The three major technical section complete letters are required to file an administrative New Animal Drug Application for approval with the FDA-CVM. VetDC plans to submit the administrative filing later this year. Once Tanovea receives FDA approval, VetDC intends to commence commercialization in early 2017.
“This is a significant milestone for VetDC, as we are one step closer to introducing the first FDA-approved drug for use in dogs with lymphoma,” stated Steven Roy, VetDC’s President and CEO. “There is a clear unmet need for new therapeutic alternatives to address this common and devastating cancer in pets. Given Tanovea’s demonstrated anti-tumor effects, rapid onset of action, generally well–tolerated profile and a substantial reduction in pet owner visits to the veterinarian, our market research suggests that Tanovea has the potential to achieve peak sales of at least $40 million annually in a rapidly growing market.”
TanoveaTM (rabacfosadine) is a novel small molecule drug designed to preferentially target and attack cancer cells implicated in lymphoma, one of the most common and deadly cancers impacting pets today. In multiple clinical studies in over 300 client-owned dogs with naturally occurring lymphoma, Tanovea has consistently demonstrated substantial anti-tumor activity in both naïve and relapsed cases, with a generally well-tolerated safety profile. Tanovea has a rapid onset of action, with responses observed in as few as 7 to 21 days. Tanovea is being investigated as a convenient, every-three-week treatment for up to five doses, representing a substantial reduction in client visits relative to non-approved ‘human’ generic chemotherapy regimens commonly utilized in dogs.
VetDC has an exclusive North American license from Gilead Sciences to develop and commercialize Tanovea for companion animal cancer.
About VetDC, Inc.
VetDC (www.vetdc.com) is changing the way new cancer medicines are developed for companion animals, leveraging novel advancements from human biotechnology that have demonstrated success in animal studies. VetDC currently has two programs in development, Tanovea for lymphoma and VDC-597 for multiple cancers.
Steven Roy, 303-859-2072