CHMP rebuffs ceftobiprole, J&J ends deal

Johnson & Johnson (NYSE:JNJ) returned to Basilea Pharmaceutica AG (SIX:BSLN) worldwide rights to ceftobiprole after the European Medicines Agency's CHMP issued a negative opinion to treat complicated skin and soft tissue infections (cSSTIs). The committee was concerned about the reliability of the data for ceftobiprole after EMA inspections showed that the clinical studies had not been conducted in compliance with good clinical practice (GCP). Basilea is reviewing strategic options and will focus on its ongoing arbitration against J&J related to the pharma's handling of clinical studies for the broad spectrum anti-MRSA cephalosporin antibiotic. Basilea expects an arbitration decision by year end (See BioCentury Extra, Tuesday, Feb. 24, 2009).

In December, J&J received a complete response letter from FDA for the antibiotic to treat complicated skin and skin structure infections (cSSSIs). FDA indicated that data from two Phase III trials of ceftobiprole were unreliable based on inspections and audits of about one third of the trial's sites. It was the second complete response letter for the compound, with FDA issuing the first in November 2008; FDA issued an approvable letter for the compound in March 2008 (See BioCentury Extra, Wednesday, Dec. 30, 2009). ...