Less than a month after thrilling investors by filing for FDA approval of Galliprant (grapiprant) to treat dogs with osteoarthritis, Aratana Therapeutics ($PETX) announced it hopes to crack the European market with the same drug. The company said after the market closed on February 17 that it has filed for approval with the European Medicines Agency (EMA) and expects to receive authorization to launch the drug there next year.
For now, though, investors are placing their hopes on a string of decisions from the FDA. The agency is expected to rule soon on Entyce (capromorelin), an appetite stimulator for dogs, and Nocita (bupivacaine), a long-acting pain reliever for dogs who have undergone surgery. On February 22, the company announced it received the second of three "technical section complete" letters it needs for FDA approval of Nocita, and that it will be ready to commercialize that drug by the end of the year if it receives the third as expected. And Aratana expects to get a verdict on Galliprant from the FDA in late March. During an investor day in November, Aratana's executives estimated the combined market for the three drugs in the U.S. could exceed $200 million a year.
The market for canine arthritis drugs is dominated by Zoetis' ($ZTS) Rimadyl, a COX-2 inhibitor that's popular in spite of side effects like gastrointestinal bleeding. Galliprant acts on a different pain receptor called EP4, and Aratana hopes it will be able to market the drug based both on efficacy and the potential for fewer side effects.
Breaking into Europe will be a challenge for the small animal health player, however, which is why Aratana has been looking for a marketing partner. CEO Steven St. Peter told investors and analysts during the November event that the company is considering a range of partnership scenarios, including co-promotion deals and equity investments.
In an interview with FierceAnimalHealth after the investor day event, St. Peter said the ideal partnership for Aratana would look much like Genentech and Roche ($RHHBY) in the early days of biotech. "We would like to be able to continue to access new products and move them forward quickly, while being partnered with an overseas company that works with us very constructively," he said.
Aratana's shares rose 4% to $3.50 in after-hours trading on Wednesday but settled back to $3.20 after the market opened.
- here's Aratana's press release
Editor's note: This story has been updated to include the most recent news on Nocita.