Pfizer May Bring Over-the-Counter Lipitor to Market, CEO Says

Pfizer Inc. (PFE) will try to introduce a nonprescription form of its top-seller Lipitor to help cushion tumbling sales of the cholesterol pill as generic versions reach the market, Chief Executive Officer Ian Read said.

Lipitor, which is Pfizer’s best-selling drug, loses U.S. patent protection on Nov. 30. The company is looking for ways to replace its $10.7 billion in annual revenue as cheaper copies drive down prices.

“There is an intent at some point to have an OTC version of Lipitor in the marketplace,” Read said today on a conference call discussing the company’s third-quarter earnings. A nonprescription version of Lipitor wouldn’t be available until at least 2013, because of the regulatory process to get it approved, he said.

“We have no definitive evidence we can do it,” Read said in an interview. An over-the-counter version of Lipitor would be the first of the statin cholesterol drugs on the market that consumers could buy without a prescription. It would still compete with generic over-the-counter versions.

The loss of Lipitor’s patent-protected revenue will relegate the New York-based company from its place atop the pharmaceutical world, where it leads all competitors in drug sales, EvaluatePharma Ltd. said yesterday in a report. In 2012, Paris-based Sanofi will hold the top spot, followed by Basel, Switzerland-based Novartis AG, and Pfizer in third, EvaluatePharma said in the report.

‘Rapid’ Decline

Read said the company expects the decline in Lipitor sales to be “very rapid.” Sales of the cholesterol drug will fall by about half next year to $4.57 billion and to $3.17 billion in 2013, according to an average estimate by four analysts surveyed by Bloomberg.

Pfizer is divesting its animal health and nutritional units to focus on producing new, brand-name pharmaceuticals. It will keep its generic drug business, which also oversees sales abroad.

The company has been examining an over-the-counter version of Lipitor, a person familiar with the situation said in August. The U.S. Food and Drug Administration must determine if patients can safely and effectively dose themselves without a doctor’s prescription.

Pfizer successfully took its allergy medicine, Zyrtec, over-the-counter in 2008 before selling its consumer unit that year to Johnson & Johnson for $16.6 billion.

Along with trying to get an over-the-counter Lipitor to market, the company has struck agreements with pharmacy benefit management companies including Medco Health Solutions Inc. and Express Scripts Inc. to sell brand-name Lipitor at a lower price, Timothy Anderson, an analyst with Sanford C. Bernstein & Co., said in a note to clients on Oct. 30. The sales agreements are mostly for customers who get their drugs by mail, he said.

Third-Quarter Results

Pfizer reported third-quarter earnings today that beat the average estimate of 18 analysts surveyed by Bloomberg by 6 cents, as increased sales overseas and favorable exchange rates helped boost revenue. Profit excluding one-time items was 62 cents a share.

Net income increased more than four-fold to $3.74 billion, or 48 cents a share, from a year earlier when the company had charges related to an acquisition and asbestos litigation, New York-based Pfizer said in a statement.

Pfizer increased less than 1 percent to $19.40 at 12:52 p.m. New York time.

To contact the reporter on this story: Drew Armstrong in Washington at darmstrong17@bloomberg.net;

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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