EX-99.1
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`EX-99.1 2 d551921dex991.htm EX-99.1
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`Exhibit 99.1
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`BioDelivery Sciences Announces NDA Submission for BUNAVAIL
`on Track Following Positive Pre-NDA Meeting with FDA
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`BUNAVAIL NDA submission continues on target for mid-summer 2013
`
`RALEIGH, N.C. – June 10, 2013 - BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that it engaged in a positive pre-
`New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding BUNAVAIL for the maintenance treatment
`of opioid dependence.
`
`The positive outcome of the pre-NDA meeting allows BDSI to maintain its expectation of an NDA filing with FDA for BUNAVAIL in mid-
`summer 2013 as planned.
`
`This scheduled meeting with FDA regarding the NDA submission of BUNAVAIL was undertaken to review the key data elements for the NDA,
`which includes data from a positive pivotal bioequivalence study versus Suboxone, an open-label safety study in patients switched from Suboxone
`film or tablets to BUNAVAIL, and product stability information. As a result of the feedback obtained, BDSI will continue forward with its NDA
`submission as planned.
`
`“We are pleased with the outcome of our pre-NDA meeting where we reviewed the key elements of our NDA with the Agency,” said Dr. Andrew
`Finn, Executive Vice President of Product Development for BDSI. “This outcome is allowing us to move confidently forward in finalizing and
`submitting our NDA.”
`
`BUNAVAIL utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment
`of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent. BDSI believes BUNAVAIL
`may offer meaningful advantages over existing treatments and could provide an alternative to the over 2 million people in the U.S. with opioid
`dependence. Currently, Suboxone is the only available film formulation of buprenorphine and naloxone, with the film formulation generating in
`excess of one billion dollars in sales in 2012. BUNAVAIL is positioned to be the next film formulation to enter the market. BDSI believes
`BUNAVAIL has the potential to generate peak sales in excess of $250 million.
`
`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 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, 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 using the BEMA technology, 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. BDSI’s third pain product in development is Clonidine Topical Gel for
`the treatment of painful diabetic neuropathy, which was recently licensed from Arcion Therapeutics.
`
`Additionally, BDSI is developing BUNAVAIL, a high dose formulation of buprenorphine in combination with naloxone for the treatment of opioid
`dependence. Both BEMA Buprenorphine and BUNAVAIL are in Phase 3 clinical development, and Clonodine Topical Gel is in Phase 2 clinical
`development.
`
`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 presentation referred to herein, 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, the timing for and results of the clinical trials and proposed NDA
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`RB Ex. 2049
`BDSI v. RB PHARMACEUTICALS LTD
`IPR2014-00325
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`EX-99.1
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`submissions for, and FDA review of, the Company’s products in development) 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. All other trademarks and tradenames are owned by their respective owners.
`
`© BioDelivery Sciences International, Inc. All rights reserved.
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`Contacts:
`
`Brian Korb
`Senior Vice President
`The Trout Group LLC
`(646) 378-2923
`bkorb@troutgroup.com
`
`Al Medwar
`Vice President, Marketing and Corporate Development
`BioDelivery Sciences International, Inc.
`919-582-9050
`amedwar@bdsi.com
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