FDAnews
www.fdanews.com/articles/90263-merck-looks-to-its-pipeline-for-earnings-growth-in-2007

MERCK LOOKS TO ITS PIPELINE FOR EARNINGS GROWTH IN 2007

December 13, 2006

Merck expects its drug development pipeline, including three expected new drug applications (NDAs) in 2007, to contribute to high earnings growth, the company announced.

The company currently has three products under FDA review and expects to have four therapies in Phase III studies by mid-2007, Merck said Dec. 12. Merck’s pipeline currently includes 28 therapies in Phase I, 21 in Phase II and five in Phase III, the company said.

The three anticipated 2007 NDAs are for MK-0518, a first-in-class HIV integrase inhibitor, insomnia treatment Gaboxadol and MK-0524A, an extended-release niacin with a flushing pathway inhibitor.

The three products currently under FDA review are: Janumet, a Type 2 diabetes treatment; Emend IV for chemotherapy-induced nausea and vomiting; and Arcoxia, a selective Cox-2 inhibitor for osteoarthritis.

Arcoxia is a potential successor for Vioxx, which Merck pulled from the market in 2004 after studies showed the drug doubled the risk of heart attack and stroke. As of Nov. 30, Merck said it knew of approximately 27,200 lawsuits over Vioxx. Study data released earlier this year showed Arcoxia had similar rates of adverse cardiovascular events as diclofenac, a commonly prescribed anti-inflammatory drug.

Merck said the FDA would hold an advisory committee meeting on Arcoxia, but no date has been announced.