SAN DIEGO, Calif., Sept. 17, 2002 (PRIMEZONE) -- Presenting at Bear Stearns 15th Annual Healthcare Conference in New York today, Women First HealthCare, Inc. (Nasdaq:WFHC) chairman, president and CEO Edward F. Calesa told attendees that the Company's priority is on managing and accelerating the growth of the Company's lead products -- Esclim(tm) (estradiol transdermal system), Vaniqa(r) (eflornithine hydrochloride) Cream, 13.9%, indicated for the reduction of unwanted facial hair in women, and Synalgos(r) DC painpak (drocode (dihydrocodeine) bitartrate, aspirin and caffeine). Calesa reminded attendees that product acquisitions continue to be an important element in the specialty pharmaceutical business model and will still play an important, albeit, secondary role in the Company's overall growth strategy.
In addition, Calesa announced that Esclim(tm), Ortho-Est(r) Tablets (estropipate, USP), an oral estrogen, and Midrin(r) (isometheptene mucate, USP, dichloralphenazone, USP and acetaminophen, USP), a migraine product, have been added to the formulary at Medco Health Solutions, Inc. and are now available to all Medco Plan Sponsors without interventions by Medco. Esclim(tm) is now on formulary at each of the big four pharmacy benefit managers -- AdvancePCS, Caremark, Express Scripts and Medco -- and on the preferred status for three of them. The Medco listing is effective October 1, 2002.
Commenting on the controversy surrounding hormone replacement therapy ("HRT"), Calesa noted, "The new prescription market share of Esclim(tm) has increased by 45% since the Women's Health Initiative ("WHI") combination HRT study was discontinued in early July. Individualization, a key component of our educational Test & Treat program supporting our transdermal strategy, has been reinforced by the authors of the WHI and the American College of Obstetricians and Gynecologists as the centerpiece of HRT therapy. We are encouraged by these early results and expect a continuation in the shift away from the `one size fits all' mentality that has characterized this market for so long."
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. Further information about Women First HealthCare can be found online at www.womenfirst.com, About Us and Investor Relations.
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.
About Vaniqa(r) (eflornithine hydrochloride) Cream, 13.9%
Vaniqa(r) is indicated for the reduction of unwanted facial hair in women. Vaniqa has been shown to retard the rate of hair growth in non-clinical and clinical studies. Vaniqa has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement. In controlled trials, Vaniqa provided clinically meaningful and statistically significant improvement in the reduction of facial hair growth around the lips and under the chin for nearly 60% of women using Vaniqa. Vaniqa is not a hair remover but complements other current methods of hair removal such as electrolysis, shaving, depilatories, waxing, and tweezing. The patient should continue to use hair removal techniques as needed in conjunction with Vaniqa. Improvement in the condition may be noticed within four to eight weeks of starting therapy. Continued treatment may result in further improvement and is necessary to maintain beneficial effects. The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment. The most frequent adverse events related to treatment with Vaniqa were skin-related adverse events.
About Synalgos(r) DC Capsules
Synalgos(r) DC Capsules (drocode (dihydrocodeine) bitartrate, aspirin and caffeine) are indicated for the relief of moderate to moderately severe pain. Salicylates (aspirin) should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities. Dihydrocodeine can produce drug dependence of the codeine type. Synalgos(r) DC should be given with caution to certain patients, such as the elderly or debilitated. The most frequently observed adverse reactions include light-headedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions.
About Ortho-Est(r) Tablets
ORTHO-EST(r) Tablets are approved by the FDA for the treatment of vasomotor menopausal symptoms such as hot flashes and night sweats. The product is additionally approved by the FDA for postmenopausal women for the prevention of osteoporosis.
About Midrin(r)
Midrin(r) is indicated for relief of tension and vascular headaches. Midrin(r) is contraindicated in glaucoma and/or severe cases of renal disease, hypertension, organic heart disease, hepatic disease and in those patients who are on monoamine-oxidase (MAO) inhibitor therapy. Caution should be observed in hypertension, peripheral vascular disease and after recent cardiovascular attacks. Adverse reactions can include transient dizziness and skin rash in hypersensitive patients, which can usually be eliminated by reducing dosage.
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) our products may not achieve or maintain market acceptance for a variety of reasons, including as a result of recent research published by the National Cancer Institute and the National Institutes of Health concerning estrogen replenishment therapy and combination estrogen/progestin hormonal replenishment therapy in healthy menopausal women, respectively; (vi) if we do not successfully manage any growth we experience, we may experience increased expenses without corresponding revenue increases; (vii) we are dependent on single sources of supply for all of the products we offer; (viii) reduced consumer confidence could adversely affect sales by our Consumer Business Division; (ix) our third party suppliers and licensors may terminate their agreements with us earlier than we expect, and as a result we may be unable to continue to market and sell the related pharmaceutical products on an exclusive basis or at all; (x ) we have incurred significant debt obligations which will require us to make debt service payments in the future; and (xi) we may not be successful in our efforts to establish strategic alliances for the sales of our existing products in new markets; (xii) 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 June 30, 2002.