Pfizer faces crucial panel vote on blockbuster hopeful tofacitinib

Wounded by plummeting Lipitor sales, Pfizer ($PFE) has high hopes for one of the gems of the pharma giant's pipeline, tofacitinib, and next week FDA advisers will take their turn dissecting the upsides and downsides of the first-in-class drug for rheumatoid arthritis. Odds are in favor of a positive panel vote, Reuters reported.

The FDA advisory panel for tofacitinib comes as Pfizer refashions its research and development efforts to become more productive and cost-efficient. And since the blockbuster hopeful emerged from Pfizer's own labs, the success of the drug could provide a major victory for the company's maligned R&D operations, according to the article. Pfizer, the world's largest drugmaker, is counting on tofacitinib and other major products in the firm's pipeline such as anti-clotting drug Eliquis and the Alzheimer's therapeutic bapineuzumab to replace skidding sales of Lipitor, which dropped 71% in the U.S. during the first quarter.

Tofacitinib, the first in a string JAK inhibitors in development for RA, comes packaged with all the promise and problems of a first-in-class experimental drug. Tablets of tofacitinib offer the advantages of oral dosing, unlike the injected anti-TNF treatments such as Abbott's ($ABT) Humira and Amgen's ($AMGN) Enbrel. As the article notes, however, Pfizer's RA drug hasn't proven to be more efficacious than the anti-TNF drugs and the long-term safety of the drug remain a mystery. For instance, it's unknown whether the risks associated with tofacitinib such as increased cholesterol and liver-enzyme levels are easily remedied or indicators that patients on the drug face future heart problems and serious organ damage.

"When we already have good treatments available, and there's no evidence that this drug really is better than others, I tend to encourage patients to go with what I know, which is things like Humira or Enbrel," Dr. Scott Zashin, clinical professor of medicine at the University of Texas-Southwestern Medical School, said, as quoted by Reuters.

Still, analysts expect an overall positive review of tofacitinib and an approval of the drug, which could gain early traction in the market for patients who fail to respond to anti-TNF drugs and methotrexate, Reuters reported. The news service cited analysts projecting $2 billion to $3 billion in eventual annual sales of the drug. Those are the types of numbers that Pfizer will need to put up to start easing the company's Lipitor aches.

The FDA staff documents on tofacitinib are expected to be available on Monday, with the advisory panel slated for Wednesday next week.

- read the Reuters report