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FDA aproves Finacea for topical treatment of rosacea

MONTVILLE, N.J., Jan. 2, 2003 -- Berlex Laboratories, the U.S. affiliate of Schering AG, Germany, announced that the FDA has approved Finacea (azelaic acid) Gel 15 percent for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Finacea is the first new therapeutic option to be approved for the treatment of rosacea in more than a decade.

Results of two multi-center, randomized, double blind, Phase III studies involving 664 patients showed that Finacea had a significantly greater efficacy than its vehicle in reducing the number of inflammatory papules and pustules associated with rosacea. Significant treatment effects were discernible as early as four weeks and progressive improvement continued to be shown week after week in the two 12-week studies. These findings were included in the New Drug Application (NDA) filed with the FDA in March 2002. Both protocols were identical.

"Prior to the FDA approval of Finacea, Rosacea patients had waited more than a decade for a new treatment for this chronic condition. We now have the opportunity to address that unmet need" said Elise Klein, Vice President and General Manager, Dermatology, Berlex Laboratories, Inc. "The approval also is an important milestone in Berlex Dermatology's commitment to building our product portfolio in the United States," she added.

Finacea contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Azelaic acid is a white, odorless crystalline solid that is poorly soluble in water, but well soluble in alcohol. The formulation of Finacea provides improved drug penetration compared with the cream formulation. Although the exact mechanism of Finacea is not fully understood, clinical studies have shown that it interferes with the pathogenic events in rosacea. An anti-inflammatory effect was found in vitro.

Rosacea, characterized by initial episodic reddening and later persistent redness and inflammatory lesions, affects more than 13 million American adults between the ages of 30 and 50; however, physicians estimate this number may be higher. In many cases, people who suffer from rosacea are unaware of the condition and do not seek medical treatment in its early stages.

While rosacea can affect anyone, fair-skinned individuals are more susceptible to the disease. People who have a family history of rosacea or tendency to flush or blush easily are also more at risk for the disease. Women are more likely than men to have rosacea, although the disease is often more severe in men.

Finacea is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

Finacea is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. The most frequently reported adverse events related to Finacea included burning/tingling, and itching. These occurred in more than 10 percent of patients. Events occurring in 1 to 10 percent of patients included dry skin and rash. The majority of adverse events were mild in severity.

Source: Berlex Laboratories

Posted: January 2003