Basilea Pharmaceutica Ltd. (CH) - Zevtera Review Process Delayed in EU
Basel, Switzerland, February 24, 2009 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that the EU Committee for Medicinal Products for Human Use (CHMP) has indicated that the European Commission decision process on Zevtera(TM) (ceftobiprole) for the treatment of complicated skin and soft tissue infections (cSSTI) is delayed.
Zevtera(TM) showed in two large multinational, double-blind, randomized phase III clinical studies, that it was effective in treating cSSTI, as demonstrated by meeting the primary endpoint using a 10% non-inferiority margin. A safety profile consistent with the cephalosporin class of antibiotics was demonstrated.
Basilea received information that the CHMP will delay the European Commission decision process relating to the Marketing Authorization Application for Zevtera(TM) by Janssen-Cilag International NV, a Johnson & Johnson company, pending Good Clinical Practice (GCP) inspections by the European Medicines Agency (EMEA). As soon as a written confirmation from the EMEA is available Basilea will provide an update with more details. Basilea anticipates the inspections to be completed by the second half of this year.
About Zevtera(TM) Zevtera(TM) (ceftobiprole medocaril for injection) is the first approved broad-spectrum anti-MRSA antibiotic belonging to the cephalosporin class. Ceftobiprole as a single intravenous agent has demonstrated broad-spectrum activity against a wide range of difficult-to-treat Gram-positive and Gram-negative hospital and community-acquired infections including methicillin-resistant Staphylococcus aureus (MRSA).
A Marketing Authorization Application was filed with the European Medicines Agency for ceftobiprole for the treatment of cSSTI by the applicant Janssen-Cilag International NV, a Johnson & Johnson company in June 2007. In November 2008 ceftobiprole received a positive benefit-risk opinion and recommendation for approval from the CHMP.
Ceftobiprole has been approved and is marketed in Canada (ZEFTERA(TM)) for treatment of skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections and Switzerland (Zevtera(TM)) for the treatment of cSSTI including diabetic foot infections.
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(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.
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Posted: February 2009
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