Pfizer Mounting Desperate Fight to Stave Off Generic Rival

by Gopalan on Nov 4 2007 2:18 PM

Taking off patent protection is beginning to be hailed in the US too.

Many observers over there are excited that the pharma giant Pfizer is having a tough time of it with its Lipitor, the cholesterol-lowering drug - for the generic rival simvastatin is gaining more and more favour with insurers. The logic is simple, the generic rival is equally effective, and cheaper.

Simvastatin is nothing but the generic version of Zocor, Lipitor’s key rival and manufactured by Merck. Zocor’s patent protection expired last year and so the generic version is having a field day in the market.

Many doctors have come to see simvastatin as a viable substitute for Lipitor. Studies show that at commonly prescribed doses Lipitor and simvastatin are equally effective at reducing LDL cholesterol, the so-called bad cholesterol.

Lipitor costs $2.50 to $3 a day, while simvastatin sells for 75 cents to $1 a day at most retail pharmacies, and as little as 10 cents a day at discount pharmacies.

Each month, doctors with patients on Lipitor are switching tens of thousands of them to simvastatin. And simvastatin is also taking a growing share of the market for new patients who need a cholesterol drug. “Simvastatin is much less expensive to society over all and to patients,” said Dr. Thomas H. Lee Jr., a prominent cardiologist. “If you put patients on generics,” he said, “the chances that they’re taking their medication six months later are higher than on a brand name drug. I think that a few hundred dollars a year does matter.”

Pfizer is trying every trick up its sleeve including promoting a study that concluded that British patients who switched to simvastatin had more heart attacks and deaths than those who remained on Lipitor. Many experts are of course skeptical of the conclusions.

The Lipitor battle has become a test of the pharmaceutical industry’s ability to defend name brands, even as insurers, patients and doctors seek to whittle the nation’s $270 billion annual prescription drug bill by using generic alternatives whenever possible, say Stephanie Saul and Alex Berenson writing in New York Times.

Lipitor and other cholesterol-lowering drugs, sometimes called statins, are the largest drug class, with spending of $22 billion last year in the United States alone.

Dr. Mark Fendrick, a professor of internal medicine at the University of Michigan and a specialist in health care economics, notes that for patients with extremely high cholesterol, Lipitor may be a better choice. An 80-milligram daily dose of Lipitor, the top dose, can reduce cholesterol by up to 60 percent, compared with about 50 percent for an 80-milligram dose of simvastatin, also the top dose.

But most patients with moderately high cholesterol take 10 or 20 milligrams of Lipitor a day, and can get comparable benefit from 40 or 80 milligrams of simvastatin, Dr. Fendrick said.

Lipitor’s share of the cholesterol-lowering drug market in this country has ebbed to 30 percent, down from 40 percent 18 months ago, when simvastatin was available only as name-brand Zocor — at prices that were higher than Lipitor’s.

No generic version of Lipitor is in the offing because the Lipitor patent remains valid until at least March 2010. But the advent of generic Zocor has dented sales enough to hurt Pfizer’s stock, which is trading near its lowest level in a decade.

In a recent conference call with Wall Street analysts, Pfizer vowed to step up its efforts to protect Lipitor. So far this year, the company has been spending more than 50 percent more on advertising the drug than it did in 2006, when its Lipitor ad spending for the year totaled $142.7 million.

Pfizer is sponsoring a speaking tour by Dr. Louis W. Sullivan, a former secretary of Health and Human Services, who without citing Lipitor specifically is arguing against insurers’ efforts to influence medical decisions.

The company has also been fighting the generics trend in the political arena. In a Sept. 10 letter to state lawmakers in Ohio, a Pfizer lobbyist cited the potential risks of switching to cheaper medicines.

Despite Pfizer’s efforts, analysts and physicians say they see little chance of the company’s stemming the generic tide.