Merck Provides Update on Cardiovascular Development Programs


August 26, 2012 7:00 am ET

Merck (known outside the United States and Canada as MSD) today provided
an update on the development programs for vorapaxar, extended release
niacin/laropirprant (MK524A, Tredaptive) and anacetrapib in
association with the European Society of Cardiology (ESC) meeting in

Vorapaxar: Merck now plans to file regulatory applications in

Following a review of the clinical trial data and discussions with
external experts, Merck now plans to file applications for vorapaxar, an
investigational anti-thrombotic medicine in the United States and the
European Union in 2013. Merck plans to seek an indication for the
prevention of cardiovascular events in patients with a history of heart
attack and no history of TIA (transient ischemic attack) or stroke.
Discussions with worldwide regulatory agencies are continuing and we
will update this information when appropriate.

Extended release niacin/laropiprant (MK-524A, Tredaptive): Merck
confirms study on track to complete later this year

For MK-524A (Tredaptive), Merck also confirmed that the
HPS2-THRIVE (Treatment of HDL to Reduce the Incidence
of Vascular Events) study is on track to complete later
this year, and Merck plans to file in the United States and the European
Union in 2013.

Anacetrapib: Merck provides information about a different
method to measure LDL cholesterol and progress on REVEAL study

Merck also today provided information about a different method to more
accurately measure LDL-C when patients are treated with anacetrapib, an
investigational CETP-inhibitor. Based on this method, called
beta-quantification, anacetrapib 100 mg daily resulted in LDL-C
reductions of approximately 25 to 35 percent, compared to the 40 percent
reduction previously reported from the DEFINE (Determining the EFficacy
and Tolerability of CETP INhibiition with AnacEtrapib)
study and other anacetrapib studies.

In DEFINE, LDL-C was calculated using the Friedewald equation, which is
the method used in most lipid studies. The Friedewald method estimates
LDL-C from direct measurements of total cholesterol, HDL-C and
triglycerides, but does not measure LDL-C directly. Because
CETP-inhibition increases the ratio of triglycerides to cholesterol in
LDL and VLDL particles, Merck and the DEFINE Steering Committee
hypothesized that methods other than Friedewald might more accurately
measure LDL-C when lowered by CETP inhibitors. The researchers believe
that these initial results indicate that the beta-quantification method
provides a more accurate measure of LDL-C after treatment with
anacetrapib. These findings are being finalized and will soon be
submitted for publication in a peer-reviewed journal, and additional
studies are underway, or planned, to more precisely determine the LDL-C
lowering of anacetrapib.

The results of other key lipid measurements such as HDL-C,
triglycerides, and apo-lipoproteins, such as A-I and B, are not believed
to be affected by this observation. As previously reported in DEFINE, at
24 weeks, anacetrapib increased HDL-C by 138 percent. Compared to
placebo, anacetrapib raised mean apo-lipoprotein (apo) A-1 (a major
protein component of HDL particles) by 45 percent, lowered mean apo B (a
major protein component of atherogenic lipoprotein particles, including
LDL) by 21 percent, and reduced mean non-HDL-C by 32 percent.
Anacetrapib reduced median Lp(a) (an LDL-like particle) by 36 percent
compared to placebo.

Based on the available data, REVEAL investigators are not planning to
change the size or duration of REVEAL ((Randomized
EValuation of the Effects of Anacetrapib
through Lipid-modification), the event-driven cardiovascular
clinical outcomes trial of anacetrapib. REVEAL is being led by Oxford
University’s Clinical Trial Service Unit, and is one of the largest
cardiovascular studies ever conducted. The study started in June 2011
and will enroll 30,000 patients with pre-existing vascular disease.
Oxford researchers reported today that more than 20,000 patients have
now been enrolled in the trial, and that the study is on track to
achieve target recruitment during 2013. The study is predicted to be
completed in 2017.

“Merck remains committed to research to bring forward innovations in
cardiovascular disease, which remains the leading cause of death
worldwide,” said Jeff Chodakewitz, M.D., senior vice president, Late
Stage Development, Merck Research Laboratories. “The clinical outcomes
studies for these three medicines have involved or will involve more
than 90,000 patients around the world. All of these studies are designed
to address the important question of whether, by adding these medicines
to the current standard of care, we can further reduce the risk of
cardiovascular events.”

About Merck

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well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
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Ian McConnell, 908-423-3046
Skip Irvine, 267-305-5397
Carol Ferguson, 908-423-4465

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