Aratana Therapeutics Announces Positive Pivotal Results for AT-003

Aratana Therapeutics, Inc. PETX, a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, today announced positive results from its pivotal field effectiveness study of AT-003, the company's innovative drug for treating post-surgical pain in dogs. AT-003 is an extended-release bupivacaine liposome injectable suspension licensed from Pacira Pharmaceuticals, Inc. PCRX. In the study, dogs receiving up to 5.3 mg/kg in a single dose of extended-release bupivacaine by infiltration during knee surgery demonstrated statistically significant improvements in pain evaluation compared to placebo (p<0.05). The study was a randomized, blinded, multicenter pivotal study conducted under protocol concurrence from the FDA's Center for Veterinary Medicine (CVM). Success criteria were based on pain evaluations at 24-hour intervals up to 72 hours after surgery, and AT-003 showed statistically significant higher success rates than placebo at each interval. Ernst Heinen, DVM, Ph.D., Chief Development Officer for Aratana Therapeutics, stated, "We are very pleased with these results, and we believe that if approved AT-003 will provide veterinarians a safe, effective and longer acting option for relieving post-operative pain in dogs." The pivotal field effectiveness study data are the final piece of the Effectiveness Technical Section that Aratana plans to submit to the CVM as the Company pursues marketing approval for AT-003. Based on current timelines for the FDA approval process, Aratana anticipates commencing commercialization of AT-003 for dogs in 2016