Apr 1, 2008 - BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Meda AB, its commercialization partner for BEMA(TM) Fentanyl in North America and Europe, has submitted a dossier seeking approval to market BEMA(TM) Fentanyl for the treatment of breakthrough pain in opioid tolerant cancer patients to the German Federal Institute for Drugs and Medical Devices (BfArm). Meda has chosen to utilize the Decentralized Procedure to obtain marketing approval throughout the European Union with Germany serving as the reference member country.
BioDelivery Sciences received a $2.5 million milestone payment for completion of the clinical trial work supporting the dossier and expects to receive an additional milestone payment on approval, followed by revenues from a double digit royalty on net sales.
"This submission clearly reflects the priority Meda has placed on gaining approval for BEMA(TM) Fentanyl both in Europe and in the U.S.," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. "It also reflects our opinion there is a clear market opportunity for BEMA(TM) Fentanyl and underscores our unwavering focus toward providing a new treatment option for cancer patients experiencing breakthrough pain."
"Breakthrough pain is a common condition in cancer patients, so it is important to continue developing improved therapies in this area," stated Anders Lonner, Chief Executive Officer of Meda AB. "We are pleased with BioDelivery Sciences' progress and are eager to introduce BEMA(TM) Fentanyl for breakthrough cancer pain to the European market where current treatment modalities continue to prove suboptimal."
As previously disclosed, the U.S. Food and Drug Administration (FDA) accepted for filing BioDelivery Sciences' New Drug Application (NDA) for BEMA(TM) Fentanyl. BioDelivery Sciences is expecting a response from FDA on the BEMA(TM) Fentanyl NDA by August 31, 2008. In September 2007, BioDelivery Sciences announced a licensing agreement with Meda AB for the distribution rights in the U.S., Canada, and Mexico for BEMA(TM) Fentanyl. In August 2006, Meda AB secured from BioDelivery Sciences the rights to distribute BEMA(TM) Fentanyl in Europe.
Breakthrough cancer pain is characterized by the episodes of severe pain that "break through" the base opioid medications used to control persistent pain. The worldwide market for breakthrough cancer pain is expected to reach $2.5 billion by 2016 according to Datamonitor. In addition, a recent European Pain in Cancer (EPIC) survey revealed that 63 percent of cancer patients report they are affected by breakthrough pain. The study 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.
About BEMA(TM) Fentanyl
BDSI's lead product under development is BEMA(TM) Fentanyl, a potential treatment for "breakthrough" pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). BEMA(TM) Fentanyl consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. The BEMA(TM) delivery technology is particularly well suited for the delivery of products where rapid onset of activity and convenient administration are important. BDSI believes there is a clear need and growing market for additional narcotic agents in alternative dosage forms to provide rapid and convenient pain relief.
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