FDA Approval and a Trial Failure: Which Is More Important?

Onyx Pharmaceuticals (Nasdaq: ONXX  ) announced on Friday that the Food and Drug Administration had approved its multiple myeloma drug Kyprolis. Today, Onyx announced a clinical trial failure for Nexavar.

Which one is more important? The Kyprolis approval. It isn't even close.

Kyprolis represents the first drug that Onyx owns fully -- it shares profits on Nexavar with its partner Bayer (OTC: BAYRY). The approval isn't all that surprising given the 11-0 FDA advisory committee endorsement of Kyprolis and how the agency supported the drug during the meeting. But there are approval issues not discussed in an advisory committee meeting, like manufacturing, which can derail a drug, so the approval is never a sure thing.

Kyprolis will be used after other therapies -- Celgene's (Nasdaq: CELG  ) Revlimid or Thalomid and Takeda's Velcade -- so the market won't be all that large. Still, an approval now allows Onyx to capture some sales instead of having to wait for a confirmatory phase 3 trial to gain FDA approval.

Switching gears, the Nexavar clinical trial tested the drug in combination with Tarceva, compared to Nexavar alone in liver cancer patients. Interestingly, even though this trial seems like it was designed to expand Tarceva into liver cancer, Tarceva isn't sold by Onyx or Bayer. The Nexavar owners would benefit indirectly if the trial had worked because the combination product would set a new higher standard that new drugs would have to reach.

With the failure of Bristol-Myers Squibb's (NYSE: BMY  ) brivanib last week, there's less of an immediate threat to Nexavar's stronghold in liver cancer. ArQule's (Nasdaq: ARQL  ) tivantinib will enter a phase 3 trial for its oncology drug in second-line liver cancer patients, but tivantinib would be used after Nexavar, so it won't be an immediate threat until ArQule tests it as a first-line treatment.

With a new drug approved and a fairly meaningless clinical trial completed, investors can get back to speculating when Onyx will be taken out by Bayer.

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Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool has a disclosure policy.
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