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

To: mrnaive who wrote (591)	11/23/1998 6:18:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 2539

mrn, it's expected news. MTC won't be trading on this news, but on the Celebrex news. Hostile takeover? So far it's just rumors.

To: mrnaive who wrote (591)	11/23/1998 7:38:00 PM
From: Anthony Wong	Respond to of 2539

Bloomberg: Merck Submits Application to FDA for New Cox-2 Painkiller Drug Bloomberg News November 23, 1998, 7:01 p.m. ET Merck Submits Application to FDA for New Cox-2 Painkiller Drug Washington, Nov. 23 (Bloomberg) -- Merck & Co., the world's biggest drugmaker, said it filed an application with the U.S. Food and Drug Administration to sell its Vioxx drug to treat pain and osteoarthritis. The drug is part of a new class known as Cox-2 inhibitors, which also includes Celebrex, developed by Monsanto Co.'s Searle drug unit. Searle is ahead of Merck in the FDA process, having filed for approval of its drug at least three months ago. Analysts say the drugs, which promise pain relief with fewer side effects than current medicines, could generate combined annual sales of as much as $5 billion. ''Vioxx is very critical for Merck,'' said Hemant Shah, an independent drug industry analyst with a ''neutral'' rating on Merck. ''Everything depends on how well this product does.'' Shares of Whitehouse Station, New Jersey-based Merck rose 4 1/2 to 156. Merck made its announcement after the market closed. Searle won't say exactly when it filed for FDA approval of Celebrex, but has said it expects approval in early 1999 if all goes well. Next week, Searle faces an expert FDA advisory panel which will decide whether to recommend the drug -- generally one of the last steps in the approval process. Searle announced in August that it had secured a so-called priority review for Celebrex, which generally means the FDA will review it in six months instead of the usual year. Now, analysts will be watching to see if Merck can do the same, Shah said. ''You need to be relatively close to the first product,'' he said. ''If they're close, they should do well.'' If approved, the Cox-2 inhibitors would compete with widely used painkillers known as NSAIDS, or nonsteroidal anti- inflammatory drugs. While NSAIDS can greatly relieve pain, they've also been shown to cause gastrointestinal side effects. The Cox-2 inhibitors 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 acid. If approved, Searle's Celebrex will be marketed by Pfizer Inc., maker of the impotence pill Viagra. --Kristin Jensen in Washington (202) 624-1843 with reporting from