Here's a more detailed Bloomberg article:
Monsanto Tells FDA Panel Its Cox-2 Drug Could Be Once-A-Day
Bloomberg News
December 1, 1998, 11:16 p.m. ET
Monsanto Tells FDA Panel Its Cox-2 Drug Could Be Once-A-Day
Silver Spring, Maryland, Dec. 1 (Bloomberg) -- Monsanto
Co.'s new Celebrex drug offers patients an advantage over
existing treatments for arthritis and pain and could be taken
just once a day, company representatives told an expert U.S.
government panel.
The company's Searle pharmaceutical unit is seeking the
backing of a U.S. Food and Drug Administration advisory panel
for the first drug in a new class of painkillers with
multibillion-dollar sales potential. The company for the first
time revealed that the drug works when taken once a day. That's
important because rival Merck & Co.'s once-a-day drug Vioxx is
not far behind Celebrex in the FDA review process.
The backing of the panel for the so-called Cox-2 inhibitor
drug is crucial for Monsanto's bid to become a pharmaceutical
powerhouse. The drug ''looks like it's as sure a winner as you
can find,'' said Samuel Isaly, managing partner of OrbiMed
Advisors LLC, before the meeting.
The FDA usually, but not always, follows the recommendations
of its expert advisory panels.
Searle representatives presented studies showing that
the drug could effectively treat osteoarthritis and rheumatoid
arthritis as well as other types of pain.
In addition, ''once-a-day dosing is possible'' with
Celebrex, Aziz Karim, Searle's senior director of clinical
pharmacokinetics and bioavailability, told the panel.
Fewer Side Effects
The drug works with fewer gastrointestinal side effects,
such as ulcers and abdominal pain, than existing treatments.
''We've achieved our clinical goals,'' said G. Steven Geis,
Searle's vice president for clinical development of the drug.
''We've developed a compound with efficacy for arthritis and pain
but without the gastrointestinal'' effects and bleeding problems
seen with current treatments, he said.
Shares of St. Louis-based Monsanto fell 1 1/4 to 44 1/16.
Shares of marketing partner Pfizer Inc., the New York-based maker
of the impotence pill Viagra, fell 2 3/16 to 109 3/4.
Expectations for the Cox-2s are high. Analysts say Merck and
Searle's drugs could generate combined annual sales of as much as
$5 billion. Still, the companies may face a challenge convincing
health insurers that it's worth paying more for painkillers even
if they can claim the drugs are safer.
The drugs are likely to be sold at much higher prices than
existing painkillers such as Roche Holding AG's Naprosyn and
Novartis AG's Voltaren.
If approved, Celebrex would also compete against Immunex
Corp's Enbrel and Hoechst AG's Arava, both recently approved for
the treatment of rheumatoid arthritis.
The FDA panel's decision will also have important
ramifications for Merck, the world's biggest drugmaker, which
filed for approval of its Vioxx once-a-day Cox-2 drug at least
three months after Searle.
Once-a-Day Dose
Most of Searle's studies looked at the effects of Celebrex
given twice a day. Two osteoarthritis studies, however, found
that the drug works just as well once a day when given in a
higher dose.
Shares of Whitehouse Station, New Jersey-based Merck fell 1
15/16 to 153 3/16.
Merck and Searle are vying for shares of the estimated $8
billion arthritis painkiller market now controlled by popular
painkillers known as NSAIDS, or nonsteroidal anti-inflammatory
drugs. These include Roche Holding AG's Toradol, American Home
Products Corp.'s Orudis and SmithKline Beecham Plc's Relafen.
While the NSAIDS can greatly relieve pain, they've also been
shown to cause gastrointestinal side effects. That's where the
Cox-2 inhibitors come in.
How It Works
The drugs work by interfering with the production of an
enzyme, cyclooxygenase-2, linked to pain and swelling. Unlike
existing painkillers, a Cox-2 inhibitor doesn't suppress a
related enzyme, Cox-1, that helps protect the stomach from its
own acid.
As a result, researchers say, the Cox-2 drugs should offer
the same benefits as NSAIDS with fewer side effects such as
bleeding and ulcers for people who take pain medication for
chronic conditions such as arthritis.
Searle representatives told the panel that the company's
studies showed patients taking NSAIDS had three to five times as
many ulcers as patients taking Celebrex, also known as celecoxib.
In some cases, NSAIDS were more effective early on than
Celebrex in relieving pain, depending on the type of patient
studied. Still, for the most part, throughout the company's
studies, Celebrex worked just as well as NSAIDS in relieving pain
and inflammation, company representatives said.
The FDA gave the panel a list of 11 questions to answer. The
first question simply asks whether Celebrex should be approved
for treatment of rheumatoid arthritis and osteoarthritis.
The second question, however, notes that the FDA doesn't
think there's enough evidence yet to support approval
specifically for ''acute pain,'' or the immediate treatment of
pain such as that following surgery. The question asks whether
the panel agrees.
The remaining questions ask for the panel's advice on
whether Searle should be able to make certain claims in the label
for Celebrex, what kinds of warnings the drug should carry and
whether any post-marketing studies should be conducted. The panel
is scheduled to meet until late afternoon.
--Kristin Jensen and Kerry Dooley in Silver Spring, Maryland
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