Analyst: Sales of Merck cholesterol pill Vytorin will keep falling, no matter what study finds

Friday, March 12, 2010

Analyst: Merck’s Vytorin sales will keep dropping

TRENTON, N.J. — Sales of Merck & Co.’s blockbuster cholesterol drug Vytorin likely will continue to fall amid rising competition from rival brands and generic versions in the same class of pills, an analyst predicted Friday.

Bernstein Research analyst Tim Anderson gave his assessment after the drugmaker said late Thursday that an interim analysis halfway through a long study of the controversial drug didn’t find serious safety problems. Such interim analyses are routinely done to ensure that drugs being tested aren’t harming study participants, in which case ethical rules require stopping the study.

Anderson, in a report to investors, said even though the safety monitoring board decided the study, called IMPROVE-IT, should continue, it might still show Vytorin works no better than a much-cheaper generic version of Zocor.

Vytorin combines Zocor and a different type of cholesterol pill, Zetia. Merck hopes the study will show Vytorin prevents heart attacks, strokes and deaths more than Zocor alone.

Generic versions of Zocor, which had been a blockbuster for Merck until it got generic competition in 2006, have been cutting into sales of pricey Vytorin and other brand-name cholesterol drugs, particularly as more people lose health insurance.

Merck got a black eye when it suspiciously delayed release of another study, called ENHANCE, showing Vytorin didn’t prevent plaque buildup in neck arteries any better than Zocor alone. After a congressional panel started investigating the delay, Merck released partial results in January 2008.

Critics said Merck deliberately held up the release to protect sales of Zetia and Vytorin, which immediately began to decline. They totaled $5.2 billion in 2007, but were down to $4.3 billion last year.

Merck officials said at the time that difficulties analyzing the complex results, including high-tech imaging of the arteries, delayed release of the results.

Analyst Les Funtleyder of Miller Tabak & Co. said Wall Street had expected the safety board would decide the study should continue, “but it should remove a very small overhang” on Merck’s shares related to Vytorin concerns.

In afternoon trading, shares of the Whitehouse Station, N.J., company rose 25 cents at $37.13.

Cleveland Clinic cardiology chief Dr. Steven Nissen said he thinks public release of the interim analysis — a normally confidential step in a study — “was unwise and probably intended to support the commercial goals of the company.”

Nissen said in an e-mailed statement that Merck’s announcement tells “very little about the likelihood that the drug is actually effective.”

“More than a decade after introduction, we still don’t know whether the drug actually improves patient outcomes,” Nissen wrote.

Research funded by Merck has shown Vytorin reduces levels of bad cholesterol more than just Zocor alone, but no study has shown it reduces risk of a heart attack, as rival Pfizer Inc. can claim for its Lipitor, the world’s top-selling drug at nearly $13 billion a year.

IMPROVE-IT, an 18,000-patient study expected to wrap up around June 2013, should answer that question.

The cholesterol drug category, with sales exceeding $30 billion a year, is among the most competitive.

Funtleyder also noted sales of Vytorin “are unlikely to recover from safety concerns.”

He referred to another study, called SEAS, that indicated a possible link between Vytorin and cancer. Food and Drug Administration researchers in December said that they found no evidence of such a link after reviewing results of multiple studies in people and animals.

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