Basilea Pharmaceutica Ltd announced that after the negative decision by the CHMP, Cilag GmbH International, a Johnson & Johnson company, has given notice that it will return global rights of ceftobiprole to Basilea.
The European Committee for Medicinal Products for Human Use (CHMP) indicated that the study results of the clinical phase-III programme of ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI) suggested that the drug was beneficial to patients. The committee, however, adopted a negative opinion on the Market Authorization Application (MAA) due to concerns about the reliability of the results of the phase-III studies supporting the MAA, stating that the studies had not been conducted in compliance with 'good clinical practice' (GCP) in some sites.
Cilag GmbH International informed Basilea of its notice of termination of the License Agreement for ceftobiprole after the CHMP's negative decision.
"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 US 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 Dr Anthony Man, chief executive officer of Basilea. "We are pleased to gain full control of the development and commercialization of ceftobiprole. Basilea is committed to take those steps necessary to allow ceftobiprole to be more widely available to patients. We are reviewing all strategic options to protect the interests of Basilea and its shareholders."
Due to the deficiencies identified by the US Food and Drug Administration (FDA) in Johnson & Johnson PRD's conduct of the clinical investigations and Basilea's claim that Johnson & Johnson PRD breached the License Agreement, Basilea submitted a Request for Arbitration under the License Agreement for ceftobiprole in February 2009. Basilea's claims under arbitration include that Johnson & Johnson PRD breached the License Agreement by, among other things, causing the delay in the approval of ceftobiprole in the US and the EU. Basilea will now focus on its damage claims under arbitration and anticipates an arbitration decision prior to the end of 2010.
Under the terms of the License Agreement, there will be a one-year transition period during which Cilag is required to fulfil all its obligations under the Agreement, including but not limited to development, manufacturing and commercialization. In a next step both parties need to agree on a transition plan that ensures proper management of ongoing clinical and regulatory activities, commercialization and manufacturing and allows for an efficient handover at no cost to Basilea.
Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic exhibiting activity against a wide spectrum of Gram-positive bacteria, including the 'superbug' methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant
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.