BioDelivery Sciences Refutes Patent Claim

RALEIGH, N.C.--(BUSINESS WIRE)-- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today responded to a process patent infringement lawsuit filed and recently served against the Company and certain co-defendants by MonoSol Rx, LLC. The purpose in responding at this time is for BDSI to strongly refute MonoSol’s claims and to assure BDSI stockholders that the Company remains focused on vigorously progressing its pipeline and not allowing this claim to present a distraction.

“After careful examination, we refute MonoSol’s assertion of patent infringement, which relates to our confidential, proprietary manufacturing process for ONSOLIS, as without merit. We intend to defend this case vigorously, and we are very confident that MonoSol’s claims will be rejected. Our manufacturing process for ONSOLIS, which MonoSol asserts infringes its process patent, is a trade secret for which no one has any access. MonoSol has failed to disclose any basis for its assertion that our confidential, proprietary manufacturing process infringes its newly-issued patent,” stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. Dr. Sirgo continued, “Importantly, we have not and will not allow this meritless claim to distract us from driving our promising development pipeline forward including our aggressive pursuit of BEMA Buprenorphine for the treatment of chronic pain and BEMA Buprenorphine/Naloxone for the treatment of opioid dependence.”

In its claim, originally filed in the Federal District Court of New Jersey on November 2, 2010, and formally served on BDSI on January 19, 2011, MonoSol claims that the manufacturing process for ONSOLIS infringes its patent. Of note, the BEMA technology itself is not at issue in the case, but rather only the manner in which ONSOLIS, which incorporates the BEMA technology, is manufactured.

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 oncology supportive care. 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 for the treatment of opioid dependence. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron) and migraine (BEMA “Triptan”). 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 the 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,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” 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 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 publically update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.



CONTACT:

BioDelivery Sciences International, Inc.
Al Medwar, 919-582-9050
Vice President, Marketing and Corporate Development
[email protected]

KEYWORDS:   United States  North America  North Carolina

INDUSTRY KEYWORDS:   Technology  Nanotechnology  Health  Biotechnology  Clinical Trials  Oncology  Pharmaceutical  FDA  Managed Care

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