Basilea’s Toctino® recommended for approval in 15 additional European countries

Basel, Switzerland, Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin) was recommended for regulatory approval under the Repeat-use Procedure in 13 additional European Union (EU) Member States as well as in Norway and Iceland. Toctino® is a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids.

“We are very pleased about the recommendation for approval from the 15 European countries that were included in the procedure. Subject to national approval and price and reimbursement decisions, the availability of Toctino for patients and physicians will continue to expand across Europe,” said Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd.

The various EU Member States and European countries concluded that the profile of Toctino® is favorable for the use in adults who suffer from severe CHE that is unresponsive to treatment with potent topical corticosteroids. The recommendation for approval is the final step before national marketing licenses are granted.

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. It is characterized by thick, scaly skin that commonly gives rise to blisters, redness, swelling and painful cracks in the skin. 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.

About Toctino® (alitretinoin)
Toctino® was developed by Basilea Pharmaceutica International Ltd. To date, Toctino® has been launched in Denmark, France, Germany and the United Kingdom for the treatment of adults with severe chronic hand eczema unresponsive to potent topical corticosteroids. Toctino® has also received marketing authorization in Austria, Belgium, Canada, Finland, Luxemburg, the Netherlands, Spain and Switzerland. Further, Toctino® has been recommended for approval in 16 European countries.

Toctino® is a once-daily capsule to be taken with food. The recommended starting dose is 30 mg in most patients and a treatment course lasts up to 24 weeks depending on response.

Alitretinoin is a naturally occurring, physiologic retinoid that is thought to work in CHE through anti-inflammatory and immunomodulatory effects.
Alitretinoin 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 has been developed and implemented. In clinical trials alitretinoin was well tolerated and has a safety profile overall consistent with the retinoid class. Side effects were generally 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 (Toctino®, ZEFTERA™/ Zevtera™) and one investigational drug (isavuconazole) in phase III clinical development. Toctino® (alitretinoin) is marketed in Denmark, France, Germany and the United Kingdom and is approved in Austria, Belgium, Canada, Finland, Luxemburg, the Netherlands, Spain and Switzerland. Toctino® has been recommended for approval in 16 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 ZEFTERA™ and in Switzerland under Zevtera™. Ceftobiprole is under regulatory review in the U.S., in the EU and several other countries. Basilea has set up commercial organizations in Canada, France, Germany, the Nordics and the United Kingdom, 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.