Tuesday January 14 9:18 AM EDT
P&G and QUIDEL To Promote H. pylori Duodenal Ulcer Products To Physicians
P&G's Helidac Therapy and QUIDEL's QuickVue Offer Physicians Easy,
Effective and Economical Option to Diagnose and Treat Duodenal Ulcers
CINCINNATI and SAN DIEGO, Jan. 14 /PRNewswire/ -- For the 3 million adults
in the United States who suffer from an active duodenal ulcer, here's a New
Year's resolution worth keeping: make 1997 the year you get rid of it for
good.
Making good on that resolution should be even easier this year, thanks to a
co-promotion agreement announced today by The Procter & Gamble Co and
Quidel Corp .
The two companies said they have formed a strategic collaboration to
promote QUIDEL's QuickVue(R) One-Step H. Pylori Test, an in-office
diagnostic test, and P&G's Helidac(R) Therapy (bismuth subsalicylate,
metronidazole and tetracycline hydrochloride), along with an H-2 acid
suppression medication, as part of a disease management program to help
physicians better identify and treat patients with active duodenal ulcers
associated with H. pylori infection.
Specifically, P&G's pharmaceutical sales force will promote QUIDEL's
QuickVue test when making calls on physicians to communicate the benefits
of its Helidac Therapy. In turn, QUIDEL will provide P&G with two-test kit
samples of its diagnostic kit. The agreement between the two companies is
valid for up to one year, and is renewable. No additional terms were
disclosed.
Currently, physicians may choose from a range of options to diagnose H.
pylori infections. Some tests rely on tissue samples removed from the
stomach or intestine through an invasive and costly endoscopic procedure,
which may require a hospital stay. Other tests rely on breath samples which
require lab analysis, which takes time, delaying initiation of treatment.
However, serological or blood-based tests, like QUIDEL's QuickVue, are seen
as quick pre-treatment diagnostic methods for identifying suspected H.
pylori infections. These tests typically are conducted in the doctor's
office, and are cost-effective and quick for the patient and physician.
"This is good news for busy physicians and busy patients," said David
Peura, MD, chief, division of gastroenterology, University of Virginia
Health Sciences Center, Charlottesville, VA. "Now, in one office visit, a
physician can easily, effectively and economically diagnose a patient with
a suspected H. pylori infection and prescribe an effective ulcer
eradication therapy to help them treat it. This saves everyone time and
money."
First And Only Kit Cleared To Be Used Broadly By Physicians
QUIDEL's QuickVue is the first and only serological test that has received
waived status from the U.S. Centers for Disease Control (CDC). This means
it is more broadly available to physicians nationwide who routinely use
in-office diagnostic tests to confirm medical conditions. Diagnostic tests
that don't have waived status require increased quality control testing,
and are available to far fewer physicians.
In addition, QUIDEL's QuickVue test is the only one-step whole blood test
intended for in-office use. Test results are available in 10 minutes from a
simple finger-stick blood sample. Clinical studies prove the test is highly
accurate and provides results with 93% agreement to laboratory methods. The
test costs physicians under $20.
P&G's Helidac Therapy Off To A Good Start; Achieves "Preferred" Status
With Managed Care Organizations
After only four weeks on the market, P&G's Helidac Therapy has produced
solid results to date. P&G said that Helidac Therapy achieved its four-week
retail distribution goal in just one week.
Helidac Therapy also has received preferred formulary status at many
managed care organizations. This means that after diagnosing a patient with
an active duodenal ulcer, a physician is recommended to use Helidac
Therapy, in conjunction with an H-2 acid suppression medication, before
other approved H. pylori eradication therapies are considered.
In fact, PCS, the nation's largest pharmacy benefit management organization
with responsibility for 56 million patients, has included Helidac Therapy
in its Clinical Formulary And Prescribing Guidelines.
P&G's Helidac Therapy combines three drugs: bismuth subsalicylate,
metronidazole and tetracycline hydrochloride in a unique, cube-shaped kit
designed for patient compliance. Helidac Therapy is priced wholesale at
$77. Even when dosed with an H-2 acid suppression medication, Helidac
Therapy is priced up to 50% less than other approved therapies.
In pivotal clinical trials, among all evaluable patients, Helidac Therapy,
when used in conjunction with an H-2 acid suppression medication, achieved
eradication rates of up to 82%. Additionally, 91% of all evaluable patients
did not have an ulcer recurrence one year after treatment. Helidac Therapy
also is well-tolerated; the most common side effects include nausea (10%),
diarrhea (5%) and abdominal pain (3%).
As with any prescription drug, however, Helidac Therapy is not for all
patients. Helidac Therapy is contraindicated in pregnant or nursing women,
pediatric patients and patients with renal or hepatic impairment, and in
those with known hypersensitivity to bismuth subsalicylate, metronidazole,
tetracycline or any related derivatives.
It is recommended that all patients not eradicated of H. pylori following
Helidac Therapy plus an H-2 acid suppression medication should be
considered to have H. pylori resistant to metronidazole. Patients who fail
therapy should not be retreated with a regimen containing metronidazole.
Background information: QUIDEL, P&G
QUIDEL Corporation discovers, develops, manufactures and markets rapid
immunodiagnostic products for point-of-care detection of human medical
conditions and illnesses. These products provide simple, accurate and cost-
effective diagnoses for acute and chronic conditions in the areas of
reproductive and women's health, infectious diseases, allergies and
autoimmune disorders.
QUIDEL's products are sold to professionals in the physician's office and
clinical laboratory, and to consumers through retail drug stores. For more
information, visit the company's web site at quidel.com.
P&G makes and markets prescription and over-the-counter products in 60
countries. P&G's focus for prescription drugs is on anti-infective, cardiac
and musculo-skeletal therapies. In OTC health care, P&G's leading brands
include Vicks. cough/cold/flu and allergy products, Crest(R), Scope(R),
Metamucil(R) and Pepto-Bismol(R).
P&G is also actively partnering with a range of leading pharmaceutical and
biotechnology companies to develop and market innovative therapies. P&G had
sales of $35 billion in fiscal 1995-96.
To receive product information on P&G's Helidac Therapy, call toll-free
1-888-4HELIDAC (1-888-443-5432).
This news release contains forward-looking statements regarding QUIDEL and
Procter & Gamble and their future sales-related activities. Actual results
could differ materially from those described or implied in this news
release as a result of a number of factors, including, but not limited to,
the development of new products in conjunction with partners, any adverse
actions by the Companies' distributors, competitive products, other
economic factors affecting the Companies' markets, the degree of acceptance
that products achieve, and seasonality and other factors discussed in the
Companies' Annual Reports on Form 10-K and subsequent quarterly reports on
Form 10-Q. Copies of Forms 10-K and 10-Q are available from each Company
upon request. SOURCE Procter & Gamble Company |
