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Elidel (Pimecrolimus) Cream 1% Produces Significant Improvement in Mild to Moderate Eczema

EAST HANOVER, NJ -- March 28, 2002 - Elidel® (pimecrolimus) Cream 1% significantly improved the signs and symptoms of eczema, particularly in the head and neck regions.

These data were published in the April issue of the Journal of the American Academy of Dermatology.

Elidel, a new non-steroid prescription cream for the treatment of mild to moderate eczema in patients age two and older, was recently made available in the United States.

"Traditionally it's been difficult to treat the head and neck regions due to concerns over side effects with using corticosteroids on these sensitive areas. These data underscore the safety and efficacy of using Elidel on these most sensitive skin areas," said Dr. Lawrence Eichenfield, chief of pediatric and adolescent dermatology, Children's Hospital, San Diego, Califorina, and lead author of the study. "Having a well-tolerated, steroid-free treatment available that can be safely used on all skin surfaces is an important advance in the treatment of this disease."

The analysis from pooled results of two independent, six-week, randomised, multi-center studies of identical design, showed significant improvement in the signs and symptoms of eczema in Elidel-treated patients, particularly in the head and neck regions, versus placebo cream. As measured by the Eczema Area and Severity Index (EASI), head and neck eczema in the Elidel-treated patients improved by more than 40 percent on average by day eight and nearly 60 percent on average by conclusion of the study. This compared with a 10 percent worsening at day eight and no improvement at the conclusion of the

study for those using placebo cream.

Overall, results also demonstrated the rapid effect of Elidel on the signs and symptoms of eczema, regardless of location on the body. By the first study return visit on day eight, 12 percent of patients treated with Elidel were clear or almost clear of all their eczema, versus only 2 percent of placebo-treated patients. At the same visit, almost half of Elidel-treated patients (45 percent) reported their eczema to be in complete or good control compared to 20 percent of placebo-treated patients.

Elidel had a significant effect on pruritus, with nearly 45 percent of patients reporting no to mild itching within the first week of treatment, compared to approximately 26 percent of patients on vehicle. More than 60 percent of Elidel-treated patients reported no to mild itching by day 29, which was maintained through the study's duration.

Developed by the Novartis Research Institute and approved by the U.S. Food and Drug Administration (FDA) in December 2001, Elidel is now available in tubes of 15 g, 30 g and 100 g. Elidel is approved for the short-term and intermittent long-term treatment of mild to moderate eczema in non-immunocompromised patients as young as two years for whom conventional therapies are inadvisable because of potential risks, inadequate response, or intolerance. The cream may be used on all surfaces, including delicate areas such as face, neck and skin folds.

The approval of Elidel was based on safety and efficacy results of clinical trials in more than 1700 pediatric and adult patients. The most common side effect on the skin was a mild to moderate, temporary feeling of warmth or burning (occurring in 8 percent of children age two to 17 and in 26 percent of adults). Other common side effects included headache and cold-like symptoms. Elidel did not induce contact sensitization, phototoxicity or photoallergy, nor did it show any cumulative irritation. Elidel did not elicit skin atrophy like that from topical corticosteroid use.

The active ingredient is pimecrolimus, which is derived from ascomycin, a natural substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus. Pimecrolimus selectively blocks the production and release of cytokines from T-cells. It is these cytokines which trigger processes leading to the inflammation, redness and itching associated with eczema.

SOURCE: Novartis Pharmaceuticals Corporation

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