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Following FDA Meeting BDSI Projects Submission of BEMA(TM) Fentanyl NDA In Second Quarter 2007

Posted on: Wednesday, 20 September 2006, 09:01 CDT

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) announced that, in light of, among other considerations, information gathered at a meeting with the FDA last week regarding the company's Phase III BEMA(TM) Fentanyl product, the company is anticipating the submission of a New Drug Application (NDA) with the FDA on BEMA(TM) Fentanyl during the second quarter of 2007. The meeting with FDA was initiated by the company in advance of an anticipated "pre-NDA" meeting expected early next year so that the company could solicit guidance on key matters regarding the NDA program for BEMA(TM) Fentanyl at this time.

BDSI's projection is contingent on the conclusion of the Phase III program for BEMA(TM) Fentanyl. Current enrollment in the pivotal Phase III efficacy trial for BEMA(TM) Fentanyl is anticipated to be completed by the end of 2006. A separate safety trial that makes up the other component of the BEMA(TM) Fentanyl Phase III clinical program is expected to be completed during the first half of 2007. As a result, BDSI expects that it will be in a position to make an NDA submission on BEMA(TM) Fentanyl to the FDA in the second quarter of 2007. BEMA(TM) Fentanyl is being targeted for the treatment of "breakthrough" cancer pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain).

Dr. Andrew Finn, Executive Vice President of Clinical Development and Regulatory Affairs for BDSI stated, "Overall, we are pleased with our progress to date, supported by our recent FDA meeting, and remain confident in our ability to prepare and submit for filing our NDA for BEMA(TM) Fentanyl during the second quarter of 2007."

Dr. Mark Sirgo, President and CEO of BDSI, stated "We are optimistic about achieving our clinical trial milestones and were encouraged by our recent meeting with FDA regarding this program. In addition, as we learn more about the marketplace and the unmet needs in treating patients with breakthrough cancer pain, our enthusiasm regarding the commercial potential of the BEMA(TM) Fentanyl product continues to grow."

Within the global market, pain medication generates estimated annual sales of more than $24 billion. In the U.S., an estimated $1 billion is targeted at breakthrough cancer pain. BDSI believes that BEMA(TM) Fentanyl has the potential to secure a share of the breakthrough cancer pain market in the U.S., with estimated minimum annual peak sales of $250 million. The company also recently announced a licensing arrangement with Meda AB of Sweden for the distribution of BEMA(TM) Fentanyl in Europe following regulatory approval there.

The company's estimates for enrollment in and completion of the two clinical studies in its Phase III clinical program for BEMA(TM) Fentanyl include consideration of, among other factors, a temporary cessation of recruitment at investigational sites which occurred in California in mid-August 2006 until clearance by the California Research Advisory Panel is obtained to restart testing at these sites, a decision on which is expected this month, as well as other issues, such as end of life decisions, which affect the recruitment of patients with breakthrough cancer pain for the studies.

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.

Forward-Looking Statements

Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement 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, 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.

Source: Business Wire

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