By Joseph Harvey
January 17, 2017
This year's Animal Pharm Awards have highlighted the upsurge in innovation for companion animals that occurred in 2016.
The voting has been completed with Zoetis claiming two awards – reflecting a successful year for the company, especially its pet portfolio.
Best product portfolio winner – Zoetis
Zoetis secured this year's award for best portfolio after it made some important additions to its offering of products for companion animals.
The judges were impressed with the innovative and game-changing nature of the additions to the Zoetis portfolio in 2016.
One of the most significant highlights from the company's 2016 came at the end of the year, when it received a US license for Cytopoint, which is the first anti-canine IL-31 monoclonal antibody approved to help reduce clinical signs associated with atopic dermatitis in dogs.
Last year's winners
Click here to see the winners of last year's Animal Pharm Awards, including Elanco, Merck Animal Health, Prevtec Microbia, Pharmaq and more…
Zoetis also began the year with a significant addition to its US companion animal portfolio when it received FDA licensure for Simparica (sarolaner), a chewable flea and tick medication for dogs that offers persistent month-long efficacy. As well as the US, Simparica was launched in the EU, Canada and Brazil in 2016.
The introduction of Cytopoint and Simparica to the Zoetis portfolio adds to the momentum the firm has been experiencing with its dermatology business as Apoquel becomes a top-selling product around the world. In 2016, Apoquel was made available to all veterinarians in the US without limits.
Zoetis was also able to boost its US companion vaccine offering in 2016. The firm gained approval for multiple vaccines in its Vanguard franchise including a preventative for Lyme disease in dogs. Zoetis also became the first company to offer intranasal, oral and injectable vaccine options for against Bordetella bronchiseptica – a common pathogen in canine infectious respiratory disease, when it received approval for its Vanguard Rapid Resp Intranasal and Vanguard B Oral vaccines.
Best new companion animal product winner – Zoetis' Cytopoint
With Zoetis securing the award for best portfolio due to its efforts in the companion animal area, it is no surprise one of its new additions won the accolade for best new companion animal product.
Cytopoint is the first caninized anti-canine interleukin-31 (IL-31) monoclonal antibody licensed in the US.
The product is designed to help reduce clinical signs such as itching associated with atopic dermatitis in dogs of any age – a significant unmet need. According to Zoetis, itching is among the most frequent complaints of pet owners, affecting roughly one in six dogs whose owners seek veterinary help. Additionally, around 15-20% of all itchy dogs will be diagnosed with atopic dermatitis.
Clinvet sponsors Animal Pharm Awards for product innovation
Three Animal Pharm awards focused on highlighting product innovation in 2016 are sponsored by Clinvet.
The firm is a contract research organization established in 1999 and specializes in conducting laboratory and field-based clinical trials to evaluate the safety, metabolism and efficacy of veterinary health products.
Clinvet sponsors the Animal Pharm Awards for best product portfolio, best new product for food animals and best new product for companion animals.
Clinvet is based in South Africa and Morocco. A group of affiliated companies enables Clinvet to provide a wide range of services in support of laboratory and clinical trials performed on veterinary health products. With a wealth of experience, Clinvet has for many years been able to support leading veterinary health pharmaceutical in ground-breaking research and development programs.
Conducting pivotal trials required for the registration of health products worldwide also forms part of Clinvet's portfolio.
In a randomized, double-blinded placebo-controlled study, a single injection of Cytopoint was shown to significantly reduce itching within one day and continued working for a full month. Zoetis said over 80% of dogs were scored as having successful pruritus reduction as early as day three.
The firm said: "Zoetis research scientists demonstrated that cytokines, soluble protein messengers secreted by cells and used to communicate with one another, play an important role in orchestrating many of the diverse changes that occur in the pathophysiology of canine allergic skin disease. This thinking differed from the prevailing viewpoint in veterinary medicine that clinical signs in this disease were driven by allergen-specific immunoglobin E and mast cell de-granulation.
"Furthermore, our scientists demonstrated IL-31 was a critical cytokine triggering itch in dogs and appeared to be dis-regulated in dogs with atopic dermatitis. The idea that targeting and neutralizing IL-31, a key protein responsible for sending the itch signal to the canine brain, with an antibody approach, spurred the design and development of this unique, caninized antibody.
"Zoetis has been building a development platform in monoclonal antibodies across multiple species and disease areas. Cytopoint is the first antibody to emerge from it."
Best new food animal product winner – Animal Ethics
This year's winner of best new food animal product is an anesthetic developed by Animal Ethics.
Although Tri-Solfen is only approved for use in Australia, the judging panel said the product has the potential to be a game-changer worldwide – it is the only topical anesthetic and antiseptic pain relief product approved for livestock anywhere in the world.
