What's the only thing more embarrassing for a drugmaker
than getting a "complete response letter" for a New Drug
Application (NDA) from the Food and Drug Administration?
Having the FDA refuse to file its NDA in the first place.
A "complete response letter" is sent after a review is
complete and the FDA needs additional information before a
drug can be approved. When the FDA refuses to file an NDA,
the agency is essentially saying that the drugmaker doesn't
have it together enough to get the application filled out
correctly.
It usually happens to small drugmakers with less
experience about what the agency wants.
Acorda Therapeutics (Nasdaq: ACOR),
Cardiome Pharma (Nasdaq: CRME), and
Pharmacyclics , have all had their drug
applications sent back after nothing more than a cursory
review for completeness by the FDA.
But for it to happen to
Merck (NYSE: MRK), which has plenty of
experience submitting NDAs over its long history, is
reallyembarrassing. So embarrassing that the company
snuck the announcement in its quarterly 10-Q, only saying
that the FDA wants "additional manufacturing and stability
data" for MK-0653C. Think Merck's regulatory department might
be a little distracted, worrying about job cuts after the
merger with
Schering-Plough (NYSE: SGP)?
The funny thing is, there seems to be little reason to
rush MK-0653C's approval. The drug is a combination of
Merck 's (NYSE: MRK) Zetia and
Pfizer 's (NYSE: PFE) Lipitor. Combining
cholesterol-lowering drugs from different classes is fairly
common. Merck's Vytorin is a combination of its Zetia and
Zocor, and
Abbott Labs (NYSE: ABT) and
AstraZeneca (NYSE: AZN) are working on a
combination of their TriLipix and Crestor, respectively. But,
as far as I know, Merck doesn't have a partnership with
Pfizer, and it would probably have to wait until the patents
expire in 2011 before selling the combination drug.
Then again, considering the glacial speed at which the FDA
is moving these days, maybe it's never too early to start the
drug approval process.
This article was originally published as
A Little Distracted, Are You, Merck?on
Fool.com
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