BioDelivery Sciences Announces EU Launch of BREAKYL

BioDelivery Sciences International BDSI announced the commercial launch of BREAKYL (fentanyl buccal film) in the European Union. BDSI's commercial partner for BREAKYL in the E.U. is Meda. Under the terms of its E.U. agreement with Meda, BDSI will now receive a final milestone payment of $2.5 million.  BDSI will also receive a royalty on net sales of BREAKYL in the E.U. BREAKYL is being launched in the E.U. by Meda and will be available for sale in a selected number of countries in 2012, including Germany.  BREAKYL will thereafter be launched in most E.U. countries throughout 2013. BREAKYL is commercialized in the U.S. as ONSOLIS (fentanyl buccal soluble film) by Meda's U.S. affiliate, Meda Pharmaceuticals.  BREAKYL and ONSOLIS are both indicated for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.  BREAKYL will compete in the market for transmucosal fentanyl products, which has grown substantially in the E.U. in recent years following the availability of new products, to over See full press release