Tri-Solfen is the first product developed from Animal Ethics' patented platform technology. The company believes the product has the potential to fill a large unmet need in the global marketplace for the management of accidental wounds and wounds caused by surgery in livestock and companion animals.
Tri-Solfen is a combination topical anesthetic and wound care agent, which is sprayed onto the wound to simultaneously anesthetize, alleviate pain, control bleeding and protect against infection. Its viscous gel base is also designed to form a long-lasting protective barrier over the wound.
The product was principally developed in Australia for use in sheep, to manage pain and bleeding associated with the invasive animal husbandry procedure mulesing. In Australia, the product has over 60% market penetration.
Animal Ethics said: "It has now proven to be highly successful in the treatment of accidental wounds, castration, tail docking, branding and disbudding in several species including cattle, pigs, sheep, goats and horses. Extensive trials in these livestock species has indicated that the onset of wound anesthesia is very rapid being readily apparent within one minute of application and there is evidence of a significant ongoing analgesic effect even after 24 hours.
"In addition, there is a clear reduction in blood loss and a statistically significant improvement in wound healing rates in treated versus untreated animals."
Last year saw the further adoption of the product – over 70 million animals have been treated with Tri-Solfen since its original registration. In Australia the product is licensed to Bayer Animal Health.
While the product's first Australian registration for the treatment of mulesing wounds was achieved in 2012, last year Tri-Solfen gained new product claims for lamb castration and tail docking. In December 2016, Australian regulatory authorities extended the use of Tri-Solfen to include the alleviation of pain in calves. These label extensions have contributed to an increase in the product's sales this year.
Best start-up winner – Zomedica Pharmaceuticals
Work in the area of companion animals also came to the fore last year in the form of Zomedica Pharmaceuticals – a young US-based business developing treatments for cats and dogs.
Over the course of the year, the company opened three investigational new animal drug (INAD) applications in the US.
The company opened an INAD application with the US FDA for ZM-007 – a canine anti-infective. Products candidates ZM-007 and ZM-012 – the latter was first product candidate Zomedica filed an INAD application for in 2016 – are complementary oral formulations being developed for the treatment of diarrhea in dogs. Zomedica's other INAD application with the FDA is for ZM-006, a candidate to target a metabolic disorder in companion animals.
The active pharmaceutical ingredient in ZM-007 and ZM-012 is metronidazole, an anti-infective that is not yet approved by the CVM for veterinary use. However, the firm said it is commonly prescribed by veterinarians for dogs using human-approved products.
ZM-007 is an oral suspension formulation being developed so veterinarians can accurately dose smaller dog breeds and puppies. Zomedica said it hopes ZM-007 will help to offset veterinarians' reliance on compounding pharmacies for medication supply and bring associated pharmacy revenue back into the veterinary clinic. It added metronidazole suspension is one of the most frequently compounded drugs for dogs.
ZM-012 is a tablet formulation being developed to replace the large, bitter tasting human-approved generic tablet prescribed by veterinarians. Zomedica said its canine-specific tablet is designed to maximize compliance and maintain affordable regimens.
Zomedica is developing a diversified portfolio of diagnostics, devices and drug delivery technology as complementary offerings to veterinarians.
Outside of its pipeline work, Zomedica also achieved some other significant milestones in 2016: it became a publically-listed company; opened an equity funding round; added considerable animal health expertise with new independent directors; and signed a peptide-based drug delivery technology deal.
Best company in North America winner – Aratana Therapeutics
In 2016, a small company made a big wave in the US companion animal health sector.
Aratana Therapeutics scored a hat-trick of US FDA licenses for its novel pet products over an unprecedentedly short period of time. In March, Aratana secured a breakthrough US approval for Galliprant, a new chemical entity to control pain and inflammation associated with osteoarthritis in dogs. The company then signed a partnership deal with Elanco for its debut product in April.
By May, Aratana had received FDA approval for its second product Entyce, an appetite stimulant for dogs. Then in August, the company had a third FDA license of the year. This time it was for Nocita, a local post-operative analgesia for cranial cruciate ligament surgery in dogs.
Last year, saw Aratana evolve from an R&D-focused start-up into a commercial entity. This transformation was entirely in line with Aratana's projected timeline, which it sketched out when it was founded around five years ago.
Aratana is the torch-holder for animal health biotechnology companies and its success paves the way for similar firms to follow in its footsteps.
Best company in Europe winner – Ceva Santé Animale
The last 12 months have been transformational for Ceva Santé Animale, as the company made large strides to achieving its top five ambitions.
Not only is Ceva stimulating growth internally with R&D in the areas of vaccines, genomics and livestock reproduction, it has also secured some significant acquisitions in 2016.
