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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its 2012 Annual Report
Date:3/18/2013

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 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 pro
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