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 (ZEFTERATM) for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis and in Switzerland (ZevteraTM) 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®, ZEFTERATM/ ZevteraTM) 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 ZEFTERATM and in Switzerland under ZevteraTM. 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.