BioDelivery Sciences received a $2.5 million prelaunch milestone payment from Meda, triggered by the first national regulatory clearance and pricing approval for Breakyl/Onsolis (fentanyl buccal soluble film) in the EU. Breakyl is indicated for the management of breakthrough pain in opioid-tolerant adult cancer patients. BioDelivery will receive another, final $2.5 million EU-related milestone when the drug is launched commercially in Europe by Meda, which the firm anticipates before the end of 2012.
BioDelivery specializes in the development of products for pain management and oncology supportive care. The firm is leveraging its BEMA and Bioral drug delivery technologies to develop an in-house and partnered pipeline of new drug formulations based on already approved compounds. The firm’s pain pipeline comprises two products, Onsolis and BEMA Buprenorphine, both of which are based on its BEMA (BioErodible MucoAdhesive) technology for the transmucosal delivery of drugs with otherwise poor oral absorption.
Onsolis is approved in the U.S., Canada, and EU (trade named Breakyl), and has been licensed to Meda worldwide, except for Taiwan (licensed to TTY Biopahrm) and South Korea (licensed to Kunwha Pharmaceutical). BEMA Buprenorphine is in Phase III-stage development for the treatment of moderate to severe chronic pain, and is licensed to Endo Pharmaceuticals worldwide.