BioDelivery Sciences International, Inc. Announces Proposed Licensing Agreement with Sigma-Tau S.p.A.

NEWARK, N.J. -- BioDelivery Sciences International (Nasdaq:BDSI) announced today it has come to an oral understanding to license to Sigma-Tau S.p.A., the right to utilize BioDelivery's proprietary formulation and delivery technology in connection with different compounds, with particular focus in the area of oncology. Under the terms of the proposed licensing agreement, which is subject to further negotiation and execution, Sigma-Tau would pay to BDSI an initial $250,000 up-front payment, upon the signing of this letter of intent and an additional $750,000 to be paid upon the accomplishment of certain milestones leading to the filing of the first IND of a compound formulated with BioDelivery's formulation and drug delivery technology. It is anticipated that should a final definitive license agreement be executed by the parties, that BioDelivery would receive additional milestone payments throughout the clinical development of each proposed product, as well as royalties on net sales.

BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery nanotechnology designed for a potentially broad base of pharmaceuticals, vaccines, over-the-counter drugs, and nutraceuticals and, through its subsidiary, Bioral Nutrient Delivery, LLC, micronutrients in processed foods and beverages and personal care products.

Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company's results to differ. Factors that may cause such differences include, but are not limited to, the Company's ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company's ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company's need for additional funding, uncertainties regarding the Company's intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results and are detailed in the company's filings with the Securities and Exchange Commission.

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