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Basilea Pharmaceutica AG (CH) - Discontinuation of Sale of ceftobiprole in Canada

 

 
Janssen-Ortho Inc., the holder of the Market Authorization in Canada, is discontinuing sale of ZEFTERA(TM) effective April 16, 2010. This action is being taken by Janssen-Ortho Inc. following discussions with Health Canada in response to recent regulatory recommendations in the United States and European Union to not approve ZEFTERA(TM) for cSSSI due to concerns regarding the conduct of clinical trials.
ZEFTERA(TM) was authorized in Canada in June 2008 for the treatment of cSSSI. There have been no safety observations that would be in conflict with the approved label of ZEFTERA(TM) in Canada. The decision to discontinue sale of the product in the Canadian market does not preclude the submission of a new application for market authorization in the future.
Recently, the European Committee for Medicinal Products for Human Use (CHMP) indicated that, although the study results suggested that ceftobiprole is beneficial to patients, it was concerned about how reliable the trial results were. The Committee therefore recommended that, in light of the uncertainty surrounding the results, ceftobiprole should not be granted marketing authorization for the treatment of complicated skin and soft tissue infections at this time. The sponsor Janssen-Cilag International NV, a Johnson & Johnson company, submitted a request for re-examination of the negative opinion by the CHMP.
In December 2009, the U.S. Food and Drug Administration (FDA) issued to the sponsor of the US filing, Johnson & Johnson Pharmaceutical Research and Development, L.L.C., a Complete Response Letter on ceftobiprole for the treatment of cSSSI, indicating that the Agency cannot approve the New Drug Application in its present form. The Agency determined that data from the phase III clinical trials could not be relied upon because of concerns regarding the overall data integrity for both studies.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Its integrated research and development operations are currently focused on antibiotics and antifungals, as well as on the development of dermatology and oncology drugs, all areas in which the medical challenge of rising resistance or non-response to current treatment options is commonly encountered. Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting.

The company owns a broad and diversified portfolio. Basilea is marketing Toctino® (alitretinoin), for the treatment of severe chronic hand eczema, in Denmark, France, Germany, Switzerland and the United Kingdom. The drug is approved in ten additional European countries as well as in Canada and has been recommended for approval in 12 further European countries. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Basilea has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. for its phase III compound isavuconazole for the treatment of life-threatening invasive fungal infections on a worldwide basis, including an option for Japan. Full rights to a third late-stage product, ceftobiprole for the treatment of potentially life-threatening resistant bacterial infections, will be transferred from Cilag GmbH International, a Johnson & Johnson company, back to Basilea.
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.
For further information, please contact:
Media Relations
Investor Relations
Adesh Kaul
Head Public Relations &
Corporate Communications
+41 61 606 1460
Barbara Zink, Ph.D., MBA
Head Corporate Development
+41 61 606 1233
 

Posted: April 2010


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