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Merck drops plans to file Tredaptive in US

Pharma company also says cardiovascular drug should not be prescribed to new patients in Europe

Merck & Co has reported disappointing results for its Tredaptive cardiovascular drug and says it will no longer seek approval for it in the US.

Moreover, the company has said that the drug, which was approved in Europe in 2008 but turned down in the US in the same year, should not be prescribed to any new patients.

Tredaptive (laropiprant and niacin) is registered in around 70 countries worldwide and is designed to boost high-density lipoprotein (HDL) cholesterol, which is thought to protect against cardiovascular disease. The effect on HDL is achieved by niacin, whilst laropiprant is added to avoid side effects such as facial flushing.

Sales of the product have been modest, and Merck was hoping that the results of the 25,000-patient HPS-2 THRIVE study would transform its fortunes.

HPS-2 THRIVE was a secondary prevention trial which looked at the effects of adding Tredaptive to statin therapy, which reduces harmful low-density lipoprotein (LDL) cholesterol.

The investigators found that Tredaptive was unable to achieve a significant reduction in coronary deaths, nonfatal heart attacks, strokes, and revascularisation procedures compared to statin therapy alone. Furthermore, it was also deemed to have increased the risk of "non-fatal serious adverse events".

This is the second major failed trial involving niacin in cardiovascular disease. Last year, the AIM-HIGH trial sponsored by the US National Heart, Lung, and Blood Institute (NHLBI) was halted prematurely after no benefit was seen with niacin on top of statin therapy.

Meanwhile, other drugs designed to boost HDL cholesterol have also run into difficulties. Roche discontinued development of dalcetrapib earlier this year, following in the footsteps of Pfizer which had earlier dropped its torcetrapib candidate.

The latest trial is a blow to Merck, which has frequently listed Tredaptive among its late-stage pipeline prospects to help it recover from generic competition to big-selling brands such as asthma blockbuster Singulair (montelukast), which lost US patent protection in August.

Others include: osteoporosis treatment odanacatib; suvorexant, a new first-in-class treatment for patients with insomnia; neuromuscular reversal agent Bridion (sugammadex); HPV-related cancer vaccine V503; and vintafolide, a first-in-class oncology agent with potential in ovarian and lung cancers.

Shares in the pharma company fell around 3 per cent on after the announcement yesterday.

21st December 2012

From: Research, Sales

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