BioDelivery Sciences to Present BEMA Fentanyl Data at the 24th Annual Meeting of the American Academy of Pain MedicineRALEIGH, N.C.--(BUSINESS WIRE)--Feb 11, 2008 - BioDelivery Sciences International, Inc. (Nasdaq:BDSI) today announced it will present a pharmacokinetic study for its lead product, BEMA(TM) Fentanyl, a potential treatment for breakthrough pain (BTP) in opioid-tolerant cancer patients at the 24th Annual Meeting of the American Academy of Pain Medicine in Orlando, Florida. In January 2008, BioDelivery Sciences announced that the U.S. FDA accepted for filing the company's New Drug Application for BEMA(TM) Fentanyl. A determination from the FDA on this NDA is expected in August 2008.
BioDelivery Sciences will present the study results in a scientific poster session comparing the blood fentanyl concentrations from its BEMA(TM) (BioErodible MucoAdhesive) drug delivery system and Actiq(R) (oral transmucosal fentanyl citrate), a currently approved product for the same indication made by Cephalon, Inc. (Nasdaq:CEPH). The abstract and poster entitled "BEMA(TM) (BioErodible MucoAdhesive) Fentanyl Demonstrates a Favorable Pharmacokinetic Profile Compared to Oral Transmucosal Fentanyl Citrate (Actiq(R)) in Healthy Volunteers" will be on display Thursday and Friday, February 14 and 15, 2008, in the exhibit hall.
"We believe the results of this pharmacokinetic study demonstrate the ability of the BEMA(TM) drug delivery system to rapidly and efficiently deliver fentanyl through the buccal mucosa and validate the potential of the technology for transmucosal delivery of other agents," said Dr. Andrew Finn, Executive Vice President of Product Development at BioDelivery Sciences.
Actiq(R), also known as oral transmucosal fentanyl citrate, is a solid formulation of fentanyl citrate on a handle that is designed to be slowly dissolved in the mouth. Actiq(R) and its generic equivalents are the leading product in the category with over $700 million in retail sales in 2007 accordingly to Wolters Kluwer. Actiq(R) is a registered trademark of Cephalon, Inc.
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. BDSI believes that 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.
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(TM) oral adhesive disc technology: BEMA(TM) Fentanyl, a potential treatment for "breakthrough" pain, and BEMA(TM) Buprenorphine, a second analgesic with a target indication of the treatment of moderate to severe pain. The company is also working with both its BEMA(TM) technology and its patented Bioral(R) 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.
Note: Except for the historical information contained herein, this press release and the statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects", "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation: (i) actual sales results and royalty or milestone payments, if any, (ii) the application and availability of corporate funds and the Company's need for future funds, or (iii) the timing for completion, and results of, scheduled or additional clinical trials and the FDA's review and/or approval and commercial launch of the Company's formulations and products and regulatory filings related to the same, may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). Peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all.
FD Ashton Partners
Michael Russell, 617-275-8746
Michael Geczi, 312-553-6735
Stephanie Brown, 312-553-6727
Posted: February 2008