New Study Shows Elidel Provides Effective Long-Term Management of Flare-Ups Associated With Eczema

NEW ORLEANS, Feb. 21 /PRNewswire/ -- Long-term intermittent treatment with Elidel(R) (pimecrolimus) Cream 1% in both adult and pediatric patients provided control of the symptoms associated with atopic dermatitis, commonly known as eczema, for up to 18 months, according to new study results announced this week during the 63rd annual meeting of the American Academy of Dermatology in New Orleans.

"Helping patients control symptoms long-term is a key goal in the overall management of eczema," says Dr. Richard Langley, Assistant Professor, Director of Research, Division of Dermatology, Dalhousie University, Canada. "This study provides encouraging news because one of the most unsettling aspects of eczema is the unpredictability of the condition. What this study shows is that using Elidel to treat a flare-up at the onset of such symptoms as tingling or itching may enable patients to control flares and better manage their condition long-term."

The objective of this multinational study was to evaluate the long-term safety and effectiveness of Elidel in pediatric and adult patients with eczema of any severity, who had previously completed a six-month 947-patient core study. The extension study included 368 of those patients who remained in the study and were treated for up to 18 months. Patients were enrolled at 61 centers in 10 countries.

During the extension phase of the study, Elidel was incorporated as needed into patients' daily treatment routines as follows: Patients applied Elidel twice daily to affected areas beginning at the earliest signs or symptoms of a flare (e.g., tingling or itching), and continued for as long as the flare persisted. Any time signs or symptoms returned, patients resumed twice daily treatment, in effort to prevent progression. Patients were not required to see their doctor before resuming treatment for a flare. However, emollients and topical corticosteroids could be added to the treatment regimen, if the treating physician felt it was warranted.

Results were evaluated by the Investigators' Global Assessment (IGA) score, using a 6-point scale of 0-5 (clear to very severe disease). Itch (pruritus) severity was rated on a scale of 0-3 (absent to severe disease). Perceptions of disease control, as provided by the patient or caregiver, were rated on a scale of 0-3 (complete control to uncontrolled disease).

As in previous long-term studies, patients treated with Elidel in a naturalistic setting -- a clinical study environment that closely replicates real life situations -- experienced sustained long-term relief of their eczema symptoms. In the core study, 79.6% (n=277) of patients who had used Elidel twice daily experienced relief from the itching associated with mild to moderate eczema. These compelling results were sustained for an additional six months in 75.3% (n=262) of the patients who continued to be monitored in the extension study. Treatment success rates, specifically for the face and whole body, at the end of the core study were 78.9% (n=224) and 53.1% (n=188). Again, these results were sustained for an additional six months during the extension study (70.4% [n=200]; 48.6% [n=172], respectively). Importantly, the quantity of Elidel used during the course of the study decreased from 3.3g/day at the end of the core study to 2.5 g/day six months later, particularly in those patients who had the most severe eczema at the start of the study. More than 75% of patients (n=269) continued to rate their disease control as either "complete" or "good" at the end of the extension study.

There were no unexpected safety findings. The most common adverse events (occurring in 5% of patients or more) were infections (nasopharyngitis 13.9%, upper respiratory tract infection 6.4%, influenza 6.1%), respiratory disorders (16.9%), application-site conditions (10%) and headache (8%). The overall incidence of viral infections was less than 1%. Treatment-related herpes simplex occurred in 4 patients (1.1%). The incidence of adverse events decreased from the end of the core study to the end of the extension study. Application-site burning, pruritus and impetigo all became less frequent in the extension study.

Overall Impact of Atopic Dermatitis on Patients' Lives

For many patients, the burden of eczema extends beyond the outwardly visible manifestation of symptoms, even impacting their overall quality of life.

Results presented yesterday by Seth Orlow, MD, PhD, New York University School of Medicine, New York, NY, from a multinational survey called the International Study of Life with Atopic Eczema (ISOLATE), showed that a majority of eczema sufferers and their caregivers (51% of patients, and 63% of caregivers) either always or sometimes worry about when they might experience their next disease flare-up. The study also revealed that about 75% of eczema patients and caregivers lack confidence in the ability to effectively manage their disease when it does flare-up.

"Patients often report that eczema flares influence multiple aspects of their lives, including the ability to sleep or even attend work or school. The stress of eczema also affects caregivers and other family members of children who suffer from eczema," says Dr. Orlow. "Eczema is not only a physical disease. It can carry a psychological burden and influence the quality of life of patients and caregivers."

ISOLATE is a large and comprehensive study, including 2,000 participants from eight countries (United States, France, Germany, Spain, Mexico, Netherlands, Poland, and United Kingdom). The data presented at the American Academy of Dermatology meeting are from a sub-analysis of approximately 400 patients and caretakers of patients from the United States. Participants underwent in-depth telephone interviews utilizing a comprehensive questionnaire developed in collaboration with national eczema patient groups and physicians. In this study, a flare was defined as inflammation of the skin requiring a physician consultation or application of prescription medication. The National Eczema Association for Science and Education (NEASE) was one of the leading groups involved in the development and implementation of this study, along with other patient-focused organizations from around the world.

A separate study presented at the meeting, involving nearly 1,000 participants, showed that in both adult patients and parents of pediatric patients (up to age 12 years) with eczema, treatment with Elidel was associated with a statistically significant improvement in quality of life at months two and six. Those parents who had previously reported concerns about corticosteroid use had a significantly greater improvement in quality of life six months after Elidel treatment than did those without such concerns (median score change =3 for concerned vs. 2 for unconcerned; p=0.006). The assessments were based on the Parent's Index of Quality of Life-Atopic Dermatitis (PIQoL-AD), a standard measure used for those patients aged 12 and under, and the Quality of Life Index for Atopic Dermatitis (QoLIAD) for those older than 18 years.

About Eczema

Currently, eczema affects up to 17 percent of the U.S. population. Eczema is a broadly used term to describe patchy, red, dry itchy and scaly skin, which, when severe, can "weep," bleed and/or crust over. This common and often distressing skin condition tends to run in families, especially when there is a family history of eczema, hay fever or asthma. Eczema almost always begins in childhood, usually during infancy. The term eczema most often refers to "atopic dermatitis," which is a chronic relapsing inflammatory skin condition and is related to both allergic rhinitis (hay fever) and asthma. Doctors use the terms eczema and atopic dermatitis interchangeably to describe the disease.

About Elidel

Elidel(R) (pimecrolimus) Cream 1%, from Novartis Pharmaceuticals, is a safe and effective treatment option for the long-term management of mild to moderate eczema. It is a prescription cream approved for the short-term and intermittent long-term treatment of mild to moderate eczema in patients two years and above, who do not respond well to, or may have side effects with, conventional treatments. Elidel can be used twice daily at the first sign of a flare, which has been described by patients as tingling or itch. If symptoms persist beyond six weeks, patients should see their doctor.

In clinical trials with Elidel, 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 2-7 years and in 26 percent of adults). This side effect was temporary and its occurrences were comparable to those experienced by patients on vehicle cream. Other common side effects included headache and cold symptoms, such as stuffy nose, sore throat, cough and, rarely, viral skin infections.

Developed by the Novartis Research Institute, Elidel may be used on all skin surfaces, including delicate areas such as the face, neck and skin folds. 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. These cytokines in the skin cause the inflammation, redness and itching associated with eczema.

This release contains certain forward-looking statements, relating to Novartis Pharmaceuticals Corporation's (the Company) business, which can be identified by the use of forward-looking terminology such as "hopes to help," "help facilitate," 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. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com/.

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