These findings are consistent with a recent re-analysis of pooled estrogen alone and estrogen plus progestin data from the WHI study, published April 4, 2007, in the Journal of the American Medical Association (JAMA). This study found no apparent increase in coronary heart disease for women who initiated hormone therapy within 10 years of menopause; and a statistically significant reduction in total mortality among women aged 50-59 in the group receiving hormone therapy compared with those in the placebo group.
"Recent analysis of the data from the WHI study have consistently clarified the initial data, to show that in the newly diagnosed population of menopausal women, estrogen therapy does not increase cardiovascular disease and that there actually is a statistically significant reduction in total mortality among women 50-59 in the group receiving hormone therapy compared with those in the placebo group," said Stephen M. Simes, president & CEO of BioSante. "These data should aid women in their consideration of hormone therapy," Simes continued.
The authors state, "The current recommendations from many organizations that hormone therapy be limited to the treatment of moderate to severe menopausal symptoms, with the lowest effective dose used for the shortest duration necessary, remain appropriate." The aut hors conclude, "Hormone therapy should not be initiated (or continued) for the express purpose of preventing cardiovascular disease in either younger or older postmenopausal women."
Elestrin(TM), developed by BioSante and marketed by Bradley Pharmaceuticals (NYSE:BDY) provides the lowest dose of estradiol currently available for the treatment of hot flashes. Elestrin is an effective, ultra-low dose transdermal estrogen therapy that was approved by the U.S. Food and Drug Administration (FDA) in December 2006 for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.
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, marketed in the U.S. by Bradley Pharmaceuticals, Inc., BioSante's licensee, and LibiGel(R) (transdermal testosterone gel) in Phase III development by BioSante for the treatment of female sexual dysfunction (FSD). Also in development is Bio-T-Gel(TM), 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 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 could c ause 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.
BioSante Pharmaceuticals, Inc.
Phillip B. Donenberg, CFO
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