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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

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Jun 21, 2007 - BioSante Pharmaceuticals, Inc. (AMEX:BPA) today provided comment on the Women's Health Initiative (WHI) Coronary Artery Calcium Study published yesterday in The New England Journal of Medicine (NEJM). The study found that younger menopausal women (aged 50-59) who received a standard dose of estrogen therapy had significantly less coronary artery calcification at the end of the study period compared with those taking placebo. Coronary artery calcification is a marker of plaque in the arteries and a predictor of future cardiovascular events.

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
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