News Releases


BioSante Pharmaceuticals Signs License Option Agreement with European Pharmaceutical Company

Deal Potentially Worth More Than $10 Million in Upfront, Maintenance, Milestone and Royalty Payments

Lincolnshire, Illinois (September 14, 2005) – BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced that it has signed a Material Transfer and Option Agreement with an undisclosed European pharmaceutical company for an exclusive option to obtain an exclusive, worldwide license to use BioSante‰s calcium phosphate nanotechnology (CaP) in the development of a series of allergy products. The partner company will fund its development of potential products for the treatment of conditions including rhinitis, asthma, conjunctivitis, dermatitis, and allergic gastrointestinal diseases.

Under the terms of the option agreement, BioSante will receive a $250,000 upfront option payment. If the option is exercised and the parties enter into an exclusive license agreement, BioSante will receive a one-time license fee, annual maintenance payments, milestone payments upon the achievement of regulatory milestones and royalties on commercial sales of any allergy product that is developed using CaP. The various payments may total up to $10 million or more, assuming at least three products are developed.

“The U.S. anti-allergy medication market is expected to exceed $10 billion by 2010, and it is estimated that up to 25 percent of the U.S. population suffers from at least one allergy,” said Stephen M. Simes, president and chief executive officer of BioSante. “This agreement is very exciting for BioSante, as it acknowledges a new potential use for CaP within this growing market.”

During the evaluation period, the European company will evaluate CaP‰s ability to improve current allergy products. The European company may exercise its option to enter into an exclusive license for the use of CaP in allergy products at any time but must exercise no later than within 60 days of the end of the 22-month evaluation period.

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bioidentical estradiol and testosterone. BioSante‰s lead products include Bio-E-Gel® (bioidentical estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel® (bioidentical testosterone gel) for the treatment of female sexual dysfunction (FSD).

The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion. The transdermal gel formulations used in the women’s gel products are licensed by BioSante from Antares Pharma Inc. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems. Additional information is available online at

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this press release that are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,” “likely,” “expects,” “anticipates,” “estimates,” “believes” or “plans,” or comparable terminology, are forward-looking statements.

Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, and other factors identified and discussed from time to time in BioSante’s filings with the Securities and Exchange Commission, including those factors discussed on pages 18 to 25 of BioSante’s Form 10-KSB, which discussion also is incorporated herein by reference.


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