Monsanto Wins FDA Panel Nod for Cox-2 Arthritis Drug [Update on labeling]
Bloomberg News
December 1, 1998, 6:13 p.m. ET
Monsanto Wins FDA Panel Nod for Cox-2 Arthritis Drug (Update3)
(Adds further panel action, closes shares)
Silver Spring, Maryland, Dec. 1 (Bloomberg) -- Monsanto Co.
won the backing of a U.S. Food and Drug Administration advisory
panel for the first of a new class of painkillers with expected
annual sales of as much as $5 billion.
The FDA panel recommended the drug, known as Celebrex,
be approved for patients with osteoarthritis or rheumatoid
arthritis. It said the standard warning label for painkillers
could be modified to indicate Celebrex has few side effects,
which could help sales of the drug for other types of pain.
The panel's endorsement is crucial for Monsanto, which is
looking to Celebrex to help spur its transformation from a
leading chemical company into a pharmaceutical powerhouse.
''It looks like it's as sure a winner as you can find,''
said Samuel Isaly, whose OrbiMed Advisors LLC manages $500
million invested in drug and biotech stocks. The FDA typically,
though not always, follows the advice of its expert panels.
Monsanto already has a head start on rival Merck and Co. in
the race to market the first of the new class of painkillers,
known as Cox-2 inhibitors. Today, Monsanto told the panel new
research shows its drug can work when taken once a day, matching
an advantage Merck had claimed for its competing drug Vioxx.
That's important because Merck's Vioxx is at least three
months behind Monsanto's Celebrex in the FDA review process.
Close Call on Labeling
The panel left it up to the FDA to decide the wording of the
Celebrex label and took no formal action on Monsanto's request to
avoid the standard label warnings.
''This is a very close call,'' said Steven Abramson,
chairman of the FDA panel and chairman of rheumatology and
medicine at New York's Hospital for Joint Diseases. ''The data is
very compelling'' and close to warranting removal of the
label, he said.
While many people never read the label, it's the key to how
a company can market a drug under the scrutiny of the FDA. In
this case, Monsanto hopes to win a label that it could use to
market Celebrex as a safer alternative to current treatments.
Monsanto representatives presented studies showing
Celebrex, developed by its Searle pharmaceutical unit, could
effectively treat osteoarthritis and rheumatoid arthritis as well
as other types of pain. Compared to existing treatments, Celebrex
also works with fewer gastrointestinal side effects, such as
ulcers and abdominal pain, they said.
Goals Achieved
''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 13/16 to 43 1/2.
Shares of marketing partner Pfizer Inc., the New York-based maker
of the impotence pill Viagra, fell 15/16 to 111.
FDA panel members were split on whether to recommend the
drug for use in patients with ''acute'' pain, such as pain
immediately following surgery, and the panel chairman decided not
to call for a vote.
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.
Several panel members, however, said they didn't yet think
there was enough evidence to allow Searle to avoid the standard
label carried by NSAIDS warning of gastrointestinal side effects.
The panel's move followed concerns voiced by FDA reviewers and by
others at an open public hearing.
New classes of drugs ''offer not only new mechanisms of
action, but also new mechanisms of potential toxicity and the
possibility of a new spectrum of adverse events,'' said Sidney
Wolfe, head of the Health Research Group at the watchdog group
Public Citizen.
Before the hearing, analysts said Merck and Searle's drugs
could generate combined annual sales of as much as $5 billion.
Still, even if they can claim their drugs are safer than existing
treatments, the companies may face a challenge convincing health
insurers that it's worth paying more for their drugs.
--Kristin Jensen and Kerry Dooley in Silver Spring, Maryland
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