SEARLE, PFIZER ANNOUNCE U.S.
AVAILABILITY OF CELEBREX(TM);
PR Wire
February 23, 1999, 7:15 a.m. ET
First Arthritis Product that Targets Only COX-2
CHICAGO, Feb. 23 /PRNewswire/ -- Celebrex(TM) (celecoxib), an important
new prescription medication for millions of people with arthritis, is now
available in 51,000 pharmacies nationwide. Discovered and developed by G.D.
Searle & Co., the pharmaceutical business unit of Monsanto Company
(NYSE: MTC), Celebrex was approved by the U.S. Food and Drug Administration
(FDA) on December 31, 1998 and was distributed to pharmacies through an
expedited distribution system.
(Photo: newscom.com )
Celebrex will be globally promoted by Searle and Pfizer Inc (NYSE: PFE) in
all markets except Japan. The product was recently cleared by regulatory
agencies in Mexico and Brazil.
"Early patient and physician demand for Celebrex has been extensive
because the product addresses a major unmet medical need," said Searle's chief
operating officer Al Heller. "As of today, patients have access to Celebrex
through physicians and pharmacies across the country."
Added Karen Katen, president of Pfizer U.S. Pharmaceuticals and executive
vice president of the global Pfizer Pharmaceuticals Group, "We are very
pleased by the initial response to Celebrex and believe it will make a
significant difference in the lives of arthritis patients."
Celebrex was designed using advanced molecular technology. In the body,
there are two enzymes that are called COX-1 and COX-2. COX-1 helps regulate
normal cell function in the stomach and blood. COX-2 plays a role in causing
arthritis pain and inflammation. It is believed that Celebrex works by
primarily inhibiting COX-2 and, at therapeutic doses, does not inhibit COX-1.
"Celecoxib is the first arthritis product to target only the COX-2
enzyme," said Jay Goldstein, MD, associate professor of medicine, University
of Illinois at Chicago. "Patients now have a treatment option that will
effectively relieve their arthritis pain and inflammation with potentially
fewer side effects, most notably in the gastrointestinal (GI) tract."
Typical non-steroidal anti-inflammatory drugs (NSAIDs) inhibit both COX-1
and COX-2. Use of these medications may lead to stomach ulcers and other
serious complications, such as gastrointestinal (GI) bleeding. In fact, a
recent study estimates that these complications cause 107,000 hospitalizations
and 16,500 deaths each year in the United States.
Celebrex, which received priority review from the FDA, is indicated to
relieve the signs and symptoms of osteoarthritis (OA) and adult rheumatoid
arthritis (RA). Tested in clinical trials that involved over 13,000 patients
and healthy volunteers, Celebrex was shown to be as effective as the
prescription-strength NSAID naproxen in treating arthritis pain and
inflammation. Importantly, Celebrex was associated with significantly fewer
endoscopically observed upper GI ulcers than prescription-strength naproxen
and another widely used prescription-strength medication, ibuprofen. The
correlation between endoscopic findings and the incidence of clinically
serious upper GI events has not been fully established. The most common side
effects of Celebrex were dyspepsia, diarrhea and abdominal pain.
Discontinuation due to each of these side effects was less than one percent.
Although Celebrex has a low potential for stomach ulcers, serious GI tract
ulcerations can occur without warning. Physicians and patients should remain
alert for signs of GI bleeding.
Celebrex is priced comparably to branded prescription arthritis pain
relievers. The average wholesale price of a 200 mg capsule is $2.42. The
recommended therapeutic dose of Celebrex for OA is 200 mg daily administered
as a single dose or 100 mg twice daily. For RA, the recommended therapeutic
dose is 100 mg to 200 mg, twice daily.
Searle, a global leader in arthritis products and educational programs, is
the pharmaceutical sector of Monsanto Company (NYSE: MTC). Searle develops,
produces and markets prescription pharmaceuticals, including major products to
treat arthritis, cardiovascular disease, cancer and its complications and
insomnia, and to promote women's health. For more information on Searle,
access www.searlehealthnet.com. As a life sciences company, Monsanto is
committed to finding solutions to the growing global needs for food and health
by sharing common forms of science and technology among agriculture, nutrition
and health. In 1998, Monsanto reported sales of $8.6 billion and invested
approximately $1 billion in research and development.
Pfizer Inc (NYSE: PFE) is a research-based, global healthcare company.
Pfizer discovers and develops innovative, value-added products that improve
the quality of life of people around the world and help them enjoy longer,
healthier, and more productive lives. The company has three business
segments: health care, animal health, and consumer health care, with products
available in more than 150 countries. In 1998, the company reported revenues
of $13.5 billion and invested more than $2.2 billion in research and
development. For more information on Pfizer, access www.pfizer.com.
SOURCE G.D. Searle & Co.
-0- 02/23/99
/NOTE TO EDITORS: For complete prescribing information, please call
toll-free 877-CELECOXIB or consult www.celebrex.com on the Internet. Media
interviews are available upon request with executives from Searle and Pfizer,
Celebrex clinical investigators, and/or Celebrex patients by calling the
contacts listed below./
/CONTACT: Kristin Fayer of Searle, 847-581-6728; or Maureen Suda of
Chandler Chicco Agency, 212-229-8448, for Searle/
/Photo: newscom.com
or NewsCom, 213-237-5431; AP PhotoExpress Network, PRN13; PressLink
Online,
800-888-6195/
/Web site: pfizer.com
/Web site: celebrex.com
/Web site: searlehealthnet.com
(MTC PFE)
CO: G.D. Searle & Co.; Monsanto Company; Pfizer Inc.
ST: Illinois
IN: MTC
SU: PDT
-0- Feb/23/1999 7:00
EOS (PRN) Feb/23/99 07:00 86
-0- (PRN) Feb/23/1999 7:15 |
