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Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?

To: John F Beule who wrote (620)	11/27/1998 1:38:00 PM
From: Anthony Wong	Respond to of 2539

Monsanto Seeks FDA Panel Backing for First of New Painkillers Bloomberg News November 27, 1998, 9:29 a.m. ET Monsanto Seeks FDA Panel Backing for First of New Painkillers Washington, Nov. 27 (Bloomberg) -- Monsanto Co.'s Searle pharmaceutical unit on Tuesday will ask an expert U.S. government panel to endorse the first drug in a new class of painkillers with multibillion-dollar sales potential. The meeting of the U.S. Food and Drug Administration advisory panel is a pivotal moment in Monsanto's bid to transform itself from a leading chemical company into a pharmaceutical powerhouse. The drug, known as Celebrex, is vital to the strategy, analysts said. ''It looks like it's as sure a winner as you can find,'' said Samuel Isaly, managing partner of OrbiMed Advisors LLC. The meeting also has important ramifications for Merck & Co., the world's biggest drugmaker, which is developing a competing drug in the so-called Cox-2 inhibitor class. Merck is hoping that the once-a-day dosing for its Vioxx will help the company compete with Monsanto's Searle, which filed for FDA approval first. Searle and marketing partner Pfizer Inc., maker of the impotence drug Viagra, are seeking approval of Celebrex to treat patients with rheumatoid arthritis or osteoarthritis and for use in other patients as a prescription painkiller. As such, it would compete with the widely used painkillers known as NSAIDS, or nonsteroidal anti-inflammatory drugs. These include Roche'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. 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 hamper a related enzyme, Cox-1, that helps protect the stomach from its own acid. This could mean less risk of bleeding and ulcers for people who take pain medication for chronic conditions, such as arthritis. High Expectations ''We're all holding our breath'' hoping that the Cox-2s will soon be on the market, said Terry Hotchkin, a nurse who works in a Vancouver, Washington rheumatology practice. ''There are a lot of people who can't take NSAIDS.'' Expectations for the Cox-2s are high among investors as well. Analysts say Merck and Searle's drugs could generate combined annual sales of as much as $5 billion. Still, the companies may face a challenge convincing health insurers that it's worth paying more for painkillers even if they can claim the drugs are safer. While the drugmakers say they've yet to decide how to price the new treatments, they'll likely be sold at much higher prices than existing painkillers such as Roche Holding AG's Naprosyn and Novartis AG's Voltaren. Persuading Insurers St. Louis-based Monsanto may try to persuade insurers that they could save money by footing the bill for Celebrex, also known as celecoxib. A recent company press release pointed out concerns about the safety of the existing NSAIDS. Recent research has found that upper gastrointestinal complications from NSAID use lead to some 107,000 hospitalizations and 16,500 deaths each year in the U.S., according to Monsanto. If approved, Celebrex would also compete against Immunex Corp's Enbrel and Hoechst AG's Arava, both recently approved for the treatment of rheumatoid arthritis. --Kristin Jensen in Washington (202) 624-1843 with reporting from quote.bloomberg.com