Merck gets FDA OK for painkiller
By Stephanie O'Brien, CBS MarketWatch Last Update: 9:50 AM ET May 21, 1999 WHITEHOUSE STATION, N.J. (CBS.MW) -- Merck & Co., the world's second-largest drugmaker, said the U.S. Food & Drug Administration approved the sale of its painkiller Vioxx.
The drug was approved to treat osteoarthritis, the most common form of arthritis, acute pain and severe menstrual pain.
Vioxx is sure to be a formidable competitor to hugely successful Celebrex, a COX-2 inhibitor manufactured and marketed by Monsanto Co.'s (MTC: news, msgs) G.D. Searle unit and Pfizer (PFE: news, msgs).
Celebrex is approved for rheumatoid arthritis and osteoarthritis.
Merck said Vioxx will be available for sale by the middle of June. The company expects its retail price per tablet to range from about $2.38 to $2.52. The wholesale price per liquid dose is expected to be about $3.00.
Last month, the drug received backing from an FDA advisory panel, which voted to approve Vioxx for the treatment of arthritis and for acute pain.
The drug, from a class of medications known as COX-2 inhibitors, is aimed primarily at treating arthritis, but treats other types of pain with fewer side effects, such as ulcers and internal bleeding. Vioxx is an alternative to prescription forms of non-steroidal anti-inflammatory drugs.
Examples of those are naproxen, which is sold over-the-counter as Aleve, and ibuprofen, sold over-the-counter as Advil.
"Vioxx got the three indications the (FDA) panel had endorsed," said Alex Zisson, an analyst at Hambrecht & Quist. "It's a label that Merck sales reps can do some damage with," he said.
Zisson estimates that 1999 sales of Vioxx will be about $300 million. He expects sales to nearly triple to $800 million by the end of 2000.
Shares of Whitehouse Station, N.J.-based Merck, the No.1 drug maker in the U.S, rose 1 1/4 to 73 1/2 in Instinet trading before the market opened Friday morning.
Still, one analyst said Vioxx might have trouble overtaking Celebrex.
"The market is not as dissatisfied as it was when Celebrex was launched," since arthritis sufferers had relatively few options, said James Keeney, an analyst at ABN Amro.
About 2.5 million people are currently taking Celebrex, Keeney said. If it's working for them, they may not be inclined to switch, he said.
Still, Celebrex lost some ground recently, following press reports that a small number of people taking the drug suffered from ulcers or died.
Merck, the No.1 drugmaker in the U.S., shares worldwide dominance with Glaxo-Wellcome PLC in prescription drugs.
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