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FDA Approves Finacea (Azelaic Acid) For Topical Treatment Of Rosacea

Finacea Offers the First New Therapeutic Option for Rosacea Patients in More Than a Decade

MONTVILLE, NJ -- January 6, 2003 -- Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany (NYSE: SHR), announced the U.S. Food and Drug Administration (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 will be marketed in the United States by Berlex Laboratories, Inc. and is expected to be available to patients in the first quarter of 2003. For full prescribing information, please call 1-888-BERLEX4.

About Finacea
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.

About Rosacea
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.

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

Contraindications and Safety Information
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.

About Berlex
Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex Laboratories, Inc. develops and markets ethical pharmaceuticals in the areas of Female Healthcare, Diagnostic Imaging, Dermatology, Oncology and Therapeutics for life-threatening and disabling diseases. Berlex has business operations in Montville and Wayne, New Jersey; Richmond and San Diego, California; as well as Bothell and Seattle, Washington. For more information on currently marketed products, please visit http://www.berlex.com.

Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.


SOURCE: Berlex Laboratories, Inc.

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