Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Subscribe to our email news alerts

Featured jobs

PMHub

Add my company
Genesis Research

Genesis Research is an international HEOR and RWE research organization. A leader in evidence strategy, generation and communication, the company...

Latest intelligence

Is communication failing us?
Compelling people to care in a world oversaturated with news and information...
Are your field teams ready to excel in the new era?
A qualitative research approach to help you critically assess post-pandemic learnings and ignite the potential of meaningful interactions with HCPs....
5 Healthcare Marketing Blunders | How To Avoid Them.
Here are 5 healthcare marketing blunders and how best to avoid them....