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New Analysis of WHI Data Shows Reduced Levels of Coronary Artery,Calcification, a Predictor of Cardiovascular Events, in Women aged,50-59 taking Estrogen Therapy

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.

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.


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