Monsanto's Cox-2 Painkiller Drug to Get Expedited FDA Review
Bloomberg News
August 24, 1998, 9:43 a.m. ET
Monsanto's Cox-2 Painkiller Drug to Get Expedited FDA Review
Washington, Aug. 24 (Bloomberg) -- Monsanto Co. said its
experimental painkilling drug, one of a new class of drugs with
multibillion-dollar sales potential, will get a faster-than-usual
review at the U.S. Food and Drug Administration.
The so-called priority review designation generally means
that the FDA will decide whether to approve the drug within six
months instead of a year. If all goes well, that could mean the
drug will be on the market in early 1999, said Lori Fisher, a
spokeswoman for St. Louis-based Monsanto, one of the world's
leading agricultural biotechnology companies.
If it wins approval, the drug will be sold with a partner,
New York-based Pfizer Inc., maker of Viagra.
Monsanto shares rose 1 1/2 to 59.
Monsanto's G.D. Searle & Co. unit is seeking approval for
Celebra to treat two forms of arthritis and to treat pain. The
company won't say when it filed the application.
The priority review designation is more good news for
Searle, which is racing with Merck & Co., the biggest U.S.
drugmaker, to market a Cox-2 drug.
The drugs, known as Cox-2 inhibitors, work by interfering
with production of an enzyme, cyclooxygenase-2, linked to pain
and swelling. Cox-2 also plays a role in other diseases,
according to researchers.
Analysts are already saying the Cox-2 inhibitors have
multibillion dollar potential, based mainly on expected sales in
treating arthritis. Other uses for the drugs could help sales
skyrocket.
Unlike existing painkillers, a Cox-2 inhibitor doesn't
suppress a related enzyme, Cox-1, that triggers production of the
stomach's natural protective lining. That could reduce the
gastrointestinal side-effects existing painkillers cause.
--Kristin Jensen in the Washington newsroom (202) 624-1843 /mfr |
