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Merck Pipeline: to file three FDA New Drug Applications in 2007
Having announced conservative sales and earnings forecasts for 2007 last week, Merck & Co yesterday outlined the highlights of its R&D pipeline t analysts and investors in a briefing that contained few surprises.
Next year, the company is planning to file three New Drug Applications: MK-518, a first-in-class HIV integrase inhibitor 2nd QTR 2007 filing, meaning FDA must decide within 6 months); the insomnia drug gaboxadol, being developed with Lundbeck; and cholesterol-lowerer MK-524A, which the firm says is an extended-release niacin combined with a novel flushing pathway inhibitor.
Furthermore, Merck is hoping to have another four products in Phase III trials by mid-2007. First up is MK-524B, which combines Merck's big-selling statin Zocor (simvastatin), now facing generic competition, with the aforementioned MK-524A, while the firm also has high hopes for weight-loss drug MK-364, a highly selective cannabinoid-1 (CB-1) receptor inverse agonist that has shown to be efficacious in weight loss versus placebo and is in the same class as Sanofi-Aventis' Acomplia (rimonabant).
The other two going into Phase III are MK-974 for migraines and MK-822, which treats osteoporosis by blocking a protein called Cathepsin K.
High hopes for MK-859
Head of research at Merck, Peter Kim, made special mention of the Phase II drug MK-859, which raised levels of 'good' HDL cholesterol by more than 50% in clinical trials, without raising blood pressure or causing serious cardiovascular side effects. It belongs to the same class of drugs as torcetrapib, Pfizer's high-profile experimental medicine which was recently terminated.
He also spoke in glowing terms of cancer drug MK-457, now in Phase II trials for a wide variety of tumours. It inhibits Aurora kinase which may be a potent inducer of apoptosis, or programmed cell death.
Dr Kim concluded that Merck has already delivered an almost four-fold increase in research productivity in its early-stage pipeline since 2002, which has been helped by integrating advances in genomic research into its drug target discovery.
Merck & Co gave its investors the jitters on Friday after withdrawing the forecast filing date for one of the great hopes in its product pipeline, the cholesterol-lowerer MK-524B, and refusing to give a new timeline for the project.
MK-524B combines Merck's big-selling statin drug Zocor (simvastatin), now facing generic competition, with MK-524A, a novel compound that is currently in Phase III testing. The main hurdle for the project is getting the fixed-dose combination of the two drugs to function well.
The company also said that the HSP2-THRIVE study, organised with Oxford University in the UK and testing the co-administration of MK-524A and simvastatin as separate pills in around 20,000 patients, is gearing up to start recruitment as planned.
MK-524A is a DP-1 inhibitor coupled with extended-release niacin that is designed to raise protective HDL cholesterol in the blood, and Merck stressed that clinical development of this project remains on track, with regulatory filing still scheduled for 2007.
News of the delay to MK-524B benefited rival company Kos Pharmaceuticals, which is developing Simcor, a rival HDL-boosting combination drug that combines simvastatin with Kos' Niaspan (niacin) product. Kos' shares rose nearly 7% on Merck's announcement.
Gustav Ando, an analyst with Global Insight, said the news "creates significant uncertainty around a company that has already been suffering from numerous problems in its research department, which was once the envy of the global pharmaceutical industry."
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