FDA Cmte To Review Monsanto's Celebrex On 12/1
11/30/98
Federal Filings Newswires
WASHINGTON (FFBN) -- The U.S. Food and Drug Administration's
Arthritis Advisory Committee will review on December 1 G.D. Searle &
Co.'s Celebrex for the treatment of acute or chronic signs and symptoms
of osteoarthritis and rheumatoid arthritis and the management of pain.
G.D. Searle, a unit of Monsanto Co. (MTC), has joined forces
with a pharmaceutical powerhouse, Pfizer Inc. (PFE), to promote the
drug. Analysts estimate that Pfizer has already paid Searle $240
million for the right to market Celebrex, reported the Wall Street
Journal.
If ultimately approved by the FDA, market watchers anticipate
sales estimates for Celebrex to be as much as $4 billion a year.
Celebrex, generically known as celecoxib, belongs to a class of
drugs known as COX-2 inhibitors. Celebrex is designed to block the COX-
2 enzyme activated in inflammation. Additionally, the drug does not
affect the activity of the COX-1 enzyme, which protects the lining of
the GI tract.
Searle conducted Phase III studies to ascertain the safety and
efficacy of Celebrex. Based on the results, the drug was not involved
in causing gastrointestinal (GI) discomfort, specifically the formation
of ulcers. This gives Celebrex an advantage over current prescription
and over-the-counter nonsteroidal anti-inflammatory inhibitors (NSAIDs)
that do have a high potential to cause GI discomfort.
In clinical studies, Celebrex was compared to the NSAID
Naproxen in patients affected by osteoarthritis and rheumatoid
arthritis. The study showed that Celebrex was just as effective as
Naproxen, but contained a "superior GI safety profile," according to the
company.
Rheumatoid arthritis is a chronic autoimmune disorder that
affects approximately 2.1 million people in the U.S. This condition
causes the body's immune system to identify non-foreign tissues as
foreign and attempts to destroy them via white blood cells and
antibodies.
Approximately 21 million individuals in the U.S. suffer from
osteoarthritis, mostly after age 45. Osteoarthritis is a joint disease
aggravated by mechanical stress. It is characterized by degeneration of
the cartilage that lines joints, leading to pain, stiffness and
sometimes loss of function of the affected joint.
Merck & Co. Inc. (MRK) will also be vying for a position in the
arthritis market. The company is developing its own investigational new
osteoarthritis drug, Vioxx (rofecoxib), and has submitted a new drug
application (NDA) with the FDA for review. This puts Merck only three
months behind Searle's application. Merck expects to file similar
regulatory applications for Vioxx worldwide by the end of the year.
As reported, Immunex Corp.'s (IMNX) Enbrel (etanercept) was
granted marketing approval in early November for the treatment of
moderate to severe rheumatoid arthritis. Recently, the company filed a
supplemental biologics license application (SBLA) with the FDA to expand
Enbrel's labeling to include the treatment of children and teenagers
with moderate to severe active polyarticular course juvenile rheumatoid
arthritis (JRA), a population consisting of approximately 50,000 in the
U.S.
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