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Merck to Face FDA Panel in April on Cox-2 Painkiller
Washington, Feb. 25 (Bloomberg) -- Merck & Co., the world's biggest drugmaker, will face a U.S. government panel in its bid to win approval for a rival pill to Monsanto Co.'s painkiller Celebrex, introduced last month with near-record early sales.
A Food and Drug Administration advisory panel will review Merck's Vioxx drug on April 20, the company said. Like Celebrex, Vioxx appears to be gentler on the stomach while treating pain about as well as older medicines such as ibuprofen.
More than 400,000 Celebrex prescriptions have been filled in the U.S. since the drug's mid-January introduction. Merck's best chance to catch up with Monsanto, which is working with Pfizer Inc. to sell Celebrex, might be to win FDA approval of a better label for its drug. This could let Merck market and promote its drug as having more advantages than Celebrex has.
''I don't think it's going to happen, but Merck should never be underestimated,'' said Hemant Shah, an independent analyst with a ''neutral'' rating on Merck. ''If there's any company that might be able to do that, it's Merck. When Merck submits a filing to the FDA, it's near perfection.''
The shares of Merck, based in Whitehouse Station, New Jersey, rose 1 1/4 to 80 3/4 in midmorning trading. Monsanto, based in St. Louis, fell 1 7/16 to 46 9/16.
The FDA usually follows the advice of its expert panels when making approval decisions. Celebrex was approved in late December after an FDA panel gave the drug a positive review.
Celebrex sales to date have made its introduction the second most successful in history, behind only Pfizer Inc.'s impotence drug, Viagra.
Celebrex and Vioxx are so-called Cox-2 drugs, which appear to be gentler on the stomach because they target an enzyme linked to pain and inflammation without blocking a related enzyme that protects the stomach from its own acid. Older drugs can hit both enzymes and, as a result, long-term use of some painkillers can lead to ulcers or stomach bleeding. |
