Basilea Pharmaceutica Ltd. announced that Basilea Pharmaceutica International Ltd. has entered into an exclusive distribution agreement with Almirall, S.A. for Basilea's Toctino (alitretinoin), a once-daily oral treatment for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids, in selected European markets and Mexico.
Basilea has appointed Almirall as its exclusive distributor for Toctino in Austria, Belgium, Czech Republic, Italy, Luxembourg, Mexico, the Netherlands, Poland, Portugal, Slovakia and Spain. Basilea retains the future right to co-promote Toctino in selected markets covered under the agreement.
Under the terms of the agreement, Basilea will be eligible for upfront and milestone payments totalling EUR 27 million, including up to EUR 16 million in upfront payments and milestones related to the launch of Toctino in two key markets of the territory.
"We are very pleased to further expand the commercial availability of Toctino through this partnership with Almirall, a leading dermatology company in Europe. Almirall has a well-established and significant sales force with a successful track record in markets where Basilea has not yet established a full commercial sales presence, including in Almirall's home market Spain," said Dr. Anthony Man, CEO Basilea Pharmaceutica Ltd. "Through this partnership Toctino will be available sooner and to more patients than otherwise possible in these selected markets."
Toctino was developed by Basilea Pharmaceutica International Ltd.
To date, Toctino is marketed in Denmark, France, Germany, Switzerland and the United Kingdom for the treatment of severe chronic hand eczema (CHE). The drug is approved in 15 additional European countries as well as in Canada and has been recommended for approval in seven 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 unresponsive to potent topical corticosteroids, with clear or almost clear hands achieved in nearly 50 percent of patients treated with 30 mg Toctino. The once-daily oral therapy for adults 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 programme 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.
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.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting.