Merck & Co has discontinued development of a tablet combining the active ingredient in its Januvia diabetes drug with cholesterol-lowering drug atorvastatin.
MK-0431E (sitagliptin and atorvastatin) started phase III a year ago as a therapy for the large number of people with both high cholesterol levels and diabetes, and had been scheduled for regulatory filings in 2014.
Citing a company spokesperson, the Wall Street Journal said that there was no safety issue with the combination product and the decision was taken for “business reasons”.
One factor in the decision may be that Merck has already launched a combination product called Juvisync that is based on sitagliptin and simvastatin, another cholesterol-lowering drug.
Juvisync was approved by the US FDA last year as the first single-tablet treatment for diabetes and hypercholesterolaemia, and, while Merck does not break out sales figures for the product in its quarterly results, take-up is rumoured to be sluggish.
As a monotherapy Januvia is currently Merck’s biggest-selling drug – pulling in almost $3bn in the first nine months of 2012.
Meanwhile, there have also been suggestions that the dynamics of the cholesterol drug market have changed following the influx of generic atorvastatin in the wake of the expiration of the patent on Pfizer’s Lipitor brand, made it harder for new entrants to establish themselves.
Merck abandoned a cholesterol-lowering combination product based on its Zetia (ezetimibe) product and niacin, citing unfavourable marketing conditions, and suffered a regulatory setback earlier this year when the FDA declined to approve MK-0653c, a fixed-dose tablet based on ezetimibe and atorvastatin.
The company has also seen declining sales of its premium Vytorin (ezetimibe plus simvastatin) combination product, with sales down 7 per cent to $1.9bn in the first nine months of the year, although Zetia monotherapy held up fairly well with 6 per cent growth to $2.4bn.