Results were based on the company's continuing analysis of the secondary efficacy endpoints from the study. A key secondary endpoint was the SPID 15 (Summary of Pain Intensity Difference at 15 minutes), a measure of the speed of onset of the medication. The study data indicate that the SPID 15 was significantly higher on BEMA(TM) Fentanyl than with placebo.
On April 25, 2007, BDSI announced statistically significant results of its primary efficacy endpoint for the BEMA(TM) Fentanyl Phase III trial, SPID 30 (Summary of Pain Intensity Difference at 30 minutes). 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. Upon administration, BEMA(TM) Fentanyl is designed to deliver a rapid, reliable dose of drug across the mucous membranes.
In addition to the SPID 15 endpoint, the company also reported that the overall global analysis of the treatment, which represents each patient's overall satisfaction with the product, was also found to be statistically superior to the placebo.
Dr. Andrew Finn, BDSI's Executive Vice President of Product Development, stated: "We are very pleased with the outcome of the results from our current secondary endpoint analyses from our Phase III efficacy study which, as previously announced, we plan to present along with other efficacy and safety data at an upcoming scientific forum to be determined. We are particularly pleased to see that the onset of analgesia with BEMA(TM) Fentanyl is rapid, since a quick onset of action is one of the anticipated features of delivering fe ntanyl through the mucosal membrane and a major need for our target patients."
Dr. Mark Sirgo, President and CEO of BDSI, commented: "These additional efficacy results continue to define the profile of BEMA(TM) Fentanyl in treating breakthrough cancer pain. Based on the combination of what we believe is a convenient and comfortable delivery form with the early pain intensity reduction demonstrated in our study, we remain confident that BEMA(TM) Fentanyl has the potential to play an important role in the future treatment of breakthrough cancer pain. Based on this additional efficacy information, and assuming NDA acceptance and approval by FDA and that our development and commercialization activities will continue as planned, we continue to believe we will ultimately reach our annual peak sales projection of $250 million for the treatment of breakthrough cancer pain."
BDSI recently announced that the New Drug Application (NDA) for BEMA(TM) Fentanyl is scheduled for submission during the third quarter of 2007. Prior to this submission, BDSI will conduct a pre-NDA meeting with the FDA on June 28, 2007 to discuss results of the efficacy trial, along with the safety data and other requirements for the NDA submission.
About the BEMA(TM) Technology
BDSI's BEMA(TM) drug delivery technology consists of a dissolvable, dime-sized polymer disc for application to the mucosal (inner lining of cheek) membrane. BEMA(TM) discs deliver a rapid, reliable dose of drug across mucous membranes for time-critical conditions or trauma cases where intravenous lines or injections are unavailable or not practical.
About BEMA(TM) Fentanyl
BDSI's lead product under development is BEMA(TM) Fentanyl, a treatment for "breakthrough" cancer pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). BDSI believes there is a clear need and growing market for additional narcotic agents in alternative dosage form s to provide rapid pain relief. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. The transmucosal form of fentanyl is a powerful narcotic used to treat breakthrough cancer pain. BDSI believes that fentanyl applied with its BEMA(TM) disc technology has the potential to meet the market need for new narcotics and, BDSI believes, will be well suited for breakthrough cancer pain in opioid-tolerant patients.
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 treatment for "breakthrough" cancer pain, and BEMA(TM) LA, 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 Morrisville, 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 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 f orward-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, actual sales results, if any, the application of funds, or the timing for completion and results of scheduled or additional clinical trials and FDA review of the Company's formulations and products, may differ 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.
Investor Relations Group
James Carbonara, 212-825-3210
Bill Douglass, 212-825-3210