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Pfizer Advances Its Pipeline

Drug Discovery: An approval and key late-stage data restore confidence in the firm’s R&D engine

by Lisa M. Jarvis
September 5, 2011 | A version of this story appeared in Volume 89, Issue 36

Much in need of a revitalized product portfolio, Pfizer has secured two wins for its drug pipeline. Late last month, FDA approved its lung cancer drug crizotinib, to be marketed as Xalkori. And just days later, Pfizer revealed promising data on the blood thinner apixaban, a potential blockbuster.

Pfizer is desperate for new products to replace its cholesterol drug Lipitor, which loses patent protection in November. Xalkori addresses just a sliver of the lung cancer population, but the drug’s $9,600-per-month price tag suggests it could still make a meaningful contribution to the company’s bottom line.

Xalkori went from lab bench to market in less than seven years, thanks to the 2007 discovery that roughly 3 to 5% of lung cancers are driven by a fusion between the genes encoding for the EML4 and ALK protiens (C&EN, July 26, 2010, page 20). Crizotinib inhibits ALK.

Pfizer calls Xalkori an example of the evolution of its cancer drug development efforts. “In the past, we’ve really had to base our R&D on the histology of the tumor—what the tumor looked like under the microscope and what organ it is in,” Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s oncology business, told reporters. Today, he said, the company is taking advantage of progress in the understanding of cancer biology to inform, and ultimately accelerate, R&D.

In a second confidence booster, Pfizer and Bristol-Myers Squibb unveiled robust Phase III results for apixaban. For the first time, a new blood thinner has been shown to be both safer and more effective than warfarin, which for decades has been the standard of care. On the basis of the data, Leerink Swann stock analyst Seamus Fernandez raised his 2017 sales estimates for apixaban by $1.1 billion to $4.2 billion.

The speedy approval for crizotinib and the positive data on apixaban have restored some faith in Pfizer’s drug engine. Bernstein Research analyst Timothy Anderson pointed out in a note to investors that the firm is expected to launch five new drugs by the end of 2012: crizotinib, apixaban, the kidney cancer treatment axitinib, the arthritis drug tofacitinib, and an adult version of the pneumonia vaccine Prevnar.



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