To: Ron Flanigan who wrote (6600 ) 1/1/1999 8:58:00 PM From: BigKNY3 Read Replies (1) | Respond to of 9523
Celebrex Ruling Benefits Merck By PHIL GALEWITZ 01/01/99 AP Online NEW YORK (AP) - Monsanto will be first to sell a revolutionary type of arthritis medication, but its battle with Merck & Co. in the high stakes painkiller drug wars is far from over. Celebrex, made by Monsanto's Searle pharmaceutical unit, on Thursday became the first "cox-2" inhibitor to win Food and Drug Administration approval. The drugs have been touted as possibly the next wonder pills because of their promise to be easier on patients' stomachs than existing medications. But Monsanto was dealt a blow when the FDA declared there is no proof that Celebrex actually is safer for patients' stomachs than older painkillers. As a result, when Celebrex hits retail outlets next month it must bear the same warning about side effects as many of its older competitors. Merck, which is awaiting FDA approval for its Vioxx drug, another cox-2 pill, hopes to get a less stern warning label. One reason Merck was behind Monsanto in seeking federal approval is because it was waiting for the results of some longer term studies. The warning label could be a key driver of physician use, and whether either drug reaches the $1 billion in annual sales that some Wall Street analysts had forecast. Merck also hopes to gain another advantage by getting approval for Vioxx to be taken only once a day for arthritis users. The recommended dose of Celebrex is once or twice a day for osteoarthritis, and twice a day for rheumatoid arthritis. "Merck may be able to use Monsanto's experience to get a better label," said Sergio Traversa, an analyst with Mehta Partners in New York. After the FDA ruling Thursday, shares of Monsanto rose $1.19 to $47.50. Pfizer, which will be co-marketing Celebrex, fell $1.12 to $125. Merck shares dropped $1.31 to $147.50. Merck spokesman John Bloomfield refused to speculate whether the company has enough research results to get a better warning label than Monsanto. Merck is working closely with the FDA to demonstrate that Vioxx has safety advantages over existing drugs, he said. "We are pretty darn happy," said Scarlett Lee Foster, a Monsanto spokeswoman. "I think we got a label we can use...to have the drug widely accepted." Monsanto is continuing to study Celebrex in hopes of providing FDA with enough evidence to advertise Celebrex as a safer painkiller. Millions of people now depend on aspirin, ibuprofen, and a host of other pills called "non-steroidal anti-inflammatory drugs," or NSAIDs for arthritis and other pains. NSAIDS can cause ulcers, stomach bleeding and other gastrointestinal side effects, and are blamed for causing 107,000 Americans to be hospitalized every year, and for killing 16,500. Monsanto said it will price Celebrex comparably to other prescription strength painkillers that cost about $2.40 a day. With the traditional safety warnings on Celebrex, Monsanto would have faced considerable difficulty convincing insurers to pay any more. Despite the warning label issue, the government approval of Celebrex is a boost for Monsanto, which last summer had to drop plans to merge with American Home Products, maker of Robitussin cough syrup and Advil pain reliever. The $33.6 billion marriage would have been the biggest merger ever in the pharmaceutical industry. Monsanto, based in St. Louis, makes the artificial sweetener Nutrasweet and is also heavily involved in genetic research for agriculture. "This adds credibility to their pipeline," said Sano Shimda, president of BioScience Securities. And the FDA approval is a boost for Pfizer, who some analysts feared would grow too dependent on its anti-impotence drug Viagra to spur sales growth. Merck knows that being first to market with a new class of drugs is no guarantee of long-term success. Merck held the lead in cholesterol lowering drugs with its Zocor drug, but Warner Lambert in the last two years has taken the market lead with its Lipitor pill.