Pfizer's Torcetrapib Failure: The Risks of New Drug Development

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Case Details:

Case Code : MKTG172
Case Length : 26 Pages
Period : 2000-2007
Pub Date : 2007
Teaching Note :Not Available
Organization : Pfizer, Inc.
Industry : Pharmaceutical
Countries : USA, Europe

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"This drug (Torcetrapib), if it worked, would probably have been the largest-selling pharmaceutical in history."1

- Steven E. Nissen, Chairman of Cardiovascular Medicine at the Cleveland Clinic,2 in December 2006.

"Pfizer's disappointment should highlight the real risks of drug R&D. Who will take such risks to develop the next generation of innovative, lifesaving drugs, other than an industry with abundant capital, intellectual resources, and the freedom to use them?... Only a vibrant, market-based, unfettered pharmaceutical industry can continue to provide us with a steady stream of lifesaving, cost-effective drugs."3

- Gilbert Ross, Executive and Medical Director of the American Council on Science and Health,4 in December 2006.

"It is a tough time in the industry right now. Almost every company is having pipeline problems. There has been no systematic change in the way companies bring products to market."5

- Kenneth Kaitin, Director of The Tufts Center for the Study of Drug Development,6 in December 2006.

A Loss for Pfizer and Heart Disease Patients

On December 02, 2006, the world's largest pharmaceutical company, Pfizer Inc. (Pfizer), announced that it had stopped all the clinical trials for its developmental drug, Torcetrapib. Pfizer said that it had stopped the development of this drug in the interest of patient safety as it was found in the Phase III clinical trials7 that 82 patients who were taking Torcetrapib in combination with Lipitor had died as compared to 51 patients who were taking Lipitor alone. The results of the clinical trial were a big disappointment for Pfizer and its investors as Torcetrapib was expected to counter the anticipated drop in sales when Lipitor, the highest selling drug in the world with over US$ 12 billion in annual sales, would go off-patent in 2010.

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Many cardiologists as well as patients who were suffering from heart disease were also disappointed as Torcetrapib represented a new approach to the management of cholesterol,8 a critical factor in preventing and managing heart disease.

Torcetrapib was unique in the sense that while other popular statin drugs9 primarily reduced the level of bad cholesterol called low density lipoprotein (LDL), Torcetrapib increased the level of good cholesterol, called high density lipoprotein (HDL).

Torcetrapib held so much promise that experts believed that it would become the largest selling drug in history with annual sales of around US$ 20 billion.10

Jami Rubin, an analyst at Morgan Stanley11 said, "This spells the death of what is arguably the most important development program at Pfizer."12

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1] Alex Berenson, "End of Drug Trial is a Big Loss for Pfizer,", December 4, 2006.

2] Cleveland Clinic, located in Cleveland, Ohio, USA, is a multispecialty academic medical center established in 1921.

3] Gilbert Ross, "Heart Care Hurdles,", December 23, 2006.

4] The American Council on Science and Health, is a non-profit organization in the US that works to educate the consumer on issues related to food, nutrition, chemicals, pharmaceuticals, lifestyle, the environment and health.

5] Theresa Agovino, "Drug Maker's R&D Risks,", December 11, 2006.

6] The Tufts Center for the Study of Drug Development, located in Boston, USA, is an independent, academic, non-profit research group affiliated with Tufts University.

7] In medicine, a clinical trial is a type of research study designed to evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings. Clinical trials are required for getting approval of new drugs from the regulatory authority. Phase III studies are randomized controlled trials on large patient groups (300-3,000 or more depending upon the condition) and are aimed at being the definitive assessment of the efficacy of the new therapy, in comparison with standard treatment. (Source:

8] Cholesterol is a fatty substance synthesized in our body. Increased level of bad cholesterol or low density lipoprotein (LDL) cholesterol in the blood is associated with a high risk of heart diseases. A number of drugs are used to reduce the level of LDL-cholesterol. Of these, the statins were the most popular. Lipitor belongs to the statin group of drugs. Another potential way to manage cholesterol is by increase the level of good cholesterol or high density lipoprotein (HDL) cholesterol. Torcetrapib was a potent HDL-cholesterol booster.

9] Statin drugs are very effective for lowering LDL cholesterol levels. They interrupt the formation of cholesterol from the circulating blood. Commonly prescribed statins include Atorvastatin (Lipitor), Fluvastatin (Lescol), Lovastatin (Mevacor), Pravastatin (Pravachol), Rosuvastatin Calcium (Crestor) and Simvastatin (Zocor).

10] "Pfizer Halts All Torcetrapib Trials; Backs Outlook Until 2009, Shares Drop In Pre-Market - Update,", December 04, 2006.

11] Morgan Stanley, headquarted at New York City, USA, is an investment bank, retail broker, and credit card provider.

12] Lisa M. Jarvis, "Pfizer Pulls Torcetrapib,", December 4, 2006.


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