~ Breakthrough reduces flares and is safe even on most sensitive areas ~
MONTREAL, Quebec —May 8, 2003 — Elidel® (pimecrolimus) cream 1%, a new non-steroid prescription cream for the treatment of eczema, has been approved by Health Canada for the short and intermittent long-term treatment of mild to moderate eczema in patients as young as 2 years old. Elidel® has been shown to be both effective and safe in a broad range of patients1,2 and can be used without limitation on all skin surfaces, including highly sensitive areas.3 Furthermore, it has also been proven to have significant therapeutic advantages over conventional therapy, in the long-term management of the disease.4
"Elidel® is a major advance in the management of eczema," says Dr. Alfred Balbul, Associate Dermatologist, Montreal General Hospital and Assistant Professor of Dermatology, McGill University. "Ever since the introduction of topical corticosteroids over 50 years ago, physicians have been looking forward to an alternative approach that is effective, safe and does not have corticosteroid-related side effects, such as skin thinning."
Over the past 20 years, there has been a dramatic, ten-fold increase in the prevalence of eczema. Currently, approximately one in five Canadians, over 6 million people, suffer from this chronic condition that is characterized by intense itching, dry skin and inflammation. Mild to moderate sufferers make up the vast majority of eczema patients with approximately 90% of them experiencing first symptoms before the age of 5. As conventional therapies can be inadvisable and/or ineffective for many of these eczema patients, Elidel® serves as a valuable treatment option for this large patient population.
In a study of 200 eczema sufferers from the United Kingdom, 72.5% were concerned about the use of topical steroid due to the risk of side effects such as skin thinning.
Elidel® provides fast relief from itching
Clinical trials have demonstrated that Elidel® provides a rapid and sustained effect in controlling itching, the primary complaint of patients with eczema. In a controlled long-term study in adults, Elidel® relieved itching within the first two days of treatment.5 This same type of relief has also been demonstrated across a diverse patient population in terms of age and severity of disease.6
Elidel® can prevent eczema flares
Large, controlled studies have shown that, when applied at the first signs and symptoms of eczema, Elidel® can prevent flares in all age groups and a broad range of patients. In a 12 month, multi-center, double-blind study involving 713 children between 2 and 17 years of age, long-term Elidel® treatment was compared with current conventional eczema therapy. Results of this study showed that Elidel® significantly reduced flare incidence at both 6 and 12 months compared to conventional therapy:7
- 61% of Elidel®-treated patients remained flare-free during the first 6 months of the study (vs. 34% of patients in the control group); and
- 51% of children treated with Elidel® remained flare-free for 12 months (vs. 28% of patients in the control group).
"By preventing flares, Elidel® provides significantly better long-term control of eczema than conventional treatment," added Dr. Balbul. "Eczema flares are not only physically painful, but they also have a profound impact on patients' quality of life and emotional well-being."
Study results are similar with adults. A clinical trial involving 192 adult patients showed that the median time to first flare was 144 days in patients treated with Elidel®, compared to 26 days in patients treated conventionally. In total, 45% of patients in the Elidel® group had no flares of eczema during this 6 month study, compared with just 19% of those in the control group.8
Elidel® has an excellent safety and tolerability profile
To date, almost 5,000 patients have been treated with Elidel® in clinical trials. Results have shown that Elidel® is well tolerated on all skin surfaces, including the face, neck and skin folds and is not associated with skin atrophy.9 The incidence of adverse events has been low, the most common being a mild-to-moderate temporary feeling of warmth or burning on the skin where the cream was applied. This occurred in fewer than 8.5% of children and adults.
"What is particularly exciting about Elidel® is the low incidence of application site burning found during clinical trials," concluded Dr. Balbul. "Given that patients report burning as one of the most frequent side effects of conventional eczema treatments, with Elidel®, they now have an alternative that is both highly tolerable and efficacious."
Elidel® 1% cream was approved by Health Canada for the short-term and intermittent long-term therapy of mild to moderate atopic dermatitis in non-immunocompromised patients 2 years of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.
Forward-looking statement
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 "first ever," "major advance," "breakthrough" and "significantly reduces" or similar expressions, or by discussions of strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Elidel® to be materially different from any future results, performance or achievements expressed or implied by such statements. Some of these are uncertainties relating to unexpected regulatory delays, further clinical trial results regarding efficacy or safety of Elidel®, government regulation or competition in general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
About Novartis Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well being of all Canadians. Novartis Pharmaceuticals Canada conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, organ transplantation and glaucoma. In 2002, the Company invested $35 million in research and development. Novartis Pharmaceuticals Canada Inc. employs approximately 700 people in Canada and its headquarters are located in Dorval, Quebec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., (including Novartis Nutrition Corporation and Gerber [Canada] Inc.) and CIBA Vision Canada Inc.
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