Monsanto Painkiller to Get FDA Priority Review
Monsanto Co. said its much-anticipated painkiller, one of a new class of drugs with multibillion-dollar sales potential for conditions such as arthritis, will get a faster-than-usual review by the Food and Drug Administration.
The priority review designation generally means that the FDA will decide whether to approve the drug within six months instead of a year.
Monsanto, which expects to complete a merger with American Home Products Corp. this year, is in a race with the biggest drug maker, Whitehouse Station, N.J.-based Merck & Co., to market the first drug in the new class, known as Cox-2 inhibitors.
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 gastrointestinal side effects caused by existing painkillers.
Monsanto’s G.D. Searle & Co. unit is seeking approval for its product, Celebra, to treat the symptoms of osteoarthritis and rheumatoid arthritis and to treat pain.
Celebra probably will be the first blockbuster drug for St. Louis-based Monsanto, which is undergoing a transformation to focus on drugs and agricultural biotechnology.
If approved, the drug will be sold with a partner, New York-based Pfizer Inc., maker of the impotence drug Viagra, in all countries except Japan.
Merck said it expects to file for FDA approval of its Cox-2 inhibitor before the end of the year.
On the New York Stock Exchange, Monsanto rose $4.06 to close at $61.56. Madison, N.J.-based American Home rose $2.88 to close at $56.13, and Pfizer fell $69 to close at $105.38, also on the NYSE.
