Pfizer is spending $800 mil. on the Phase III development program for the cholesterol agent torcetrapib, Worldwide Development President Joe Feczko, MD, said during a Nov. 30 analysts meeting in Groton, Conn.

"This program in total will encompass 40 studies, 25,000 subjects at a cost of approximately $800 mil.," Feczko said.

The coronary heart disease therapy combines torcetrapib with Pfizer's top-selling medicine, Lipitor (atorvastatin).

"Lipitor alone is very effective in lowering LDL levels," Feczko noted. "With torcetrapib, this two molecule combination not only enhances the LDL lowering for a 40 mg Lipitor dose, but dramatically increases patient HDL levels," Feczko said.

"While Phase II data have been very encouraging, the validity of this medical hypothesis must be proven in the clinic and that is what we are attempting to do with a comprehensive Phase III clinical program."

"We are making progress towards our filing goal of assembling a package of irrefutable clinical evidence," Feczko declared.

The 40 trials focus on five major areas of investigation: image studies to demonstrate atherosclerosis effects, lipid studies to support dyslipidemia claims, head-to-head comparison studies, scientific development programs and a comorbidity and mortality study.

"We have nearly completed recruitment of the three imaging studies in two vascular paths that will provide evidence of a direct benefit of therapy on plaque regression in the arterial wall," Feczko said.

One fully recruited 1,100-patient study will observe volume change, and two studies totaling 1,600 patients will measure changes in plaque thickness.

The lipid program includes seven studies in over 5,000 patients to support five dyslipidemia claims in patients with both lipid and triglyceride disorders.

The comparator studies will define performance against other agents such as statins, fibrates and various combinations.

The scientific development program is intended to increase understanding of the cholesteryl ester transfer protein, HDL structure and function and the basic method of action underlying HDL cholesterol and LDL cholesterol effects.

The 13,000-patient morbidity and mortality study is being run to demonstrate reduction in fatal coronary heart disease, non-fatal myocardial infarction and stroke.

The company's extensive Phase III program and its recent acquisition of Esperion underscore its commitment to remaining a leader in the cardiovascular field, Pfizer said.

In January, Pfizer purchased Esperion for $1.3 bil., reuniting the Lipitor research team and adding two acute high cholesterol therapies to its pipeline (¹ Also see "Pfizer/Esperion Deal Reunites Lipitor Team; $1.3 Bil. Buys Two HDL Agents" - Pink Sheet, 5 January, 2004., p. 6).

CEO Hank McKinnell was asked about the potential for Roche/Japan Tobacco's JT 705 HDL increaser to beat the torcetrapib/atorvastatin combination to market.

"We are not very concerned about its availability as a stand alone agent," McKinnell declared. "Clearly [the combination is] going to be the leading candidate in the field."

"It's not clear to me how they're going to develop a stand alone HDL CETP inhibitor," Feczko added. Regulators are not yet willing to accept HDL elevation alone as an endpoint, Feczko maintained.

"It's not clear from the discussion we had with regulators that" developing a stand-alone agent "is even a possibility right now unless they want to embark on a program about four times larger than we have."

Pfizer highlighted the torcetrapib program both because of its importance to the future of the company and as part of its case that its post-merger scale is a clear competitive advantage (see ² [A#00660490002]).

"It's an extremely ambitious program to say the least," Feczko said. "No other organization - governmental or academic institution, or pharmaceutical company - would be in a position to make this kind of investment."

Pfizer Torcetrapib Phase III Program Will Cost $800 Mil.

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