Merck hopes third try is the charm for Mevacor
FDA advisors to consider, for the third time, Merck's cholesterol drug Mevacor for over-the-counter; but sales boost wouldn't be significant, analysts say.
NEW YORK (CNNMoney.com) -- The drugmaker Merck is taking its third swing at trying to get over-the-counter approval for its cholesterol lowering drug Mevacor.
An advisory panel for the Food and Drug Administration will vote on Thursday as to whether Mevacor should be sold without a prescription. The result of this non-binding vote will be taken as advice by FDA regulators when they rule on the matter on Thursday.
Mevacor was the first cholesterol-lowering statin to hit the market back in the 1980s and one of the first drugs to achieve billion-dollar blockbuster status. But sales have plunged since 2001, when the patent expired on Mevacor and it became a low-cost generic. Mevacor's worldwide sales for 2006 were a mere $20 million.
In theory, OTC status would make the drug more accessible to more patients, resulting in higher sales for GlaxoSmithKline (Charts), which acquired the license to market the drug in the U.S., and for Merck & Co., (Charts, Fortune 500) which receives milestone payments and royalties.
"We believe that 14 million people could potentially benefit from this," said Merck spokesman Jerry Hansen, stating his company's estimates for Americans with high cholesterol who are not being treated.
But analysts don't think the sales boost will be significant, assuming that Merck can get the drug past FDA advisors.
[OTC status] can't hurt, but it's not going to move the needle much," said Les Funtleyder, analyst for Miller Tabak.
For years, Merck has lobbied hard to get an OTC label for Mevacor. The drugmaker first went before an advisory panel in 2000 with a proposed 10-mg dose, but was told to come back with a larger 20-mg dose. At the next meeting, in 2005, the panel voted that Mevacor was safe and effective, but the advisors wanted more data showing that patients could properly "self-select" the drug without a prescription.
Hansen of Merck said the proposed label contains very specific information intended for self-evaluations of patients with "moderately high" cholesterol levels between 200 and 240.
Funtleyder said it's "not clear" how the vote on Thursday will turn out. Either way, the results could serve as an interesting barometer for where the FDA stands on converting prescription drugs to over-the-counter, he says.
"As consumers are being asked to shoulder more of the financial burden for healthcare [in the form of growing co-pays and deductibles,] they want more control over their healthcare," said Funtleyder. "Behind-the-counter and over-the-counter seems to be the direction American healthcare is headed."