NICE Issues Positive Final Guidance Recommending The Use Of Basilea's Toctino(R)

Main Category: Eczema / Psoriasis
Also Included In: Dermatology
Article Date: 26 Aug 2009 - 3:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that the National Institute for Health and Clinical Excellence (NICE) issued its final guidance recommending the use of Toctino® (alitretinoin) within its licensed indication, as a treatment option for adults with severe chronic hand eczema that has not responded to potent topical corticosteroids.

The NICE Appraisal Committee recognized that Toctino®, an innovative therapy shown to be highly effective in Phase III trials, is a cost-effective use of National Health Service (NHS) resources. The final guidance is in line with the Final Appraisal Determination issued in July this year and can be found on the NICE http://www.nice.org.uk website.

"We welcome the publication of NICE's positive final guidance. It confirms the value Toctino brings to patients and the healthcare community," said Dr. Anthony Man, CEO, Basilea Pharmaceutica Ltd. "This decision will allow access to Toctino across England and Wales by patients suffering from severe chronic hand eczema."

The NHS will fund Toctino® for patients with severe disease, as defined by the physician's global assessment and a dermatology life quality index score of 15 or more. It is stated that NHS must provide funding and resources within three months of the final guidance being published.

In March of this year the Scottish Medicine's Consortium accepted Toctino® for use within the NHS Scotland.

Chronic hand eczema - a debilitating skin disease

Hand eczema is a common inflammatory skin disease and is often chronic and relapsing. It is characterized by thick, scaly skin that commonly gives rise to blisters, redness, swelling and painful cracks in the skin. 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) is the only therapy approved for severe refractory chronic hand eczema

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, the Netherlands and Spain. In addition, Toctino® has been recommended for approval in Italy and is under regulatory review in Canada, Switzerland and 15 additional European countries.

In the largest ever phase III clinical trial program in chronic hand eczema (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.

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 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
Basilea Pharmaceutica Ltd.