Cenestin, the New Plant-Derived Synthetic Complex Mixture Conjugated Estrogens, Approved for Marketing by FDA.

CINCINNATI--(BUSINESS WIRE)--March 25, 1999--

Gives Freedom of Choice to Menopausal Women and Baby Boomers

Now Entering Menopause Seeking the Benefits of

Conjugated Estrogens Replacement Therapy

Duramed Pharmaceuticals, Inc. (Nasdaq:DRMD) today announced that the United States Food and Drug Administration (FDA) has granted the company approval to market Cenestin(TM) (synthetic conjugated estrogens, A) Tablets, the new plant-derived synthetic complex mixture conjugated estrogens product for the treatment of hot flashes, night sweats and other moderate-to-severe vasomotor symptoms associated with menopause. Cenestin, synthesized 100% from soy and yam plants, will be available by prescription within 90 days in two dosage strengths -- 0.625 mg and 0.9 mg.

According to Duramed Chairman and Chief Executive Officer E. Thomas Arington, "With the approval of Cenestin, millions of menopausal women, along with the millions more Baby Boomers soon to enter menopause, will have a new plant-derived choice in conjugated estrogens products for the treatment of vasomotor symptoms associated with menopause, such as hot flashes and night sweats."

For the past 56 years, the only complex mixture conjugated estrogens product women could choose has been one derived from pregnant mares' urine.

Dr. Florence Comite, founder, Women's Health at Yale and Associate Clinical Professor, Yale University School of Medicine said, "Women today are approaching menopause as a natural transition. They have a great deal of information and seek to make decisions that are affecting their bodies in partnership with their physicians. They like to better understand why they are taking a prescription and the source of the medication. Having a new plant-derived estrogen allows the physician the ability to tailor the specific medication to the individual woman's preference."

Estrogen Replacement Therapy (ERT)/Hormone Replacement Therapy (HRT) Market Growth Outlook Driven by Baby Boomers

The average age of American women at menopause is 51. According to the American College of Obstetricians and Gynecologists (ACOG), the first wave of Baby Boomer women (born 1945-1960) are now entering menopause and another 20 million more will reach menopause in the next decade. Currently, over 40 million women in the U.S. are over 50 and eligible to take either ERT (estrogen only) or HRT (estrogen with a progestin).

The combined ERT/HRT market is over $2 billion in the U.S. alone with a projected growth rate of 15% according to NDC Health Information Services, a Phoenix-based pharmaceutical market data provider.

Cenestin Clinical Trials

Cenestin was shown to be safe and effective in a double-blind, placebo-controlled, randomized twelve-week clinical trial of 120 women, chosen with minimal restriction to race, maximum weight and time into menopause. Cenestin was well tolerated. The most frequently reported adverse events were headache and insomnia, which occurred with similar frequency in the placebo group. There was a statistically significant reduction in the number of moderate-to-severe hot flashes at four weeks in the Cenestin group versus the placebo group.

Risks and Precautions

The risks and precautions associated with all ERT products include:

- ERT should not be administered during known or suspected

pregnancy. There is an increased risk of endometrial cancer

connected with ERT. In women with an intact uterus, ERT should be

accompanied by administration of progestin to decrease this risk.

- ERT should not be administered to women diagnosed with, or at

significant risk of, certain cardiovascular disorders.

- ERT should not be administered to women presenting undiagnosed

genital bleeding or estrogen dependent neoplasia.

- ERT should not be administered to women with known or suspected

cancer of the breast.

Duramed Pursuing Market Leadership in Women's Health Through a Family of Hormone Products

Cenestin is the first brand product for which Duramed has received FDA approval and its launch is the first step in Duramed's long-term program to build a family of hormone products. Arington commented, "Duramed is focused on a product development plan designed to make the company a leader in women's healthcare and the hormone replacement therapy market. The approval of Cenestin for the treatment of vasomotor symptoms is a significant step toward that objective. Based on our assessment of the $1.4 billion U.S. ERT market, we believe Cenestin has the potential to become a market leader. With the first plant-derived synthetic complex mixture conjugated estrogens and a focused and aggressive marketing plan, our goal is to achieve an annualized sales rate for Cenestin in excess of $100 million within 15-18 months after the product is launched."

Duramed recently filed an Investigational New Drug (IND) application with the FDA to study the effects of medroxyprogesterone acetate (MPA) administered cyclically in combination with Cenestin.

Duramed anticipates initiating the related Phase III clinical trials in the coming months and filing the NDA upon completion of those trials. The company will be initiating a clinical program to evaluate Cenestin in additional dosage strengths and for the treatment of osteoporosis. Further, the company has three Abbreviated New Drug Applications (ANDAs) for hormone products currently pending with the FDA and an active product development pipeline.

About the Company

Duramed Pharmaceuticals develops, manufactures and markets prescription drug products. The company's business strategy emphasizes products with attractive market opportunities and potentially limited competition due to technological barriers to entry, focusing on women's health and the hormone replacement therapy market.

Duramed's containment manufacturing facilities for the production of hormones with enclosed product flow and state-of-the-art environmental controls ensures purity, stability and precise tablet uniformity for Cenestin and other hormone products. While Duramed's primary focus will be solid oral dose hormones, the company's other areas of concentration controlled release technology and oncology continue to represent attractive market opportunities that will be pursued, as appropriate.

The company's stock is traded on Nasdaq using the symbol DRMD. Additional information about the company can be found on the World Wide Web at www.duramed.com

For more information, please see full prescribing information available upon request.

The Securities and Exchange Commission (SEC) encourages companies to disclose forward-looking information so that investors can better understand a company's future prospects and make informed investment decisions. Due to changing market conditions, product competition, the nature of product development and regulatory approval processes, the achievement of forward-looking statements contained in this press release are subject to risks and uncertainties. For further details and a discussion of these risks and uncertainties, see Duramed's SEC filings, including its annual report on Form 1O-K.