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Glaxo Cholesterol Plan Faces FDA Hurdle
By JEANNE WHALEN

November 27, 2007; Page D3

GlaxoSmithKline PLC acquired the rights to sell a cholesterol-lowering drug without a prescription in the U.S. but could face a tough time winning Food and Drug Administration approval to start selling the product.

Glaxo said it has bought the marketing rights to the drug Mevacor from Merck & Co.; the price wasn't disclosed. Despite two attempts, Merck has been unable to get the FDA to approve Mevacor for sale without a prescription.

Selling a cholesterol-lowering drug without a prescription could potentially be big business for Glaxo, of Brentford, England. The drugs, known as statins, are available only by prescription in the U.S. and are among the industry's top sellers. The drugs racked up U.S. sales of $21.6 billion last year, according to health-care research firm IMS Health.

An FDA advisory panel is scheduled to meet Dec. 13 to consider Merck's most recent application to sell Mevacor without a prescription. A Merck spokesman said the Whitehouse Station, N.J., company plans to present new data addressing earlier concerns that consumers wouldn't take the drug correctly. A Glaxo spokesman said the companies haven't decided what they will do if the FDA rejects the drug again, but Glaxo would own the marketing rights.

Merck will handle that FDA meeting, but Glaxo will take over marketing of the drug should the FDA grant approval, the Merck spokesman said. Merck will receive royalty payments on any sales, he said. The company's decision to sell the rights doesn't reflect any concern that over-the-counter Mevacor won't be approved, he said. \"We're optimistic,\" he said.

Glaxo has switched at least three prescription brands to nonprescription status in the past: Nicorette gum and patches for smoking cessation; the heartburn medication Zantac; and the weight-loss drug Alli.

Glaxo had a tough time winning FDA approval to sell Alli without a prescription. The FDA initially expressed concern that consumers wouldn't take the drug correctly, but Glaxo managed to convince the regulator that it would carry out a marketing campaign that would ensure proper use of the drug.

Separately, the FDA said promotional materials involving the introduction of Glaxo breast-cancer drug Tykerb left out important safety and risk information. Glaxo said it \"will work with the agency to address its concerns.\"