BioDelivery Sciences International, Inc. in Exclusive Negotiations With
Affiliate of Italy's Sigma-Tau to Formulate New Type of Aspirin
NEWARK, N.J., Feb. 11 /PRNewswire-FirstCall/ -- BioDelivery Sciences
International, Inc. announced today that ithas 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. DATASOURCE: BioDelivery Sciences International, Inc.
CONTACT: Francis E. O'Donnell, Jr., M.D, President and CEO of BioDelivery Sciences International, Inc., +1-973-972-0015, or Leonardo Zangani of L.G.
Zangani, LLC, +1-908-788-9660 Web site: http://www.biodeliverysciences.com/ http://www.zangani.com/
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