Merck KGaA’s prolonged-release nicotinic acid formulation, Niaspan, launched in 2003, is likely to be boosted by growing interest in raising the heart protective high-density lipoprotein (HDL) cholesterol fraction. Interest in Niaspan will increasingly be stimulated by big pharma with HDL-raising drugs in development.

At a briefing for journalists in Paris yesterday, Merck emphasised the importance of raising HDL and Niaspan’s efficacy in achieving this. Professor Eric Bruckert of University Hopital Pitie-Salpetriere, Paris presented a pan-European survey of HDL showing 40% of women and a third of men at risk of heart attack or stroke have HDLs below recommended levels despite receiving statin therapies to improve blood cholesterol. The survey highlights residual risk after statins. Professor James Shepherd of Glasgow University commented: “On average, statins alone reduce mortality by only 25%.”

While statins raise HDL by only a few per cent Niaspan produces a 20%-30% increase, said Professor Eberhard Windler of Hamburg University. The prolonged-release formulation has largely overcome drawbacks of nicotinic acid, notably flushing, which discouraged its use, he said. Niaspan has no liver toxicity and has reduced flushing by over 75%. And because it is taken at night any flushing occurs during sleep and causes no bother.

Meanwhile, Pfizer released data on a study supporting its proposed LDL-lowering/HDL-raising torcetrapib/atorvastatin combination at the American College of Cardiology meeting two weeks ago.

Further data from the company’s $800 million research program will steadily raise awareness of the benefits of raising HDL as torcetrapib heads for market availability from 2008. Torcetrapib raises HDL by over 40% alone but by over 60% in combination with atorvastatin. If Pfizer markets torcetrapib only as a combined tablet, physicians preferring generic or other statins could opt for a stand-alone agent like Niaspan.

Roche has an HDL-raising agent, JTT-705, in Phase II testing, while Novartis has D-4F, an HDL-based treatment that reduced inflammation in Phase I.

Source: Olwen Glynn Owen in Paris