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Biotech / Medical : Monsanto Co.
MTC 2.305+9.2%Nov 21 9:30 AM EST

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To: John F Beule who wrote (698)12/2/1998 9:23:00 PM
From: Anthony Wong  Read Replies (1) of 2539
 
<The panel hasn't approved Searle's request to market Celebrex for "general management of acute pain." That would have vastly increased its sales.> (from one of the news articles)

John, even if Celebrex is approved for management of acute pain, can we really expect vastly increased sales? Would doctors prescribe Cox-2 inhibitors for relief of acute pain? I'd hope my doctor would prescribe something stronger than that.

It seems that the Street is disappointed that Celebrex won't get this indication approved.

The following is from labpuppy.com:

12/2/98

It was a mixed bag regarding the FDA advisory committee's report on Monsanto's (MTC) Celebrex.

Analysts were disappointed that Celebrex will require additional studies regarding its management of acute pain. Celebrex will probably get this indication but later than expected. This could give an
advantage to Merck's (MRK) Vioxx if it can get this indication, as it would help to differentiate the two products. Merck generally runs very strong clinical trials.

In addition, the committee had labeling issues regarding Celebrex and its fewer side effects when compared to older NSAIDs drugs – this is still under negotiation.

The good news is that Celebrex is approved for osteoarthritis and rheumatoid arthritis so it will be eventually a $1+ billion drug. However, it did not get the additional indication of pain management, which some analysts were counting on in their aggressive estimates.

The stock benefited today from the surprising news that it is possible that Celebrex could gain once-a-day dosing approval (which would put it more on par with Vioxx).

Overall, it was a neutral to modestly positive report for Celebrex. The FDA will finally rule on this drug (and they usually follow the advice of their advisory committee) in January or February.

labpuppy.com
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