NICE issues positive Final Appraisal Determination recommending the use of Basilea's Toctino®
Basel, Switzerland, July 16, 2009
Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that the National Institute for Health and Clinical Excellence (NICE) today issued the Final Appraisal Determination (FAD) 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 FAD published today will become the Institute's final guidance to the National Health Service (NHS) at the end of August, according to NICE's publication schedule, assuming no appeals are made by the appraisal consultees.
"The positive Final Appraisal Determination is an important milestone for Basilea and is confirmation of the value Toctino brings to patients and the healthcare community," said Dr. Anthony Man, Chief Executive Officer, Basilea Pharmaceutica Ltd. "The NICE recommendation should provide patients in England and Wales who suffer from severe chronic hand eczema a real chance to obtain hands cleared of eczema and the possibility to resume normal activities."
NICE determined that Toctino®, an innovative therapy shown to be highly effective in phase III trials, is a cost-effective use of NHS resources. Toctino® is recommended for patients with severe disease, which is defined by a physician's global assessment and a dermatology life quality index score of 15 or more.
In March of this year the Scottish Medicine's Consortium determined Toctino® should be made available to patients in Scotland.
The FAD can be found on the NICE www.nice.org.uk website.
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) is 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, 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 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.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated research and development operations are currently focused on new antibacterial, antifungal and oncology agents to fight drug resistance and on the development of dermatology drugs. Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting. The company owns a diversified portfolio including two commercialized drugs (Toctino®, ZEFTERATM/ ZevteraTM) and one investigational drug in phase III (isavuconazole). Toctino® (alitretinoin) is marketed in the United Kingdom, Denmark and Germany and is approved in Austria, Belgium, Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoin has been recommended for approval in Italy and is under regulatory review in Canada, Switzerland and 15 additional European countries. Furthermore a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Ceftobiprole is marketed in Canada under the brand name ZEFTERATM and in Switzerland under ZevteraTM. Marketing applications for ceftobiprole were submitted in the U.S., the EU and several other countries. The company has set up commercial organizations in UK, Denmark, Germany and Canada, while it is building sales and marketing organizations in other countries to commercialize alitretinoin and to co-promote ceftobiprole, subject to approval.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.