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SOURCE BioDelivery Sciences International, Inc.
RALEIGH, N.C., May 8, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, will present at the Bank of America Merrill Lynch 2014 Health Care Conference. The presentation is scheduled for Tuesday, May 13, 2014 at 8:40 a.m. Pacific Time (11:40 a.m. Eastern Time) at Encore at Wynn in Las Vegas.
The New Drug Application (NDA) for BUNAVAIL for the treatment of opioid dependence is currently under review by the U.S. Food and Drug Administration (FDA), and based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the BUNAVAIL NDA is expected to be completed by June 7, 2014.
Dr. Sirgo will be providing an update on BUNAVAIL commercial preparations and the anticipated market opportunity as well as progress made by BDSI and its commercial partner, Endo Pharmaceuticals, with the ongoing Phase 3 clinical program for BEMA Buprenorphine for the treatment of chronic pain. The update will include the previously announced positive topline results from the Phase 3 clinical study of BEMA Buprenorphine in opioid naive patients and the anticipated timing of the second Phase 3 study, which was conducted in opioid experienced patients. Additionally, an update will be provided on the progress of the Phase 3 clinical study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy, which reached 50% enrollment early this month.
The presentation will be webcast live and can be accessed at www.bdsi.com. For those who are not available to listen to the live broadcast, a replay of the webcast will be available on the BDSI website.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.
BDSI's pain franchise consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, E.U. (where it is marketed as BREAKYL) and Taiwan (where it will be marketed as PAINKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).
BEMA Buprenorphine is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Pharmaceuticals. Clonidine Topical Gel for the treatment of painful diabetic neuropathy is currently in Phase 3 development.
An NDA for BUNAVAIL, a BEMA formulation of buprenorphine in combination with naloxone, is currently under review for the maintenance treatment of opioid dependence and has a PDUFA date of June 7, 2014.
BDSI's headquarters is located in Raleigh, North Carolina. For more information visit www.bdsi.com.
Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto (including, without limitation, at the presentations described herein) 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," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" 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, the results of the FDA's review of BUNAVAIL, the results of the Company's commercial efforts for BUNAVAIL, and the results of the Company's clinical trials for BEMA Buprenorphine and Clonidine Topical Gel) 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). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences logo and BUNAVAIL™ are trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark owned by Meda Pharma GmbH & Co. KG. PAINKYLTM is a trademark owned by TTY Biopharm. All other trademarks and tradenames are owned by their respective owners.
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