- Corporate
Alitretinoin
Alitretinoin belongs to the well studied family of retinoids and is targeted at adult patients with severe chronic hand eczema (CHE) who do not respond to topical corticosteroids.
Current status
Toctino® (alitretinoin) is marketed in Austria, Canada, Denmark, Finland, France, Germany, Italy, Norway, Switzerland and the United Kingdom. In addition, the drug is approved in 17 further European countries as well as Israel. Basilea has appointed distributors for Toctino® in selected European markets, Canada, Israel, Mexico and the Republic of Korea. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S.
The need of a new therapy
Hand eczema is a common inflammatory skin disease and is often chronic and relapsing. Hand eczema is estimated 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 many of whom do not respond, or no longer respond to treatment with potent topical corticosteroids.
Phase III data
The two placebo-controlled pivotal phase III trials included almost 2000 patients and healthy volunteers treated with alitretinoin. In the BACH trial (Benefit of Alitretinoin in Chronic Hand eczema) alitretinoin met its primary endpoint and the drug was effective in patients suffering from severe and refractory chronic hand eczema, as determined by the endpoint of clear and almost clear hands. In a second pivotal phase III trial, patients who relapsed after being initially responsive to alitretinoin also responded to a second course of treatment.
Basilea Pharmaceutica is currently conducting a phase III study on alitretinoin for the treatment of severe chronic hand eczema in the U.S. The "HANDEL" trial (HAND Eczema research of aLitretinoin) is the first ever multi-centered, controlled clinical study for patients with severe CHE performed in the U.S. The study takes place across the United States and will enroll 600 patients.
Alitretinoin is generally well tolerated and the observed side effects were typical of the retinoid class. Similar to other systemic retinoids, alitretinoin is a teratogen and therefore, alitretinoin is strictly contraindicated in women of child-bearing potential unless strict pregnancy testing and contraception is followed one month before, during and one month after cessation of treatment.
© 2012 Basilea Pharmaceutica Ltd.
