Basilea's Toctino included in expert consensus for management of chronic hand eczema in France

The comprehensive review provides a practice-oriented expert opinion for the management of chronic hand eczema in France and recommends prompt intervention with oral alitretinoin therapy, the first systemic treatment authorized for the management of severe chronic hand eczema that is unresponsive to topical corticosteroids. The document is published in Annales de dermatologie et de vénéréologie (B. Halioua, M.-A. Richard; Vol 137, No. 4: pp. 315-327; April 2010).

"The inclusion of Toctino as treatment of choice for chronic hand eczema unresponsive to topical corticosteroids into this expert consensus indicates that Toctino has a clear role to play in the management of this very debilitating and painful skin disease," said Hans Christian Rohde, Chief Commercial Officer, Basilea Pharmaceutica International Ltd. "This state-of-the-art guideline supports optimal management of a condition that severely impacts patients' quality of life and their ability to perform everyday activities."

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, the only therapy approved for severe chronic hand eczema unresponsive to potent topical corticosteroids
Toctino was developed by Basilea Pharmaceutica International Ltd. To date, Toctino is launched in Denmark, France, Germany, Switzerland and the United Kingdom for the treatment of severe chronic hand eczema. The drug is approved in 11 additional European countries as well as in Canada and has been recommended for approval in 11 further European countries.

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 30 mg Toctino. The once-daily oral therapy 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.


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