Novartis’ Galvus May Be Delayed: Analyst
4 CommentsBy Ed Silverman // February 16th, 2007 // 12:28 pm
That’s what Tim Anderson, drug-industry analyst at Prudential, wrote in a note issued a short while ago. As he sees it, the issue of skin toxicity seen in monkeys will prompt the FDA to wait another few months to approve the diabetes pill, and speed past the PDUFA date later this month.
That would be swell news for Merck, which a few months ago launched its own Januvia pill. Both drugs are in a new class of Type 2 diabetes meds, and while the Novartis drug is seen to have an edge, ongoing delays will make it harder to grab market share, at least for awhile.
Nonetheless, Anderson writes “we believe that Galvus will ultimately emerge from the regulatory process with a competitive label. Our belief is that the primate skin toxicity issue will, ultimately, fade into the background and will not have much commercial relevance apart from Galvus’ delayed market entry.”
Meanwhile, what will Novartis do with all those sales reps who were hired and primed to start pigeonholing doctors?
[tags]Galvus, Januvia, Merck, Novartis[/tags]
MS
Any word on what type of skin toxicity and at what rate in the trials? Given approval of Januvia & other options like metformin or subQ insulin, the FDA will sit on this one - they don’t want another Katek on their hands
ed
Hi,
No, I don’t have that level of detail, unfortunately. The whole thing has been a bit of a puzzle since the FDA issued an ‘approvable letter’ last November, instead of full approval, in order to get more insight into the issue.
recall hearing last fall that, in general, lesions aren’t terribly unusual, but are expected to show up in early or mid-stage clinical trials, not during animal studies. But again, I’m not in possession of all the facts in this instance.
I also have no idea what the FDA will ultimately do, which is why I found Anderson’s investor note so interesting. It suggests a concern for safety, which the agency has been accused of lacking. Unfortunately, it’s often hard to draw sweeping conclusions from one scenario. In any event, this isn’t over yet.
ed
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