Immunex Corp. thinks its new arthritis drug could be a major turning point in its evolution from a research firm to a commercial pharmaceutical business.
The Seattle-based company, which has spent $150 million developing Enbrel, hopes to submit its latest test results to the U.S. Food and Drug Administration in the first half of next year. If approved, the new drug could reach the market in 1999.
The results from Phase 3 testing - the last stage required before the data may be submitted to the FDA - were released Sunday in Washington, D.C., at a meeting of the American College of Rheumatology.
The data showed that of the 234 severely afflicted patients enrolled in the studies, 50 percent or more had at least a 71 percent reduction in the number of swollen joints. The patients received 25-milligram doses twice a week through injections. The median reduction in painful joints for patients on a placebo was 6 percent. Some doctors said Enbrel shows more promise than any drug in the past 10 years.
“This is very exciting for us,” said Dr. Philip Mease, a Seattle heumatologist attending the conference. “There hasn’t been another drug that’s come on the scene in more than a decade that’s been as effective as Enbrel.”
“I’ve been in the practice of rheumatology since 1980, and there’s basically been nothing new since then,” said Dr. Scott Baumgartner of Physicians Clinic in Spokane, who has about 60 patients in the ongoing studies.
There is no known cure for rheumatoid arthritis, a painful autoimmune disease causing inflammation and destruction of joints. The disease afflicts about 2.5 million people in the United States and 5 million people worldwide. Many with advanced stages of the ailment no longer respond to medication. The patients in the Phase 3 study suffered from advanced rheumatoid arthritis and had failed to respond to at least one of the several drugs currently on the market.
Mease, who practices at the Minor and James Medical Clinic in Seattle, said many patients in the studies have had dramatic improvement in their quality of life.
Lindagail Dixon, 43, of Spokane is one of them. She’s had arthritis since she was 16, and nothing worked to stop the pain. Three years ago, she started taking Enbrel as part of the first study of the drug. She continues to take it and has gone from being a sedentary secretary to a restaurant manager on her feet 10 to 12 hours a day.
“There is no pain, no morning stiffness,” she said. “I feel wonderful.”
Doctors cautioned, however, that it is too soon to say whether the drug’s effects will wear off after a few years. They also cautioned that people’s experiences on the drug varied. For some patients, the improvement was modest, Mease said.
The current arthritis medications include nonsteroidal anti-inflammatory drugs (such as ibuprofen), corticosteroids (such as prednisone), and methotrexate, a powerful immune-system drug that has toxic side effects.
Enbrel, which is a natural molecule found in the immune system, works by preventing another molecule in the immune system from turning on the body’s inflammatory response.
Enbrel would be a sweet payoff for Immunex.
The company’s first drug, Leukine, used in conjunction with chemotherapy to help boost patients’ white cell counts, has respectable sales and is a steady source of revenue for the company. But it was eclipsed in the marketplace by rival Amgen Inc., which turned a similar drug, Neupogen, into a billion-dollar sales engine.
If approved by the FDA, Enbrel could generate between $500 million and $1 billion a year in revenue for Immunex, analysts say.
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