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Merck says late-stage research pipeline looking good

Shrugs off development disappointment after FDA declined to approve its new oral contraceptive and glaucoma drugs

Merck & Co shrugged off news of some late-stage product setbacks yesterday with an upbeat presentation of its pipeline, which now includes 19 candidates in phase III testing and five new drugs due for filing in the next two years.

CEO Kenneth Frazier said the pharma company was putting in place a four-part strategy based on leveraging its R&D pipeline, growing in emerging markets, extending its animal health and consumer care businesses and managing costs to increase shareholder return.

The overall objective is to rebuild the pharmaceutical giant as a "sustainable enterprise" in the new, tougher operating environment for the drug industry, he said.

Merck has suffered a few pipeline disappointments of late - the US FDA declined to approve two new products just this week, including an oral contraceptive and a glaucoma drug - and it is facing some significant headwinds next year including the loss of patent protection on asthma drug Singulair (montelukast).

Merck also revealed this week that it is discontinuing the clinical development programme for diabetes treatment MK-0431C, a combination of the firm's Januvia (sitagliptin) and Takeda's Actos (pioglitazone).

The president of Merck Research Laboratories Peter Kim told the meeting that Merck would seek approval for svorexant for insomnia, atherosclerosis treatment Tredaptive (extended-release niacin/laropiprant), odanatacin for osteoporosis, cervical cancer vaccine V503, and Bridion (sugammadex), a drug used to reverse neuromuscular blockade in general anaesthesia.

Kim also highlighted two clinical candidates with considerable potential to transform patient care, namely anacetrapib, a cholesteryl ester transfer protein (CTEP) inhibitor in phase III for the treatment of atherosclerosis, and a new Alzheimer's disease treatment called MK-8931 which works by inhibiting the BACE1 enzyme implicated in the formation of amyloid plaques.

Merck also reaffirmed its commitment to the development of biosimilars, saying it will "strategically advance into phase III for specific opportunities where the company can be a first mover upon patent expiry of the originator product".

The company also said it would raise its quarterly dividend by 4 cents to 42 cents a share - the first increase for seven years - and said it expects sales next year to be in line with 2011.

11th November 2011


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