Pfizer expects to have 24 to 28 programs in Phase III development by the end of 2009, up from an existing 16 programs in late-stage development, Global R&D President Martin Mackay said during an analyst day in New York March 5.

The enhanced research productivity will translate into 15 to 20 regulatory submissions from 2010 to 2012, with the aim of delivering a steady flow of new products and indications to offset the looming loss of exclusivity for cholesterol-lowering Lipitor (atorvastatin).

Management forecast a positive outlook for the company, highlighting opportunities in cancer, diabetes and pain as well as in emerging markets. But with the bulk of Pfizer's pipeline in early-stage development, the company won't soon fill the chasm left by the loss of income from Lipitor - a brand that generated $12.68 billion worldwide in 2007 - when it faces generic competition, likely in 2010.

"In the immediate aftermath of the Lipitor [loss of exclusivity], our revenues and earnings will be meaningfully impacted," CEO Jeff Kindler acknowledged.

"We will continue to pursue now, through and beyond the Lipitor LOE a wide range of opportunities that we believe will provide us many sources of sustainable revenue growth," he assured analysts. "Second, we will do what is necessary to size the company appropriately for our revenues and our opportunities, whatever they are, so that we deliver growing profitability after Lipitor."

Rebuilding the pipeline is the cornerstone of Pfizer's growth strategy. The R&D team recently completed a review of every compound under development, and accelerated some while halting others, based on criteria such as unmet medical need, best-in-class or first-in-class opportunity and high market growth, Mackay said. The company halted development of 24 compounds in total, of which 14 were in Phase I or Phase II clinical development; the others were preclinical.

The pared down therapeutic areas on which Pfizer will now focus include oncology, pain, immunology/inflammation, diabetes/obesity, Alzheimer's disease and schizophrenia. The company will maintain another group of disease areas considered to have less potential with level-funded resources.

Among the 20 development programs Pfizer is accelerating is CP-690550, a JAK3 inhibitor for rheumatoid arthritis, transplant rejections, psoriasis and Crohn's disease; CP-751871, an IGF-1R inhibitor for non-small cell lung cancer and other tumors; PF-734200, a DPP-4 inhibitor for diabetes; and the approved smoking cessation drug Chantix (varenicline) for broader neuroscience indications.

Pfizer will have 15 to 20 Phase III starts in 2008 and 2009, including both new molecular entities and new indications for existing drugs, according to Mackay. NMEs that will start Phase III trials include axitinib for pancreatic cancer, tremelimumab for melanoma, apixaban for venous thromboembolism prevention, S,S-reboxetine for fibromyalgia, CP-945598 for obesity and PD-332334 for generalized anxiety disorder.

"This is a tall order for R&D," Mackay said of the productivity initiative. "In fact, I do believe it is the R&D challenge of a lifetime."

The company's pipeline also includes 26 biologics spanning eight therapeutic areas. Kindler implemented a biologics strategy at Pfizer last year aiming to position the firm as a top-tier biotech company with the opening of a Biotherapeutics & Bioinnovation Center in San Francisco (¹ Also see "Pfizer Unveils New San Francisco-Based Biotech Center, R&D Leaders" - Pink Sheet, 4 October, 2007.).

However, Biotherapeutics & Bioinnovation Center President Corey Goodman said, "If we are going to be a top-tier player, we have to do better. We have to make sure that 20 to 25 percent of the pipeline are biotherapeutics."

Pfizer also announced it is establishing a new business unit focused on oncology within the worldwide pharmaceutical group. The group will aim to strengthen Pfizer's position in oncology by expediting launches of novel agents and focusing research efforts on cancers common in Asia, such as liver, esophagus and nasopharynx cancer.

Management also outlined opportunities to extend Pfizer's global reach in emerging markets such as Latin America, Eastern Europe and Asia. Japan/Asia President Dudley Schleier highlighted opportunities in China in particular, where established brands, such as the calcium channel blocker Norvasc (amlodipine), that have gone off patent continue to generate strong sales despite the availability of lower-cost generics.

Pfizer expects to expand commercial operations in China from the 110 cities now served to 650 cities, Schleier said.

-Jessica Merrill (j.merrill@elsevier.com)

Pfizer Plots Major Phase III Push

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