Basilea Pharmaceutica files claims against Johnson & Johnson

Basilea Pharmaceutica has filed claims in arbitration against Johnson & Johnson and affiliated companies related to delays in approval of ceftobiprole.

Basilea submitted a request for arbitration to the Netherlands Arbitration Institute under the licensing agreement for ceftobiprole, naming Johnson & Johnson companies, Johnson & Johnson Pharmaceutical R&D (Johnson & Johnson PRD) and Cilag International, a wholly owned Swiss subsidiary of Johnson & Johnson (collectively Johnson & Johnson) as respondents. The request for arbitration relates to damages suffered by Basilea that result from delay in the approval of ceftobiprole in the US and EU as well as milestone payments.

Johnson&Johnson was granted an exclusive worldwide license to ceftobiprole in February 2005. A marketing authorization application was filed with the European Medicines Agency (EMEA) for ceftobiprole for the treatment of complicated skin and soft tissue infections by the applicant Janssen-Cilag International, a Johnson&Johnson company in June 2007.

In November 2008 ceftobiprole received a positive benefit-risk opinion and recommendation for approval from the EU Committee for Medicinal Products for Human Use (CHMP). The CHMP has now communicated that the EMEA will conduct good clinical practice (GCP) inspections and that it has halted the EU commission decision process until review of the inspection outcome is completed. Basilea anticipates the CHMP GCP inspections to be completed in the second half of 2009.

A new drug application for ceftobiprole was submitted to the FDA in the US by Johnson&Johnson PRD in May 2007. The FDA issued an approvable letter in March 2008. Thereafter, the agency conducted additional inspections of the investigator sites and an inspection of the sponsor Johnson&Johnson PRD and issued a sponsor 483 report.

The FDA concluded from inspections that Johnson&Johnson PRD failed to ensure proper monitoring of the studies. The FDA indicated in its complete response letter the existence of data integrity issues and that further resolution of specific deficiencies of study conduct is necessary, said Basilea.

The agency has also requested information on Johnson&Johnson PRD’s clinical quality assurance programs. Furthermore, as a result of FDA inspections at investigator sites and of the sponsor, Johnson&Johnson PRD, the FDA suggested that Johnson&Johnson PRD have additional clinical site audits performed. These additional audits are anticipated to occur in the first half of 2009 with a complete response submission foreseen in the second half of 2009.

Ceftobiprole is marketed in Canada under the brand name Zeftera and in Switzerland under Zevtera.