) recently announced that the FDA has granted standard review for
its new drug application (NDA) for fertility candidate,
corifollitropin alfa. Merck is looking to get the candidate
approved for controlled ovarian stimulation (COS) in women
participating in assisted reproductive technology.
FDA approval would make corifollitropin alfa the first
sustained follicular stimulant to be approved for use in a
fertility treatment regimen.
We note that the candidate is already approved in more than 50
markets outside the U.S. including the EU where it is known as
Merck, which is facing generic competition for erstwhile
blockbuster drug, Singulair, is working on developing its
pipeline to help make up for the loss of revenues resulting from
genericization. The company currently has several candidates
under regulatory review including its ragweed pollen (ambrosia
artemisiifolia) sublingual allergy immunotherapy tablet,
sugammadex and vorapaxar.
While Merck is looking to get sugammadex approved for the
reversal of neuromuscular blockade (NMB) induced by rocuronium or
vecuronium, vorapaxar is under FDA review for the secondary
prevention of cardiovascular events in patients with a history of
heart attack and no history of stroke or transient ischemic
Merck currently carries a Zacks Rank #3 (Hold). The company
has been facing headwinds in the form of Singulair's loss of
exclusivity, unfavorable currency movement and pipeline setbacks.
We believe Merck will look towards cost-cutting initiatives and
share buybacks to drive the bottom-line.
At present, companies like
Questcor Pharmaceuticals, Inc.
Forest Laboratories Inc.
) look well-positioned. While Questcor is a Zacks Rank #1 (Strong
Buy) stock, Forest Labs and Jazz are Zacks Rank #2 (Buy)
FOREST LABS A (FRX): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
MERCK & CO INC (MRK): Free Stock Analysis
QUESTCOR PHARMA (QCOR): Free Stock Analysis
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