Nexvet Biopharma public limited company and its subsidiaries (the “Company”) is a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals by developing and commercializing novel, species-specific biologics. Biologics are therapeutic proteins derived from biological sources. As a class, biologics have transformed human medicine in recent decades and represent many of the top-selling therapies on the market today. The Company’s platform technology, which it refers to as “PETization,” is an algorithmic approach that enables the Company to rapidly create monoclonal antibodies (“mAbs”) a type of biologic, that are designed to be recognized as “self” or “native” by an animal’s immune system, a property referred to as “100% species-specificity.” PETization is designed to build upon the safety and efficacy data from clinically tested human therapies to create new therapies for companion animals, thereby reducing clinical risk and development cost.
Biologics generally include mAbs, which are targeted antibodies derived from identical (“clonal”) cells. The Company’s most advanced product candidate, NV 01 or “ranevetmab,” is a mAb that targets and inhibits the function of nerve growth factor (“NGF”) for the control of pain associated with osteoarthritis in dogs. NGF is a protein involved in neural signaling, including pain signals, and NGF inhibitors (“anti-NGFs”) seek to interrupt those signals to reduce pain.
In November 2015, the Company announced that its pivotal safety and efficacy study of ranevetmab met its primary efficacy endpoint: a statistically significant improvement over placebo in the assessed level of pain (p=0.038) as measured using changes in Client Specific Outcome Measures (“CSOM”) score between enrollment and day 28. Ranevetmab was found to be safe and well-tolerated with no significant adverse safety signals observed in the study. Clinically meaningful magnitudes of benefit and statistically significant differences over placebo were also achieved for the majority of the secondary endpoints measured in the study, which used a monthly subcutaneous injection for three months.
The Company has a master collaboration, supply and distribution agreement, and a specific distribution agreement for ranevetmab, with Virbac S.A., (“Virbac”), one of the largest animal health companies in the world. Under these agreements, we appointed Virbac as our sole and exclusive distributor of ranevetmab (and any other products for which the Company enters into a specific distribution agreement with Virbac) in the veterinary field worldwide, except for the U.S. and Canada. For ranevetmab, Virbac must provide clinical, regulatory, marketing and sales advice, sell it, meet or exceed minimum annual net sales obligations and provide other services specified in the agreements. The Company will receive a fixed percentage between 45-55% of the commercial margin from Virbac’s sales of ranevetmab. The Company has retained the rights to distribute ranevetmab in the U.S. and Canada and intends to market and distribute ranevetmab through a dedicated sales team and distributors.
The Company’s second product candidate, NV-02, is an anti-NGF mAb for the control of pain associated with osteoarthritis in cats. The Company announced positive and statistically significant top-line results from its proof-of-concept efficacy study and its pilot safety study of NV-02 in June 2015. The Company expects results from a placebo-controlled, blinded, multi-site pilot field safety and efficacy study, which has enrolled 126 cats, in the second quarter of 2016.
Since the Company’s initial public offering, the Company has focused on clinical development of its most advanced candidates and securing infrastructure to become a vertically integrated veterinary biopharmaceutical company. The Company has built a pipeline of research programs and development candidates, most derived from PETization, in therapeutic areas where human mAbs and therapeutic proteins have had significant impact. After chronic pain in dogs and cats, the Company’s next most advanced programs are in the areas of inflammation, allergy and immuno-oncology.
In the area of chronic inflammation, the Company’s drug discovery team has identified new, potent neutralizing mAbs with high affinity for both canine and feline tumor necrosis factor (TNF), and these mAbs have been successfully PETized. Targeting TNF is the basis for several of human medicine’s top-selling pharmaceuticals.
In July 2015, the Company entered a research and development collaboration with Zenoaq, a leading animal health company based in Japan, which involves applying PETization to convert mAb candidates identified by Zenoaq into 100% species-specific candidates in the areas of immuno-oncology and allergy/inflammation. This collaboration has yielded fully caninized, or ‘100% dog,’ mAbs that bind and potently inhibit the immuno-oncology target programmed cell death protein 1 (PD-1).
In September 2015, the Company secured a biopharmaceutical manufacturing facility in Tullamore, Ireland. The Company is reconfiguring this facility to be a dedicated veterinary biopharmaceutical facility with the capability to meet anticipated future clinical and commercial production needs for therapeutic drug substance. A team of process scientists, quality assurance personnel and support staff has been assembled. The facility has obtained state-of-the-art large-scale disposable bioreactors and other equipment in preparation for manufacture of veterinary mAbs in accordance with good manufacturing practices.