PITTSBURGH What better way to try and get a statin sold as a nonprescription remedy than to sign on switch maverick GlaxoSmitthKline, the company that successfully switched complex OTC regimens associated with drugs like orlistat and smoking cessation products?
GlaxoSmithKline and Merck on Monday announced that they have entered into an agreement for the over-the-counter marketing rights for Mevacor. Under the agreement, GSK will have exclusive rights to market non-prescription Mevacor in the United States. Terms of the agreement are confidential but include milestone and royalty payments from GSK to Merck.
“This new partnership with Merck will enable GSK to address the important public health issue of high cholesterol and help patients better manage their health,” stated GSK chief executive officer JP Garnier. “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.”
Merck had been planning to present to the Food and Drug Administration its justification to switch Mevacor OTC in December. It’s the third bite at the switch apple for Merck, this time without partner Johnson & Johnson. The companies will jointly seek approval of OTC Mevacor 20mg taken once daily to help lower cholesterol. OTC Mevacor 20mg is proposed for use in women age 55 and older and men age 45 and older with moderately elevated cholesterol and one or more heart disease risk factors.