Firms Want to Sell OTC Cholesterol Drugs
Bristol-Myers Squibb Co. said on Friday it will ask federal regulators to allow it to sell its cholesterol-lowering medicine, Pravachol, without a prescription.
Meanwhile, Merck & Co. disclosed on Friday it had already filed an application with the U.S. Food and Drug Administration to sell its cholesterol drug, Mevacor, over the counter and that its request would be reviewed next month.
Earlier this year, British health officials approved the world’s first switch of a cholesterol drug to nonprescription status when it allowed Merck’s Zocor to be sold over the counter.
Bristol-Myers wouldn’t discuss when it planned to file its application but said it had reached an agreement with Bayer HealthCare LLC to market the over-the-counter version of Pravachol if the FDA approves the switch. Terms were not disclosed.
Whether the FDA will allow such switches remains to be seen. It rejected similar efforts in 2000.
Some doctors have expressed concerns that some patients won’t see a doctor regularly to address the other risk factors that sometimes accompany High cholesterol such as high blood pressure and diabetes.
Friedman, Billings, Ramsey analyst David Moskowitz said patients on such drugs should be monitored carefully to check that dosing is appropriate and that they aren’t developing any serious side effects.
“I don’t think these are going to be easy approvals,” said Moskowitz. He questions whether companies’ motivations are really in the best interest of patients.
Pravachol loses its patent in 2006, when sales are expected to plummet. Last year, Pravachol was Bristol-Myers best selling drug, bringing in $2.8 billion in revenue.
Bristol-Myers spokesman Robert Hutchinson said the move could “broaden consumer access to cholesterol lowering medications to potential millions of consumers.”
Merck is seeking approval along with its partner Johnson & Johnson through their joint venture, which already sells an OTC version of heartburn medication Pepcid.
Officials with the joint venture said this spring that nonprescription Mevacor likely would cost about $1 for each daily 20-milligram pill. That’s less than the price of prescription Mevacor, about $2.10 per pill, but more than what many insurance plans charge for a co-payment on a brand-name prescription drug.
Launched in 1987, Mevacor had peak sales of $1.3 billion in 1994. That dropped to $31 million in 2003 amid competition from generics and from Pfizer Inc.‘s heavily advertised Lipitor.
Bristol-Myers shares closed up 16 cents, at $23.81 Friday during the regular session on the New York Stock Exchange, but shed 9 cents of that, to $23.72 in after hours trading. Merck shares gained a penny, to $28.74, during the regular session, and added another 1 cent in after hours trading.
Business Writer Linda Johnson contributed to this story.
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Revision date: June 11, 2011
Last revised: by Sebastian Scheller, MD, ScD