Pfizer keeps rolling with $1B bid for OTC Lipitor

Pfizer recently started a trial for over-the-counter Lipitor--Courtesy of Pfizer

Pfizer's once-gargantuan statin drug Lipitor has been cut down to size by generic competition. But if the drugmaker's plan to win over-the-counter status for the drug succeeds, Pfizer ($PFE) could add up to $1 billion back into its Lipitor franchise.

As the Wall Street Journal reports, Pfizer recently started a 1,200-patient trial to test whether consumers using over-the-counter Lipitor would (a) get their own blood tests to see whether they qualify, and (b) make the right decisions based on those test results.

The trial is designed to answer FDA concerns that the wrong patients could end up taking Lipitor. The popular statin has proven effective at lowering "bad" cholesterol, but it does have potential side effects, including muscle and tendon problems.

The issue is complicated by an ongoing debate about the role of statin drugs in treating or preventing heart disease. Recently, the American Heart Association and the American College of Cardiology changed their guidelines for prescribing the cholesterol fighters in a way that puts millions more patients in line for therapy. The U.K.'s cost-effectiveness watchdog proposed similar changes just last month.

As the WSJ notes, the new U.S. guidelines don't allow for OTC statins. And some doctors question whether patients would use enough of the nonprescription version to make a difference. The proposed OTC dose is 10 mg, which is the lowest dose available by prescription. On the high end, prescription doses can run up to 80 mg.

But Pfizer and others say that OTC Lipitor would reach at-risk patients who wouldn't otherwise use statins. That could save the healthcare system money by preventing costly cardiovascular problems. "The OTC status is another access point," Mark Gelbert, Pfizer's SVP of consumer health R&D, told the Journal.

The FDA has rejected nonprescription statin use before; Merck ($MRK) lost a bid to put its Mevacor drug for sale over the counter back in 2008. But the agency has said that it would like to open more drugs up to over-the-counter use, to give patients with chronic health problems better access to treatments. Just last month, the FDA said it is moving toward an OTC-approval revamp, hoping to speed OTC meds to market and respond more quickly to safety concerns.

If Pfizer can persuade the FDA to put Lipitor on its OTC list, the drug could add up to $1 billion to its sales, analysts have said. That wouldn't take Lipitor back up to its record-setting, $9-billion-a-year levels, but it could keep it in Pfizer's top 5. Plus, Pfizer split its internal operations three ways as of January 1, with one of those new units comprising established products--including Lipitor--and consumer health. Building up sales there could help make the case for a sale or spinoff of that business.

- read the WSJ piece (sub. req.)

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