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GSK wins OTC rights to Merck & Co statin

GSK and Merck & Co enter into an agreement for US over-the-counter marketing rights for Mevacor

UK-based pharmaceutical company GlaxoSmithKline (GSK) and US-headquartered Merck & Co have entered into an agreement for over-the-counter (OTC) marketing rights for Mevacor (lovastatin). 

Terms of the agreement are confidential but include milestone and royalty payments from GSK to Merck over the exclusive rights.

Mevacor was launched on the US market back in 1987, while the regional patent expired in 2001. The drug posted sales of around USD 20m in FY06.

The FDA will review Merck & Co's new drug application (NDA) for OTC Mevacor 20 mg at a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on 13 December. A final decision is expected in Q1 2008.

The FDA rejected a similar request in 2005. Merck & Co argued then that OTC Mevacor could help unmedicated patients with moderate risk of heart disease.

JP Garnier, GSK's CEO, said: "OTC Mevacor will be a dynamic new addition to our fast-growing OTC business and is further evidence of GSK's ability to partner in new OTC switch opportunities."

30th September 2008

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