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

To: jopawa who wrote (665)	12/1/1998 2:14:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 2539

See this excerpt from a Bloomberg update (reson for lack of euphoria so far): One of the major issues at the meeting will be whether Searle can convince the panel that its drug doesn't need the standard warning label about gastrointestinal side effects carried by many existing painkillers. FDA reviewers said they can't yet be sure of the long-term effects of the new drug and warned that new, unforeseen side effects could appear. Several speakers at an open public hearing raised similar concerns. Sidney Wolfe, head of Public Citizen's Health Research Group, said there isn't yet enough evidence to allow Celebrex, also known as celecoxib, on the market without the standard warning label. ''Purported new classes of drugs such as celecoxib offer not only new mechanisms of action, but also new mechanisms of potential toxicity and the possibility of a new spectrum of adverse events,'' Wolfe said in a statement to the panel. If the panel turns down Searle's request to avoid the standard warning label it would be a blow to the company's plans to distinguish Celebrex from existing treatments. The panel will discuss this issue this afternoon. Expectations for the class of drugs, known as Cox-2 inhibitors, are high. 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. The drugs are likely to be sold at much higher prices than existing painkillers such as Roche Holding AG's Naprosyn and Novartis AG's Voltaren. 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.