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July 1, 2009
Vanda Comes Back From the Dead
Posted by Derek
I wrote last summer about Vanda Pharmaceuticals and their difficulty getting a new antipsychotic Fanapt (iloperidone) through the FDA. At the time, they'd received one of those wonderful requests for more information from the agency, of the kind that spread cheer whenever they appear. I couldn't see how the company could clear this up without (probably) having to spend a lot of money that it didn't have, and I was very pessimistic about their survival.
And I was wrong. Big-time. Vanda received approval for iloperidone, in what is a major surprise not just for me, but for the company's hardy shareholders and for the few analysts left covering them. After congratulating the company, I feel like asking them "So, how did you do that, anyway?" To the best of my knowledge, the company didn't go back into the clinic - and it's hard to see how they even could have. Less than a year just isn't feasible from a standing start in an antipsychotic trial just on logistic grounds, let alone the fact that Vanda doesn't seem to have had the funds to even try.
So was this all just a regrettable misunderstanding? And if so, on whose part? Did the FDA misinterpret something, only to be argued back by the company? Or did Vanda mess something up in the original regulatory package? We may never know.
The question now that the dog has caught the mail truck is what to do with it. No deal has been announced yet to market the compound, and Vanda still doesn't seem to have the funds to sell it by itself. (Moreover, they don't seem to be recruiting a sales force). Some observers think that the company may have had time selling itself off, and that the run in the stock was overdone just for that reason.
In the meantime, though, the company should enjoy its good fortune (as should anyone who was holding its stock when the news hit). And readers of this blog should make a note that, in case there was any doubt, I can be completely, totally wrong about the field I work in. . .
Comments (8)
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1. Ganesh Mugundu on July 1, 2009 8:38 AM writes...
The major reasons for the issuance of not approvable letter were
1. Lack of effectiveness (Iloperidone was found to be inferior to haloperidol and rispersidone, but faired well with the placebo)
2. Lack of safety (All doses resulted in QT prolongation)
3. Issues with hepatic compromise study and PgP interaction study (now Phase IV commitments)
It seems that they have managed to convince FDA that despite being inferior to comparators, Iloperidone has better safety margin (except for QTc). The summary review has all the interesting discussions between Vanda and FDA which can be found here
Permalink to Commenthttp://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022192s000_SumR.pdf
2. barry on July 1, 2009 9:27 AM writes...
In my experience, compounds with potent hERG binding were shot down before ever getting to human trials even if they would have been the only treatment for a novel indication. That this one--with demonstrated QT prolongation in humans--got approval for an indication for which existing treatment is available is a puzzlement. Did Vanda satisfy the FDA that QT prolongation is not a meaningful marker for cardiotox? That would change the way we do drug discovery.
Permalink to Comment3. Muruga on July 1, 2009 12:40 PM writes...
The inferiority of iloperidone, compared to the active comparators, appears to be temporary due to difference in time to achieve the steady state concentration. This was somewhat positive for iloperidone. Beyond that, it is largely or solely the favourable safety profile compared to the existing antipsychotics that could have made the FDA for thumbing up.
Permalink to Comment4. partial agonist on July 1, 2009 1:01 PM writes...
Interesting on the compounds' wiki page, Hoechest Marion Roussel (now part of Sanofi-Aventis after two mergers) studied this compound, discontinued research, and outlicensed the rights (or gave away, it says in the wiki) in 1997. http://en.wikipedia.org/wiki/Iloperidone
I'm guessing they had qualms about QTc, since their compound terfenadine (Seldane) started the intense interest in hERG and cardiotox at around that same time.
I guess they gave up too easily and might have paid for a few of those people getting layed off (or, technically, people turning down a relocation offer)
Permalink to Comment5. Greg on July 1, 2009 2:13 PM writes...
The observers you mention are a couple of amateurs on a blog referencing a few other amateurs on the same blog. Seemingly bitter amateurs who missed the massive gains on May 7th. Please reference professional analysts in the future, not amateurs.
Permalink to Comment6. Mark on July 1, 2009 3:26 PM writes...
Why is the stock holding steady? Do investors think there isn't much there, even with an approval?
Permalink to Comment7. Alan on July 1, 2009 5:30 PM writes...
It's holding steady because the float is only 26M and the shares are locked up. Everyone is waiting for buyout news and doesn't want to miss the next pop.
Permalink to Comment8. greasedpalms on July 2, 2009 7:03 AM writes...
Um, by taking someone golfing on a Gulfstream jet staffed by gorgeous women?
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