The US Department of Justice is investigating claims that Merck falsely advertised the effectiveness of its cholesterol drug Vytorin.
The SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study jointly sponsored by Merck and Schering Plough showed that Vytorin was not effective in treating complications from heart valve disease.
Merck stock fell by 4.8% after an UBS analyst downgraded the company, saying that Gardasil may have come short of expected sales by $50 million.
The FDA issued a not-approvable letter for Merck's experimental cholesterol drug, which it planned to call Cordaptive. Stocks fell by 10.8 percent after the news.
At a meeting of the American College of Cardiology, Yale University cardiologist Harlan Krumholtz cautioned thousands of doctors against the use of Zetia and Vytorin. Together, these drugs brought in over $5B in 2007 for their makers, Merck and Schering-Plough.
On January 14, Merck and Schering-Plough released a study that showed Vytorin may not be more effective than Zocor alone. Vytorin is a cholesterol drug jointly developed with Schering-Plough that is a combination of Merck's best-selling Zocor, which had lost patent protection in 2006, and Zetia, a newer drug. While sales of the drug are strong, totaling $3 billion in the fourth quarter, Vytorin has faced controversy over its comparative efficacy and marketing techniques. As a combination drug, Vytorin enjoys patent protection, which allows Merck and Schering-Plough to charge significantly higher prices than its Zocor counterpart. However, the two companies recently released the results of a study that showed Vytorin may not be any more effective than Zocor alone. Over the last year, Merck and Schering-Plough had aggressively advertised Vytorin as a better alternative to Zocor, and the two companies are currently defendants in about 50 civil suits related to Vytorin's potentially misleading marketing.
Shares fell 0.65% to $58.39, after Merck announced earnings expectations below analyst estimates. The company predicted 2007 adjusted EPS of $3.08 to $3.14 and 2008 adjusted EPS of $3.28 to $3.38, while analysts expected $3.15 and $3.39, respectively.
Merck reported third quarter earnings of $1.53 billion, up from $941 billion a year ago. Revenue rose 12 percent to $6.07 billion. Stock prices rose by 3.4%, from $54.64 to $56.36 per share.
The FDA states that Isentress is a safe and effective treatment for HIV patients who have developed a resistance to other medications.
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Merck stock price recovers from the Vioxx shock: A US court dismisses a security class-action lawsuit against Vioxx, and the Wall Street Journal reports that a Texas judge may invalidate all Texas lawsuits against Vioxx.
FDA approved Janumet, which is a combo diabetes pill that includes the recently approved Januvia and metformin, a widely used diabetes drug.
Merck profit in the fourth quarter fell 58% due to generic competition for cholesterol drug Zocor and Vioxx lawsuit expenses.
Merck stock price drops after the company announces that it owes up to $5.5 billion in taxes due to a potential accounting adjustment.
FDA approved oral drug Zolina, which treats cutaneous T-cell lymphoma, and Januvia, a potential blockbuster diabetes drug.
The results of Merck's VIGOR trial found Vioxx to significantly increase a patients cardiovascular risk if taken for longer than 18 months.
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