Pfizer Arthritis Med Meets Clinical Trial Goal
Pfizer Inc. said on Friday that its rheumatoid arthritis drug met the main goals of a late-stage clinical trial.
The drug is one of the most important in Pfizer’s pipeline. The company said the safety profile of the drug was consistent with that seen previously in the clinical program.
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 trial tested the drug in patients with moderate to severe disease who had failed to respond adequately to traditional therapies.
Results of the first trill were released Last November. Damien Conover, an analyst at Morningstar, said that if the drug is approved it will generate peak annual sales of about $2 billion.
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 told Reuters, referring to the U.S. Food and Drug Administration. “I think there is a strong likelihood we’ll see delays, potentially the need for new trials.”
The medicine belongs to a new class of oral drugs that affect the signaling of proteins involved in inflammatory and autoimmune diseases.
Pfizer’s drug would compete with multiple injectable treatments like Humira, made by Abbott Laboratories, Amgen Inc.’s Enbrel, and Remicade, made by Johnson & Johnson.
Tim Anderson, an analyst at Sanford Bernstein, said the fact that Pfizer’s drug is given by mouth gives it an edge over competition.
“It is an oral therapy that will be competing in a category dominated by injectable products that currently sell about $12 billion a year in rheumatoid arthritis, or about $20 billion when considering other indications,” he said in a recent research report.
Anderson said he assumes Pfizer will have to price the drug at a discount of around 20 percent to injectable products, implying a cost of about $17,000 per year.
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