RALEIGH, N.C., July 23, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Adrian Hepner, M.D., Ph.D., has joined the company as Vice President of Clinical Research and Regulatory Affairs. Dr. Hepner joins BDSI with over twenty years of experience in U.S. and international clinical research and drug development, which includes development and implementation of the clinical and regulatory strategy for a number of products from early stage development through New Drug Application (NDA) and E.U. regulatory filings.
After receiving his M.D. degree, Dr. Hepner completed visiting research physician experiences in the Department of Psychiatry at Harvard Medical School and the Department of Neurology at the National Institute of Mental Health and a post-doctoral fellowship in neuropharmacology at the University of Ottawa. Additionally, he spent fifteen years in neuropsychiatry private practice and participated in clinical research studies.
Dr. Hepner's pharmaceutical industry experience includes over twelve years of progressively increasing drug development responsibilities, including a critical leading role in the regulatory and clinical activities for FDA approval of the first product for Pseudobulbar Affect and successfully completing placebo-controlled studies in Painful Diabetic Neuropathy. Most recently, Dr. Hepner held the role of Senior Medical Director at UCB BioSciences, Inc., where he was responsible for global development projects in the central nervous system therapeutic area. Prior to his experience at UCB, Dr. Hepner was Vice President of Clinical Research at Avanir Pharmaceuticals and led clinical research inLatin America for TEVA Pharmaceuticals.
Dr. Hepner will initially concentrate on the clinical development program for Clonidine Topical Gel for the treatment of Painful Diabetic Neuropathy, which is expected to begin later this year. His prior experience and clinical research in this disorder will be instrumental in leading the Clonidine Topical Gel development program.
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 currently 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, and the E.U. (where it is marketed as BREAKYL), 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.).
BDSI's second pain product using the BEMA technology, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Health Solutions. BDSI's third pain product in development is Clonidine Topical Gel for the treatment of painful diabetic neuropathy and was recently licensed from Arcion Therapeutics.
Additionally, BDSI is developing BUNAVAIL (buprenorphine and naloxone buccal film) for the treatment of opioid dependence. Both BEMA Buprenorphine and BUNAVAIL are in Phase 3 clinical development, and Clonodine Topical Gel is in Phase 2 clinical development.
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, the presentation referred to herein, and any 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," "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 and those that relate to the Company's ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy. Actual results (including, without limitation, the timing for and results of the clinical trials and proposed NDA submissions for, and FDA review of, the Company's products in development) 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. All other trademarks and tradenames are owned by their respective owners.
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