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FDA Approves Finevin (Azelaic Acid Cream 20%) For the Treatment of Mild to Moderate Acne MONTVILLE, NJ -- May 3, 2001 -- Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany, today announced the U.S. Food and Drug Administration (FDA) has approved the marketing of Finevin™ (azelaic acid cream 20%) for the topical treatment of mild to moderate inflammatory acne vulgaris. Finevin, also known as Skinoren® in Europe, is distributed worldwide by Schering AG to more than 70 countries and has been used by approximately five million patients for over 10 years. Available in mid-May, Finevin will be the second azelaic acid product available on the U.S. market. "As the originator of azelaic acid and a global leader in dermatology, Schering AG has a long history and tradition with azelaic acid. We are proud to leverage our parent company's experience with this product by now offering it as Finevin in the U.S. to meet the needs of patients and healthcare professionals who are seeking a cost-effective and well-tolerated treatment for mild to moderate acne," said Elise Klein, Vice President and General Manager, Dermatology, Berlex Laboratories, Inc. Berlex will market and distribute Finevin at a competitive price with an average wholesale price (AWP) of $36.95 U.S. The company will also launch a patient education and compliance program designed to provide a value-added service for physicians who prescribe Finevin for their acne patients. Available at launch, a comprehensive informational guide will provide detailed patient information about the recommended course of therapy for Finevin as well as an explanation of its mechanism of action and expectations in reducing acne lesions. This counseling tool will assist physicians in maintaining patient compliance. “Through our combined efforts to provide Finevin at a competitive price and to educate patients about its excellent tolerability through value-added programs, we believe Finevin will be recognized as a reliable alternative for physicians, pharmacists, and especially patients seeking a safe, effective and well-tolerated acne therapy," added Ms. Klein. Clinical studies have shown the following properties contribute to the efficacy of Finevin in treating mild to moderate acne: * demonstrates antimicrobial activity against Propionibacterium acnes (P. acnes) and Staphylococcus epidermidis (Staph. epidermidis) * normalizes the follicular hyperkeratosis associated with acne possesses anti-inflammatory effects. * The mechanism of action of Finevin, while not completely understood, leads to the reduction of acne lesions. "Antimicrobial agents such as Finevin can help improve physicians' ability to control acne in patients," said Ruth Thieroff-Ekerdt, MD, Clinical Director, Dermatology, Berlex Laboratories, Inc. "Clinical studies have demonstrated that azelaic acid is effective against P. acnes and Staph. epidermidis, both types of bacteria that play a role on acne-bearing skin. It also has an excellent safety profile with minimal side effects." Acne affects more than 17 million people in the U.S. and is the most common skin disease treated by physicians. Although acne is considered a disease more prevalent among adolescents, a greater number of adults, especially women, seek treatment. Acne vulgaris, better known as common acne, is a disease of the sebaceous glands and hair follicles of the skin usually presenting as a combination of inflammatory lesions (papules, nodules and pustules) and/or non-inflammatory lesions (comedones). Four pathogenic factors work together for the development of acne vulgaris: sebum production, follicular hyperkeratinization, microbial colonization by P. acnes and the release of inflammatory chemicals produced by bacteria into the follicle and surrounding skin. The efficacy of azelaic acid cream 20% in the treatment of mild to moderate inflammatory acne has been established in many controlled clinical trials, conducted in Europe and the U.S. During comparison trials, azelaic acid was studied with topical 2% erythromycin, topical 5% benzoyl peroxide gel, and topical 0.05% tretinoin cream in the treatment of mild to moderate inflammatory acne. Studies have shown that azelaic acid is well-tolerated in comparison with other acne treatments. In U.S. clinical trials with Finevin, the most common side effects occurring in approximately 1 to 5 percent of patients were pruritus, burning, stinging and tingling. Adverse reactions associated with Finevin were generally transient and mild in nature. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis and contact dermatitis were reported in less than one percent of patients. Finevin should be applied twice a day, in the morning and evening. A majority of patients with inflammatory lesions may experience an improvement in their acne within four weeks of beginning treatment. However, treatment may be continued over several months, if necessary. Finevin should not be used in patients with known hypersensitivity to azelaic acid or any of the components of the formulation. It is not recommended for use in children under 12 years of age. Finevin is categorized as a pregnancy Category B and should only be used in pregnant women if medically necessary. Patients with dark complexions should be monitored for early signs of hypopigmentation. SOURCE: Berlex Laboratories, Inc. Related Link: Berlex Laboratories, Inc. 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