ceftobiproleTreatment for Skin and Structure Infection
FDA accepts for review the Complete Response submission to ceftobiprole NDA
Basel, Switzerland, September 1, 2009 - Basilea Pharmaceutica Ltd. announces that the U.S. Food and Drug Administration (FDA) has accepted the response submitted by the sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (PRD) as complete. The Complete Response submission addresses the FDA Complete Response Letter issued in November 2008 concerning the ceftobiprole NDA for complicated skin and skin structure infections.
The FDA informed Johnson & Johnson PRD that it considers the resubmission a complete, class 2 response. "We are pleased that the FDA has accepted for review the submission related to the Complete Response Letter. We look forward to the advancement of ceftobiprole through the FDA review process," commented Dr. Anthony Man, CEO.
Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic. It is marketed in Canada (Zeftera) for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis and in Switzerland (Zevtera) for the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections without concomitant osteomyelitis.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International, a Johnson & Johnson company.
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(TM)/ Zevtera(TM)) and one investigational drug in phase III (isavuconazole). Toctino® (alitretinoin) is marketed in the United Kingdom, Denmark and Germany and is approved in Austria, Belgium, Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoin has been recommended for approval in Italy and is under regulatory review in Canada, Switzerland and 15 additional 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(TM) and in Switzerland under Zevtera(TM). Ceftobiprole is under regulatory review in the U.S. and marketing applications are submitted in 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: September 2009
- FDA Issues Complete Response Letter for Ceftobiprole - December 30, 2009
- FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections - November 26, 2008
- FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter - September 15, 2008
- FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections - March 18, 2008
- FDA Published Today That It Will Not Hold an Advisory Committee Meeting on Ceftobiprole in the Treatment of Complicated Skin and Skin Structure Infections - February 13, 2008
- Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting - January 10, 2008
- U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin - July 18, 2007
- New Drug Application Submitted For Novel Investigational Antibiotic Ceftobiprole - May 18, 2007