Pfizer Inc. said on Friday its experimental rheumatoid arthritis drug met most of the main goals of a late-stage clinical trial.
If approved, it would compete with injectable treatments such as Humira, made by Abbott Laboratories, Amgen Inc.’s Enbrel, and Remicade, made by Johnson & Johnson.
The world’s biggest drugmaker is seeking new products to offset those that are losing patent protection and its experimental arthritis drug, tofacitinib, is one of the most important in its pipeline.
The latest study, the third of five pivotal trials, showed that when given at a twice-daily dose of 10 milligrams, the drug significantly reduced the signs and symptoms of the disease compared with a placebo at six months.
It also significantly reduced the progression of structural joint damage at six months; and improved physical function at three months. It also showed significantly greater disease remission at six months.
When given at a 5 milligram dose twice a day, the drug significantly reduced the signs and symptoms of the disease but did not significantly reduce the progression of structural joint damage.
Results of two additional late-stage studies will be reported around the middle of this year.
Some analysts expect the drug, if approved, to generate peak annual sales of $2 billion or more. That would go some way to offsetting the expected loss of sales from Pfizer’s cholesterol drug Lipitor, which generated nearly $11 billion in sales last year and is set to lose patent protection in November.
Investors are cautiously optimistic the drug will be approved, though a previous trial showed the drug raised bad cholesterol and liver enzymes in some patients.
The drug, previously known as tasocitinib, belongs to a new class of oral drugs, known as JAK inhibitors, that affect the signaling of proteins involved in inflammatory and autoimmune diseases.
There are 12 JAK inhibitors from 11 companies being developed for rheumatoid arthritis, according to Thomson Reuters Pharma, with Pfizer’s by far the furthest along. Pfizer has not said when it plants to see approval for the drug.
Pfizer shares were up 6 cents at $20.55 in early trading on the New York Stock Exchange.
