Healthcare Industry News:  ceftobiprole 

Biopharmaceuticals Dermatology Regulatory

 News Release - March 11, 2009

Basilea's Toctino(R) Receives Marketing Authorization in Belgium and Luxemburg

BASEL, SWITZERLAND--(Healthcare Sales & Marketing Network)--Mar 11, 2009 -- Basilea Pharmaceutica Ltd. (Other OTC:BPMUF.PK ) (Swiss:BSLN.SW ) announces that Toctino® (alitretinoin), a new once- daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the health authorities in Belgium (Agence Fédérale des Medicaments et des Produits de Santé [AFMPS]) and in Luxemburg (Ministère de la Santé [MS]).

Subsequent to the recommendation for regulatory approval under the European decentralized procedure, Basilea received the marketing authorization for Toctino® in Belgium and Luxemburg. Following the regulatory approval of Toctino® in Belgium and Luxemburg, Basilea will submit a pricing and reimbursement dossier to the country authorities.

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®, the only therapy approved for severe chronic hand eczema unresponsive to potent topical corticosteroids

Toctino® (alitretinoin) was developed by Basilea Pharmaceutica International Ltd.

The Belgian AFMPS and the MS in Luxemburg approved Toctino® for the use in adults who have severe CHE that is unresponsive to treatment with potent topical corticosteroids.

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 also received marketing authorization in Finland and France. It has also been recommended for approval in four additional EU Member States and is under regulatory review in Canada and Switzerland.

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 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 Belgium, Finland, France and Luxemburg. Alitretinoin has been recommended for approval in four 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(TM)/Zevtera(TM)) 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.


Source: Basilea Pharmaceutica

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