Friday, Janssen-Cilag International NV, of Johnson & Johnson Co. (JNJ) announced that the Committee for Medicinal Products for Human Use, or CHMP, of European Medicines Agency adopted a negative opinion on its Marketing Authorisation Application for the antibiotic Zeftera to treat complicated skin and soft tissue infections, or cSSSI.
The Committee adopted a negative opinion citing concerns about the reliability of the results of the phase III studies, which did not adhere to "good clinical practice" in some sites.
Zeftera or ceftobiprole medocaril is an anti-MRSA, or methicillin-resistant Staphylococcus aureus, broad-spectrum cephalosporin antibiotic exhibiting activity against a wide spectrum of Gram-positive bacteria, including the 'superbug' MRSA and penicillin-resistant Streptococcus pneumonia as well as many clinically important Gram-negative bacteria, including Pseudomonas.
In February 2005, Basilea Pharmaceutica Ltd. granted Johnson & Johnson's Cilag GmbH International an exclusive worldwide license to develop, manufacture and commercialize ceftobiprole. In June 2007, the MAA for ceftobiprole for the treatment of cSSTI was filed by Janssen-Cilag.
The Basel, Switzerland-based Basilea submitted a request for Arbitration under the License Agreement for ceftobiprole in February 2009. It claimed that Johnson & Johnson PRD breached the License Agreement by, among other things, causing the delay in the approval of ceftobiprole in the U.S. and the EU. Basilea intends to focus on its damage claims under arbitration and anticipates an arbitration decision prior to the end of 2010.
In its statement, Basilea said that it is "pleased to gain full control of the development and commercialization of ceftobiprole" and is reviewing all strategic options.
As part of the clause agreed upon, Cilag issued a notice of termination of the worldwide license, development and co-promotion agreement to Basilea. Cilag is required to fulfill "all its obligations under the Agreement, including but not limited to development, manufacturing and commercialization."
In December 2009, the U.S. Food and Drug Administration, or FDA issued to the sponsor, Johnson & Johnson PRD, a Complete Response Letter indicating that the Agency cannot approve the NDA in its present form. The FDA recommended two new, adequate, and well-controlled studies to evaluate the safety and efficacy of ceftobiprole for the treatment of cSSSI.
Ceftobiprole is marketed in Canada as Zeftera for the treatment of cSSSI, including non-limb threatening diabetic foot infections without concomitant osteomyelitis and in Switzerland as Zevtera for the treatment of cSSTI including diabetic foot infections without concomitant osteomyelitis.
"The CHMP indicated today that study results suggested that ceftobiprole was beneficial to patients. The rejection of the New Drug Application (NDA) and MAA by health authorities in the U.S. and EU, respectively, because of data integrity issues have led to significant delays in ceftobiprole being available to patients with potentially life-threatening resistant bacterial infections," commented Basilea's CEO Anthony Man.
Friday, JNJ finished regular trading at $63.81, on the NYSE.
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