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| |  Trial of Betamethasone Mousse Shows Benefit In Scalp Psoriasis PALO ALTO, CALIF. -- August 5, 1997-- The results of a Phase III clinical trial with betamethasone mousse, a novel foam formulation of betamethasone valerate, demonstrated statistically significant improvement over placebo for the treatment of scalp psoriasis, a condition that affects approximately three million Americans. The 190-patient, placebo-controlled, randomized, double-blind, multi-center Phase III study demonstrated that patients treated with betamethasone mousse, administered twice-daily for 28 days, experienced a statistically significant improvement over patients in the groups treated with betamethasone lotion or placebo in all primary endpoints, including erythema, plaque thickness and scaling. The investigators completed a physicians global assessment which showed that overall, 71 percent of patients treated with the mousse formulation had complete or almost complete clearance compared with 46 percent for lotion and 18 percent for placebo. Both betamethasone mousse and lotion were generally well tolerated. "Because the new mousse formulation stays localized on the disease area, it should reduce unintentional exposure to other areas such as the face, eyes, ears and neck, and result in better therapeutic outcomes. It has been extremely well received by both patients and clinicians in the clinical trial," noted Ken Washenik, M.D., Ph.D., Director of Dermatopharmacology, New York University Medical Center. It is estimated that more than 3 million Americans suffer from scalp psoriasis, with millions more afflicted by other dermatoses of the scalp and skin. The U.S. market for betamethasone mousse is more than $200 million. Connetics Corporation, who developed the drug, intends to file a New Drug Application (NDA) with the Food and Drug Administration (FDA) to market the product for use in all steroid-responsive dermatoses, including psoriasis, in the first quarter 1998. Betamethasone mousse is a stabilized foam formulation of betamethasone 17-alpha-valerate, a mid-potency corticosteroid. When applied to the body, betamethasone mousse liquefies and remains localized at the disease site. In addition, the mousse formulation is designed to be easier-to-apply, less messy and cosmetically more acceptable than currently marketed dermatological lotions, creams and ointments. The mousse product is currently marketed in the United Kingdom for the treatment of scalp psoriasis and seborrheic dermatitis (severe dermatitis) by Medeva PLC under the trade name Bettamousse(TM). Connetics Corporation, headquartered in Palo Alto, California, is focused on the acquisition, development and marketing of products in the areas of rheumatology and dermatology. Ridaura(R) (auranofin) is a treatment for rheumatoid arthritis that Connetics acquired from SmithKline Beecham. Several products are under development: gamma interferon for the treatment of atopic dermatitis and keloids; betamethasone mousse for the treatment of scalp psoriasis and other dermatoses; ConXn(TM) (relaxin) for the treatment of scleroderma and other fibrotic conditions; and TCR vaccines for the treatment of rheumatoid arthritis and multiple sclerosis. More information on: Connetics Corporation, SmithKline Beecham
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