BDSI Announces Agreement With Aveva Drug Delivery Systems A Key Milestone As BDSI Enters Phase III Trials

MORRISVILLE, N.C.--(BUSINESS WIRE)--Nov. 8, 2005--BioDelivery Sciences International, Inc. (NASDAQ: BDSI, BDSIW), a specialty pharmaceutical company, today announced that it has entered into a supply agreement with Aveva Drug Delivery Systems, Inc. (Aveva) under which Aveva will prepare clinical supplies for BDSI's Phase III trials and provide commercial manufacturing for BEMA(TM) Fentanyl. BDSI's BEMA(TM) Fentanyl is an oral adhesive disc formulation of the narcotic fentanyl. BDSI has been and expects to continue its production ramp-up of the clinical trial materials for Phase III BEMA(TM) Fentanyl trials during the fourth quarter of 2005. BDSI plans on completing its Phase III program during the second half of 2006 for the treatment of "breakthrough" cancer pain (i.e., episodes of severe pain which "breakthrough" the medication used to control the persistent pain).

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