BioDelivery Sciences' partner Meda to launch ONSOLIS for managing breakthrough pain

Oct 8 2009

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that its commercial partner Meda will launch the FDA-approved ONSOLIS (fentanyl buccal soluble film) next week for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

ONSOLIS will be commercialized by Meda Pharmaceuticals, the U.S. subsidiary of Meda, a leading international specialty pharmaceutical company. Meda has initiated a national sales campaign, with a full sales force effort specifically targeting pain management physicians, oncologists, and other healthcare professionals who treat cancer breakthrough pain. ONSOLIS will be promoted through a highly-experienced and well-trained specialty sales force. BDSI receives double-digit royalties on the sales of ONSOLIS as well as milestone payments of up to an additional $30 million upon reaching specified sales thresholds.

“Today is a banner day for BDSI and serves as validation of our business model and ability to bring important new therapeutics to market,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. “All of us at BDSI, along with our partner Meda, are very excited to provide healthcare practitioners and their patients suffering from breakthrough cancer pain with a new treatment option for this serious and debilitating condition. We are confident that the quality, focus, and dedication of Meda and their specialty sales force will lead to a positive commercial launch and overall sales effort for ONSOLIS.”

ONSOLIS is the first product to utilize BDSI’s patented BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek). ONSOLIS utilizes the BEMA technology to deliver the opioid fentanyl. ONSOLIS has been demonstrated in clinical trials to provide rapid plasma concentrations of fentanyl and effective relief of breakthrough pain, in a novel and easy to use buccal soluble film formulation.