Merck (MRK - Analyst Report) 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 Elonva.
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 attack (TIA).
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. and Jazz Pharmaceuticals (JAZZ - Analyst Report) look well-positioned. While Questcor is a Zacks Rank #1 (Strong Buy) stock, Forest Labs and Jazz are Zacks Rank #2 (Buy) stocks.