ARTICLE | Company News

BEMA fentanyl clears EU hurdle

October 21, 2010 12:20 AM UTC

BioDelivery Sciences International Inc. (NASDAQ:BDSI) and partner Meda AB (SSE:MEDAA) are expecting national marketing authorization approvals in each of 25 individual EU countries over the next several months for Breakyl BEMA fentanyl to manage breakthrough cancer pain in opioid-tolerant adults. The MAA has already received approval via the European decentralized procedure, with Germany acting as the reference member state, but national approvals are still required before commercialization can commence. The companies expect to launch the product before the end of 2011.

BioDelivery is eligible for a $2.5 million milestone payment from Meda upon the first national marketing authorization of Breakyl. BioDelivery also is eligible for a $2.5 million milestone payment upon the first commercial sale. ...