BioDelivery Sciences International, Inc.’s (Nasdaq: BDSI) President and Chief Executive Officer, Mark A. Sirgo, Pharm.D., will present at the following upcoming investor conferences:
- The Rodman and Renshaw 10th Annual Healthcare Conference at the New York Palace Hotel in New York City on Monday, November 10, 2008, at 10:20 a.m. EST. A live webcast and archived presentation can be accessed at www.biodeliverysciences.com.
- The Lazard Capital Markets 5th Annual Healthcare Conference at the St. Regis Hotel in New York City on Wednesday, November 19, 2008, at 3:30 p.m. EST.
During both conferences, Dr. Sirgo will be presenting an update on the status of BDSI’s lead product, ONSOLIS™, formerly known as BEMA™ Fentanyl. In August, BDSI received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for ONSOLIS. 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 during the first half of 2009. In North America and Europe, the commercial rights to ONSOLIS are licensed to Meda AB.
The conference presentations will be accessible at www.biodeliverysciences.com following the meetings.
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 oral adhesive film technology: ONSOLIS, a potential treatment for “breakthrough” pain in opioid tolerant patients with cancer, and BEMA 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 technology and its patented Bioral® 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).
Contacts:
Al Medwar
Vice
President, Marketing & Corporate Development
919-582-9050
amedwar@bdsinternational.com
