Monsanto's Celebra Seen Getting FDA Panel Review in December
Bloomberg News
October 14, 1998, 2:28 p.m. ET
Monsanto's Celebra Seen Getting FDA Panel Review in December
Washington, Oct. 14 (Bloomberg) -- Monsanto Co. said its
experimental painkiller Celebra, a member of a new class of drugs
promising unprecedented relief for conditions including
arthritis, will be reviewed in December by a government advisory
panel.
The advisory committee for the U.S. Food and Drug
Administration will take up the Celebra, developed by Monsanto's
G.D. Searle & Co. drug unit, during a two-day meeting beginning
Dec. 1, the company said.
''We understand that Celebra will be high on the agenda and
that there will be specific discussion around the compound,''
said Kristin Fayer, a spokeswoman for Monsanto.
The final agenda for the meeting has not been set, and FDA
officials said that the agency cannot comment on meeting agendas
until they are officially reported through the Federal Register
and phone notices.
Panel hearings, where a group of outside experts are
convened by the FDA to offer counsel on often thorny issues, are
a common procedure for ''first of a kind'' medical products. A
December review -- where committee members are likely to make a
recommendation as to whether the drug should be approved by the
full agency - would keep Celebra on track for a potential launch
at the beginning of 1999.
''We're hopeful that it will keep to that timeline,'' Fayer
said.
Time is crucial because Monsanto is racing the biggest
drugmaker, Merck & Co., to market the first drug in the new
class. The drugs, known as COX-II inhibitors, will mainly be used
to treat arthritis pain, a market worth billions, analysts said.
If it is approved by the FDA, Celebra will be sold by Pfizer
Inc., the maker of Viagra and a marketing powerhouse. The two
companies will compete against Whitehouse Station, New Jersey-
based Merck's drug, called Vioxx.
Merck plans to file its application with the FDA by the end
of this year.
Monsanto has applied with the FDA to sell the drug as a pain
reliever for use in treating both age-related osteoarthritis and
the more serious rheumatoid arthritis form of the disease, which
strikes its victims earlier and can swiftly become debilitating.
Designed to control pain without the side effects associated
with most anti-inflammatory drugs, COX-II drugs have also shown
promise in a range of other diseases such as Alzheimer's and
stroke.
Shares in Monsanto, one of the world's biggest agricultural
biotechnology companies, fell 2 5/16 to 34 11/16 in recent
trading. Yesterday the company's shares fell more than 26 percent
as it announced it had canceled a $35 billion merger with
American Home Products Corp. over clashes in management styles.
Shares in American Home fell 5/8 to 44 3/8.
--Kristin Reed in Washington (202) 624-1858 /mfr |
