) recently gained US Food and Drug Administration (FDA) approval
for its combination cholesterol treatment, Liptruzet. The FDA
granted approval to Liptruzet for the treatment of elevated
low-density lipoprotein (LDL) cholesterol in patients with
primary or mixed hyperlipidemia as adjunctive therapy to diet
when diet alone is not enough.
Liptruzet is basically a combination of two drugs - Merck's
Zetia (ezetimibe) and
) Lipitor (atorvastatin). While ezetimibe will help inhibit the
absorption of cholesterol in the digestive tract, atorvastatin
will inhibit the production of cholesterol in the liver.
However, Liptruzet is yet to show any additional benefit
compared to Lipitor where cardiovascular morbidity and mortality
We note that Merck has another Zetia/statin combination in its
portfolio in the form of Vytorin. Vytorin is a combination of
Zetia and Zocor (simvastatin). Merck's cardiovascular franchise
currently consists of Vytorin and Zetia. While Zetia sales
increased 5.7% to $2.6 billion in 2012, Vytorin sales declined
7.2% to $1.7 billion.
Merck has entered a challenging period with erstwhile
blockbuster drug, Singulair, losing exclusivity in the US as well
as the EU. With Singulair and a few other products facing generic
competition, we expect the top- and bottom-line to remain under
pressure. Other headwinds remain in the form of unfavorable
currency movement and pipeline setbacks.
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 mid-13.
Once it is approved, the Drug Enforcement Administration (DEA)
will assess and assign the schedule for the drug before it is
Suvorexant belongs to a new class of medicines called orexin
receptor antagonists which target and block orexins. However, we
note that the insomnia market is highly competitive and
genericized especially given the presence of generic versions of
Merck, Pfizer and Sanofi are all Zacks Rank #3 (Hold) stocks.
) looks attractive with a Zacks Rank #2 (Buy).
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