Merck to File Three New Drug Applications in 2007

Merck said it plans to file for U.S. regulatory approval next year for drugs to treat HIV, cholesterol and insomnia, and expects to have another four products in late-stage trials by mid-2007.

Merck is providing analysts with a look into its pipeline at an analyst meeting today at its Whitehouse Station, N.J., headquarters. Last week, the company issued its earnings forecast, which calls for profits of $2.48 to $2.52 a share this year.

Merck will file new drug applications for MK-0518, a first-in-class HIV integrase inhibitor; Gaboxadol, an insomnia treatment; and MK-0524A, an extended-release niacin combined with a novel flushing pathway inhibitor that treats cholesterol.

The products that will be in late-stage trials include MK-0524B, which raises good "HDL" cholesterol and lowers blood fats called triglycerides. Merck intends to file an FDA application on it in 2008.

Also, in late-stage development is a weight loss drug MK-0364, which works through the same mechanism as Sanofi-Aventis' Acomplia and MK-0974 for migraine headaches; and MK-0822, which treats osteoporosis by blocking a protein called Cathepsin K.

The pharmaceutical concern also confirmed ongoing trials for an inhibitor of the Cholesterol Ester Transfer Protein, or CETP, that Merck said has shown promise in early trials in raising good cholesterol and cutting bad cholesterol.

This treatment is in same class of drugs as torcetrapib, the compound Pfizer suddenly stopped developing this month because of a
higher-than-expected fatality rate among users. In the wake of the Pfizer announcement there have been concerns there could be problems with similar drugs being developed by other companies.

At the meeting, Merck said it has observed no serious cardiovascular problems associated with its CETP inhibitor after an eight-week trial.

Merck also said that as of Nov. 30 it has been named a defendant in about 27,200 lawsuits tied to its Vioxx medication. Nearly two-thirds of these suits are part of the coordinated proceeding in New Jersey state court.

CNBC pharmaceutical reporter Mike Huckman said Merck has cut the time it takes to move drugs through its late-stage development process by 10 months.