ONSOLIS (BEMA Fentanyl) Data to be Presented at the American Society of Anesthesiologists (ASA) Annual Meeting

RALEIGH, N.C.--(BUSINESS WIRE)--Oct 20, 2008 - BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that data from clinical studies assessing the pharmacokinetics, efficacy, and safety of ONSOLIS(TM) (formerly referred to as BEMA(TM) Fentanyl) will be presented at the 2008 Annual Meeting of the American Society of Anesthesiologists (ASA) to be held from October 18 through October 22, 2008, in Orlando, Florida. The scientific poster presentations will include previously presented data from two Phase III clinical studies assessing the efficacy and safety of ONSOLIS(TM), a potential treatment for breakthrough pain (BTP) in opioid tolerant patients with cancer, as well as data summarizing the favorable pharmacokinetic profile. These data include:

"BEMA(TM) Fentanyl Shows a Favorable Pharmacokinetic Profile and Dose Linearity in Healthy Volunteers," Dr. Niraj Vasisht, Senior Vice President of Product Development and Chief Technical Officer, BioDelivery Sciences. Poster displayed Monday, October 20, from 9:00 to 11:00 a.m.

"BEMA(TM) Fentanyl Offers High Absolute Bioavailability and Favorable Efficacy and Tolerability Profiles," Dr. James North, Carolina's Pain Institute. Poster displayed Tuesday, October 21, 2:00 - 4:00 p.m.

In August, BDSI received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its lead product ONSOLIS(TM). The FDA requested modifications to the submitted risk management program and informed BioDelivery Sciences that all other aspects of the NDA review were complete. BDSI anticipates an FDA approval for ONSOLIS(TM) during the first half of 2009. In North America and Europe, the commercial rights to ONSOLIS(TM) are licensed to Meda AB.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize 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 film technology: ONSOLIS(TM), a potential treatment for "breakthrough" pain in opioid tolerant patients with cancer, and BEMA(TM) Buprenorphine, a second analgesic with at least one potential target indication for the treatment of moderate to severe pain. The company is working with its BEMA(TM) technology and its patented Bioral(R) cochleate technology on products targeted at conditions common to oncology and surgical patients such as pain and infections. The company headquarters is located in Raleigh, North Carolina, and its principal laboratory is located in Newark, New Jersey. For more information please visit www.biodeliverysciences.com.

Cautionary Note on Forward-Looking Statements

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 or other regulatory 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).

Contact

Investors:
FD Ashton Partners
James Koppa, 312-553-6709
james.koppa@fdashtonpartners.com

Media:
BioDelivery Sciences International, Inc.
Al Medwar, 919-582-9050
amedwar@bdsinternational.com

Posted: October 2008

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