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BioSante Pharmaceuticals Announces Oral Contraceptive Phase II Study Initiation

LINCOLNSHIRE, Illinois (June 19, 2007) – BioSante Pharmaceuticals, Inc. (AMEX: BPA) today announced that it and Pantarhei Bioscience B.V., a Netherlands-based pharmaceutical company have initiated a Phase II human clinical trial of a new oral contraceptive. BioSante will co-fund the development of the oral contraceptive up to $1.0 million. Pantarhei will be responsible for all additional expenses to develop and market the product.

The Phase II study, being conducted in the Netherlands, will enroll approximately 72 women in a double-blind, placebo controlled, randomised, comparative 2-way crossover study to determine the effect of a new patented oral contraceptive on sexual arousability and the vascular component of the sexual arousal response in women. Results should be available by year-end 2008.

BioSante licensed U.S. rights to the new oral contraceptive to Pantarhei earlier this year. Under the license agreement, BioSante received $1.0 million in an upfront signing fee and BioSante may receive certain development and regulatory milestones for the first product developed under the license. In addition, BioSante will receive royalty payments on sales of the product in the U.S., if and when approved and marketed. If the product is sublicensed by Pantarhei to another company BioSante will receive a percentage of any and all payments received by Pantarhei for the sublicense from a third party. BioSante has retained all rights under the BioSante-licensed patents to the transdermal delivery of triple hormone contraceptives.

“We are excited to initiate this oral contraceptive clinical trial,” said Stephen M. Simes, president & CEO of BioSante. “This license agreement with Pantarhei and initiation of this Phase II clinical trial are additional examples of how BioSante can expand our pipeline of products under development while carefully controlling our own expenses,” Simes continued.

The oral contraceptive market in the U.S. was approximately $3.0 billion in sales in 2006, with about 12 million women in the U.S. using hormonal contraception, approximately 25 percent of sexually active women. Paradoxically, many women who use oral contraceptives have reduced sexual desire, arousabilty and activity. This new oral contraceptive is designed to improve the condition known as female sexual dysfunction in oral contraceptive users, among other potential benefits

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 bio-identical estradiol and testosterone. BioSante’s lead products include Elestrin (estradiol gel) developed through FDA approval by BioSante indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, marketed in the U.S. by Bradley Pharmaceuticals, Inc., BioSante’s licensee, and LibiGel® (transdermal testosterone gel) in Phase III development by BioSante for the treatment of female sexual dysfunction (FSD).

Also in development is Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3.0 billion. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including hepatitis B, avian flu and biodefense vaccines for toxins such as anthrax, as well as a system for delivering drugs via alternative routes of administration. Additional information is available online at

About Pantarhei Bioscience B.V.

Pantarhei Bioscience B.V. is a bioscience company located in Zeist, the Netherlands. It employs nine persons with an extensive track record in the pharmaceutical industry. Pantarhei develops in the clinic, patent protected new medical uses of existing molecules (hormones, biologicals and approved drugs) for gender related diseases. Pantarhei operates in a close to virtual set-up with the objective to obtain patent protection of concepts and demonstrate proof of concept in the human. For development and commercialization into the next phases, Pantarhei will generally seek partnerships with pharmaceutical companies. 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 news release that are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,” “likely,” “expects,” “anticipates,” “estimates,” “believes,” “plans,” “hopes,” 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 could cause actual results to differ materially from those expressed in such forward-looking statements include the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante’s filings with the Securities and Exchange Commission, including those factors discussed in BioSante’s most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which discussions also are incorporated herein by reference. All forward-looking statements speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.


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