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New 12-Month Data Show Elidel (Pimecrolimus) Cream Demonstrated Long-Term Eczema Control In Infants

Elidel Reduced the Need For Topical Corticosteroids in Infants

LOS ANGELES, CA -- May 16, 2002 -- Treatment with Elidel® (pimecrolimus) Cream 1% provided effective long-term control of eczema in infants, according to new 12-month data presented today at the Society for Investigative Dermatology congress in Los Angeles, CA. Early intervention with Elidel (application at the first signs or symptoms of the disease) lead to better long-term control of eczema in infants, compared with a conventional treatment regimen (emollients; reactive use of topical corticosteroids for disease flares). These results demonstrated that Elidel considerably reduced reliance on topical corticosteroid use.

"Parents of infants with eczema should be aware of the risks commonly associated with chronic topical corticosteroid use," said Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology at Children's Hospital, San Diego. "These promising new data support the use of Elidel as a potential therapeutic option for this difficult-to-treat patient population." Dr. Eichenfield, while not an investigator in this study, is an expert in pediatric dermatology.

Elidel treatment was significantly more effective than a conventional treatment regimen in controlling eczema flares. The proportion of patients remaining flare-free for 12 months was more than twice as high in the Elidel-treated group versus the conventional treatment group (57% vs. 28%). As a result, treatment with Elidel considerably reduced the need for topical corticosteroids, with only 36% of Elidel treated patients requiring a steroid over the 12-month period, versus 65% in the conventional treatment group.

This 12-month, double-blind, multicenter, parallel-group study, comprising 251 patients aged 3-23 months, compared the long-term efficacy and safety of Elidel with that of a conventional treatment regimen. At the first signs or symptoms of eczema, patients applied study medication twice daily to prevent disease flares. Emollients were applied for dry skin, and mid-potency topical corticosteroids were used to treat disease flares not controlled by study medication.

About Elidel
Elidel is the first steroid-free prescription cream for mild to moderate eczema patients as young as two years old. It is approved for the short-term and intermittent long-term treatment of mild to moderate eczema in non-immunocompromised patients, for whom conventional therapies are inadvisable because of potential risks, inadequate response, or intolerance. Currently, eczema affects up to 17 percent of the US population. Mild to moderate sufferers make up the vast majority of this eczema patient population. As conventional therapies may be inadvisable and/or ineffective for some eczema patients, Elidel serves as a valuable treatment option for this large population.

Elidel, which was approved by the FDA in December 2001, is now available in tubes of 15 g, 30 g and 100 g. The approval 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 aged 2-17 years and in 26 percent of adults). This side effect was temporary, mostly seen at the beginning of treatment, and comparable to that experienced by patients on placebo cream. 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. In contrast to topical corticosteroids, Elidel did not cause skin atrophy.

This release contains certain forward-looking statements, relating to the Company's business, which can be identified by the use of forward-looking terminology such as "promising," "support," "potential," or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the potential benefit of Elidel (pimecrolimus) Cream 1% as evidenced by clinical trial results and FDA approval. Those statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There are no guarantees that the aforementioned events will result in the commercial success of Elidel (pimecrolimus) Cream 1% in any market. Any such success can be affected by, among other things, uncertainties relating to product development, adverse results in clinical trials regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general and other risks and factors referred to in the Company's current Form 20-F on file with the Securities and Exchange Commission of the United States.

About Novartis
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 71,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

SOURCE: Novartis Pharmaceuticals Corporation

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