Merck's (
MRK
) plan to seek approval of the U.S. FDA for its investigational
cardiovascular drug Tredaptive early next year seems to be on the
right track as researchers plan to announce the much anticipated
results of a large clinical trial "HPS2-Thrive" by early 2013.
Tredaptive reduces bad cholesterol in the blood and the clinical
trial is being conducted to see the drug's efficacy in
reducing the risk of heart attacks and strokes. Merck had earlier
unsuccessfully applied for U.S. FDA approval back in 2007, and the
FDA asked to wait for the outcome of HSP2-Thrive.
The company may also be getting ready for approval of another
investigational cardiovascular drug, Vorapaxar, a blood
thinner, at the same time. If approved, these drugs could fend-off
a decline in sales within the company's cardiovascular franchise
even as the potential of these drugs remains uncertain. Below we
take a look at the prospects of company's cardiovascular
division.
Check out our complete analysis of Merck
Declining Cardiovascular Sales
Merck's sales from cardiovascular drugs were above $10 billion
in 2007 but declined to under $7 billion in 2011 mainly due to
Cozaar/Hyzaar losing patent exclusivity in major markets including
the U.S. and Europe in 2010. Now the company is dependent on Zetia
and Vytorin, which together bring nearly 8% of its total sales and
50% of cardiovascular sales. Going forward, we expect total
cardiovascular sales (excluding pipeline drugs) to decline due to a
number of factors. Zocor, which already lost its patent protection,
will likely be further affected by the launching of generic
versions of Pfizer's (
PFE
) Lipitor, which was the world's largest selling drug until last
year.
New Drugs Could Offset Declines
Due to the aforementioned factors, Merck is hoping for approval
for the new drugs sooner rather than later. However, there are a
number of concerns about these new drugs. According to some
clinical studies, while Vorapaxar lowered the risk of
cardiovascular diseases, it also led to an increased risk of major
bleeding, including bleeding in the head. Merck will seek approval
for use of the drug to prevent cardiovascular issues instead of a
broader use, including patients who have suffered a stroke.
Additionally, Abbott Labs's (
ABT
) Niaspan, a competing drug, is going off-patent in September 2013.
This will lead to the launch of cheap generic versions of Niaspan
in the market, which could hurt Tredaptive's sales potential. We
have, accordingly, forecast the drugs' expected sales on the lower
side in our model.
Another experimental cardiovascular drug, Anacetrapib, may hold
more promise than the aforementioned drugs. Anacetrapib preserved
HDL function in preclinical studies and increased reverse
cholesterol transport. The recent termination of Roche
Holdings' (
RHHBY
) cholesterol drug Dalcetrapib gives Anacetrapib the
opportunity to grab a larger share of the addressable market.
Another experimental drug, MK-0524A, has also recently demonstrated
the ability to lower LDL-cholesterol ("LDL-C" or "bad" cholesterol)
and raise HDL-cholesterol ("HDL-C" or "good" cholesterol) and lower
triglycerides with significantly less flushing than traditional
extended release of niacin alone. However these drugs are not
likely to receive FDA approval anytime soon. However, they could be
launched just before Zetia and Vytorin lose their patent
exclusivity.
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