- 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
Alitretinoin (Toctino®), for the treatment of severe chronic hand eczema, in Denmark, France,
Germany, Switzerland and the United Kingdom. The drug is
approved in 16 additional European countries as well as in Canada and has
been recommended for approval in six further European countries.
Basilea has appointed Almirall S.A. as its distributor for Toctino®
in selected European markets and Mexico.
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.
© 2010 Basilea Pharmaceutica Ltd.
