) recently announced that its resubmitted new drug application
(NDA) for its ezetimibe and atorvastatin combination has been
acknowledged by the US Food and Drug Administration (FDA). Merck
intends to submit regulatory applications for the combination
therapy in other countries as well.
The FDA had issued a complete response letter (CRL) to the
company for this combination therapy for the treatment of primary
or mixed hyperlipidemia last year. However, with the NDA being
resubmitted, Merck now expects a final response from the FDA in
the first half of 2013.
Merck has another FDA decision coming up later this year. The
company, which submitted an NDA for its insomnia candidate -
suvorexant, should receive a response from the FDA regarding the
approvability of the candidate in the second half of 2013.
Merck said that the FDA's Controlled Substance Staff will
review the suvorexant NDA. Once it is approved, the Drug
Enforcement Administration (DEA) will assess and assign the
schedule for the drug before it is launched.
Suvorexant belongs to a new class of medicines called orexin
receptor antagonists which target and block orexins. Approval
would make suvorexant the first orexin receptor antagonist to
reach the market. However, we note that the insomnia market is
highly competitive and genericized especially given the presence
of generic versions of
Neutral on Merck
We currently have a Neutral recommendation on Merck, which
carries a Zacks #3 Rank (Hold). While headwinds remain in the
form of the Singulair genericization, EU pricing pressure,
unfavorable currency movement, US health care reform, the
Remicade/Simponi transition and pipeline setbacks, some of the
company's recent launches should start contributing significantly
to the top line in the forthcoming quarters.
Large-cap pharma companies that currently look
). All three companies carry a Zacks #2 Rank (Buy).
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