J&J is washing its hands of the Phase III Clostridium difficile-associated diarrhea program for the antibiotic cadazolid.
The pharma giant obtained rights to the antibiotic in their $30 billion buyout of Actelion. But as the deal was being completed, cadazolid floundered — hitting the goal posts in one study but missing in another — after recruiting 1,263 patients to compare 250 mg of cadazolid twice daily against 4 daily doses of 125 mg vancomycin.
Typically the FDA requires a success in two pivotal studies to warrant an approval — a standard that has bedeviled a variety of small players like Tetraphase. Last June the execs at Actelion, who were taking some assets and spinning out into a new company called Indorsia, said they’d do a final analysis and determine what to do next.
J&J wrote it off in their quarterly release, saying only that they would discontinue the Phase III program.
J&J won the deal to buy Actelion last year after Sanofi managed to tick off Actelion CEO Jean-Paul Clozel. The cadazolid pact was put in place alongside a partnership on ponesimod, the more closely-watched drug.
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