J&J-Sponsored Antibiotic Trial Cited In Second Warning Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
Another potential obstacle arises to the approval of Johnson & Johnson and Basilea’s investigational antibiotic ceftobiprole, as the contract research organization that conducted a clinical trial of the drug receives a warning letter.
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As if a dispute that has gone into arbitration and a "complete response" letter aren't enough challenges for Johnson & Johnson's and Basilea Pharmaceutica's investigational antibiotic ceftobiprole, FDA has issued a second warning letter about the conduct of a clinical trial of the drug. The first warning letter was sent Aug. 10 to J&J, the trial's sponsor and the NDA holder ('The Pink Sheet' DAILY, Aug. 19, 2009). On Dec. 8, FDA posted on its website a second warning letter relating to the trial. The new warning letter, which is dated Nov. 27, went to ICON Clinical Research, a Dublin, Ireland-based international contract research organization that conducted the drug trial. It was Basilea that hired ICON to run the trial, J&J spokesman Ernie Knewitz said in an interview. The warning letters overlap in their description of the problems with the trial, such as the enrollment of ineligible patients and the fact that "study monitors failed to identify that on multiple occasions, site personnel documented administration of study drug to different subjects at precisely the same time," FDA said. The latter point might seem to raise questions about the reliability of the study data. Knewitz declined to comment directly on this point, but said J&J has audited the trial and submitted the results to FDA. How the second warning letter affects the prospects for approval of ceftobiprole are unclear. Other antibiotics, notably the still-pending telavancin and Sanofi-Aventis' Ketek , have suffered from data integrity problems as well ('The Pink Sheet' DAILY, Oct. 16, 2008), and the additional warning letter could be a message from FDA to industry and vendors that it plans on very strict enforcement in this area. J&J's Knewitz said that the problems cited in the warning letters are not related to J&J's dispute with Basilea or to the "complete response" letter FDA sent J&J in November 2008. Basilea is seeking damages and missed milestone payments from J&J due to delays in ceftobiprole's approval. "We're still committed to work through our issues with Basilea," Knewitz said. "We are still committed to developing the drug." In September, Basilea said FDA had accepted J&J's "complete response" to the agency's "complete response" letter. Ceftobiprole is approved in Canada and Switzerland for the treatment of complicated skin and skin structure infections. The brand name in Canada is Zeftera, while in Switzerland the drug is sold as Zevtera . J&J is seeking a similar indication for the drug in the U.S. -Martin Berman-Gorvine ([email protected]) |