Merck Faces FDA Panel on Experimental Painkiller Vioxx (Repeat)
Bloomberg News
April 16, 1999, 11:51 a.m. PT
Merck Faces FDA Panel on Experimental Painkiller Vioxx (Repeat)
(Repeats to restore dropped letter in 2nd paragraph)
Whitehouse Station, New Jersey, April 16 (Bloomberg) --
Merck & Co., the world's No. 2 drugmaker, will seek the backing
of an expert U.S. government panel for its painkiller Vioxx, a
potential big seller that Merck needs to replace drugs losing
patent protection.
Analysts expect the panel to recommend Vioxx be cleared for
sale. What's less certain is whether the panel will recommend
less restrictive labeling for Vioxx than Monsanto Co.'s rival
drug Celebrex has. The safety benefits listed on a drug's label
determine how it can be marketed.
Merck needs that edge to catch up with Monsanto, which
teamed with Pfizer Inc. to introduce Celebrex in January. Since
then, more than 2.4 million Celebrex prescriptions have been
filled in the U.S. That poses a challenge for Merck, which needs
Vioxx sales because it will face generic competition after 2001
for four of its drugs with combined annual sales of about $5
billion.
''You've got a very successful and powerful sales force from
Pfizer. Celebrex has had one of the best introductions for a new
drug ever,'' said Jack Lafferty, an analyst for U.S. Trust, which
holds about 9 million Merck shares, according to regulatory
filings. ''That presents some concern for Merck.''
Celebrex and Vioxx could each eventually become blockbusters
with top annual sales of over $1 billion because they appear less
likely than older drugs -- like aspirin -- to cause stomach
irritation and bleeding.
Promotion for Pain
Though Merck will likely be the second entrant into the so-
called Cox-2 painkiller market, the panel's decision Tuesday
could give an advantage to Merck by allowing the company to
promote Vioxx for a wider range of uses than Celebrex, including
use in acute pain, such as pain following surgery.
''We think they might be able to get the pain indication,
that would be the edge,'' said Barney Rosen, an analyst at Argus
Research. ''If you can show you have better efficacy, the medical
community is going to embrace it.''
Merck is expected to argue a convincing case on the use of
Vioxx to treat pain, analysts said. Monsanto didn't yet have
adequate data on short term use of Celebrex for acute pain when
the drug was reviewed by the FDA panel in early December.
Merck is also expected to tell the panel that its painkiller
is even less likely to irritate the stomach than Celebrex,
analysts said, which could give the company a marketing edge.
''The big differentiation (between painkillers) isn't
efficacy, it's the safety profile,'' said Alex Zisson, an analyst
with Hambrecht & Quist.
Safer Drug?
It's unlikely Merck, though, will get a big labeling
advantage over Monsanto, analysts say. Although both companies
have described their drugs as part of a new class, the FDA tagged
Celebrex with the same warnings as it requires for ibuprofen and
aspirin. Merck's drug likely will get the same treatment in this
regard.
Monsanto tried to avoid this so-called ''NSAIDs'' label, the
warning put on non-steroidal anti-inflammatory drugs. At a
December panel meeting, Monsanto's top scientist, Philip
Needleman tried to persuade the FDA panel to see Celebrex as
something different from an NSAID.
''Here is now a targeted drug, a smart drug,'' said
Needleman, who pioneered Celebrex. The drug was developed out of
research that Needleman began at Washington University before
becoming Monsanto's chief scientist.
Building on research that show how older painkillers worked,
Needleman set out on a path that led to a drug that homes in more
precisely on an enzyme linked to pain, cyclooxygenase-2.
The problem with existing, inexpensive painkillers such as
ibuprofen is that they hit that enzyme as well as a related one,
cyclooxygenase-1. This second enzyme plays a role in protecting
the stomach from its own acids. Interfering with it can lead
eventually to ulcers and bleeding.
That's a concern for arthritis suffers and other people who
will take painkillers every day. More than 100,000 people may be
hospitalized in the U.S. each year because of complications
stemming from use of NSAIDs, such as aspirin. An estimated 16,500
die as a result of these complications.
To prove its drug is safer than NSAIDs, Merck tested Vioxx
in more than 10,000 patients. As in Monsanto's tests of Vioxx,
some of the patients underwent a procedure known as endoscopy in
which a medical device was put into their gut to check for signs
of bleeding.
At the panel Tuesday, the doctor who oversaw this research
will defend Merck's conclusion before the expert panel, arguing
that Merck's emphasis on eliminating side effects merits a less
stringent warning label.
Beth Seidenberg, who also supervised the trials for Merck's
asthma drug Singulair, said company researchers kept a close eye
on the results as Vioxx tests proceeded. They combed through
reports, looking to see if there might an effect of the drug,
positive or negative, that was being overlooked.
''I tell them, You're a detective','' said Seidenberg.
''That's your job. We don't want to miss anything.''
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