NICE Issues Preliminary Recommendations For Basilea's Toctino(R)

Main Category: Eczema / Psoriasis
Also Included In: Dermatology
Article Date: 03 May 2009 - 0:00 PDT

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Basilea Pharmaceutica Ltd. (SWISS: BSLN) (PINKSHEETS: BPMUF) announces that the Appraisal Committee of the National Institute for Health and Clinical Excellence (NICE) has developed preliminary positive recommendations with some limitations on the use of Toctino® (alitretinoin) within its licensed indication, as treatment for adults with severe chronic hand eczema that has not responded to potent topical corticosteroids.

The Committee's preliminary recommendations in the appraisal consultation document (ACD) does not constitute the Institute's formal guidance. A consultation period with all stakeholders will now occur and the preliminary recommendation may change after consultation. The second Appraisal Committee meeting is scheduled in June 2009 and the final guidance from NICE is anticipated by the end of August 2009.

"We continue to work together with NICE on these preliminary recommendations. Our goal is to ensure that all patients who fall within the approved indication for Toctino have access to this breakthrough treatment through the National Health Service in England and Wales," said Hans Christian Rohde, Chief Commercial Officer, Basilea Pharmaceutica International Ltd.

The preliminary recommendations (ACD) can be found on the NICE website http://www.nice.org.uk

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. 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 corticosteroids

Toctino® was developed by Basilea Pharmaceutica International Ltd. To date, Toctino® is launched in Denmark, Germany and the United Kingdom, and has received marketing authorization in Austria, Belgium, Finland, France, Luxemburg and the Netherlands. In addition, Toctino® has been recommended for approval in two additional EU Member States and is under regulatory review in Switzerland, Canada and 15 additional 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, with clear or almost clear hands achieved in nearly 50 percent of patients treated 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.

A phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S.

Source
National Institute for Health and Clinical Excellence