INSIDE THE INDUSTRY - CELEBREX: ARTHRITIS DRUG SCORES FDA ADVISORY PANEL OK
12/02/98
American Health Line
A hotly anticipated new osteoarthritis and rheumatoid arthritis drug is on the verge of Food and Drug Administration approval after a positive recommendation yesterday from an advisory panel. The expert panel unanimously approved celecoxib, to be marketed by Monsanto Co.'s G.D. Searle & Co. as Celebrex, the first in a potentially revolutionary new class of painkillers known as COX-2 inhibitors. The Washington Post reports that the panel "tempered its recommendation by urging that the drug carry some of the same warnings about potential side effects" as older painkillers (Gillis, 12/2). Known as COX-1 inhibitors or non-steroidal anti-inflammatory drugs, this class included drugs such as ibuprofen, which can cause stomach lining perforation and bleeding. (Winiarski, USA Today, 12/2). The Post reports that Celebrex was specifically designed to bypass those side effects, which cause 100,000 hospitalizations and up to 20,000 deaths annually (12/2). USA Today reports that "[w]hile FDA scientists acknowledge Celebrex seemed to have fewer gastrointestinal side effects, the FDA must still decide whether the label should warn of possible gastrointestinal problems until further studies can prove otherwise" (12/2). The Post reports the panel "adopted a middle ground, urging the agency to warn doctors about the potential for serious side effects while alerting them to the Searle studies suggesting the drug is relatively safe" (12/2).
SHOW ME THE MONEY
Wall Street industry analysts were paying exceptionally close attention to yesterday's panel meeting, as the approval of Celebrex -- to be co-marketed by Pfizer Inc. -- is expected to usher in $1 billion in sales of the drug by 2000 and $2 billion by 2001. The Chicago Tribune reports that "one in six Americans will be able to take advantage" of the drug. It will be a highly anticipated and overdue win for Searle, which "hasn't had a drug come through its own pipeline since Monsanto bought the company in 1985," according to J.P. Morgan analyst Donald Carson. However, managed care plans are expected to closely monitor the prescription of the expensive drug, projected to cost $2 to $4 per day. Hambrech & Quist analyst Alex Zisson said, "Managed care companies will reimburse it, but they will try to be very strict that those patients are taking it for chronic therapy. One thing HMOs are worrying about is getting a $4 prescription for Celebrex rather than a 20-cent prescription for ibuprofen" (Japsen, 12/2). Bloomberg/New York Times reports that "Monsanto told the panel that research showed its drug could work when taken once a day," potentially erasing an advantage for Merck & Co., which had touted its COX-2 inhibitor, Vioxx, as a once-a- day drug. Vioxx is several months from FDA approval (12/2). Celebrex could be approved as early as January (USA Today, 12/2).
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