One of the most closely watched drugs in Pfizer's ($PFE) late-stage pipeline has cleared a pair of key hurdles, hitting two primary endpoints for rheumatoid arthritis while failing to overcome a third endpoint. Researchers say that tasocitinib--one of a group of new oral RA drugs angling for a near-term approval--significantly improved patients' disease symptoms and helped improve their ability to function physically. And that data emboldened analysts who believe the therapy can go on to achieve blockbuster income.
"This is the first oral medication for rheumatoid arthritis that has had a successful Phase III study this century," Dr. Roy Fleischmann, a principal investigator, told Reuters. "When it works, it really works." Bloomberg notes that Pfizer is in a hot race to win an approval for an RA pill, with Rigel ($RIGL), Vertex ($VRTX) and Incyte ($INCY) all in the hunt.
Pfizer's new data is impressive. Investigators reported Sunday that the drug significantly reduced pain and inflammation for almost three out of every four patients. And that puts the drug, which is in four other late-stage trials, on track for a regulatory filing. Sanford C. Bernstein & Co.'s Tim Anderson said that the drug could deliver $2 billion a year to Pfizer, which needs new blockbusters to replace drugs that are on the verge of losing patent protection.
"We see the ability, with all of these studies, to get a very broad label," Saeed Fatenejad, who heads up immunology clinical trial work for Pfizer, tells Bloomberg. "This might be the first drug that is going for the original filing with everything: signs and symptoms, quality of life, X- ray data, and then really looking at the various types where the drug could be used."
- here's the story from Bloomberg
- check out the Reuters report