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BioDelivery Sciences Provides Business Update and Summary of Third Quarter Results of Operations
Date:11/8/2012

3.  Additionally, this action will likely assist in expanding healthcare professional and patient interest in film formulations, all of which potentially benefit BNX.  Given the merits of the BEMA drug delivery technology, we believe BNX is particularly well positioned to garner significant market share from Suboxone film.  Our original peak annual sales projection for BNX was near $300 million.  However, based on the apparent removal of the Suboxone tablets, we now anticipate potential BNX peak sales could be in excess of $300 million.  As the events relating to Suboxone unfold and are confirmed, we will be able to better quantify the upside potential this presents for BNX.

Additionally, Reckitt Benckiser issued a Citizens Petition to request that the FDA require all manufacturers of buprenorphine-containing products for the treatment of opioid dependence to implement public health safeguards including child-resistant, unit-dose packaging to reduce the risk of pediatric exposure.  Should the Citizens Petition be upheld by FDA, the entry of generic Suboxone tablets could be further delayed beyond the first half of 2013, creating additional potential upside opportunity for BNX.
  • ONSOLIS/BREAKYL.  BDSI announced the commercial launch of BREAKYL (fentanyl buccal film) in the European Union.  BREAKYL is the brand name in the E.U. of BDSI's FDA approved product ONSOLIS.  BDSI's commercial partner for BREAKYL in the E.U. is Meda.  Under the terms of its E.U. agreement with Meda, BDSI received a final milestone payment in October 2012 of $2.5 million, which will be reflected in BDSI's fourth quarter financials.  BDSI will also receive a royalty on net sales of BREAKYL in the E.U.

    In the U.S., as previously announced, the re-launch timing of ONSOLIS will be determined once we reach agreement with the FDA over our resolution of certain appearance or
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SOURCE BioDelivery Sciences International, Inc.
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3. BioDelivery Sciences Announces Completion of Enrollment in Pivotal Pharmacokinetic Study of BEMA Buprenorphine/Naloxone Compared to Suboxone
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