Updated from 9:40 a.m. EST
expects to seek U.S. approval for three new drugs next year, joining three other experimental products it now has under review by the Food and Drug Administration.
The new drug applications announced Tuesday had been anticipated by Wall Street. One is MK-0518, a treatment for HIV and AIDS, another is Gaboxadol for insomnia, and the third is MK-0524A, which raises so-called good cholesterol and reduces the risk of heart disease.
Additionally, Merck confirmed for the first time that it's working on a drug that belongs to the same class as torcetrapib, a product
stopped developing earlier this month after a late-stage clinical trial revealed it could
increase the risk of death.
Merck's drug has completed the second of three phases of clinical testing. It has shown no dangerous cardiovascular side effects and no elevation of blood pressure, but the tests have lasted only eight weeks.
Peter Kim, president of Merck Research Laboratories, said the data were being carefully evaluated to determine when and if the drug will enter Phase 3 testing, which involves many more patients over a longer period of time.
Merck's decision will depend in part on an analysis of several Pfizer clinical trials scheduled for release in March. Scientists at Merck,
and other companies developing similar drugs, known as CETP inhibitors, want to know if there was a problem with torcetrapib or if there's a flaw in the whole class.
CETP inhibitors are meant to elevate the levels of good cholesterol in the bloodstream and lower the amount of bad cholesterol.
Merck discussed its research and development activities at a Tuesday meeting with analysts, one week after it issued
financial predictions for 2006 and 2007. Both forecasts were in line with Wall Street estimates. Excluding restructuring charges, this year's earnings per share will be $2.48 to $2.52. Next year, the EPS forecast is for $2.51 to $2.59, excluding restructuring charges.
Recently, Merck's stock was down 38 cents, or 1%, to $43.64.
Merck expects a first-quarter decision from the FDA on Janumet, a blood-sugar control product for diabetics that combines the company's Januvia and the generic metformin, a popular diabetes medication.
A decision should come in the second quarter for Emend IV for chemotherapy-induced nausea and vomiting. The drug is an intravenous version of the Emend pill that Merck introduced in 2003.
Finally, Merck forecasts an FDA ruling by April on Arcoxia, but the agency will want to convene a panel of outside experts first. A meeting date hasn't been set.
Arcoxia is a COX-2 inhibitor, the same type of drug as Vioxx, which Merck pulled from the market in September 2004 due to safety concerns.
Merck executives devoted considerable time discussing plans for fighting heart disease with drugs would raise good cholesterol. Zocor, which lost U.S. patent protection in mid-2006, reduces bad cholesterol.
MK-0524A combines two experimental drugs -- an extended-release version of the vitamin niacin and a compound that combats a prominent side effect of niacin.
The drawback to niacin, which raises good cholesterol, is flushing - an uncomfortable reddening of the skin, especially around the face and neck. Merck says it has found a way, via a drug called a DP1-receptor, to reduce flushing.
Merck is chasing
which sells Niaspan, an extended-release niacin. Kos is being acquired by
Merck says its good-cholesterol drug can be used with any statin, drugs like Zocor or Lipitor that cut bad-cholesterol. Merck also is developing a combination pill that combines MK-0524A and Zocor. The company had hoped to file an application next year, but it has revised the filing date to 2008 because it continues to work on an acceptable fixed-dose combination.
This pill is in Phase 3 trials, and so is a weight loss drug, MK-0364, which works in the same way as Acomplia by
. Although Acomplia has been approved in the European Union,
it remains under review by the FDA. Merck will seek FDA approval in 2008.
Among other experimental products, Merck said it expects to begin Phase 3 trials on a migraine drug and an osteoporosis drug in 2007.