Pfizer Inc., the world’s biggest drugmaker, leads a race against three rivals to sell the first new pill in a decade for rheumatoid arthritis, a joint disease treated by injected drugs with $12 billion in annual sales.
The tablet, called tasocitinib, curbed inflammation and stopped the disease from worsening, Pfizer reported last week. Pfizer may edge out shots sold by Johnson & Johnson, Abbott Laboratories, and Amgen Inc. if research to be presented Nov. 10 at the American College of Rheumatology in Atlanta suggests its tablet is also a safe alternative.
Tasocitinib is the most advanced pill in a family of experimental drugs to target a protein, called JAK, which leads to joint destruction in 1.3 million Americans with rheumatoid arthritis. Pfizer’s study is the first late-stage JAK trial, one of six the company plans to complete by the end of next year. The pill can generate peak annual sales of $2 billion, said Tim Anderson, an analyst with Sanford C. Bernstein & Co.
“Tasocitinib’s main value proposition is that it is a first-in-class novel oral therapy launching into an area filled with injectable products that collectively sell about $12 billion a year for rheumatoid arthritis alone,” Anderson said in a Nov. 1 research report.
Pfizer shares fell 20 cents, or 1.2 percent, to $17.18 at 4 p.m. in New York Stock Exchange composite trading. The New York-based drugmaker rose less than a percent in the 12 months through today.
Pfizer is counting on revenue from tasocitinib to help offset losses when its top-selling Lipitor cholesterol pill, with $11.4 billion in annual sales, faces competition next year from cheaper copies in the U.S. The company gained the arthritis remedy Enbrel in last year’s $68 billion purchase of Wyeth. The anti-inflammatory medicine generated $799 million in the third quarter, making up 5 percent of Pfizer’s revenue.
Rheumatoid arthritis is a chronic disease where the immune system mistakenly attacks healthy tissue, causing inflammation in and around joints. Shots known as anti-TNF therapy are standard care for the 80 percent of patients who don’t respond to treatment with methotrexate, a generic drug that can block cell growth in people with certain cancers and immune disorders.
Three biotechnology companies are trying to catch up to Pfizer with their own JAK drugs - Rigel Pharmaceuticals Inc., Incyte Corp., and Vertex Pharmaceuticals Inc. Pfizer’s pill is the only one in the third and final stage of tests generally needed for U.S. approval.
Tasocitinib “appears to be in the lead by at least two years in comparison to other JAK inhibitors,” said Marc Goodman, an analyst with UBS Securities, in an Oct. 27 note to clients. “We believe that the safety issues are key to gaining the appropriate label and could limit its use to patients with low cardiovascular risk.”
Investors are most concerned about whether Pfizer’s drug will raise cholesterol levels enough to limit the number of patients who might use it, Goodman said. The pill showed signs of this side effect in previous study results.
Doctors may be slow to adopt new JAK drugs for patients who are already getting relief from older treatments, said David Pisetsky, professor of rheumatology and immunology at Duke University School of Medicine. While high cholesterol linked to tasocitinib may be treatable, physicians may resist adding an additional drug to patients’ daily treatment regimens.
“Because it’s a new mode of action, there’s great interest, but what’s going to happen in terms of efficacy and safety when you really put it out there?” Pisetsky said in a telephone interview. “There’s always a difference between what happens in a trial setting and what happens in real life.”
The rheumatoid arthritis market is dominated by three anti-TNF treatments: Enbrel from Pfizer and Thousand Oaks, California-based Amgen; Humira, from Abbott Park, Illinois-based Abbott; and Remicade, sold by New Brunswick, New Jersey-based J&J and Merck & Co., based in Whitehouse Station, New Jersey. The treatments cost as much as $20,000 a year and leave patients susceptible to infections.
Summary results of the first three months of Pfizer’s six-month study were released last week. The study’s 611 patients took one of two doses of the drug or a placebo pill. After three months of treatment, 66 percent of patients taking the higher dose had at least a 20 percent improvement of symptoms, compared with 27 percent in the placebo group. Side effects were reported by 330 patients, with 25 seriously affected. Thirteen patients stopped taking the drug. A 79-year-old woman with a history of heart disease and diabetes died after developing diarrhea followed by renal failure.
The complete six-month data from the trial will be released Nov. 7 and presented Nov. 10 at the rheumatology meeting. The presentation will include the number of patients with 70 percent improvement and will describe side effects in greater detail.
Incyte Corp., based in Wilmington, Delaware, will present the second of three stages of testing of its drug, INCB-28050, at the rheumatology meeting. Early results of the 125-patient trial show similar effectiveness to Pfizer’s drug and comparable anti-TNFs, though more studies are needed, said Goodman of UBS. Incyte is partnered with Eli Lilly & Co., of Indianapolis.
Rigel, of South San Francisco, California, in September entered late-stage research for its JAK drug, called fostamatinib, in joint development with London-based AstraZeneca Plc. A study in July 2009 failed to show statistically significant improvement for patients taking the drug.
Vertex, based in Cambridge, Massachusetts, is conducting a mid-stage trial of its JAK drug, VX-509.
Methotrexate, now generic, was approved in 1988 and sells for less than $1 a pill. Arava, a pill approved in 1998 for Paris-based Sanofi-Aventis SA, is also sold as a generic.