Panel Approves Monsanto Unit's Arthritis Pain Reliever
Bruce Japsen, Chicago Tribune
12/02/98
KRTBN Knight-Ridder Tribune Business News: Chicago Tribune
Dec. 2--Clearing a path for the next multi-billion dollar blockbuster drug, an advisory panel Tuesday recommended the Food and Drug Administration allow G.D. Searle & Co. sell its pill for arthritis pain relief.
An estimated one in six Americans will be able to take advantage of Celebrex, a prescription drug researchers and Wall Street analysts say offers people relief from gastrointestinal side effects common with other arthritis treatments like aspirin or ibuprofin.
An FDA arthritis advisory committee recommended the drug Celebrex be approved for patients suffering osteoarthritis, the disease of the joints affecting an estimated 20 million Americans. Celebrex should be available next spring; the FDA typically approves the recommendations of its committees.
Developed at Monsanto Co.'s Skokie-based Searle unit laboratories, Celebrex is projected to generate more than $1 billion in annual sales by 2000, doubling to more than $2 billion by 2001, analysts estimate. Pfizer Inc., manufacturer of the most recent blockbuster drug, the impotency pill Viagra , has paid Searle over $200 million for the rights to market Celebrex almost all over the world.
The panel also approved Celebrex for patients suffering rheumatoid arthritis, a more severe disease in which the body attacks its own tissues in its joints. More than 2 million people suffer from rheumatoid arthritis.
"Clearly the market is huge," said Donald Carson, an analyst with J.P. Morgan Securities in New York. "Searle hasn't had a drug come through its own pipeline since Monsanto bought the company in 1985. They have licensed in compounds from other people, but this is their own compound they discovered in the lab."
Providers of medical care have long awaited Celebrex, part of a class of drugs known as COX-2 inhibitors hailed for more effective long-term usage because they don't harm the lining of the stomach like aspirin or ibuprofin, which are known as "nonsteroidal anti-inflammatories."
"All of the current drugs have toxicity," said Steve Geis, vice president of clinical research for Monsanto and Searle.
However, medical-care providers will be watched closely by managed-care companies paying for doctors' Celebrex prescriptions because it is expensive, with treatments costing $2 to $4 a day.
Analysts anticipate managed-care companies are likely to limit the use of Celebrex to patients suffering chronic arthritis pain.
"Managed-care companies will reimburse it, but they will try to be very strict that those patients are taking it for chronic therapy," said Alex Zisson, an analyst with Hambrecht & Quist in San Francisco. "One thing HMOs are worrying about is getting a $4 prescription for Celebrex rather than a 20-cent prescription for ibuprofin."
Doctors are expected to be able to begin writing prescriptions for Celebrex some time in the first three months of next year after the FDA's expected approval.
When Celebrex hits the market, it will also carry a warning label despite the manufacturer's efforts to convince the FDA it doesn't need the standard warning label carried by most other pain killers already on the market.
"They (the FDA panel) thought there should still be a warning on it," Geis said. "We still need to discuss this and come up with what the labeling should read."
When Celebrex does become available, it will have the COX-2 inhibitor market to itself for several months, analysts estimate. Merck & Co. Inc. has also submitted a similar drug, known as Vioxx, for FDA approval, but analysts say it is six to 12 months behind Celebrex in the regulatory process.
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