News Releases

 

BioSante Pharmaceuticals Announces Notice of Allowance of Elestrin™ Patent by U.S. Patent & Trademark Office

LINCOLNSHIRE, Illinois (February 7, 2007) – BioSante Pharmaceuticals, Inc. (Amex: BPA) announced that a notice of allowance from the United States Patent & Trademark Office (USPTO) has been received covering the formulation used in Elestrin™ (estradiol gel), BioSante’s newly approved treatment for menopausal women. The notice of allowance is the official communication issued by the USPTO reporting that the application has successfully completed examination and that a patent will be issued after the applicant pays the necessary fee. This new patent will expire on June 23, 2021.

“The named inventors on this new patent include personnel of both BioSante and Antares, our licensor. BioSante received FDA approval of Elestrin in December 2006 for the treatment of vasomotor symptoms in menopausal women. In addition, the Elestrin trademark under which the product will be sold is owned by BioSante,” said Stephen M. Simes, president and chief executive officer of BioSante. “We look forward to the launch of Elestrin mid-year 2007 by Bradley Pharmaceuticals, Inc., BioSante’s marketing licensee.”

Two doses of Elestrin, 0.87 grams per day and 1.7 grams per day, were approved by the FDA. Elestrin 0.87 grams per day is the lowest dose of estradiol approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe vasomotor symptoms.

About Elestrin™

Elestrin is a fast-drying gel formulation of bio-identical estradiol, the same estrogen produced naturally in women. Elestrin was developed to be absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner. Elestrin is administered using a metered dose applicator that delivers 0.87 grams of gel per actuation, thereby allowing for precise titration from dose to dose. The gel dries quickly in one to two minutes.

About Estrogens

Estrogen products today are approved for the treatment of menopausal symptoms, including hot flashes. Estrogen products are not approved for and should not be used for the treatment or prevention of heart disease, breast cancer or dementia. The Women’s Health Initiative (WHI) study reported increased risk of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with 0.625 mg of oral conjugated equine estrogens alone per day, relative to placebo. The WHI study reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during five years of daily treatment with 0.625 mg of oral conjugated equine estrogens combined with 2.5 mg of medroxyprogesterone acetate per day.

Although studies involving hormone use and breast cancer risk have produced varied results, newly reported estrogen-only data provide strong evidence that estrogen alone does not increase the risk of breast cancer, and in fact may decrease the risk. The North American Menopause Society (NAMS), the American College of Obstetricians and Gynecologists and the FDA all recommend women use the lowest effective dose of estradiol for the shortest period of time.

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, and LibiGel® (transdermal 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. 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.

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, 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. Additional risk factors include the risk that Elestrin may not be successfully marketed. 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.

###

For more information please contact:

For Media:
Harris D. McKinney, Inc.
Alan Zachary
(312) 506-5220
azachary@harrisdmckinney.com