The firm became one of the largest animal health companies in Brazil by acquiring two local businesses in November, while a month earlier it bought a range of products for pigs, cattle and companion animals from Merial.
In fact, Ceva has been on the acquisition trail all year long. In February, the company entered exclusive negotiations to merge its hatchery automation business with French firm iD Projects. A month later, Ceva broke into the Indian market after purchasing Indian business Polchem. Then, in June, it acquired Biovac Laboratories – another French business with expertise in autogenous vaccines, allergy treatments and reagents.
The firm's expertise in markets such as veterinary vaccines, poultry and swine is helping it ride a wave of growth, while it also expands its horizons and becomes a truly global player.
Best company in Latin and South America winner – Biogénesis Bagó
This year's award returns to the company that received the accolade in 2014 – Argentina's Biogénesis Bagó.
Over the course of 2016, the company strengthened its global position as a leading innovator in the veterinary vaccines space, especially for the prevention of foot-and-mouth disease (FMD). The firm particularly grew its presence in Asia.
Biogénesis completed construction of its vaccine manufacturing plant in China. Yangling Jinhai Biotechnology was constructed for the production of FMD preventatives with an initial capacity of 400 million vaccines a year. The company also opened commercial headquarters in Shanghai.
Elsewhere in Asia, the firm struck a supply deal in South Korea for its FMD vaccines. In the last three months of the year, Biogénesis exported 8.8 million of doses to meet the needs of South Korea. In 2016, South Korea suffered from nine FMD outbreaks and had to destroy almost 30,000 pigs.
Additionally, over the last 12 months, the company was granted two international tenders for more than three million doses of its anti-rabies vaccine.
Biogénesis also launched a range of products domestically in 2016. These included the intra-mammary antibacterials Ubresan LAC 200 and Ubresan SEC, as well as the internal sealant Ubresan SELL – all effective in the treatment of mastitis.
Biogénesis added: "Our company is working on innovation not only as regards to new technology but also on the development of business services and models that might help with having a better potential productivity of meat and milk herds. Latin America could improve meat production by 30% and 20% with regards to milk, with the technology currently available in the region and tightening of production procedures."
Considering this, Biogénesis is building on its Fronteras Productivas program, through which it tries to make farmers and dairy producers in Latin America more aware of the production capacity they have.
Best company in India/Africa/Middle East winner – Zydus Animal Health
Ahmedabad-based Zydus Animal Health wins this award for the second year in a row, highlighting the company's recent growth.
In 2016, Zydus expanded its product portfolio by entering new therapeutic areas in the fields of pharmaceuticals and nutraceuticals. The company said it launched six new products in India during 2016.
Although 20 of Zydus' products are first-to-market, in-house innovations, the company sealed a big external move in 2016 that significantly added to its portfolio. The firm acquired 79 brands from Zoetis India and consolidated its domestic market share, as it strives to become the largest animal health company in India.
As part of the deal, Zydus also acquired a WHO- GMP manufacturing plant based at Haridwar from Zoetis India. Not only does the addition of this facility allow Zydus to fulfil the growing demands from its domestic market, it is also supports the company's expansion plans and its exports business.
The company said it has previously established a European export business, whereas in 2016 it focused on growing its network in the rest of the world.
Zydus said its animal health business is expected to post revenues exceeding INR4,500 million ($66 million) for its most recent fiscal year. This represents a year-on-year sales increase of around 46%.
Best company in Asia and Australasia winner – Jinyu Group
This year's award goes to the Jinyu Group – a fast-growing animal health company in China.
In 2016, Jinyu established itself as the leader in China's animal vaccines market particularly in the space of foot-and-mouth disease (FMD).
The firm has a complete portfolio for animal vaccines, which covers ruminants, swine and poultry. It is the leading manufacturer of FMD vaccines in China.
Jinyu has an appetite for growth – its average annual sales growth rate has been over 30% since 2012. In the most recent financial year, Jinyu recorded 17% sales growth with a 38% profit margin.
Jinyu is also one of the few Chinese animal health companies whose products meet international standards. In 2016, the firm exported vaccines to a number of countries such as South Korea, Bangladesh and Egypt.
The company also has China's only designated national animal vaccine R&D center, where it develops its pipeline of advanced vaccines. The company is working on inactivated vaccines, attenuated vaccines, multivalent vaccines and genetically-engineering vaccines. Jinyu also recently revealed plans to open a new biological science and technology industrial park in 2018.
The firm also secured several partnerships during 2016, including a collaboration project with Kansas State University in 2016 for vaccine research and veterinary training. The company additionally kickstarted an investment project in Africa for vaccine manufacturing. This will provide advanced technology to protect animals from severe disease such as FMD in Namibia.
