Merck & Co. provides pipeline updateMerck & Co. provides pipeline update
by Marie-Eve Laforte
During a pipeline update on Tuesday, Merck & Co. said that it plans to file three drugs with US regulators in 2007. Additionally, the company noted that four compounds are expected to be in Phase III testing by the middle of next year.
Merck indicated in its update that it anticipates submitting HIV drug MK-0518 to the FDA next year. The company also expects to file insomnia treatment gaboxadol, developed in collaboration with Lundbeck, as well as MK-0524A, a combination product that includes an extended-release niacin and a novel flushing pathway inhibitor, to US regulators in 2007.
MK-0524B, a combination of cholesterol drug simvastatin plus an experimental atherosclerosis compound, is currently in late-stage development, and Merck said it may file the drug for US approval in 2008. Merck has a different cholesterol drug, MK-0859, in mid-stage testing that is similar to torcetrapib, which Pfizer recently stopped developing over safety concerns. Dr. Peter Kim, president of Merck Research Labs, remarked that "no serious cardiovascular disturbances have occurred" in Phase II trials for MK-0859, as reported in CNN Money. Additionally, Kim said that data showed that the compound increased HDL cholesterol by 50 percent and lowered LDL cholesterol by 20 percent.
Meanwhile, MK-0364, a highly selective cannabinoid-1 receptor inverse agonist under development as an obesity drug, should enter late-stage testing by the end of the year, and the compound may be filed with the FDA in 2008. The company also expects to launch a late-stage programme during the first quarter of 2007 for experimental migraine drug MK-0974, and anticipates a US filing in 2009. Phase III testing of osteoporosis compound, MK-0822, may be initiated next year, and the treatment could be submitted to US regulators in 2011.
Merck currently has three products under FDA review, including diabetes treatment Janumet, anti-emetic Emend IV, and COX-2 inhibitor, Arcoxia. The drugmaker said the US regulatory agency will hold an advisory committee meeting for Arcoxia, and a decision on the treatment is expected in 2007.
In a statement, Merck commented that it has 28 programmes in Phase I testing, and 21 programmes in Phase II trials. The company also reiterated its full-year earnings guidance of $2.48 to $2.52 per share and indicated that it is facing about 27 200 lawsuits related to Vioxx, as of November 30.