Dermik Laboratories Canada, Inc. Announces DERMATOP Now Available in Canada for the Treatment of Eczema and Psoriasis.

Business Editors/Health & Medical Writers

TORONTO--(BUSINESS WIRE)--April 4, 2001

DERMATOP(R)Cream Is the Only Topical Corticosteroid Approved for Use

in Infants and Children

Dermik Laboratories Canada, Inc. has announced the availability of DERMATOP(R) (prednicarbate 0.1%), a new topical corticosteroid for the treatment of the skin disorders eczema and psoriasis.

Cleared for marketing by the Therapeutic Products Programme (TPP), DERMATOP is available by prescription now in pharmacies throughout Canada, as an ointment or an emollient cream. DERMATOP Emollient Cream was shown in studies to be safe and effective in infants and children, and is the only topical corticosteroid in Canada approved for use in this pediatric population.

In clinical studies, DERMATOP Emollient Cream was shown to be significantly more effective than hydrocortisone cream 1% in the treatment of children with atopic dermatitis, one of the most common forms of eczema. The cream also was shown to be at least as effective as betamethasone valerate cream 0.1% in the treatment of adults with atopic dermatitis.

"We are pleased to provide physicians with DERMATOP, an important new option for the treatment of their patients with corticosteroid-responsive dermatoses," said Edward Dahl, General Manager of Dermik Laboratories Canada. "We are excited that DERMATOP Emollient Cream, unique among agents in its class, is approved for pediatric use and can help relieve suffering and improve the quality of life for young children with these disorders."

DERMATOP Ointment and Emollient Cream should be applied to affected areas of the skin twice daily. Treatment should be limited to two weeks. DERMATOP should not be used with occlusive dressings unless directed by a physician, and the emollient cream, if used with infants, should not be applied in the diaper area.

Clinical Studies Show DERMATOP Is Effective, Well-Tolerated

DERMATOP Emollient Cream 0.1% was compared with hydrocortisone cream 1% in 235 patients aged two months to 12 years with atopic dermatitis of at least 20% body surface involvement. DERMATOP showed significantly better improvement of overall disease severity (p<0.001), greater decrease in the mean total body surface affected, and greater improvement in total scores for key signs and symptoms of the disorder.

In a second study, 59 pediatric patients with atopic dermatitis involving greater than 20% body surface area were treated with prednicarbate cream twice daily for 21 consecutive days. By day 22, total scores for key signs / symptoms had improved by 85%. None of the 59 patients showed evidence of adrenal suppression.

DERMATOP Emollient Cream 0.1% was compared to its vehicle in two studies involving 394 patients with atopic dermatitis or psoriasis. After three weeks of therapy, excellent improvement occurred in 72% of the dermatitis patients, and moderate improvement was seen in 34% of those with psoriasis.

DERMATOP is a "mid-level" topical corticosteroid that was developed to minimize the adverse reactions associated with corticosteroids, such as skin thinning or atrophy. In clinical studies with adults, the total incidence of adverse reactions reported with DERMATOP was low - 1.6% with the ointment, 1.8% with the emollient cream. The reaction most frequently seen was pruritus or itching (0.6% for the ointment, 0.9% for the cream).

In pediatric studies, the overall incidence of adverse reactions with the emollient cream was 5.1%. Reactions were usually mild, and included application site reaction (2.8%) and skin disorder (1.1%).

Because of its favorable safety profile, DERMATOP may be especially useful in the long-term management of chronic dermatoses. It may be of particular value in geriatric patients, in whom skin atrophy and systemic absorption of topical steroids may be a concern due to age-related skin thinning.

About Eczema, Psoriasis and Topical Corticosteroids

Eczema is a general term for various inflamed skin conditions; one of the most common is atopic dermatitis. Approximately 10 to 20 % of the world's population is affected by this dry, red extremely itchy skin rash. Eczema affects both children and adults, but usually appears during infancy, and can occur on just about any part of the body. Children are challenging patients, since they tend to scratch their eczema and worsen the condition. There is no known cause for the condition, but it appears to be an abnormal, inflammatory response of the body's immune system, and often affects people with a history of allergies.

Psoriasis is a chronic, genetic disorder that may affect any area of the body, but is most commonly found on the scalp, elbows, knees, hands and feet. The most common type of the disease is characterized by raised, thickened patches of red skin covered with silvery white scales. The affected area may be extensive, causing physical discomfort and social embarrassment. Although psoriasis strikes both children and adults, it is usually diagnosed between the ages of 15 and 35.

Topical corticosteroids work by a variety of mechanisms on both the outermost layer of skin, the epidermis, and the layer just below it, the dermis. These agents have vasoconstrictive, antiproliferative and anti-inflammatory properties. Since eczema is characterized by inflammation, topical steroids probably exert their primary effect on eczema through their anti-inflammatory activity. In psoriasis, the body's immune system triggers excessive skin cell reproduction. Thus, the antiproliferative action of topical steroids probably has the most benefit in treating psoriasis.

About Dermik Laboratories

Dermik Laboratories, Inc. conducts the global dermatology business of Aventis Pharma AG, the pharmaceutical company of Aventis S.A. 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.

Aventis Pharmaceuticals conducts the U.S. business of Aventis Pharma AG. With headquarters in Parsippany, NJ, 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 Pharma AG is the pharmaceutical company of Aventis S.A. (NYSE:AVE). Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture, and sale of innovative pharmaceutical products aimed at fulfilling unmet medical needs. The corporate headquarters of Aventis Pharma is Frankfurt, Germany. Aventis Pharma is comprised of Aventis Pharmaceuticals; Aventis Pasteur, a world leader in vaccines, headquartered in Lyon, France; and Aventis Behring, a world leader in therapeutic proteins, headquartered in King of Prussia, PA.

Aventis S.A., a world leader in pharmaceuticals and agriculture, is headquartered in Strasbourg, France. The company employs approximately 95,000 people in more than 120 countries. Aventis was launched in December 1999 through the merger of Hoechst AG and Rhone-Poulenc S.A.