BioSante Pharmaceuticals Announces Issuance of New Patent Covering Elestrin™ and LibiGel®
LINCOLNSHIRE, Illinois (April 10, 2007) – BioSante Pharmaceuticals, Inc. (Amex: BPA) announced that a new patent has issued covering the formulations used in Elestrin™ (estradiol gel), BioSante’s newly approved treatment for moderate to severe vasomotor symptoms associated with menopause and LibiGel® (testosterone gel), which recently moved into Phase III clinical development for the treatment of female sexual dysfunction. The patent, which issued on April 3, 2007 covering both Elestrin and LibiGel, will expire on June 25, 2022.
“The named inventors of this new patent are from BioSante and Antares, our licensor. BioSante received approval of Elestrin from the U.S. Food and Drug Administration (FDA) in December 2006. In addition, the Elestrin trademark 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. The product will be promoted through Bradley’s Kenwood Therapeutics division.”
Two doses of Elestrin, 12.5 micrograms per day and 37.5 micrograms per day, were approved by the FDA. The 12.5 micrograms dose of Elestrin is the lowest dose of estradiol approved by the FDA for the treatment of moderate-to-severe vasomotor symptoms and is 50 percent lower than the next lowest dose available.
Elestrin is a fast-drying gel formulation of bio-identical estradiol, the same estrogen produced naturally in women. Elestrin is 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 thereby allowing for precise, uniform dosing. The gel dries quickly in one to two minutes.
LibiGel is a gel formulation of bioidentical testosterone designed to be quickly absorbed through the skin after application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
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) in Phase III clinical 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 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.
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Harris D. McKinney, Inc.