The plant, based in Ireland and costing $90 million, has just produced its first batch of drugs aimed at reducing the risk of heart disease. The facility will manufacture torcetrapib, which Pfizer is combining with Lipitor (atorvastatin calcium) in a new medicine. Torcetrapib was discovered as part of the company’s research efforts to raise HDL, or “good” cholesterol. Researchers believe HDL plays an important role in heart disease.
Pfizer believes torcetrapib/atorvastatin will build on the proven efficacy and safety of Lipitor, the world’s most-prescribed medicine to lower bad cholesterol. Numerous studies with statins have established the critical importance in LDL-lowering for reducing the risk of cardiovascular disease.
Pfizer says it has undertaken the largest and most comprehensive clinical trial development program ever. Torcetrapib/atorvastatin’s clinical program will involve 25,000 patients at hundreds of medical centers worldwide at a cost of about $800 million. Pfizer’s scientists are testing the hypothesis that simultaneously raising HDL and lowering LDL could provide the largest reduction in the risk of cardiovascular disease.
“If we prove our hypothesis, torcetrapib/atorvastatin has the potential to benefit millions of lives around the world,” said Dr John LaMattina, president of Pfizer global R&D. “Nothing is certain except our huge investment. Even if this fails as a new medicine, we will have advanced scientific understanding in this area.”
Pfizer researchers began the torcetrapib/atorvastatin program more than 15 years ago, basing their HDL-raising approach on inhibiting CETP, a protein in the liver that transfers cholesterol.
While torcetrapib alone was inadequate in lowering LDL, consultation with external experts confirmed that the compound should be used with atorvastatin, which has been widely studied and shown to be highly effective at reducing LDL levels.