Healthcare Industry News: transdermal testosterone gel
News Release - May 7, 2007
BioSante Pharmaceuticals Signs Oral Contraceptive License with Pantarhei BioscienceBioSante receives $1.0 million on signing
LINCOLNSHIRE, Ill.--(HSMN NewsFeed)--BioSante Pharmaceuticals, Inc. (Amex: BPA ) today announced that it has signed an exclusive agreement with Pantarhei Bioscience, a Netherlands-based pharmaceutical company for the development and marketing of an oral contraceptive in the United States. BioSante will co-fund the early development of the oral contraceptive up to $1.0 million. Pantarhei will be responsible for all other expenses to develop and market the product.
In addition to the $1.0 million upfront signing fee, 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 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 sign this hormone oral contraceptive license agreement," said Stephen M. Simes, president & CEO of BioSante. "We have known Herjan Coelingh Bennink, the founder and CEO of Pantarhei for many years and we believe this is an excellent company to develop further our issued patents for oral contraceptive uses. This license is another example of how BioSante can increase our product development potential and maximize our assets 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.
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(TM) (estradiol gel), developed through U.S. Food and Drug Administration (FDA) approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and LibiGelŪ (transdermal testosterone gel) in Phase III development 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 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: www.biosantepharma.com.
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: www.pantarheibio.com
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 cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, the success of clinical testing, 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 in BioSante's most recent Forms 10-K and 10-Q, which discussion also is 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.
Source: BioSante Pharmaceuticals
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