Healthy Skepticism Library item: 7231

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Publication type: news

Cortez MF, Zimm A.
Pfizer's Cholesterol Setback May Help Roche, Merck
Bloomberg.com 2006 Nov 13
http://www.bloomberg.com/apps/news?pid=20601202&sid=arnbA7OebE.8&refer=healthcare

Abstract:

Pfizer Inc., the world’s biggest drugmaker, may face competition for the promising cholesterol medicine intended to replace revenue lost when its top-selling Lipitor pill loses patent protection.

Roche Holding AG is studying a drug similar to torcetrapib, a new kind of cholesterol pill in advanced testing by New York- based Pfizer. Merck & Co. may be developing a similar product, according to analysts and researchers. All three therapies are designed to fight heart disease by raising blood levels of so- called good cholesterol. Lipitor works by reducing the bad type of the artery-clogging substance.

Pfizer, which a year ago said torcetrapib might get U.S. approval as early as mid-2008, reported last month that the drug may cause side effects and could require longer trials. A delay may allow Roche and Whitehouse Station, New Jersey-based Merck to market their versions of the drugs, called CETP inhibitors, in time to compete against torcetrapib.

Roche and Merck are ``moving forward aggressively with their own CETP inhibitor programs,’‘ said Seamus Fernandez, a Leerink Swann & Co. analyst in Boston, in a Nov. 3 note to clients. ``The timing of torcetrapib’s approval coupled with increased competition highlights a significant risk for Pfizer,’‘ he wrote.

Lipitor, the world’s best-selling drug, dominates the $20 billion-a-year market for statins, which prevent up to 35 percent of heart complications by reducing LDL, or bad, cholesterol in the blood. The drug is scheduled to go off patent in 2010, opening the way for cheaper generic copies.

Pfizer plans to fend off the competition by combining Lipitor and torcetrapib, which the company said last year may produce $15 billion a year when approved for sale.

2010 or Beyond

Pfizer said in March that it would submit an application to sell the drug with U.S. regulators by late 2007, and analysts said they believed torcetrapib would be quickly approved. On Oct. 31, Pfizer said patient studies found the drug increases blood pressure. Tests to determine if the drug is safe may delay approval to 2010 or beyond, analysts now say.

Pfizer shares have declined 4.8 percent since Oct. 30. The stock rose 18 cents to $25.89 at 4:00 pm in New York Stock Exchange composite trading. Merck’s shares rose 34 cents to $43.46. Basel-based Roche rose 1.1 Swiss francs to 220.5 francs in Zurich.

Doctors say they are still waiting to see results from Roche, and perhaps Merck, to see how those pills compare with torcetrapib.

`Coattails’

``They may be able to ride the coattails,’‘ of Pfizer’s research to help smooth the path for approval of their drugs, said Alan Tall, an expert on good cholesterol and a professor of medicine at Columbia University Medical School in New York in a telephone interview last week.

Pfizer already has spent $1 billion in research into torcetrapib, including a study of the drug’s ability to prevent death and heart complications due in 2009 or 2010, according to the company. The trial is designed to see whether a combination of Lipitor and torcetrapib boosts good cholesterol and delivers more health benefits than Lipitor alone.

``Without knowing details of their programs, we feel very comfortable where we are at and with our filing strategy,’‘ said Joseph Feczko, Pfizer’s chief medical officer, in a telephone interview yesterday. ``There is always competition as new science breaks. All we can do is focus on our program and we have a very robust program.’‘

Blockers

All three drugs under development work by blocking the so- called cholesterol ester transfer protein from converting good cholesterol, called HDL, into the bad form, known as LDL.

Doctors say HDL tends to carry cholesterol away from the arteries and back to the liver, where it’s passed from the body. LDL can slowly build up in the inner walls of the arteries that feed the heart and brain, blocking blood flow and causing heart attacks.

The new drug may meet a medical need because existing therapies haven’t been able to control heart disease, the leading cause of death worldwide, said Steven Nissen, chairman of cardiology at the Cleveland Clinic, the top-rated heart hospital in U.S. News & World Report’s annual review.

More than 13 million Americans suffer from heart disease, which kills more than 650,000 Americans a year, according to the American Heart Association. Statins such as Lipitor ``only reduce cardiac events by about one-third,’‘ Nissen said in a Nov. 8 telephone interview.

``If we had statins in the water supply, heart disease would still be the leading cause of death,’‘ he said.

Raising Good Cholesterol

Torcetrapib’s effectiveness in studies has impressed doctors. Pfizer said last week the drug, combined with Lipitor, raised good cholesterol by 56 percent while simultaneously cutting bad cholesterol by 27 percent. The results showed the combination is more potent than Lipitor alone.

Roche announced in 2004 that it had licensed a CETP inhibitor from Tokyo-based Japan Tobacco Inc. That treatment is now in the second of three phases of patient studies needed for approval, and Roche could file an application with the U.S. Food and Drug Administration after 2009, said Darien Wilson, a company spokeswoman. Roche officials declined further comment.

The Swiss drugmaker may be more forthcoming next year, after phase 2 studies are complete, Wilson said in a Nov. 8 telephone interview.

Janet Skidmore, a Merck spokeswoman, declined to comment on reports by analysts and doctors that her company is working on a CETP inhibitor.

One Milligram

Population-based studies and animal research show high HDL levels protect against heart disease and reduce plaque in the arteries. Raising HDL by 1 milligram can cut risk by 2 percent to 3 percent, said Bryan Brewer, director of the lipoprotein and atherosclerosis research at Washington Hospital Center.

It’s not clear that raising HDL alone will help the human heart. Doctors say having numerous studies showing similar results will help validate the theory.

``These are different drugs, but they are working on the same mechanism,’‘ Brewer said. ``That’s why you are seeing several pharmaceutical companies working on this issue to see if raising HDL using CETP inhibitors will be beneficial.’‘