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Watson Pharmaceuticals, Inc. Announces Preliminary Results From Phase III Onychomycosis Trials; Second Trial Failed To Demonstrate A Statistically Significant Greater Number Of Complete Cures As Compared To Placebo

Published: Dec 11, 2003

CORONA, Calif., Dec. 10 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today preliminary results from two Phase III trials of its topical anti-fungal therapy for the treatment of onychomycosis, or nail fungus.

(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO )

Two multi-center, double blind, randomized Phase III trials compared the safety, efficacy and tolerability of the topical anti-fungal treatment in 670 patients with toenail onychomycosis. Patients were randomized into one of two treatment groups: topical anti-fungal treatment or placebo. Topical anti-fungal patches were applied to the toenail on a daily basis for 12 months. Patients were evaluated at 6, 12, 15 and 18 months, following the start of treatment.

In one trial, the topical anti-fungal treatment achieved a statistically significant greater number of complete cures, as compared to placebo. Complete cure required success on three parameters: growth of a completely clear nail, negative fungal culture and a potassium hydroxide (KOH) test, negative for the physical presence of fungus. In the second trial, the topical anti-fungal treatment arm failed to demonstrate a statistically significant greater number of complete cures, as compared to placebo. Both trials showed the topical anti-fungal treatment to be well tolerated, with a low incidence of side effects.

Watson plans to complete and review the full data analysis over the next six to eight weeks to determine next steps for the program.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes branded and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.

For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watsonpharm.com/ .

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts about Watson are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, market acceptance of and continued demand for Watson's products, including the impact of competitive products and pricing; patents and other intellectual property rights held by competitors and other third parties; the difficulty of predicting the timing or outcome of product development efforts, results of clinical trials and United States Food and Drug Administration approvals and actions; successful compliance with governmental regulations; and other risks and uncertainties detailed in Watson's Annual Report on Form 10-K for the year ended December 31, 2002 and its Quarterly Report on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2003.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.comWatson Pharmaceuticals, Inc.

CONTACT: Investors, Patty Eisenhaur, +1-909-493-5611, or Media, ChrisEso, +1-909-493-4013, both of Watson Pharmaceuticals, Inc.

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