Basilea’s Toctino® accepted for use by the Scottish Medicines Consortium

Basel, Switzerland, Basilea Pharmaceutica Ltd. announces that the Scottish Medicines Consortium (SMC) has accepted Toctino® (alitretinoin) for use within National Health Service (NHS) Scotland for the treatment of adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids.

Toctino® is the only therapy approved for severe CHE unresponsive to potent topical corticosteroids.

The SMC considered Toctino’s® economic case demonstrated.
The SMC provides advice to NHS Boards and associated committees in Scotland regarding financial support of all newly licensed medicines. The SMC advice takes into account clinical data (efficacy and safety) as well as cost effectiveness. The Minister for Health and Community Care encourages NHS Boards to take account of the SMC recommendation and to ensure that recommended medicines are made available to meet clinical need.

“It is important for us to develop innovative therapies and bring them to market successfully as we have with Toctino®, and it is critical that patients have access to these treatments,” said Hans Christian Rohde, Chief Commercial Officer, Basilea Pharmaceutica Ltd. “With this decision, the SMC has confirmed that Toctino® is both efficacious and cost effective. We look forward to working with the NHS Boards in Scotland such that Toctino® is available for patients as soon as possible.”

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.

“People who have chronic hand eczema are severely disadvantaged since they are unable to use their hands normally,” said Margaret Cox, Chief Executive of the National Eczema Society, U.K. “This can lead to them taking time off work or even leaving their job altogether. Also, since the eczema is in a highly visible area – the hands – many patients experience embarrassment and low self esteem. Anything that can help treat the symptoms of this painful and distressing condition will be welcomed by chronic hand eczema sufferers.”

In the largest ever phase III clinical trial program in CHE, Toctino® was the first treatment able 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®.

Toctino® is a once-daily oral therapy for the treatment of adults that is given for 12 to 24 weeks, depending on patient response. In the six-month post-treatment observation in the pivotal phase III clinical trials, patients who responded to Toctino® experienced long periods free from relapse and improved patient satisfaction. Toctino® has been launched in Denmark, Germany and the United Kingdom and has received marketing authorization in Finland and France. It has also been recommended for approval in six additional EU Member States and is under regulatory review in Canada and Switzerland.

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.
About Basilea
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 (alitretinoin, ceftobiprole) and one investigational drug in phase III (isavuconazole). Toctino® (alitretinoin) is marketed in the United Kingdom, Denmark and Germany and is approved in Finland and France. Alitretinoin has been recommended for approval in six additional EU Member States and is under regulatory review in Canada and Switzerland. Furthermore a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Marketing applications for ceftobiprole (ZEFTERA™/Zevtera™) 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.
Disclaimer
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.