SAN DIEGO, Calif., July 10, 2002 (PRIMEZONE) -- The Women First HealthCare, Inc. (Nasdaq:WFHC) Health Advisory Board (HAB) is comprised of opinion leaders and professors in the OB/GYN community. They advise the Company on medical issues relating to women. The Women First HAB today reaffirmed its strong support of the use of estrogen-only therapy for all postmenopausal women who have had a hysterectomy. For women who have not had a hysterectomy, the HAB believes that the use of transdermal estradiol with a progestin is still beneficial for healthy postmenopausal women because estradiol has been shown to prevent the progression of atherosclerosis in women with normal arteries.
The HAB reaffirmation is in response to the announcement yesterday by the National Institutes of Health (NIH) that its National Heart, Lung and Blood Institute (NHLBI) has stopped the Women's Health Initiative (WHI) clinical trial of the risks and benefits of combined estrogen and progestin in healthy menopausal women. NIH/WHI will continue its separate study of unopposed estrogen because there was no indication of increased risk of breast cancer in the estrogen-only group.
Offering perspective on the findings and implications of the WHI trials, Women First HAB member Daniel R. Mishell, Jr., MD, Professor and Chairman, Department of OB/GYN, Keck School of Medicine at the University of Southern California, stressed, "the WHI study was discontinued because of increased breast cancer risk with combination oral estrogen/progestin therapy. However, in the same study there was no increased risk of breast cancer in women taking estrogen alone. In addition, the authors of the WHI study said that these results do not necessarily apply to estrogens and progestins administered through the transdermal route. The authors furthermore stated that it is possible transdermal estradiol with progesterone, which more closely mimics the normal physiology and metabolism of endogenous sex hormones, may provide a different risk/benefit profile." Dr. Mishell also notes the WHI study reaffirmed estrogen reduces the rate of fractures in the hip and vertebral column and reduces colorectal cancer. In addition, strong observational data shows estrogen reduces the risk of women developing Alzheimer's Disease.
Fellow HAB member, Leon Speroff, MD, Professor, Department of OB/GYN, Oregon Health & Science University, additionally noted, "the average age of participants in the WHI estrogen/progestin trial is 63. A significant number of participants, because of their age, already had existing atherosclerosis, and we are increasingly aware that the beneficial effects of hormone therapy on the cardiovascular system are progressively diminished with increasing atherosclerosis."
Nathan Kase, MD, Chairman of the HAB, and Professor, Department of OB/GYN and Reproductive Science, and Interim Dean of the Mount Sinai School of Medicine, believes the educational concept "Test and Treat" is an effective way to manage patients, particularly in light of these recent findings. "This concept suggests starting patients on transdermal estrogen and titrating the dose so each woman has the least amount of estrogen that is effective for her particular needs. The estrogen patch allows for measuring the actual estrogen in the blood, which would be very difficult to do with oral estrogen. By retesting once each year, the clinician and patient can discuss any new studies or issues that affect continuation for a particular patient."
Responding to the NIH news, Women First chairman, president and CEO, Edward F. Calesa, said, "We support good medical practice as learned from our HAB and the estrogen products that we provide -- Esclim(tm) transdermal estrogen and ORTHO-EST(r) Tablets, an oral estrogen. Most importantly, we support the concept of individualizing therapy for each woman. We are pleased that the estrogen-only segment of the study will be continued and hope that more women will benefit from learning that estrogen alone has not been found to cause breast cancer."
Women First HealthCare, Inc. (Nasdaq:WFHC) is a San Diego-based specialty pharmaceutical company. Founded in 1996, its mission is to help midlife women make informed choices regarding their health care and to provide pharmaceutical products -- the Company's primary emphasis -- and lifestyle products to meet their needs. Women First HealthCare is specifically targeted to women age 40+ and their clinicians. Further information about Women First HealthCare can be found online at www.womenfirst.com, About Us and Investor Relations.
This press release may contain certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to various risks, and Women First HealthCare, Inc. cautions you that any forward-looking information is not a guarantee of future performance. Women First HealthCare, Inc. disclaims any intent or obligation to update these forward-looking statements. Actual results could differ materially due to a number of factors, including (i) we have incurred significant losses since we were founded in November 1996, and if midlife women do not use, and their clinicians do not recommend, the products we offer, we will experience losses in the future; (ii) there is a limited market awareness of our Company and the products and services we offer; (iii) we may not be able to identify appropriate acquisition, licensing, or co-promotion candidates in the future or to take advantage of the opportunities we identify; (iv) we and our products face significant competition; (v) if we do not successfully manage any growth we experience, we may experience increased expenses without corresponding revenue increases; (vi) we are dependent on single sources of supply for all of the products we offer; (vii) reduced consumer confidence could adversely affect sales by our Consumer Business Division; (viii) we have incurred significant debt obligations which will require us to make debt service payments in the future; and (ix) additional factors set forth in the Company's Securities and Exchange Commission filings including its Annual Report on Form 10-K for the period ended December 31, 2001 and its Form 10-Q for the period ended March 31, 2002.