BDSI is focusing its resources on achievement of the following key milestones:
- Submission of BUNAVAIL NDA for opioid dependence. Based on demonstrating bioequivalence in the pivotal pharmacokinetic study and positive results in the safety study, BDSI anticipates it will submit a New Drug Application (NDA) to the FDA for BUNAVAIL in mid-2013.
- Recruitment of two Phase 3 studies for BEMA Buprenorphine. BDSI and Endo expect to continue recruitment in the two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naïve patient groups. The trials are expected to complete in late 2013 or early 2014. Upon completion of study enrollment and database lock for each trial, and the acceptance of filing of the NDA with the FDA, BDSI is expected to receive milestone payments from Endo totaling $30 million.
- BUNAVAIL commercialization opportunities. BDSI will continue to evaluate its strategic options for the commercialization of BUNAVAIL, which include partnership, internal approaches or a combination of these. BDSI expects to finalize its strategy in the second half of 2013.
- Re-introduction of ONSOLIS in the U.S. In March 2013, BDSI and Meda submitted a proposal to FDA to reintroduce ONSOLIS into the U.S. marketplace following previously reported appearance issues with the product. If approved by FDA, the original ONSOLIS formulation may be on the market during the second-half of this year while stability data is collected on a newly formulated version of ONSOLIS. These data may be submitted to FDA before the end of the year, and if approved, could allow introduction of the new formulation sometime in 2014.
- Exploration of potential new products and technologies. In addition to advancing its lead products in development, BDSI is also, as in the past, exploring the application of its BEMA drug delivery technology to additional pharmaceuticals. In addition, BDSI has been investigating potential new products and technologies to complement and diversify its existing portfolio.
About BioDelivery Sciences InternationalBioDelivery 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 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, 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. Additionally, BDSI is developing a high dose formulation of buprenorphine in combination with naloxone for the treatment of opioid dependence. The product, which has been known as BEMA Buprenorphine/Naloxone, or BNX, will be marketed under the brand name BUNAVAIL. Both BEMA Buprenorphine and BUNAVAIL are in Phase 3 clinical development. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
Cautionary Note on Forward-Looking StatementsThis 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 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: (i) the timing for and results of the clinical trials and proposed NDA submissions for, and FDA review of, BEMA Buprenorphine and BUNAVAIL, (ii) the prospects for U.S. commercial re-launch of ONSOLIS and (iii) the results of the Company's exploration and/or acquisition of new products or technologies) 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.© 2013 BioDelivery Sciences International, Inc. All rights reserved.
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