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Combination Therapy Reduces Acne-Causing Bacteria by 90 Percent After One Day; Study Published in the Journal Cutis Shows Unprecedented Results

BERWYN, PA -- July 1, 2002 -- Two topical medications combined, an antibiotic and an antimicrobial, resulted in an unprecedented reduction of P. acnes bacteria levels by 90 percent after only 24 hours according to a study published in the current issue of the dermatology journal Cutis. The findings were from a controlled trial of healthy subjects free of acne but with high levels of the P. acnes bacteria.

"Reductions of this magnitude following 24 hours of treatment have not previously been reported in the literature," said James J. Leyden, MD, professor of dermatology at University of Pennsylvania and lead author of the study, which compared the combination of benzoyl peroxide and clindamycin to clindamycin alone and placebo. "These results demonstrate that the combination therapy produces rapid and clinically relevant reductions in the bacteria P. acnes that are significantly greater than those produced by single agent therapy."

As an additional consideration, the use of benzoyl peroxide with an antibiotic in acne to help inhibit the emergence of resistant organisms is discussed in the article. Donald R. Graham, MD, FACP, an infectious disease specialist, believes a growing concern is whether a hospitalized patient who receives acne therapy will become infected by a strain that is resistant to one of the antibiotics used to treat acne. Dr. Graham is chief of the Department of Infectious Diseases, Springfield Clinic and clinical associate professor in the Division of Infectious Diseases, Department of Medicine at Southern Illinois University School of Medicine in Springfield. "Such a patient would need an antimicrobial program that recognizes the potential for infection by an organism resistant to the agent used for the acne,"(1) said Dr. Graham.

Combination Therapy as an Approach
The data released in the current issue of Cutis, in an article entitled: "Effect of Topical Benzoyl Peroxide/Clindamycin Versus Topical Clindamycin and Vehicle in the Reduction of Propionibacterium acnes," add to the growing body of evidence that combination antimicrobial therapy using agents that have complementary activity is a sound approach to acne treatment. The randomized trial involved 60 healthy volunteers who had high levels of facial P. acnes bacteria. The onset of action and reduction of P. acnes of three topical preparations (a combination acne product, commercially known as BenzaClinŽ [clindamycin 1% -- benzoyl peroxide 5% gel] Topical Gel, clindamycin solution, and vehicle gel) were studied over a two-week period of twice-daily treatment. The combination therapy significantly reduced P. acnes by 90 percent following 24 hours of application, and by 99.9 percent, a virtual elimination, at the end of the two-week study period. This combination product has not been studied in trials to demonstrate the clinical significance of the reduction of P. acnes.

Dermik Laboratories makes BenzaClin, a prescription acne product that is generally well-tolerated; side effects are usually limited to the skin and include dry skin, reaction at the site of application, itching, peeling, redness and sunburn. Also, clindamycin, an ingredient in BenzaClin, may cause diarrhea. Discontinuation is recommended if significant diarrhea develops. BenzaClin should not be used in the case of allergies to clindamycin, benzoyl peroxide, or the antibiotic lincomycin, or in the case of a history of colitis.

About Acne
Acne is the most commonly diagnosed skin disorder in the U.S. and is most prevalent in the teenage population. According to the American Academy of Dermatology, close to 100 percent of people between the ages of 12 and 17 have an occasional pimple, regardless of race or ethnic background. By their mid-teens, however, more than 40 percent of adolescents have acne severe enough to require medical treatment by a physician.(2)

About Dermik Laboratories
Dermik Laboratories, Inc. conducts the global dermatology business of Aventis Pharmaceuticals, the prescription drug business of Aventis. Dermik Laboratories is dedicated to providing innovative dermatological products to satisfy the needs of health care providers and patients. Dermik focuses on treatments for a wide range of skin and nail problems, including acne, antifungals, pre-cancerous lesions, psoriasis and rosacea. Its corporate headquarters is located in Berwyn, Pa. Please visit us at our website: http://www.dermik.com.

About Aventis
Aventis Pharmaceuticals conducts the U.S. prescription drug business of Aventis. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system.

Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of Euro 17.7 billion ($15.9 billion), invested approx. Euro 3 billion ($2.7 billion) in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: http://www.aventis.com.

Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.

References:

(1) Leyden J, Eichenfield L, Graham D, Shalita A, Thiboutot D, The Acne Challenge, Management in an Age of Bacterial Resistance. Medical Crossfire. 2002;3;8.

(2) AcneNet. American Academy of Dermatology, Available from URL: http://www.skincarephysicians.com/acnenet/acne.html.


SOURCE: Dermik Laboratories

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