pharmafileJune 12, 2017
Tag: Actelion
Idorsia, the spin-off R&D company of Actelion, has been hit a blow even before it has left the ground. The new biotech had agreed a revenue sharing deal with Johnson & Johnson on its antibiotic candidate, cadazolid.
However, the company has released the news that the antibiotic achieved mixed results in Phase 3 trials – hitting the primary endpoint in one trial and missing it in the other.
J&J are in the process of wrapping up its deal for Actelion but the news that one of the products that it would share revenues on will sting, just before it completes the deal. The results are unfortunate but not a major blow for the company, as it has a keener interest in the existing assets at Actelion.
However, for Idorsia, the hit is heavier, as the antibiotic represents a larger prospect for the company. It means that the spin-off will have to return the antibiotic to further clinical trials before pursuing approval through the FDA.
Cadazolid was being tested in a total of 1263 patients globally, with it being tested against vancomycin. Actelion released a statement regarding the faring of the antibiotic in the trials: "In the pivotal program, IMPACT 1 met its primary endpoint, while the second study IMPACT 2 did not meet the primary endpoint. Cadazolid demonstrated an acceptable tolerability and safety profile in the IMPACT program…The company will now work diligently to complete the analyses of the full study results and detailed results will be made available through scientific disclosure at upcoming congresses and in peer-reviewed publications."
To say the press release was brief would be something of an understatement; the above statement from the company constitutes almost the entirety of the release.
When pressed for further details, a spokesperson suggested that the press release was the extent of information that would be provided on the development of the antibiotic in the short-term.
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