Basilea's Toctino(R) Receives Marketing Authorization In Canada

Main Category: Eczema / Psoriasis
Also Included In: Regulatory Affairs / Drug Approvals;  Dermatology
Article Date: 18 Nov 2009 - 9:00 PST

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Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has obtained regulatory approval from Health Canada.

"We are delighted that Health Canada has approved the use of Toctino for patients with severe chronic hand eczema unresponsive to potent topical steroids. These patients have often suffered with this chronic debilitating condition for many years. Our rigorous, well designed clinical studies have clearly shown that Toctino has the potential to benefit a significant number of patients suffering from chronic hand eczema," said Dr. Anthony Man, CEO Basilea Pharmaceutica Ltd.

Toctino® has recently been launched in France and is already being marketed in Denmark, Germany and the United Kingdom for the treatment of adults with severe chronic hand eczema unresponsive to potent topical corticosteroids. Toctino® has also received marketing authorization in Austria, Belgium, Finland, Luxemburg, the Netherlands, Spain and Switzerland. Further, Toctino® has been recommended for approval in Italy. Alitretinoin is under regulatory review in 15 additional European countries.

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. It is characterized by thick, scaly skin that commonly gives rise to blisters, redness, swelling and painful cracks in the skin. 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.

About Toctino® (alitretinoin)

Toctino® was developed by Basilea Pharmaceutica International Ltd. Health Canada approved Toctino® for the treatment of severe chronic hand eczema refractory to high potency topical corticosteroids in adults.

Toctino® is a once-daily capsule to be taken with food. The recommended starting dose is 30 mg in most patients and a treatment course lasts up to 24 weeks depending on response. Alitretinoin is a naturally occurring, physiologic retinoid that is thought to work in CHE through anti-inflammatory and immunomodulatory effects.

Alitretinoin 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 has been developed and implemented. In clinical trials alitretinoin was well tolerated and has a safety profile overall consistent with the retinoid class. Side effects were generally dose-dependent.

Source
Basilea Pharmaceutica Ltd.