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Merck & Co stock battered on vorapaxar study problems
 
 
  pharmatimes. World News | January 14, 2011
 
Merck & Co has suffered a major setback following the news that its much-touted blood clotter vorapaxar has been pulled from one major study and discontinued from stroke patients in another.
 
The US giant has been studying vorapaxar in two major clinical endpoint trials: TRACER, a 13,000-patient study for acute coronary syndrome, and the 26,5000-patient TRA-2P (also known as TIMI 50), in people with prior heart attack, stroke and peripheral artery disease. Now, the combined data and safety monitoring board for the two studies has reviewed the available safety and efficacy data, and called for changes, which Merck has agreed to implement.
 
Specifically, with TRACER, patients will discontinue study drug and investigators "are to begin now to close out the study in a timely and orderly fashion", while in TRA-2P, vorapaxar will be continued in patients who had experienced a previous heart attack or peripheral arterial disease (approximately 75% of the patients enrolled in the study), but immediately discontinued in patients who experienced a stroke prior to entry or during the course of the study. No details as to why vorapaxar may be inappropriate for stroke patients have been disclosed yet.
 
Merck keeps faith in cardiovascular all eyes on anacetrapib New Merck trumpets streamlined best in industry pipeline
 
Vorapaxar, a first-in-class thrombin receptor antagonist vorapaxar, was touted as one of the most promising compounds in the pipeline of Schering-Plough, which was acquired by Merck for $41 billion in 2009. However investors have reacted badly to the latest news and Merck's shares fell 6.7% on the news, wiping almost $8 billion from the stock.
 
Some analysts are claiming that vorapaxar could be dead in the water. Sanford Bernstein analyst Tim Anderson issued a less dismissive research, saying that the possible safety risk, plus the reduced potential for the drug "will partly call into question the value of Merck buying S-P". He added that "it appears that excessive bleeding may have been the culprit" in terms of treatment for stroke patients.
 
The company is not giving up on the compound and Peter Kim, president of Merck Research Laboratories, said "we remain committed to conducting large clinical trials such as TRACER and TRA-2P". He added that "we thank the investigators and the patients involved in these two studies for their continued efforts to understand the potential role of vorapaxar".
 
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Merck keeps faith in cardiovascular, all eyes on anacetrapib
 
World News | November 12, 2010
 
Merck & Co has reiterated its commitment to cardiovascular research and highlighted some promising candidates, notably anacetrapib.
 
Speaking at a recent briefing in London, Daniel Bloomfield, head of clinical and translational medicine, cardiovascular, at Merck Research Laboratories, noted that while a number of big players have pulled out of the area, notably Pfizer, his firm believes it is still very much an area of unmet need. He said that despite medical advances, "death rates are still incredibly high, there is no question it is still important".
 
Dr Bloomfield spoke of the "incredible breadth" of Merck's cardiovascular pipeline, the largest in the pharmaceutical industry. He concentrated on three compounds, with anacetrapib taking centre-stage.
 
Merck Cardiome heart drug OK in Europe Merck presents pipeline and biosimilar programme to analysts
 
The drug is a cholesterol ester transfer protein inhibitor and is designed to raise good HDL cholesterol. Safety and efficacy data from the 1,800-patient DEFINE study for anacetrapib for the treatment of atherosclerosis will be presented in a late-breaker presentation on November 17, at the American Heart Association meeting in Chicago.
 
The data is eagerly-anticipated, especially as anacetrapib is in the same class as Pfizer's torcetrapib, development of which was terminated in Phase III in December 2006 due to safety concerns. Dr Bloomfield is confident about the safety profile of Merck's drug and he believes it can "change the landscape of heart disease".
 
During his presentation in London, Dr Bloomfield made special mention of the first-in-class thrombin receptor antagonist vorapaxar, which is in Phase III development and betrixaban, its oral factor Xa inhibitor for atrial fibrillation. Phase III trials of the latter will begin next year.
 
When asked by PharmaTimes World News whether betrixaban will have too much ground to make up on Boehringer Ingelheim's factor Xa inhibitor Pradaxa (dabigatran), which was approved by the US Food and Drug Administration for stroke risk reduction in non-valvular AF last month, Dr Bloomfield said the Merck drug has a place. Within the class, he noted that "there will still be room for improvement, enhance safety and approve efficacy. We believe betrixaban is superior".
 
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New Merck trumpets streamlined 'best in industry' pipeline
 
World News | March 02, 2010
 
Merck & Co has announced its updated pipeline following the merger with Schering-Plough which includes more than 20 candidates in Phase III or under regulatory review, and over 20 others in Phase II.
 
The New Jersey-based major has completed a "comprehensive prioritisation process" based on a series of criteria, including "potential for impact on human health, molecular characteristics, stage of development, probability of success and commercial potential". Merck claimed that the pipeline is particularly strong in areas in which both companies have "long-established research programmes", such as cardiovascular and infectious diseases and the company has eight investigational drugs in each of these two categories.
 
Highlights of the pipeline include vorapaxar, S-P's novel oral thrombin receptor antagonist, or TRA, for blood clots, which analysts believe will be a blockbuster. Another potentially huge earner is boceprevir, another S-P drug, for hepatitis C, which could be filed with regulators before the end of the year.
 
Merck also made special mention of MK-4305, its novel orexin antagonist being evaluated for insomnia, and an immunotherapy tablet for ragweed allergies, known as SCH 39641. Both have just moved into Phase III, though one candidate that has not made the grade, for "strategic reasons", is esmirtazapine, an S-P drug for hot flushes and insomnia.
 
The company added that the complementary nature of the two pipelines "is underscored by the fact that only two programmes, hepatitis C and cancer, needed to prioritise a lead molecule for continued development". The 'winners' were both Merck drugs - vaniprevir, a second-generation hepatitis C protease inhibitor candidate and dalotuzumab, an IGF-1R inhibitor - and both are currently in Phase II trials.
 
The rest of the pipeline is composed of "small molecules, vaccines and biologics targeting a broad range of unmet medical needs", including atherosclerosis, diabetes and schizophrenia. Peter Kim, president of Merck Research Laboratories, said he believes the pipeline is the best in the industry and analysts agree it has the potential to soften the blows the company has suffered - and will continue to suffer over the next couple of years - from patent expiries on key products,
 
 
 
 
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