Pfizer Inc. said Friday that its experimental rheumatoid arthritis drug met the main goals of a late-stage clinical trial, a welcome boost for the world’s largest drugmaker as it seeks new products to offset those losing patent protection.
The drug, tofacitinib, is one of the most important in Pfizer’s pipeline. The company said the safety profile of the drug was consistent with that seen in the clinical program, and no new safety signals were seen.
The trial showed the drug reduced the signs and symptoms of rheumatoid arthritis by a statistically significant amount compared with a placebo at six months. The drug significantly improved physical function at three months. It also showed significantly greater disease remission at six months.
The trial tested the drug in patients with moderate to severe disease who didn’t respond adequately to traditional therapies.
It is the second of six late-stage trials. Results of the first were released in November. Results from the remaining four are expected to be released by the middle of this year. Damien Conover, an analyst at Morningstar, expects the drug, if approved, to generate peak annual sales of about $2 billion.
While that would not offset the expected loss of sales from Pfizer’s cholesterol drug Lipitor, which generated nearly $11 billion last year and is set to lose patent protection in November, it would be a start. Investors are reasonably optimistic that the drug will be approved, but Conover said it may take longer than expected since it was shown in a previous trial to raise bad cholesterol and liver enzymes in some patients.
“We’re in a climate where the FDA is very risk averse,” Conover said of the Food and Drug Administration. “I think there is a strong likelihood we’ll see delays, potentially the need for new trials.”
The medicine, 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.
If approved, Pfizer’s drug would compete with injectable treatments such as Humira, made by Abbott Laboratories, and Amgen Inc’s Enbrel.
Shares of Pfizer were little changed at $19.79 in early trading on the New York Stock Exchange.
