GlaxoSmithKline will buy the rights to market Merck's cholesterol-lowering drug Mevacor (lovastatin) over-the-counter (OTC) in the US, pending FDA approval. Financial terms of the deal were not disclosed.
The deal is the second recent purchase by GSK of OTC rights to a treatment by another drugmaker. Earlier this year, GSK launched Alli, the OTC version of Roche's obesity treatment Xenical, purchased by GSK in 2004.
An FDA advisory committee is scheduled to meet Dec. 13 to review Merck's application to sell Mevacor in pharmacies in a once daily 20 mg for women 55 and older and for men at least age 45, GSK said.
Merck has twice failed to convince the FDA – once in 2000 and once in 2005 – that patients could safely use Mevacor without a doctor's prescription.
GSK's purchase of Mevacor's OTC rights “reinforces the commitment it has to this particular part of the business," said Mike Ward, an industry analyst at Nomura Code Securities, in a published report. “The over-the-counter usage of products that are switching from prescription to non-prescription use is a good area to be in. A lot of health authorities would like to switch more products, so that the costs fall on the patients.”
Nomura Code's Ward said he believed Mevacor had a better chance of winning approval this time around, but Mevacor's exact status as a non-prescription medicine is likely to be the subject of debate by regulators. The final outcome will determine the size of payments from GSK to Merck.
Mevacor lost US patent protection in 2001, with Merck and prospective marketing partner Johnson & Johnson trying to secure OTC status for the drug in the years that followed.
The UK became the first nation to approve an OTC statin in 2004, allowing the sale of a 10 mg version of simvastatin, which is marketed as Zocor Heart-Pro by Merck.