) recently announced that the US Food and Drug Administration
(FDA) has accepted its new drug application (NDA) for its
insomnia candidate, suvorexant. The agency granted standard
review which means a response should be out in the second half of
Merck said that the FDA's Controlled Substance Staff will
review the 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.
Earlier this year, Merck had presented encouraging data on
suvorexant from two pivotal phase III efficacy trials. Suvorexant
was shown to significantly lower the time it took for patients to
fall asleep. Moreover, patients in the suvorexant arm stayed
asleep longer as early as the first night as well as at the
three-month time point.
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
Merck has several more regulatory filings scheduled for the
next few quarters. The company plans to seek US and EU approval
for its osteoporosis candidate, odanacatib, in the first half of
2013 and in Japan in the second half of 2013.
The resubmission of the sugammadex (reversal of certain muscle
relaxants used during surgery) filing in the US is also slated to
take place by year end.
Other candidates for which Merck intends to seek regulatory
approval in the coming months include vintafolide (oncology),
Tredaptive (cholesterol management) and V503 (a vaccine that
expands protection against certain HPV-associated cancers by
including additional HPV types).
Neutral on Merck
We currently have a Neutral recommendation on Merck, which
carries a Zacks #3 Rank (short-term 'Hold' rating). 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.
MERCK & CO INC (MRK): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
To read this article on Zacks.com click here.