RALEIGH, N.C., June 10, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, will present at two important upcoming healthcare conferences:
34th Annual William Blair Growth Stock Conference
Wednesday, June 11, 2014
3:20 PM Central Time (4:20 PM Eastern Time)
Four Seasons Hotel, Chicago, IL
Wells Fargo 2014 Healthcare Conference
Tuesday, June 17, 2014
4:40 PM Eastern Time
InterContinental Hotel in Boston, MA
On Friday, June 6, BDSI announced approval of the New Drug Application (NDA) for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA). BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BDSI expects to launch BUNAVAIL late in the third quarter of 2014 where it will compete in the $1.7 billion and growing market for opioid dependence treatments. Dr. Sirgo will be focusing his presentation on the approval of BUNAVAIL, commercial preparations and the anticipated market opportunity.
Dr. Sirgo will also discuss 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. Results of the Phase 3 study in opioid experienced patients are anticipated in early July.
The presentations 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.
BDSI's approved product for the maintenance treatment of opioid dependence is BUNAVAIL, which was approved by the FDA in June 2014 and is expected to be commercially launched during late third quarter 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, the presentations referred to herein 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 Company's marketing and sales efforts for, and revenue generated from, BUNAVAIL as well as the results of the Company's clinical trials for, and FDA review of, BEMA Buprenorphine) 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.
Readers are cautioned that 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 estimates are accurate or that such sales levels will be achieved, if at all.
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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