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Archived
Press Release - 3/18/99
FOR
IMMEDIATE RELEASE
CONTACT:
Jon Sendach
The Rowland Company
(212) 527-8800
FDA
APPROVES WORLD'S LEADING
ANTI-ULCER MEDICATION FOR HORSES AND FOALS
ISELIN,
N.J., March 18, 1999 - Merial, a Merck (NYSE: MRK) and Rh™ne-Poulenc
(NYSE: RP) company, announced today that it has received clearance
from the U.S. Food and Drug Administration (FDA) to market GASTROGARD™
(omeprazole) Paste, the first and only prescription medication
approved by the FDA to heal and prevent the recurrence of stomach
ulcers in horses. Omeprazole is the same active ingredient found
in PRILOSEC® the world's leading anti-ulcer medication for
humans.
"Only recently,
with advances in diagnostic testing, has the seriousness of Equine
Gastric Ulcer Syndrome (EGUS) been understood and until now, there
was no approved medicine specifically designed for treating ulcers
in horses," said Dr. Frank Andrews, associate professor and section
chief, Large Animal Medicine, University of Tennessee College
of Veterinary Medicine, Knoxville, Tenn. "GASTROGARD is an important
new drug because it is the first medication that has been proven
to heal stomach ulcers and, just as significantly, can prevent
them from recurring even while the horse is still in training.
This drug will have a significant impact on the equine industry."
GASTROGARD was granted accelerated review by the FDA because the
molecule was new to veterinary medicine and had potential therapeutic
value for an important, often serious condition. EGUS may affect
as many as 1.8 million U.S. performance horses. Recent studies have
shown that EGUS affects up to 93 percent of racehorses, almost 60
percent of other performance horses and up to 57 percent of foals
(horses under the age of one year). GASTROGARD will be available
from veterinarians in two weeks.
Like People,
Horses Get Ulcers, Too
As with human
ulcers, stomach acid appears to be the main cause of horse ulcers.
Excess acid can eat through the protective lining and damage the
stomach. Among the most noticeable signs of ulcers are decreased
appetite, colic, poor hair coat, poor body condition and poor
performance. In foals, clinical signs may include grinding of
teeth, colic, intermittent nursing, decreased appetite and weakness.
Feeding practices, training and trailering, competing, and even
hospitalization can contribute to ulcer formation in horses. Intensity
of training may also contribute to ulcer formation. Helicobacter
pylori, bacteria that are a factor in the development of human
ulcers, have not been isolated from horse stomachs and are not
currently considered to be a cause of horse ulcers.
"Gastric
ulcers are very common in adult horses as well as foals. Symptoms
of ulcers are often not apparent because our patients can't
talk to tell us they are uncomfortable," said Dr. Michael J.
Murray, associate professor and Adelaide C. Riggs Chair in Equine
Medicine, Marion duPont Scott Equine Medical Center, Virginia-Maryland
Regional College of Veterinary Medicine, Leesburg, Va. "In most
cases, foals and horses exhibit signs of ulcers in ways that
can be missed or misunderstood, and an owner or trainer may
not recognize that there is a problem unless the horse shows
overt signs of colic."
GASTROGARD
Contains Same Ingredient as PRILOSEC , the No. 1 Anti-Ulcer Drug
for Humans
The active
ingredient in GASTROGARD is omeprazole -- the same compound as
in PRILOSEC® (marketed as LOSEC® outside the US) --
the world's No. 1 anti-ulcer medication for humans and the No.1
selling prescription drug in the world.
"In the
past, many different medications used to treat heartburn and
stomach ulcers in humans have been used by veterinarians to
treat horses," said Dr. Nicholas Vatistas, department of veterinary
surgical and radiological sciences, University of California,
Davis, Calif. "This is a common and accepted practice. Unfortunately,
many of these medications had variable results, even at high
doses, and had no recommended dose or administration schedule
proven through controlled research studies. Often, treatment
required that the horse be removed from training."
None of these medications have been evaluated or approved for
use in horses by the FDA, and their safety in horses has not been
assessed.
GASTROGARD
Safely Heals and Prevents Recurrence of Ulcers in Horses
Clinical field
trials showed that daily use of GASTROGARD for four weeks effectively
healed or reduced the severity of gastric ulcers in 99 percent
of treated horses. The product was tested for both safety and
efficacy in major multicenter studies at more than 15 trial sites
involving more than 300 horses of more than nine different breeds.
GASTROGARD is the only medication to meet FDA standards for the
treatment of equine stomach ulcers.
"In clinical
trials, GASTROGARD allowed horses to remain in active training
during treatment," explained Andrews, one of the lead researchers
of the studies. "This will be of greatest benefit in treating
ulcers in racehorses and other equine athletes, such as show
jumpers and three-day event horses, because valuable conditioning
will not be lost through lay-up." (Lay-up is a break in training
or rest period.)
GASTROGARD provides superior acid suppression because it effectively
shuts down acid production in the stomach, giving the ulcer time
to heal. The stomach cells contain several acid-stimulating receptors.
When any of these receptors are activated, they send a message to
acid pumps (enzyme systems) to secrete acid into the stomach. GASTROGARD
works by disabling the acid pumps so when receptors send the message
to produce acid, the acid pumps are unable to respond.
GASTROGARD has been proven safe, with adult horses in clinical trials
experiencing no drug-related health problems, even when the product
was administered at 10 times the recommended dose. It also can be
used safely in foals as young as 4 weeks old and in breeding stallions.
"GASTROGARD
is one of the most rigorously and extensively tested drugs in
equine medicine, " said Kevin Schultz, vice president of research
and development at Merial. "All the horses whose health and performance
are diminished by ulcers will now benefit from the only medication
proven to heal and prevent gastric ulcers."
GASTROGARD is the first and only once-a-day medication designed
for convenient administration to horses. The oral paste is contained
in pre-filled single-dose applicators, is well accepted by horses,
and is easily administered. GASTROGARD is for use by or on the order
of a licensed veterinarian.
Merial:
Making the Vital Difference
Merial is the world's leading animal-health company dedicated
to the research, development, manufacture and delivery of innovative
pharmaceuticals and vaccines for use by veterinarians, food-animal
producers and pet owners to improve the health, well-being and
performance of all animal species. The company is also market
leader in the development and production of poultry breeding stock.
With its worldwide headquarters in London, Merial employs around
6,500 people and operates in more than 150 countries. Total 1998
sales were US$1.76 billion. Merial is jointly owned by Merck and
Co., Inc., and Rh™ne-Poulenc S.A.
For more information on GASTROGARD and Equine Gastric Ulcer Syndrome,
please visit the Websites http://www.gastrogard.com
and http://www.egus.org, or
call toll-free (877) GASTROGARD - (877) 427-8764.
See Product Information for a full description of product and
prescription details.
™GASTROGARD; is a trademark and ®PRILOSEC is a registered
trademark of Astra AB.
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