BioDelivery Sciences International, Inc. (Nasdaq:BDSI)(http://www.biodeliverysciences.com) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing BDSI’s new drug application (NDA) for BEMA™ Fentanyl that was submitted on October 31, 2007, for the management of breakthrough cancer pain in opioid tolerant patients. The acceptance of the filing means the FDA has made an initial determination that the NDA is sufficiently complete to warrant a substantive review. A final decision by FDA is expected in August 2008.
If BEMA™ Fentanyl is approved by the FDA, BDSI is expected to receive milestone payments from its commercial partner, Meda AB, totaling $30 million and could begin receiving royalty revenues from the product as early as fourth quarter of 2008. BDSI believes that BEMA™ Fentanyl would be the next product to enter the U.S. market for approved treatments for breakthrough cancer pain, a market which is expected to exceed $1.5 billion over the next several years.
In September 2007, BDSI announced a licensing agreement with Meda AB for the distribution rights in the U.S., Canada, and Mexico for BEMA™ Fentanyl. In August 2006, Meda AB secured from BDSI the rights to distribute BEMA™ Fentanyl in Europe. Plans for submitting a regulatory application in Europe are underway.
BEMA™ Fentanyl consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes. As previously announced, the efficacy results from the pivotal Phase III efficacy trial in patients with breakthrough pain associated with cancer demonstrated that patients treated with BEMA™ Fentanyl had a significantly greater reduction in pain as early as 15 minutes (study primary endpoint) compared to patients treated with placebo. A subsequent safety study demonstrated a very good tolerability profile, including a lack of oral irritation or ulceration related to product administration and use.
About BEMA™ Fentanyl
BDSI’s lead product under development is BEMA™ 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™ 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™ 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.
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to treat acute conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize clinically-significant new products using proven therapeutics. BDSI’s pain franchise currently consists of two products in development utilizing the company’s patented BEMA™ oral adhesive disc technology: BEMATM Fentanyl, a treatment for “breakthrough” pain, and BEMATM Buprenorphine, a second analgesic with a target indication of the treatment of moderate to severe pain. The company is also working with both its BEMATM technology and its patented Bioral® nanocochleate technology on products targeted at other acute treatment opportunities such as insomnia, nausea and vomiting, and infections. The company’s headquarters are located in Raleigh, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com.