Pfizer Stops Trial on Torcetrapib Cholesterol Pill (Update4)
By Shannon Pettypiece and Michelle Fay Cortez
Dec. 2 (Bloomberg) -- Pfizer Inc., the world's biggest drugmaker, said it is ending development of its most important experimental drug, the torcetrapib cholesterol pill, after patients using the medicine died during a study.
Pfizer had expected torcetrapib would help replace revenue lost when its Lipitor cholesterol pill, the world's biggest selling drug, loses patent protection in 2010. The New York- based company said in a statement it has notified both U.S. regulators and doctors that the patients involved in the trial should no longer use the drug.
While Pfizer didn't say how many people died or give the circumstances related, torcetrapib was tied in recent research to high blood pressure in some patients. The drug had been expected to eventually generate as much as $20 billion in annual revenue, said Trevor Polischuk, an analyst with Orbimed Advisors LLC in New York, in an interview last week.
``I'm terribly disappointed on behalf of our patients,'' said Steven Nissen, head of cardiology at the Cleveland Clinic, the top heart hospital in the U.S. News & World ranking, in a telephone interview today.
Drugs like Lipitor, which lower so-called bad cholesterol, or LDL, ``only reduce cardiovascular events by about one third,'' Nissen said. ``We were very hopeful'' use of drugs like torcetrapib, which raise HDL, the good cholesterol, ``would improve patient outcomes.''
``It didn't work out for Pfizer, but stopping the trial was obviously the right thing to do,'' Nissen said.
`Interests of Patients'
Pfizer Chief Executive Officer Jeffrey Kindler said in the statement that the company halted the trial, which involves about 15,000 people, in the ``interests of patients and making sure all this information is communicated to appropriate medical and regulatory authorities as quickly as possible.''
Pfizer is in need of torcetrapib to replace the $13 billion in annual revenue the company may lose from sales of Lipitor, when that drug's patent protection ends and cheaper generic copies are allowed on the market.
Lipitor was the source of a quarter of last year's revenue for Pfizer, and almost half of the company's earnings. Ofizer spent $1 billion already in its development of torcetrapib.
The announcement comes two days after Pfizer said it planned to seek U.S. marketing approval of torcetrapib in the second half of 2007. The company also said during a Nov. 30 meeting with analysts that it was in the early stages of studying two other drugs, beyond torcetrapib, as potential candidates to replace Lipitor.
`Understand the Challenge'
``With regard to our business, we understand the challenge that this represents and we will respond quickly and aggressively to it,'' Kindler said in the statement.
Pfizer said during the analyst meeting that early results from its last-stage human testing showed the drug elevated patients' blood pressure an average of three to four millimeters in patients taking the drug, combined with Lipitor. Raising blood pressure that much could cause complications in patients already at risk of having a heart attack, analysts said.
All three candidates to replace Lipitor are designed to elevate levels of good, or HDL, cholesterol. Good cholesterol helps sweep LDL from arteries, doctors say.
Pfizer is in a race with other drugmakers to develop the new class of cholesterol drugs. Roche is studying a drug that works the same way as torcetrapib, and Merck may be developing a similar product, according to analysts and researchers. Abbott Laboratories is acquiring Kos Pharmaceuticals, the maker of Nias pan, the strongest HDL-raising drug on the market.
``We are first in class, best in class and I believe we wil own this class for as long as it exists,'' said John LaMattina, Pfizer's senior vice president for global research, in a Nov. 30 meeting with analysts.
To contact the reporter on this story: Shannon Pettypiece in Washington at spettypiece@bloomberg.net
Last Updated: December 2, 2006 23:20 EST
By Shannon Pettypiece and Michelle Fay Cortez
Dec. 2 (Bloomberg) -- Pfizer Inc., the world's biggest drugmaker, said it is ending development of its most important experimental drug, the torcetrapib cholesterol pill, after patients using the medicine died during a study.
Pfizer had expected torcetrapib would help replace revenue lost when its Lipitor cholesterol pill, the world's biggest selling drug, loses patent protection in 2010. The New York- based company said in a statement it has notified both U.S. regulators and doctors that the patients involved in the trial should no longer use the drug.
While Pfizer didn't say how many people died or give the circumstances related, torcetrapib was tied in recent research to high blood pressure in some patients. The drug had been expected to eventually generate as much as $20 billion in annual revenue, said Trevor Polischuk, an analyst with Orbimed Advisors LLC in New York, in an interview last week.
``I'm terribly disappointed on behalf of our patients,'' said Steven Nissen, head of cardiology at the Cleveland Clinic, the top heart hospital in the U.S. News & World ranking, in a telephone interview today.
Drugs like Lipitor, which lower so-called bad cholesterol, or LDL, ``only reduce cardiovascular events by about one third,'' Nissen said. ``We were very hopeful'' use of drugs like torcetrapib, which raise HDL, the good cholesterol, ``would improve patient outcomes.''
``It didn't work out for Pfizer, but stopping the trial was obviously the right thing to do,'' Nissen said.
`Interests of Patients'
Pfizer Chief Executive Officer Jeffrey Kindler said in the statement that the company halted the trial, which involves about 15,000 people, in the ``interests of patients and making sure all this information is communicated to appropriate medical and regulatory authorities as quickly as possible.''
Pfizer is in need of torcetrapib to replace the $13 billion in annual revenue the company may lose from sales of Lipitor, when that drug's patent protection ends and cheaper generic copies are allowed on the market.
Lipitor was the source of a quarter of last year's revenue for Pfizer, and almost half of the company's earnings. Ofizer spent $1 billion already in its development of torcetrapib.
The announcement comes two days after Pfizer said it planned to seek U.S. marketing approval of torcetrapib in the second half of 2007. The company also said during a Nov. 30 meeting with analysts that it was in the early stages of studying two other drugs, beyond torcetrapib, as potential candidates to replace Lipitor.
`Understand the Challenge'
``With regard to our business, we understand the challenge that this represents and we will respond quickly and aggressively to it,'' Kindler said in the statement.
Pfizer said during the analyst meeting that early results from its last-stage human testing showed the drug elevated patients' blood pressure an average of three to four millimeters in patients taking the drug, combined with Lipitor. Raising blood pressure that much could cause complications in patients already at risk of having a heart attack, analysts said.
All three candidates to replace Lipitor are designed to elevate levels of good, or HDL, cholesterol. Good cholesterol helps sweep LDL from arteries, doctors say.
Pfizer is in a race with other drugmakers to develop the new class of cholesterol drugs. Roche is studying a drug that works the same way as torcetrapib, and Merck may be developing a similar product, according to analysts and researchers. Abbott Laboratories is acquiring Kos Pharmaceuticals, the maker of Nias pan, the strongest HDL-raising drug on the market.
``We are first in class, best in class and I believe we wil own this class for as long as it exists,'' said John LaMattina, Pfizer's senior vice president for global research, in a Nov. 30 meeting with analysts.
To contact the reporter on this story: Shannon Pettypiece in Washington at spettypiece@bloomberg.net
Last Updated: December 2, 2006 23:20 EST
( and remember, there was no negative news until the weekend ,hehe