Basilea’s Toctino included in guidelines for

The guidelines, developed by a panel of leading experts, provide practice recommendations for managing hand dermatitis to dermatologists and other health care professionals in Canada. Intervention with oral alitretinoin is recommended as a treatment of choice for severe chronic hand eczema (CHE) that is unresponsive to potent topical corticosteroids. Alitretinoin is the first and only treatment approved for this condition. The document is published in the Journal of Cutaneous Medicine and Surgery (C. Lynde, L. Guenther, T .L. Diepgen, D. Sasseville, Y. Poulin, W. Gulliver, T. Agner, K. Barber, R. Bissonnette, V. Ho, N.H. Shear, J. Toole; Vol 14, No 6 (November/December), 2010: pp 267-284).

“The evidence-based recommendation of Toctino as systemic treatment of choice for severe chronic hand eczema by a panel of leading Canadian and European experts indicates that Toctino has an important role to play in the management of this very debilitating and painful skin disease,” said Prof. Achim Kaufhold, Chief Medical Officer of Basilea. “This condition severely impacts patients’ quality of life as well as their ability to perform everyday activities. The publication of Canadian guidelines now that Toctino is available in Canada is good news for hand eczema patients as it supports physicians in identifying and implementing the optimal treatment.”

For accessing the document “Canadian Hand Dermatitis Management Guidelines”, please visit: http://www.bcdecker.com/productDetails.aspx?BJID=339

Chronic hand eczema – a debilitating skin disease
Hand eczema is a common inflammatory skin disease and is often chronic and relapsing. Hand eczema is reported to affect up to ten percent of the general population. The more severe, chronic form of the condition is thought to affect five to seven percent of these patients, causing impaired use of their hands and a considerable impact on their ability to perform everyday activities.

Toctino (alitretinoin), the only therapy approved for severe chronic hand eczema unresponsive to potent topical treatments
Toctino was developed by Basilea Pharmaceutica International Ltd. Basilea markets Toctino in France, Germany, the United Kingdom, Switzerland and Denmark for the treatment of severe CHE. The company has appointed Actelion Pharmaceuticals Canada Inc. as its distributor for Toctino in Canada and Almirall, S.A. as its distributor in selected European markets and Mexico.

Health Canada approved Toctino for the treatment of severe chronic hand eczema refractory to high potency topical corticosteroids in adults.

In the largest ever phase III clinical trial program in CHE, Toctino was the first treatment to show effective clearing of severe CHE, with clear or almost clear hands achieved in nearly 50 percent of patients treated with 30 mg Toctino. The once-daily oral therapy for adults is given for 12 to 24 weeks, depending on patient response, and six-month post-treatment observations in patients who responded to Toctino indicate that treatment can provide long periods free from relapse and improve patient satisfaction. Toctino is a known teratogen (a substance that can cause birth defects when women are exposed during pregnancy). Strict pregnancy prevention one month before, during, and one month after cessation of treatment as well as monthly pregnancy testing are required for women of childbearing age. A comprehensive pregnancy prevention program for Toctino has been developed and implemented.

In clinical trials, Toctino was well tolerated and demonstrated a safety profile overall consistent with the retinoid class. Overall, the most frequently reported adverse events in the phase III clinical trials were headache and increased levels of blood lipids. Side effects were dose-dependent and reversible.

Contact
Basilea Pharmaceutica Ltd. Adesh Kaul Head Public Relations & Corporate Communications T.: +41 61 606 1460 E.: media_relations@basilea.com

Barbara Zink, Ph.D., MBA Head Corporate Development T.: +41 61 606 1233 E.: investor_relations@basilea.com