Merck's
(
MRK
) vorapaxar was in the news recently with researchers presenting
detailed results on the candidate from the TRA-2P
(Thrombin-Receptor Antagonist in Secondary Prevention of
Atherothrombotic Ischemic Events) TIMI 50 study.
Results showed that vorapaxar, when added to the standard of
care, led to a significant reduction in the risk of the composite
of cardiovascular (
CV
) death, heart attack, stroke or urgent coronary revascularization.
Researchers noted that this is the first time that the addition of
an anti-thrombotic medicine to the standard of care has resulted in
additional and significant reduction in the secondary prevention
setting.
However, higher bleeding risks continue to haunt vorapaxar. In
this study too, a significant increase in bleeding, including
intracranial hemorrhage (
ICH
) or bleeding within the brain, was observed in the vorapaxar arm.
Merck noted that the risk of ICH was lower in patients who had not
suffered a stroke previously.
TRA-2P was a prevention study conducted in patients who had
experienced a heart attack or ischemic stoke or who had documented
peripheral artery disease (PAD). The detailed results were
presented at the American College of Cardiology Annual Scientific
Session and were also published online in the
New England Journal of Medicine
.
Vorapaxar has already been in the news due to its higher
bleeding risk. Merck had presented disappointing results on the
candidate from another study at the American Heart Association in
2011. Results from the TRACER (Thrombin Receptor Antagonist for
Clinical Event Reduction in Acute Coronary Syndrome) study showed
that vorapaxar failed to meet its primary endpoint.
Besides failing to achieve its primary endpoint, a higher rate
of bleeding was observed in the vorapaxar treatment arm compared to
the standard of care. There was also a three-fold increase in
intracranial hemorrhage.
Vorapaxar is being developed by Merck for the prevention of
thrombosis and the reduction of cardiovascular events. Now that
full results from the TRA-2P study are available, Merck intends to
conduct discussions with investigators and other experts regarding
vorapaxar's role in secondary prevention.
We note that vorapaxar did not feature in Merck's planned
regulatory filings for 2012 and 2013 when the company announced
fourth quarter results earlier this year. The five candidates that
will be filed for regulatory approval include Bridion (a
neuromuscular reversal agent), V503 (an investigational vaccine to
help protect against certain HPV associated cancers), odanacatib
(once-weekly oral treatment of osteoporosis), Tredaptive
(atherosclerosis) and suvorexant (insomnia).
Neutral on Merck
We currently have a Neutral recommendation on Merck, which
carries a Zacks #3 Rank (short-term ). With vorapaxar, Merck is
looking to carve a position in a market which is dominated by
players like
Bristol-Myers Squibb Co.'s
(
BMY
) Plavix,
Eli Lily & Co.'s
(
LLY
) Effient and
AstraZeneca plc's
(
AZN
) Brilinta among others. However, the increase in bleeding
associated with vorapaxar could make it challenging for the
candidate to take share once approved.
ASTRAZENECA PLC (
AZN
): Free Stock Analysis Report
BRISTOL-MYERS (
BMY
): Free Stock Analysis Report
LILLY ELI & CO (
LLY
): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis
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