Basilea, J&J infectious news
Basilea filed a request for arbitration to the Netherlands Arbitration Institute alleging that Johnson & Johnson mishandled its clinical and regulatory responsibilities for Zevtera ceftobiprole in the EU and the U.S under the partners 2005 license deal. Basilea is seeking damages, including about CHF100 million ($86.5 million) in regulatory milestones plus other undisclosed damages suffered by Basilea due to regulatory delays. The biotech filed the arbitration request at the same time EMEA's CHMP said it would delay a decision on an MAA for Zevtera to treat complicated skin and soft tissue infections (cSSTIs) pending Good Clinical Practice (GCP) inspections. Basilea expects the inspection to be completed in 2H09.
In November, FDA issued a complete response letter for an NDA for Zevtera to treat complicated skin and skin structure infections (cSSSIs), including diabetic foot infections, seeking further resolution of "deficiencies of study conduct" and cited a "failure to ensure proper monitoring" of studies. J&J did not respond to a request for comment (see BioCentury, Dec. 8, 2008). ...