Basilea Pharmaceutica AG (CH) - Discontinuation of sale of ceftobiprole in Switzerland
Basel, Switzerland, September 09, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that Janssen-Cilag AG, a Johnson & Johnson company, will be discontinuing sale of ceftobiprole (Zevtera(TM)) for the treatment of complicated skin and soft tissue infections (cSSTI) in Switzerland.
Janssen-Cilag AG, the holder of the Marketing Authorization in Switzerland, has requested Swissmedic to withdraw the marketing authorization of Zevtera(TM) and will discontinue sale of Zevtera(TM) as of September 17, 2010. This action is being taken based on the unfavorable assessments of the marketing authorization applications for ceftobiprole in the United States and the European Union.
Physicians are advised to allow all patients on Zevtera(TM) to complete their course of therapy and not to initiate treatment of new patients. Zevtera(TM) was authorized in Switzerland in November 2008 for the treatment of cSSTI. There have been no safety observations that would be in conflict with the approved label of Zevtera(TM).
The decision to discontinue sale of the product in the Swiss market does not preclude the submission of a new application for marketing authorization in the future.
Corresponding requests for the withdrawal of Marketing Authorizations are being submitted to health authorities by a respective Janssen-Cilag company holding the Marketing Authorization in Russia, Ukraine and Azerbaijan, the remaining countries in which ceftobiprole is currently approved.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Its fully integrated research and development operations are currently focused on antibiotics, antifungals and oncology drugs, as well as on the development of dermatology drugs, targeting the medical challenge of resistance and non-response to current treatment options in the hospital and specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only approved treatment for severe chronic hand eczema unresponsive to potent topical corticosteroids, in Denmark, France, Germany, Switzerland and the United Kingdom and has appointed distributors for Toctino® in other selected European markets, Canada and Mexico. Furthermore, a phase III clinical program on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. The company has entered into a global partnership with Astellas Pharma Inc. for its phase III compound isavuconazole, a potential best-in-class azole antifungal, for the treatment of life-threatening invasive fungal infections. Full rights to ceftobiprole for the treatment of potentially life-threatening resistant bacterial infections, are being transferred back to Basilea from Cilag GmbH International, a Johnson & Johnson company.
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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Ceftobiprole Discontinuation SWI<http://hugin.info/134390/R/1443360/387537.pdf>
Posted: September 2010