Basilea antibiotic hit with complete response letter
This article was originally published in Scrip
The US FDA has issued a complete response letter denying approval for Basilea Pharmaceutica and Johnson & Johnson's Zeftera (ceftobiprole) for the treatment of complicated skin and skin structure infections. In the letter, the agency questioned the integrity of the trial data.
Basilea – who saw its share price fall by 15% to CHF64.30 ($62.36) on the Swiss exchange on December 30th – is seeking remuneration from J&J for the way the clinical trials were run.
J&J licensed the broad spectrum cephalosporin from Basilea in February 2005, and an NDA was submitted in May 2007. After issuing an approvable letter in March 2008, the FDA then issued a complete response letter in November 2008 due to concerns about the monitoring of the studies. In the EU, an approval was similarly delayed, despite a positive CHMP opinion, to allow for the completion of a good clinical practice inspection.
The companies now face a new delay, after the drug was re-filed with the FDA in September 2009. In its latest complete response letter, the agency said that some of the data from two pivotal studies – BAP00154 and BAP00414 – were unreliable and unverifiable, raising concerns about overall integrity of both studies. The FDA previously issued J&J with a warning letter about "objectionable conditions" in two clinical trials (scripnews.com, August 19th, 2009).
Two new studies assessing both safety and efficacy, along with some other measures, will be needed to support a filing, the agency says. Jefferies analysts noted that such trials could take around two years to complete, potentially delaying approval until 2013.
An EU decision on the drug is expected in the first quarter of 2010.
Basilea says it is disappointed with the delay, but that it remains committed to making Zeftera available. It says it is "reviewing all strategic options to protect the interests of the company and its shareholders."
Zeftera is also in development for hospital-acquired pneumonia, and Jefferies analysts forecast a 2012 filing for this indication.
Arbitration
Basilea is already seeking arbitration, alleging that J&J breached the license agreement by, among other things, delaying the approval of Zeftera. Basilea's initial damage claims – including milestone payments and additional damages – will increase as a result of this new delay, it says.
Basilea anticipates an arbitration decision before the end of 2010.