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BioDelivery Sciences International (BDSIU) In Exclusive Negotiations With Affiliate Of Italy's Sigma-Tau Finanziaria S.p.A. To Formulate New Type Of Aspirin


10/19/2005 5:09:59 PM

NEWARK, N.J., Feb. 11 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. announced today that it has entered into exclusive negotiations with Defiante Farmaceutica LDA, a wholly-owned subsidiary of Sigma-Tau Finanziaria S.p.A. of Rome, Italy, one of Italy's leading pharmaceutical groups, regarding a potential intellectual property license. It is the intention of the parties that such license would allow Defiante Farmaceutica to incorporate BDSI's Biroal(TM) drug delivery technology into a new formulation of aspirin for use in humans. Sigma-Tau group, through Defiante, is currently a stockholder of BDSI.

Dr. Raphael Mannino, Executive Vice-President and Chief Scientific Officer of BDSI, said, "Aspirin is certainly a widely used pharmaceutical, and a potential license with a well established pharmaceutical group like Sigma-Tau gives us evidence to back up our belief that aspirin cochleates represent a potentially important advance with significant market potential, both in the U.S. and abroad." The potential benefits of aspirin cochleates, including data showing substantially reduced gastrointestinal side effects and significantly improved efficacy, were presented in September 2003 at the "Inflammatory Processes in Drug Delivery" meeting in Philadelphia.

The Bioral(TM) delivery technology consists of cochleates, which are crystalline delivery vehicles made from all-natural components: soy-derived phospholipid and calcium. The cochleates wrap around the cargo pharmaceutical (in this case aspirin) like a shell and have been demonstrated in an established animal model of acute inflammation to allow the cargo pharmaceutical to be delivered into the body safely and more effectively than without the cochleate coating. The Bioral(TM) delivery technology is potentially simple, inexpensive and commercially scalable.

Pursuant to their understanding, BDSI and Defiante Farmaceutica will negotiate exclusively towards entering into a license agreement (either for an exclusive or non exclusive world wide license, depending upon the terms negotiated between the parties) to develop, manufacture, promote, distribute, sell and sublicense products containing the aspirin cochleates for all applications. The term of the exclusivity period ends on July 31, 2004. In the event the parties fail to reach a mutually satisfactory license agreement by such date, BDSI will be able to negotiate with other potential licensees for the aspirin application of its technology. As part of the agreement, Defiante has agreed to bear all expenses of evaluating BDSI's technology for the proposed application.

BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology 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.

L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.

BioDelivery Sciences International, Inc.

CONTACT: Francis E. O'Donnell, Jr., M.D, President and CEO of BioDeliverySciences International, Inc., +1-973-972-0015, or Leonardo Zangani of L.G.Zangani, LLC, +1-908-788-9660


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