Visionary CEO winner – Michael Burke of Chanelle
This year's winner of the award for best chief executive signifies the growing influence of generic treatments in the veterinary medicines space.
Chanelle commented on its leader Michael Burke and his history of innovations: "A veterinary surgeon by profession, in 1983 Michael Burke revolutionized the industry in Ireland to provide a 24-hour delivery service of veterinary medicines. With an instinctive entrepreneurial spirit, he then began to manufacture products coming off patent in 1985 and thus the Chanelle story in generic pharmaceuticals began.
"In an industry where consolidation is rife, Chanelle is a unique company in that it is owned 100% by Michael Burke. Despite over 30 years at the helm of the company, Michael's commitment and determination has never been compromised and it is therefore unsurprising that the company has grown steadily and organically to become a key player in the generics pharmaceutical market in Europe.
"The past 12 months have been pivotal for Chanelle. Michael has carved a remarkable growth strategy that will see the company launch 75 products over the next five years following a €70 million investment announced in February 2016. As part of the investment, the company will expand its footprint to include two FDA-approved manufacturing facilities on site at its headquarters in Loughrea between 2017 and 2018.
"With sales growth in excess of 30% over the past three years, Chanelle is on track to achieve sales of over €110 million in 2016. Today, the company holds over 1,700 veterinary licenses – the largest of any company in Europe. Chanelle will launch 15 veterinary products in 2017/18, 28 in 2018/19 and 13 in 2019/20.
"A key milestone for the company in 2016 was the launch its first super generic, highly palatable meloxicam granules for horses – a world first for the equine industry.
"This success is undoubtedly a reflection of Michael's keen leadership and his innate interest in animal health. As a vet, Michael holds an active role in the company's R&D. His pledge to R&D enables the company to continually invest in product development including the company’s latest strategy to launch nine more super generics within the next five years.
"Michael's keen foresight and vision have been a key characteristic from the beginning. What is remarkable is Michael's passion for Chanelle. He lives and breathes the company every single day and is relentless in seeking to improve the company.
"At the heart of Michael's success is his commitment to his customers and his team. Michael maintains the traditional method of visiting all international customers at least once a year, but often two or three times. At every success Michael credits his staff and his customers and has always said: 'I don't pay your wages, our customers do'.
"In Michael's 30-year-plus tenure, his passion, strength-of-will, industry knowledge and undisputable vision has catapulted Chanelle to become a recognized key player in a notoriously competitive industry. Despite all success, he remains a very humble man and only ever credits his outstanding staff, all 385 of whom he knows by name, for the company's remarkable success."
Best contract research organization winner – Clinvet
Established in 1999, Clinvet is a contract research organization (CRO) based in South Africa. The firm specializes in the conduct of laboratory and field-based efficacy, as well as safety and metabolism trials for veterinary health products.
Clinvet said it has recently shown a significant increase in productivity and efficiency, and has been able to successfully complete the in-life phase of 136 studies during the past 12 months, and 1,330 studies since inception.
The firm is currently managing projects in Brazil, Morocco, Tanzania, Ethiopia, Uganda, Burkina Faso, Nigeria, Benin and Ghana.
Clinvet said it is not only involved in research supporting veterinary health product discovery and R&D, but also crucial research aimed at improving parasite control strategies for small-scale livestock farmers in Africa, funded by the Bill and Melinda Gates Foundation.
The company has continuously shown growth in the number of studies it conducts, its workforce (181 in 2016), its customer base and its turnover. It is an accredited Good Clinical Practice CRO and one of only two Good Laboratory Practice accredited test facilities in Africa. It has also been successfully audited on-site by the US FDA and the US Environmental Protection Agency.
Clinvet also pointed out its involvement in novel research in the areas of parasite infection and molecular-based assays. Clinvet co-authored 22 scientific papers in 2016 and a total of 111 papers since 1999.
In 2016, Clinvet successfully started three spin-off companies offering services to the animal health industry. These companies are: Clinglobal (clinical trials, support and contract holding services); Clinomics: (animal and parasitological genetic and diagnostic laboratory services); and Clintest (in vitro testing).
The company said: "Over the last few years, Clinvet has established itself as a market leader in the CRO industry. The extraordinary growth of the company is a testimony of the trust our valued clients puts in our expertise and quality of work.
"As a company we are proud of not only what has been achieved up to date but also the culture of excellence, solutions, innovation and productivity instilled in our staff. Be assured that in an ever-changing research environment, Clinvet will keep on evolving to better serve the needs of our research partners."
Editorial note: Clinvet's sponsorship of several of the categories in the Animal Pharm Awards had no influence on the judges, who were not aware of the sponsorship. Reprinted with permission of Animal Pharm News