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BioDelivery Sciences Provides Business Update and Summary of Third Quarter Results of Operations
Positive outcome achieved from pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence; NDA filing in 2Q 2013
By: PR Newswire
Nov. 8, 2012 05:00 PM
RALEIGH, N.C., Nov. 8, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of the Company's recent achievements and upcoming milestones.
"This has been a year of remarkable progress, having made key strides with our lead product candidates - BEMA Buprenorphine for the treatment of chronic pain and BNX for the treatment of opioid dependence," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "In conjunction with our partner, Endo Health Solutions, in July we initiated two pivotal Phase 3 trials of BEMA Buprenorphine for the treatment of moderate to severe chronic pain. As we have previously stated, we believe this is a product that has the opportunity to reach $500 million in projected peak annual sales in the U.S."
"In September we announced positive data from our pivotal pharmacokinetic study of BNX for the maintenance treatment of opioid dependence," continued Dr. Sirgo. "We expect this to lead to an NDA filing for BNX in the latter part of the second quarter of next year. Importantly, we have the opportunity to be the next branded buprenorphine/naloxone film to compete against Suboxone in the rapidly growing opioid dependence market, where Suboxone sales surpassed $1.5 billion in the last twelve months. In addition, we believe that with the announced withdrawal of Suboxone tablets from the marketplace, which would leave only Reckitt's film product in the market, our BNX sales could expand beyond our current forecast of $300 million in projected peak annual U.S. sales. Finally, our partnering discussions continue around BNX as we also consider the option of commercializing this product ourselves."
At September 30, 2012, BDSI had $31.3 million in cash compared to $10.8 million at December 31, 2011. For 2012 year-to-date, BDSI had positive cash flow of $19.7 million compared to negative cash flow in the same period in 2011 of $18.9 million. In October 2012, BDSI received a $2.5 million milestone payment from Meda as a result of the launch of BREAKYL in Europe.
Research and development costs in the third quarter 2012 totaled $12.5 million, compared to $6.2 million in the third quarter of 2011. The increase is due to additional research and development costs associated with the concomitant running of the BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX) Phase 3 trials.
Third Quarter 2012 and Recent Corporate Update
The following are key events that occurred at BDSI during the third quarter of 2012:
Anticipated 2012/13 Milestones
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 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 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 Health Solutions. 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 and 2013 initiatives and potential milestones 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.
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.
SOURCE BioDelivery Sciences International, Inc.
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