BioDelivery Sciences International, Inc. (Nasdaq: BDSI) is in receipt of a $2.5 million milestone payment from commercialization partner Meda AB, who has filed for approval of its breakthrough pain medicine BEMA™ Fentanyl in Germany.
The payment comes upon completion of a clinical trial that supported the filing. Meda seeks to obtain marketing approval throughout the European Union with Germany serving as the reference member country by utilizing the Decentralized Procedure.
BEMA™ Fentanyl has proven in trials to help cancer patients suffering break through pain to manage these periods of high-intensity pain. The company expects to receive an additional milestone payment on approval, followed by double-digit royalties on net sales.
“This submission clearly reflects the priority Meda has placed on gaining approval for BEMA™ Fentanyl both in Europe and in the U.S.,” said Mark A. Sirgo, chief executive officer of BioDelivery Sciences. “It also reflects our opinion there is a clear market opportunity for BEMA™ Fentanyl and underscores our unwavering focus toward providing a new treatment option for cancer patients experiencing breakthrough pain.”
Approval is expected by August 31, 2008 for BioDelivery Sciences’ filing with the U.S. Food and Drug Administration (FDA) for BEMA™ Fentanyl, submitted this past September 2007. Meda AB hast the the rights to distribute BEMA™ Fentanyl in Europe and a put a licensing agreement with BioDelivery Sciences for distribution rights in the U.S., Canada, and Mexico in September 2007.
According to Datamonitor, the worldwide market for breakthrough cancer pain is expected to reach $2.5 billion by 2016. A recent European Pain in Cancer (EPIC) survey revealed that 63 percent of cancer patients report being affected by breakthrough pain. The study also disclosed that only one-third of these patients take additional medications to treat their breakthrough pain, and merely 35 percent of patients taking additional medications report the medicine is effective.
“Breakthrough pain is a common condition in cancer patients, so it is important to continue developing improved therapies in this area,” stated Anders Lonner, CEO of Meda AB. “We are pleased with BioDelivery Sciences’ progress and are eager to introduce BEMA™ Fentanyl for breakthrough cancer pain to the European market where current treatment modalities continue to prove suboptimal.”