RALEIGH, N.C., Aug. 9, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 with the U.S. Securities and Exchange Commission. In connection therewith, BDSI is providing a review of its recent achievements in 2012, as well as an update on business operations and upcoming milestones for the balance of the year.
At June 30, 2012, BDSI had $43.0 million in cash compared to $10.8 million at June 30, 2011. Contributions to BDSI's cash balance during the second quarter included a milestone payment of $15 million associated with the licensing and development agreement with Endo Health Solutions (Endo) for BEMA Buprenorphine. The milestone was triggered by the granting of a patent extending the exclusivity for BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX) by seven years to 2027.
BDSI also received a milestone payment from Meda in the amount of $2.5 million following the first E.U. country registration and pricing approval for BREAKYL (trade name for ONSOLIS in the E.U.). Meda is BDSI's worldwide commercial partner for ONSOLIS/BREAKYL, outside of Taiwan and South Korea, where the product is separately partnered.
Last week, BDSI and Endo announced initiation of enrollment in the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. Additionally, data is anticipated to be available by the end of September for the pivotal bioavailability study for BNX, which is currently ongoing.
"We are extremely pleased to have both of our key assets, BEMA Buprenorphine for chronic pain and BNX for opioid dependence, move into pivotal registration trials," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We announced a number of exciting achievements in the first quarter of this year, including the signing of the licensing and development agreement for BEMA Buprenorphine with Endo and a positive meeting with FDA on our BNX development program. Since the first quarter, we have built on these prior accomplishments by progressing both BEMA Buprenorphine and BNX into registration studies. These are significant achievements and have ushered in a very exciting period of time at BDSI. As it relates to the BNX clinical development program, we look forward to the availability of data from our pivotal pharmacokinetic study in late September."
The following are key events that occurred at BDSI since the start of the second quarter of 2012:
Anticipated 2012 Milestones
In 2012, BDSI is focusing its resources on achievement of the following key milestones:
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 two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be 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, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is registered trademark of Meda Pharma GmbH & Co. KG.
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 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 2012 initiatives described herein) 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.
SOURCE BioDelivery Sciences International, Inc.