Actelion’s R&D group will spin off into a new biotech soon with a stinging setback to deal with.
The Swiss biotech, which has been at work finalizing the $30 billion J&J deal to acquire the commercial drug portfolio and partner on the experimental pipeline, announced early Thursday that it racked up one win and one loss in Phase III for its antibiotic cadazolid.
That’s all we know and evidently about all we’re going to find out right now. In a short statement the biotech said that their antibiotic had been tested in a Phase III program with 1,263 patients, comparing 250 mg of cadazolid twice daily against 4 daily doses of 125 mg vancomycin.
The next step: Do the full analyses of the Phase III studies and then release it as the company figures out what to do with it.
History would suggest that Actelion’s spinout, Idorsia, will have to do another successful Phase III to get the FDA’s endorsement. Tetraphase went through one successful trial and one flop with eravacycline, saw their share price crushed and were told to do another Phase III non-inferiority study.
And that’s what they’re doing now.
J&J set up a revenue sharing deal for the spinout on two late-stage efforts for ponesimod — the more closely-watched therapy — and cadazolid in order to complete the buyout.
Antibiotic development overall has been a hit and miss affair for the past few years. Cempra recently was hit hard by successive failures for its lead antibiotic, while Paratek —partnered with Allergan — and Zavante are both lining up regulatory applications.
While antibiotic development hasn’t been completely abandoned by Big Pharma — Merck and Roche have been involved — R&D activity slowed considerably as developers abandoned a field known for thin margins. Drug resistance subsequently brewed up with only a thin industry pipeline to fight back. And with a host of cheap generics on the market, there’s still plenty of reluctance to dive back in without more incentives.
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