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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product -- Ignore unavailable to you. Want to Upgrade?

To: Doug Bean who wrote (622)	2/23/1998 11:24:00 AM
From: art slott	Respond to of 1837

Stocks IPO Corner Internet News Mergers/Acquisitions News by Industry News Search Mutual Funds Zacks Duramed Pharmaceuticals Completes Clinical Program Evaluating Synthetic Conjugated Estrogens in Postmenopausal Women PR Newswire - February 23, 1998 10:35 DRMD %MTC V%PRN P%PRN Satisfactory Completion Constitutes Basis for Filing New Drug Application NDA Filing Scheduled For March 1998 CINCINNATI, Feb. 23 /PRNewswire/ -- Duramed Pharmaceuticals, Inc. (Nasdaq: DRMD), moving forward in its bid to bring synthetic conjugated estrogens to the U.S. market, today announced the successful completion of a multi-center, double-blind, placebo-controlled trial to evaluate its drug in the treatment of postmenopausal vasomotor symptoms in women. This pivotal trial provides Duramed with the clinical data that constitutes the basis for the filing of a New Drug Application (NDA) with the Food and Drug Administration (FDA). The company anticipates filing the NDA in March 1998. Clinical Results The company believes that the results from the clinical trial were statistically significant in the reduction of hot flashes and other vasomotor symptoms in postmenopausal women. E. Thomas Arington, chairman and chief executive officer stated, "Duramed continues to focus on developing hormone replacement products, and today's announcement is a major step in bringing this new synthetic conjugated estrogens drug product to market." "The company plans to conduct additional clinical trials to evaluate its synthetic conjugated estrogens product for other postmenopausal therapeutic indications," added Arington. New Drug Application Arington added, "We are in the final stages of assembly of the New Drug Application for this product, and expect to file the application with the FDA by the end of March 1998. This will mark Duramed's first NDA filing and entry into the branded drug market." "We recognize a significant opportunity exists for a conjugated estrogens product which is synthesized from a plant source. Duramed is well positioned to respond to this opportunity with its proven product technology and its containment manufacturing capability. When authorized by the FDA, our product will provide an alternative therapy for millions of postmenopausal women." Product Strategy Mr. Arington noted Duramed continues to aggressively pursue and invest in its research and development program. "Duramed has made the conscious commitment to seek product opportunities with high margin potential and limited competition. We have invested heavily in this program, and we believe results will begin to become evident during 1998 and beyond. Today's clinical trial results represent a significant milestone in the execution of our overall strategy. "We received five Abbreviated New Drug Application (ANDA) product approvals in 1997, including Estradiol, which is the first Duramed developed and manufactured hormone replacement therapy product," Arington said. "We have a growing commitment to product development and we expect both filings and approvals in 1998 to exceed 1997 levels. Our focus has been and will continue to be in hormonal products and controlled release technology." In conclusion, Arington stated, "Duramed is executing its business plan and expects to return to profitability later in 1998." About the Company Duramed Pharmaceuticals, Inc. currently develops, manufactures and markets generic prescription drug products. The company's product development program is focused on hormonal therapies and controlled release technology. As of February 1998, the company had 9 Abbreviated New Drug Applications filed with the Food and Drug Administration and an active product development pipeline with several new filings anticipated in 1998. The Company's common stock is traded on Nasdaq under the symbol DRMD. Additional information on the company can be found on the World Wide Web at duramed.com. 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 10-K. SOURCE Duramed Pharmaceuticals, Inc. /CONTACT: Investor Relations of Duramed Pharmaceuticals, 513-731-9900, or Media, Ellen Knight or Julie Harrison of Dan Pinger Public Relations, 513-564-0700/ /Web site: duramed.com (DRMD) Enter Stock Symbols (eg: IBM, T, GM) or Company Name. Search for: Text SearchTicker Search text examples: "General Motors", bio technology and venture, yen