BREAKYL drug receives European approval

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) and Meda today announced approval of BEMA Fentanyl in Europe via the Decentralized Procedure, with Germany acting as Reference Member State. BEMA Fentanyl is indicated for the management of breakthrough pain in opioid tolerant, adult patients with cancer. National marketing authorization approvals, enabling commercial sales in each of the 25 individual EU countries, are now expected over the next several months. BEMA Fentanyl, which is approved in the U.S. and Canada as ONSOLIS (fentanyl buccal soluble film), will be marketed as BREAKYL (fentanyl buccal film) in Europe.

“We are pleased with this achievement, and we look forward to making BREAKYL available to patients across Europe who are afflicted with this indication. There is a growing medical need and BREAKYL offers a novel and patented delivery technique compared with current treatment alternatives.”

Under the terms of its licensing agreement with Meda, BDSI receives a milestone payment of $2.5 million triggered by the first national marketing authorization of BREAKYL and another $2.5 million at the time of the first commercial sale that is anticipated sometime prior to the end of 2011. Additionally, BDSI will receive a double-digit royalty on net sales.

"We are very pleased to expand the availability of BEMA Fentanyl to include another significant region of the world," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "BREAKYL is the first product to be approved in the EU using our BEMA drug delivery technology, and we believe it will provide a novel approach to the treatment of breakthrough pain in opioid tolerant patients. The approval of BREAKYL is the result of a continued strong collaborative effort between BDSI and Meda."

Anders Lönner, Chief Executive Officer of Meda, added, "We are pleased with this achievement, and we look forward to making BREAKYL available to patients across Europe who are afflicted with this indication. There is a growing medical need and BREAKYL offers a novel and patented delivery technique compared with current treatment alternatives."