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Atrisone (Dapsone Topical Gel) Effective for Treatment of Acne

FORT COLLINS, CO -- March 29 -- The first Phase III study of Atrisone™ (dapsone topical gel; Atrix Laboratories, Inc.) for the treatment of acne found the drug to be statistically superior to vehicle on all four primary efficacy end points and both secondary efficacy end points.

"Based on the results of this initial Phase III study, Atrisone appears to be safe and clinically effective for the management of acne," said Dr. Stephen Warren, Atrix's vice president of research and development. "We have surpassed our study objectives by achieving superiority on all six endpoints."

"Of particular significance, he said, "the product appeared to be effective at reducing inflammatory lesions, often associated with the more severe cases of acne. We now plan to move forward with the second Phase III clinical trial."

This first Phase III trial was a 500 patient, multi-center, double blind, vehicle controlled study. Atrisone, dapsone 5% twice-a-day in Atrix's proprietary SMP™ topical drug delivery technology, was found to be clinically and statistically superior to vehicle (SMP alone) in all four pre-established primary efficacy endpoints: reduction in inflammatory lesion count, reduction in non-inflammatory lesion count, reduction in overall lesion count, and improvement of overall appearance (so-called "global assessment").

Atrisone was also superior in two secondary endpoints: lesion count change from baseline and percent change from baseline.

"The study data indicates we may have another major near-term revenue opportunity in Atrisone," said David R. Bethune, chairman and chief executive officer at Atrix. "These results put Atrix one step closer to building a multiple products earnings company."

Dapsone, the active compound in Atrisone, is a potent antibiotic with independent anti-inflammatory activity. Dapsone is highly lipophilic and previously has only been commercially available as an oral tablet. The Atrix SMP technology provides a platform for highly water-insoluble drugs, such as dapsone, to be delivered topically, right at the site of disease. This proprietary technology is one of three topical drug delivery systems developed by Atrix's scientists.

"We were pleased with the rapid progress and superior results of this first Atrisone clinical trial," said Hideo Fukumoto, president and chief executive officer of Fujisawa Healthcare Inc. "We believe Atrisone, with its targeted delivery of a potent antibiotic and anti-inflammatory compound right at the site of the lesion, could provide both patients and physicians with an important option in the treatment of this prevalent condition."

In an agreement signed in October 2001, Atrix licensed the exclusive North American marketing and distribution rights for Atrisone™ to Fujisawa Healthcare, Inc., a subsidiary of Fujisawa Pharmaceutical Co., Ltd., a leading global developer and marketer of dermatological and other proprietary pharmaceutical products.

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