BDSI secures US commercial partnership for BEMA Fentanyl wi...( MORRISVILLE N.C.--(BUSINESS WIRE) Se...),Health

MORRISVILLE, N.C.--(BUSINESS WIRE) September 5, 2007 BioDelivery Sciences International, Inc. (Nasdaq: BDSI) has entered into an exclusive and perpetual license and related supply agreement with Meda for the U.S., Canadian and Mexican commercialization rights to BDSIs flagship BEMATM Fentanyl product for the treatment of breakthrough cancer pain. Under this agreement, Meda will be responsible for the marketing and distribution of BEMA Fentanyl in the U.S., whose launch is anticipated in late 2008. In addition, Meda will be responsible for the management of the post-NDA approval clinical development program.

Financial Aspects of the Partnership:

• 1st milestone: $30 million upon closing which is contingent upon antitrust approval by the Federal Trade Commission, which typically occurs within 30 days of filing.

• 2nd milestone: $30 million upon receipt of FDA approval, which is anticipated in late 2008.

• Royalty: BDSI to receive a significant double digit royalty on net sales. Guaranteed minimum annual royalties, based on low sales, exist during the first 7 years.

• Sales milestones: A total of $30 million payable at:
  • $10 million when annualized sales exceeds $75 million
  • $10 million when annualized sales exceeds $125 million
  • $10 million when annualized sales exceeds $175 million
• A gross margin above 70% is secured for Meda.

BEMA Fentanyl consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal (inner lining of cheek) membranes. BEMA Fentanyl has shown in clinical studies important patient advantages compared to competing products, especially fewer side effects. According to published results, the two currently largest competing fentanyl products in the U.S. with the same indication had combined sales of nearly $700 million in 2006 and grew by approximately 60% versus 2005.