Bloomberg: Monsanto Wins FDA Panel Backing for Its Cox-2 Painkiller for Arthritis
Bloomberg News
December 1, 1998, 1:54 p.m. PT
Monsanto Wins FDA Panel Backing for Cox-2 Drug for Arthritis
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 painkiller drugs with
multibillion dollar sales potential.
The FDA panel in two separate votes backed approval of the
drug known as Celebrex, developed by Monsanto's Searle
pharmaceutical unit, for patients suffering from osteoarthritis
and rheumatoid arthritis. The panel is still discussing other
uses for the drug as well as how it should be labeled.
The panel's endorsement is crucial for Monsanto, which is
looking to Celebrex to help build its pharmaceutical business.
The company told the panel that the drug offers patients a safer
alternative to existing treatments for arthritis and pain.
''It 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 typically, though not always, follows
the advice of its expert panels.
Earlier, the company for the first time revealed that the
drug can work when taken once a day.
That's important because rival Merck & Co., which is at
least three months behind Searle in the FDA review process, had
held up the once-a-day dosing of its Vioxx drug as a possible
advantage.
Fewer Side Effects
Searle representatives presented studies showing Celebrex
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.
''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 were down 1 5/16 at 44
after trading as low as 41 9/16 before the panel vote. Shares of
marketing partner Pfizer Inc., the New York-based maker of the
impotence pill Viagra, were down 3/4 at 111 3/16 after trading as
low as 108 5/8.
One of the major issues at the meeting will be whether
Searle can convince the panel that its drug doesn't need the
standard warning label about gastrointestinal side effects
carried by many existing painkillers. FDA reviewers said they
can't yet be sure of the long-term effects of the new drug and
warned that new, unforeseen side effects could appear.
Public Citizen Concerns
Several speakers at an open public hearing raised similar
concerns. Sidney Wolfe, head of Public Citizen's Health Research
Group, said there isn't yet enough evidence to allow Celebrex,
also known as celecoxib, on the market without the standard
warning label.
''Purported new classes of drugs such as celecoxib offer not
only new mechanisms of action, but also new mechanisms of
potential toxicity and the possibility of a new spectrum of
adverse events,'' Wolfe said in a statement to the panel.
If the panel turns down Searle's request to avoid the
standard warning label it would be a blow to the company's plans
to distinguish Celebrex from existing treatments. The panel will
discuss this issue this afternoon.
Expectations for the class of drugs, known as Cox-2
inhibitors, 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.
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 -- potentially negating what had been perceived as an
advantage for Merck's once-a-day Vioxx drug.
Shares of Whitehouse Station, New Jersey-based Merck rose 1
1/4 to 156 3/8.
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 in some cases had
significantly more ulcers than patients taking Celebrex.
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.
--Kristin Jensen and Kerry Dooley in Silver Spring, Maryland |
