Basilea Pharmaceutica Ltd has received a milestone payment of EUR 5.5 million under its distribution agreement for Toctino (alitretinoin) with Almirall, S.A.
The milestone payment of EUR 5.5 million relates to Italy where Toctino will become available in the coming weeks and local market access activities have been initiated in the individual regions throughout Italy.
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.
In Italy, Toctino is approved for the use in adults who have severe chronic hand eczema (CHE) that is unresponsive to treatment with potent topical corticosteroids.
Basilea is marketing Toctino in France, Germany, the United Kingdom, Switzerland and Denmark and has appointed distributors for Toctino in other selected European markets, Canada and Mexico.
In the largest ever phase-III clinical trial programme 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 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.