DUBLIN, Ireland and MELBOURNE, Australia, Dec. 3, 2014 (GLOBE NEWSWIRE) -- Veterinary biologic therapy developer Nexvet Biopharma today announced the signing of a ten year collaboration and distribution agreement with Virbac (EPA:VIRP), one of the largest animal health dedicated companies in the world. Under the terms of the agreement, Virbac will distribute NV-01, Nexvet’s most advanced product, in territories outside the U.S. and Canada. NV-01 is an anti-nerve growth factor monoclonal antibody (mAb) for the control of pain associated with osteoarthritis in dogs, which has recently commenced its pivotal safety and effectiveness study.
“Virbac is an established leader in the companion animal health space with expertise in navigating the differentiated regulatory and commercial environments within European and other international markets, which together represent over 50 percent of the global market for companion animal health. This partnership is a strategic milestone, securing NV-01’s commercial launch in key international markets by accessing Virbac’s proven expertise and networks,” commented Dr. Mark Heffernan, Chief Executive Officer of Nexvet.
The collaboration consists of the following core terms:
1. Nexvet will have responsibility for development, manufacturing and supply of NV-01 while Virbac will provide clinical and regulatory advice and have responsibility for distribution, marketing and sales of NV-01 in Europe and other non-U.S. or Canadian territories.
2. Nexvet will retain sole distribution rights to NV-01 in the U.S. and Canada.
3. A Joint Steering Committee will be established to optimize clinical development, regulatory submissions, medical education and marketing strategies.
4. The parties have agreed to share profits from Virbac’s sales of NV-01 equally. In addition, Virbac will pay Nexvet milestone payments upon NV-01’s first marketing authorization and its first commercialization in a major European country. 5. Virbac will have the right to negotiate access to future Nexvet products on a product-by-product basis for development, distribution, marketing and sales. This is subject to separately agreed-upon financial terms.
“We are impressed with the Nexvet platform technology, PETization™, and its ability to rapidly create a unique and differentiated portfolio of biological products. NV-01 is unlike any other product on the market or in clinical development for chronic canine pain, and we look forward to working with the Nexvet team to optimize the development and launch of this innovative product in key global markets,” commented Christian Karst, Member of the Executive Board of Virbac. Nexvet received funding from the Australian Government, which accelerated its business development efforts, including work underpinning this partnership.
About Nexvet (www.nexvet.com)
Nexvet is a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s proprietary PETization™ platform is designed to rapidly create monoclonal antibodies (“mAbs”) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates also build upon the safety and efficacy data from clinically tested human therapies, thereby reducing clinical risk and development cost. Nexvet’s first product candidate, NV-01, is an anti-nerve growth factor mAb for the control of pain associated with osteoarthritis in dogs. Nexvet’s second product candidate, NV-02, is an anti-nerve growth factor mAb for the control of pain associated with degenerative joint disease in cats. Nexvet expects data from its pivotal safety and efficacy study for NV-01 by the end of 2015 and for NV-02 in 2016. Nexvet’s third product candidate, NV-08, is a fusion protein that is a tumor necrosis factor, or TNF, inhibitor for the treatment of chronic inflammatory diseases, including atopic dermatitis, in dogs.
Nexvet’s team members have international track records in the development of human biologics and veterinary drugs, and are committed to developing biologics to drive innovation in the global animal health therapeutic market.
About Virbac (http://www.virbac.com)
Founded in 1968 by a French veterinarian, Virbac is an independent pharmaceutical company exclusively dedicated to animal health. Ranked 8th worldwide and present in more than 100 countries, the company offers a comprehensive range of products and services intended for veterinarians, farmers and animal owners. With a turnover of €736 million in 2013, the company has more than 4,350 employees. Quoted on the Paris stock exchange since 1985, Virbac has remained a family company, not only as regards its shareholding but also through its management principles, its culture and its company values.
Further information
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