Celebrex Approved!
Monsanto Wins FDA Approval for First of New Cox-2 Pain Drugs
Washington, Dec. 31 (Bloomberg) -- Monsanto Co. won U.S. Food and Drug Administration approval to sell the first drug in a new class of painkillers with expected annual sales of as much as $5 billion.
The FDA approved the drug for use in osteoarthritis and rheumatoid arthritis.
The approval puts Searle months ahead of its nearest competitor, Merck and Co., in introducing the first of the new painkillers, known as Cox-2 inhibitors.
In a blow to Searle's marketing plans, the FDA will require that the drug carry a standard warning label about potential side effects including ulcers and bleeding that have been associated with current painkillers. The label's wording is crucial for Celebrex. The billion-dollar annual sales predicted by analysts depend on Searle's ability to distinguish Celebrex as a safer alternative to current drugs.
Still, the FDA will likely allow the company to describe studies that show potential safety advantages for the drug.
Shares of St. Louis-based Monsanto rose 2 7/8 to 49 3/16, and are up 11 percent in the past two days of trading. Shares of marketing partner Pfizer Inc., the New York-based maker of the impotence pill Viagra, rose 1 9/16 to 127 11/16. Merck shares fell 1 1/8 to 147 11/16.
Searle plans to introduce Celebrex in 16 countries in 1999 and in 35 countries by 2001, Richard De Schutter, CEO of Searle and vice chairman of Monsanto, told analysts earlier this month.
Monsanto's next challenge will be convincing health insurers that its drug has enough benefits to warrant a higher price than the generally cheap alternatives.
The FDA's action follows the recommendation of an FDA advisory panel in early December that the agency approve the drug for patients with osteoarthritis or rheumatoid arthritis.
Panel members were split on whether the drug should be approved for other types of pain, and the panel didn't take a formal vote on that issue. It also didn't take a formal vote on the labeling of the drug, though panel members said the standard warning label for painkillers could be modified to indicate Celebrex has fewer side effects, which could help sales of the drug for other types of pain.
Key for Monsanto
Celebrex is a key part of Monsanto's bid to transform itself from a leading chemical company into a pharmaceutical powerhouse.
The company already has a head start on Merck in the race to market the first Cox-2 drug. Merck is not expected to present research on its competing drug Vioxx until April.
Searle, which filed for FDA approval five or six months ahead of Merck, won a favorable recommendation from an FDA panel on Dec. 1. earlier this month. In addition, Searle told the panel that new research shows its drug can work when taken once a day, matching an advantage Merck had claimed for Vioxx.
Effective for Pain
Searle officials told the FDA advisory panel that Celebrex could effectively treat osteoarthritis and rheumatoid arthritis as well as other types of pain. Compared to existing treatments, Celebrex also works with fewer gastrointestinal side effects, such as ulcers and abdominal pain, they said.
''We've achieved our clinical goals,'' said G. Steven Geis, Searle's vice president for clinical development of the drug. ''We've developed a compound with efficacy for arthritis and pain but without the gastrointestinal'' effects and bleeding problems seen with current treatments, he said.
Merck and Searle are vying for shares of the estimated $8 billion arthritis painkiller market now controlled by popular painkillers known as NSAIDS, or nonsteroidal anti-inflammatory drugs. These include Roche Holding AG's Toradol, American Home Products Corp.'s Orudis and SmithKline Beecham Plc's Relafen.
While the NSAIDS can greatly relieve pain, they've also been shown to cause gastrointestinal side effects. That's where the Cox-2 inhibitors come in.
How It Works
The drugs work by interfering with the production of an enzyme, cyclooxygenase-2, linked to pain and swelling. Unlike existing painkillers, a Cox-2 inhibitor doesn't suppress a related enzyme, Cox-1, that helps protect the stomach from its own acid.
As a result, researchers say, the Cox-2 drugs should offer the same benefits as NSAIDS with fewer side effects such as bleeding and ulcers for people who take pain medication for chronic conditions such as arthritis.
Still, critics caution that not enough is yet known about the drugs.
New classes of drugs ''offer not only new mechanisms of action, but also new mechanisms of potential toxicity and the possibility of a new spectrum of adverse events,'' said Sidney Wolfe, head of the Health Research Group at the watchdog group Public Citizen. Wolfe spoke at the FDA advisory panel meeting. |
