New Analysis of WHI Data Shows Reduced Levels of Coronary Artery Calcification, in Women aged 50-59 taking Estrogen Therapy, a Predictor of Cardiovascular Events
LINCOLNSHIRE, Illinois (June 21, 2007) – BioSante Pharmaceuticals, Inc. (AMEX: BPA) today provides comment on the Women’s Health Initiative (WHI) Coronary Artery Calcium Study published today 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 younger population of menopausal women, estrogen therapy is shown to be not only safe, but from a cardiovascular standpoint actually prove to be protective,” said Stephen M. Simes, president & CEO of BioSante. “These data should aid in the decision process in newly menopausal women seeking treatment for their symptoms,” Simes continued.
The authors conclude, “Hormone therapy should not be initiated (or continued) for the express purpose of preventing cardiovascular disease in either younger or older postmenopausal women.” The authors further 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.”
Elestrin, developed by Biosante and marketed by Bradley Pharmaceuticals (NYSE: BDY) provides the lowest dose of estradiol for the treatment of hot flashes, currently available.
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® (transdermal testosterone gel) in Phase III development by BioSante for the treatment of female sexual dysfunction (FSD).
Also in development is Bio-T-Gel™, 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.
About Pantarhei Bioscience B.V.
Pantarhei Bioscience B.V. is a bioscience company located in Zeist, the Netherlands. It employs nine persons with an extensive track record in the pharmaceutical industry. Pantarhei develops in the clinic, patent protected new medical uses of existing molecules (hormones, biologicals and approved drugs) for gender related diseases. Pantarhei operates in a close to virtual set-up with the objective to obtain patent protection of concepts and demonstrate proof of concept in the human. For development and commercialization into the next phases, Pantarhei will generally seek partnerships with pharmaceutical companies. Additional information is available online at www.pantarheibio.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 cause 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.
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