SAN DIEGO, Dec. 17, 2001 (PRIMEZONE) -- Women First HealthCare, Inc. (Nasdaq:WFHC) today announced that it has successfully completed another corporate milestone by meeting and exceeding projected patient enrollment objectives associated with its Phase IV patient satisfaction research study of Esclim(tm), the Company's estrogen transdermal patch system. The study involves 182 physicians and a heterogeneous, nationwide sampling of 903 postmenopausal women undergoing hormone replenishment therapy. The patient goal was 750 patients.
Results of the Phase IV study evaluating the use, comfort and overall satisfaction of the Esclim(tm) patch as compared with treatment, if any, patient enrollees had used in the past, will be available during the first quarter of 2002. Research data collected will assess women's preferred patch application site, comfort and stretchability during physical exercise and sexual activity, adhesion during bathing or showering, and whether or not wearing a patch influences women's other activities. Importantly, the study will also assess whether or not women feel self-conscious wearing a patch.
Commenting on the study, Saundra L. Childs, Women First Vice President - Pharmaceuticals, said, "We are very pleased with the level of physician and patient participation in our Esclim(tm) study and look forward to learning even more about women's preferences and experiences with our product. Approved in 20 countries and the leading estrogen transdermal patch in France, Esclim(tm) continues to achieve high acceptance while demonstrating a very low incidence of skin irritation, which can be a problem in some patients using estrogen patches. We expect the research data collected from our Phase IV study will position our product even more favorably within the $250 million U.S. estrogen patch market and will continue to exemplify the benefits of Esclim's(tm) maximum dosage flexibility, excellent bioadhesive properties and good skin tolerance."
Women First markets Esclim(tm) exclusively in the U.S. under a distribution and licensing agreement with Laboratoires Fournier S.A. of France. Women First's distribution platform for Esclim(tm) includes Novation, the largest supply cost management company in health care managing more than $17 billion in annual purchases for its members, and AdvancePCS, the nation's largest independent provider of health improvement services, serving more than 75 million health plan members and managing more than $21 billion in annual prescription drug spending. AdvancePCS will additionally feature Esclim(tm) on its highest priority Performance Drug List (PDL) effective January 1, 2002.
Esclim(tm) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of vasomotor menopausal symptoms such as hot flashes and night sweats. Its active ingredient is estradiol, the principal form of estrogen produced naturally by a woman's ovaries during the reproductive years. The Esclim(tm) transdermal patch system offers maximum dosing flexibility with five dosage options (0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day) and is applied twice weekly. Esclim(tm) provides a unique ethylene vinyl acetate (EVA) matrix system with flexible foam backing to assure suppleness that follows the movements of a woman's skin.
About Women First HealthCare, Inc.
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. An internationally recognized Health Advisory Board of experts in women's health guides Women First HealthCare in the development of information and products for women and clinicians as women transition from perimenopause through postmenopause. The Company operates in three segments: Pharmaceuticals, Consumer Business and Corporate Marketing. Product focus currently includes estrogen replenishment, headache/pain management, antibacterial/urinary tract infection management, dietary supplementation and self-care/lifestyle. Further information about Women First HealthCare can be found online at www.womenfirst.com, About Us and Investor Relations. Information about the Company's As We Change(r) national mail order catalog and Internet retailer can also be found online at www.aswechange.com.
About Esclim(tm)
Esclim(tm) (estradiol transdermal system) is indicated for the relief of moderate to severe vasomotor symptoms associated with menopause. The most commonly reported side effects of Esclim(tm) are those typical of estrogen replenishment therapy: breast tenderness, headache, nausea and abdominal pain. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women. Estrogens are contraindicated in patients with known or suspected pregnancy, undiagnosed abnormal genital bleeding, known or suspected breast cancer, known or suspected estrogen-dependent neoplasia, or active thrombophlebitis or thromboembolic disorders. For more information about this product and to see the package insert, please visit www.womenfirst.com, Rx Products area.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: 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 continue to experience losses; (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 licensing, co-promotion or acquisition 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; and (viii) 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, 2000 and its Form 10-Q for the period ended September 30, 2001.