2020,” said the VNA.

“The main objective of the ACCAHZ is to facilitate coordination and cooperation among ASEAN member states and relevant national and international partners and stakeholders in prevention, control and eradication of transboundary animal and zoonotic diseases in the region.”

ASEAN members include Indonesia, Malaysia, the Philippines, Singapore, Thailand, Brunei, Cambodia, Laos, Myanmar and Vietnam. The ASEAN headquarters are headquartered in Jakarta. Vietnam has been hit hard in recent years by avian flu, foot and mouth disease and different swine diseases.

USDA hands out animal nutrition grantsBY JOSEPH HARVEY

The USDA awarded $6.6 million for academic research focused on improving animal nutrition and growth in fiscal 2015.

The funded projects include South Dakota State University research aimed at improving understanding of starch digestion in cattle, as well as work conducted at Iowa State University to improve delivery and availability of nutrients to pigs facing disease challenges, in order to minimize losses in growth rates and production efficiency.

Other research areas supported by the grants include: studying how animals use the nutrients in their feed; improving the use of traditional feed; exploring opportunities to use non-traditional feedstuffs; increasing the quality and efficiency of producing meat, milk and eggs; and mitigating metabolic disorders.

The grants were made through the Agriculture and Food Research Initiative Foundational program and administered by the USDA’s National Institute of Food and Agriculture.

The grants were awarded to: University of Arizona ($485,000); University of California ($500,000); University of Connecticut ($150,000); University of Delaware ($500,000); University of Illinois ($485,000); Iowa State University ($990,487 as part of two awards); North Dakota State University ($20,000); Dartmouth College, New Hampshire ($500,000); South Dakota State University ($500,000); University of Wisconsin ($1 million as part of two awards); Virginia Polytechnic Institute and State University ($500,000); West Virginia University Research Corporation ($500,000); and University of Wyoming ($500,000).

New aquaculture development center opened in Malaysia

BY DR ATSUO HATA

Universities in Malaysia and Japan have collaborated to establish an aquaculture development center on the island of Borneo.

The University Malaysia Sabah (UMS) partnered with Wakayama-based Kinki University (Kindai) to establish the UMS-Kindai Aquaculture Development Center. The facility is now operational.

The new laboratory aims to produce a lot of high quality fish such as Napoleon wrasse, sea bass, catfish and eel for aquaculture farmers. The facility will also help to improve aquaculture technology for local Malaysian staff.

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Australian vets urged to vaccinate against tetanus in horses

BY MALCOLM FLANAGAN

Australian veterinarians are being urged to take the possibility of horses contracting the deadly disease tetanus more seriously and vaccinate equine patients.

The New South Wales-based Equine Veterinarians Australia (EVA) organization said currently, only 12-15% of horses in Australia are vaccinated against tetanus. Tetanus enters the body through a wound.

Tetanus is a devastating disease, often resulting in the death of affected horses. EVA member, Dr Steve Dennis, is now spearheading a new research project to identify the role tetanus antitoxin has in the prevention of this fatal disease in horses.

Dr Dennis has been working with colleagues at Melbourne University and the University of Sydney to determine correct dosage and the effectiveness of tetanus antitoxin and the vaccine tetanus toxoid. There are an estimated 230,000 horses in Australia.

“Animals are susceptible to contracting tetanus through open wounds, so for me, it has been routine to offer tetanus antitoxin at the time of any surgical procedures to protect unvaccinated horses from contracting this deadly disease,” Dr Dennis said.

Through his discussions with other equine vets, Dr Dennis has discovered that not everyone follows this practice.

“Some vets give tetanus antitoxin as a preventative, some don’t. Some provide booster vaccinations every five years, some yearly,” Dr Dennis said.

“Our current working knowledge in this area is based on 70-year-old research and mostly on laboratory animals. I’m hoping this survey will open up doors for further research to be conducted to help establish best practice in protecting Australian horses from tetanus.

“We have the means to protect our horses from this fatal disease and we should. Vaccination appears to be highly effective and safe. The question is whether tetanus antitoxin is a useful part of our preventive approach and hopefully we’ll start getting the answers we need as a result of this research.”

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