Monsanto Painkiller Approved; Label to Bear Warning
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, but won't be allowed to make the safety claims it hoped for.
The FDA, in approving the drug Celebrex for arthritis pain, said the label needs to carry standard warnings about potential side effects including ulcers and bleeding. That's a blow to Monsanto's plans to market the drug as a safer alternative to current painkillers.
''That is not good news at all,'' said Hemant Shah, an independent drug-industry analyst. ''If you don't have a side effect advantage, why would anybody use a product that is 10 to 20 times more expensive?''
Still, the approval puts Monsanto's Searle pharmaceutical unit months ahead of its nearest competitor, Merck and Co., in introducing the first of the new painkillers, known as Cox-2 inhibitors. The Cox-2 drugs were expected to achieve annual sales of as much as $5 billion if their makers could claim a safety advantage over existing painkillers.
Shares of St. Louis-based Monsanto rose 1 3/16 to close at 47 1/2, after rising as high as 50 before the FDA announcement. Shares of marketing partner Pfizer Inc., the New York-based maker of the impotence pill Viagra, fell 1 1/8 to 125. Merck shares fell 1 5/16 to 147 1/2.
While the labeling is a disappointment for Monsanto, the FDA clearance to market the drug is still a plus for the company, said Ira Loss, an analyst with HSBC Washington Analysis.
''I think the game is whether or not people are going to use this drug, and in that, I think they are going to be big winners. People will use this drug,'' he said.
Warning Label
Like existing painkillers, Celebrex will carry a warning about ulcers and bleeding, noting that such problems occur in about 2 percent to 4 percent of patients treated for a year. The Celebrex label, however, will say it's ''unclear'' whether that rate will apply to patients who use Celebrex.
The label cites company research that shows only 0.04 percent of patients who took Celebrex for six months or less experienced ''significant'' gastrointestinal bleeding.
The company originally wanted to be able to sell the drug without any warning label, and still hopes to do so.
''We certainly expect to be able to get rid of that'' warning label eventually, said Al Heller, chief operating officer for Searle.
Heller said the label will explain how the drug works and will say it doesn't have an effect on tiny blood cells known as platelets which are important to the body's natural clotting process. Current drugs can affect platelets and cause bleeding.
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.
FDA Questions
FDA officials granted the drug a quicker-than-normal review because they thought the drug could have important safety advantages. At this point, however, the agency can't be sure that's true and will carefully monitor Searle's promotions, said Murray Lumpkin, deputy director in the FDA's drug branch.
If Searle were to claim ''this is definitively a safer product'' than other painkillers, ''we would come back and say you haven't shown that,'' Lumpkin said.
Searle will be allowed to describe studies using an endoscope, a device that allows doctors to look into patients' stomachs, that suggest a safety advantage for Celebrex. The company won't be able to make a specific safety advantage claim, however, because the FDA isn't sure how those benefits seen on endoscopes translate into reductions in actual events such as ulcers and bleeding, Lumpkin said.
''The question is what kind of clinical significance or clinical meaning does that data have?'' he said.
Worth the Money?
Monsanto may also face a challenge convincing health insurers that its drug has enough benefits to warrant a higher price than the generally cheap alternatives. Monsanto's Foster said the drug will offer important benefits and that it will be ''priced comparable'' to the current nonsteroidal anti- inflammatory drugs, or NSAIDS. These include Roche Holding AG's Toradol, American Home Products Corp.'s Orudis and SmithKline Beecham Plc's Relafen.
Monsanto will discuss the drug's price on Monday, Heller said.
One large health insurer, WellPoint Health Networks Inc., will limit its coverage of Cox-2 drugs largely to higher-risk patients, such as people over 65, rheumatoid arthritis patients and those who have already had a bad reaction to other painkillers.
''The Cox-2s are new. They will have a role in therapy, but their clear role is still to be defined,'' said Robert Seidman, vice president for pharmacy at Blue Cross of California, a WellPoint subsidiary.
Monsanto Strategy
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. If Merck has to undergo an FDA advisory panel meeting for its competing drug Vioxx as expected, it probably won't do so 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. 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.
Merck and Searle are vying for shares of the estimated $8 billion arthritis painkiller market now controlled by NSAIDS painkillers.
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. |
