Merck Plans Late-Stage Trials; Backs Forecast

Merck said Tuesday it plans to begin late-stage trials next year on a drug to raise "good" HDL cholesterol that has not been dogged by the problems that sank a similar high-profile drug being developed by Pfizer.

Merck

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[MRK  Loading...      ()   ] said it would move its product, called anacetrapib, into sequenced Phase III trials before starting far larger "outcomes" trials to determine if the drug prevents heart attacks, strokes and death. The Merck product, also known as MK-859, works through the same mechanism as Pfizer's failed torcetrapib, by blocking a protein called CETP.

Torcetrapib, which Pfizer had hoped would become a $10 billion product, was scrapped late last year after it was linked to worrisome numbers of deaths in an $800 million late-stage trial -- the most expensive in history.

Merck said its product has had a very favorable safety record through mid-stage trials. "The safety and tolerability profile of anacetrapib was comparable to placebo in clinical studies conducted to date," the drugmaker said in a release.

Merck, which is hosting a meeting at its New Jersey headquarters on Tuesday with hundreds of investors and industry analysts, said it plans to file for approvals for seven drugs in the next five years.

It will seek U.S. approval next year for MK-524b -- which combines Merck's older Zocor cholesterol fighter with a niacin-based drug called Cordaptive that raises HDL cholesterol -- and an obesity drug called taranabant.

Taranabant, like Sanofi-Aventis' drug rimonabant, blocks the so-called canniboid receptor, the same brain circuit that stimulates hunger in people smoking marijuana. But U.S. regulators earlier this year rejected the Sanofi drug due to its links to depression and suicidal thoughts.

The company plans in 2009 to seek approvals for MK-974, a new type of drug for migraine headaches, and a treatment for acute heart failure called MK-7418 (rolofylline) -- with applications in 2010 for cancer treatment MK-8669 (deforolimus) and a vaccine for hepatitis B called Heplisav.

In 2012, Merck said it will seek U.S. marketing approval for osteoporosis treatment MK-0822 (odanacatib).

Merck on Dec. 4 said 2007 profit would rise 22 percent to 24 percent, due largely to booming sales of newer products, including its Gardasil vaccine against the virus that causes cervical cancer and its year-old oral Januvia treatment for diabetes.

The company's stock has risen 39 percent this year, a top gainer in the Dow Jones industrial average, as Merck seemingly bolted out of its sickbed after two years of anemic profits related to the September 2004 withdrawal of its $2.5 billion-a-year Vioxx arthritis drug.

Merck is hoping to retire thousands of Vioxx product-liability lawsuits with a $4.85 billion settlement reached last month with plaintiffs' lawyers.

Although the drugmaker has projected only a 4.5 percent to 10 percent rise in 2008 earnings, many analysts expect Merck to raise its forecast during the year, as it has done repeatedly in 2007.

Wall Street remains optimistic about Merck's prospects even though the patent expires next year on its $3.1 billion osteoporosis drug Fosamax, and Gardasil faces potential competition from GlaxoSmithKline Plc's Cervarix, a cervical cancer vaccine that is available in Europe but not yet approved in the United States.

Merck's shares slipped 34 cents, or .50 percent, to $60.43 on the New York Stock Exchange amid a slight decline for the drug sector.