GlaxoSmithKline has reached an agreement with fellow drugs giant Merck & Co to sell an over-the-counter version of the latter’s old cholesterol-lowering product Mevacor which has still not been approved by US regulators.

GSK says it has acquired exclusive OTC marketing rights in the USA for Mevacor (lovastatin), noting that the terms of the agreement are confidential but include milestone and royalty payments for Merck. The New Jersey-based firm started selling prescription Mevacor in 1987 and its US patent expired in 2001.

Jean-Pierre Garnier, GSK’s chief executive, said this new partnership with Merck will enable his firm “to address the important public health issue of high cholesterol and help patients better manage their health”. He went on to claim that OTC Mevacor “will be a dynamic new addition to our fast-growing over-the-counter business and is further evidence of GSK’s ability to partner in new OTC-switch opportunities”. Dr Garnier cannot be faulted for his optimism especially given that OTC Mevacor is not approved and has indeed received a number of regulatory setbacks in the past.

Last month, Merck said it has been advised that a New Drug Application for an OTC version of Mevacor 20mg taken once-daily will be reviewed by the US Food and Drug Administration on December 13. This comes after a similar application made in January 2005 with then-partner Johnson & Johnson was rejected by the agency which was worried about patients who would not be able to make appropriate assessments about whether they require a cholesterol-lowering drug. This followed another unsuccessful bid in 2000 to sell an OTC 10mg version of Mevacor. This time, however, Merck has submitted additional data and is hopeful of getting an approval.

Also GSK has proved pretty adept at selling switched products, most notably with Alli, a low-dose OTC variant of Roche’s weight loss drug product Xenical (orlistat). It has been quickly capturing market share since its launch in February and Alli is well on the way to being a $500 million product.

GSK warned over promotion of Tykerb
Less good news for GSK was a letter from the US Food and Drug Administration sent to health professionals criticising the way the firm is promoting the new breast cancer drug Tykerb (lapatinib).

The FDA said that part of letters to doctors from GSK, which are part of the launch campaign for Tykerb, "are misleading in that they omit and minimise the most serious and important risk information" and "selectively present efficacy information for Tykerb, thereby overstating the efficacy of the drug." The agency goes on to say that the materials “minimise the important risk of decreased left ventricular ejection fraction".

The letter also calls the materials misleading because they fail to present risk information about Tykerb, launched in the USA in March, including warnings about pregnancy, patients with liver impairment and diarrhoea. "We are particularly concerned that these materials, which were disseminated to healthcare professionals during the product's launch and formed the basis of their first impressions of the drug, suggest…that Tykerb is safer and more effective than has been demonstrated", the FDA concluded.

GSK said that it takes seriously the concerns outlined in the FDA letter, and that it will work with the agency to address its concerns.