Merck Says Painkiller Vioxx Approved by FDA; to Be Sold in June
Bloomberg News
May 21, 1999, 7:02 a.m. ET
Merck Says Painkiller Vioxx Approved by FDA; to Be Sold in June
Washington, May 21 (Bloomberg) -- Merck & Co., the world's
No. 3 drugmaker, said its new painkiller Vioxx won approval from
the U.S. Food and Drug Administration, kicking off a marketing
battle with Monsanto Co.'s rival Celebrex.
The once-a-day drug has been approved by the FDA for relief
of symptoms of osteoarthritis, acute pain in adults and menstrual
pain. The FDA was to face a financial penalty if it didn't act on
Merck's application by Sunday; an FDA advisory panel last month
recommended approval of the drug.
Analysts say Vioxx and Celebrex could each top $1 billion in
annual sales within a few years. They are both so-called Cox-2
painkillers, designed to cause less stomach irritation than older
drugs. More than 3.4 million prescriptions have been filled in
the U.S. for Celebrex since its January introduction. Celebrex
was the first of the Cox-2 painkillers to win U.S. approval.
''Vioxx, which underwent a priority review by the FDA,
should be available in pharmacies beginning in the second week of
June,'' Merck said.
Vioxx should do well even as the second Cox-2 painkiller on
the U.S. market, according to Linda Miller, who manages John
Hancock's Global Health Sciences fund. Many arthritis sufferers
are looking for a medicine that is less likely to irritate their
stomachs and cause ulcers, Miller said.
Vioxx and Celebrex target an enzyme, cyclooxygenase-2, or
cox-2, that is linked to pain and swelling. They are designed to
be less likely to interfere with a related enzyme, cyclooxygenase-
1, that helps protect the stomach from its own acid.
Merck, the No. 1 U.S. drugmaker, needs to build Vioxx
quickly into a blockbuster. Next year, Merck will lose patent
protection on one of its biggest drugs, the high-blood-pressure
medicine Vasotec. Vasotec had 1998 sales of $2.4 billion.
By 2001, there probably will be generic competition for
three other Merck drugs that had more $2.5 billion in combined
1998 sales.
Shares in Merck, based in Whitehouse Station, New Jersey,
rose 1 3/4 to 72 1/4 in New York yesterday.
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