Inc. (NASDAQ: SNTS) today announced the completion of enrollment in
the CONTRIBUTE clinical study designed to evaluate the incremental
benefit of adding UCERIS® (budesonide) extended release 9 mg
tablets to oral aminosalicylate (5-ASA) therapy for the induction of
clinical remission in adult patients with active, mild to moderate
ulcerative colitis. UCERIS is currently approved in the U.S. for the
induction of remission in patients with active, mild to moderate
A total of 509 patients were enrolled in the CONTRIBUTE study, a
multicenter, randomized, double-blind, placebo controlled clinical
trial. The primary endpoint of the study is clinical remission, defined
as a score of 0 for both rectal bleeding and stool frequency on the
Ulcerative Colitis Disease Activity Index (UCDAI) scale. All patients
were randomized to either the UCERIS or placebo arm and will continue
their existing background 5-ASA regimen during the 8 week study.
"We believe the data from this combination study will provide valuable
information for physicians who treat patients with active ulcerative
colitis," said Wendell Wierenga, Ph.D., executive vice president of
research and development. "We expect to have top-line data from the
study available by year-end, and plan to release expanded study results
at an appropriate medical meeting in 2014."
UCERIS Indication and Usage
UCERIS is a prescription corticosteroid medicine used to help get mild
to moderate ulcerative colitis under control.
Dosage and Administration
UCERIS is taken once daily in the morning with or without food for up to
Important Safety Information
Do not take UCERIS if you are allergic to budesonide or any of the
ingredients in UCERIS.
Before you take UCERIS, tell your doctor if you have liver problems,
are planning to have surgery, have chickenpox or measles or have
recently been near someone with chickenpox or measles, have or had a
family history of diabetes, cataracts or glaucoma, have high blood
pressure (hypertension), decreased bone mineral density
(osteoporosis), stomach ulcers, any other medical condition, are
pregnant or plan to become pregnant, or breastfeed or plan to
Tell your doctor about all the medications you take, including
prescription and over-the-counter vitamins and herbal supplements.
UCERIS and other medicines may affect each other causing side effects.
Do not eat grapefruit or drink grapefruit juice while taking UCERIS
because these can increase the level of UCERIS in your blood.
Long-time use of UCERIS can cause you to have too much
glucocorticosteroid medicine in your blood (hypercorticism). Tell your
doctor if you have any of the following signs and symptoms of
hypercorticism: acne, bruise easily, rounding of your face (moon
face), ankle swelling, thicker or more hair on your body and face, a
fatty pad or hump between your shoulders (buffalo hump), or pink or
purple stretch marks on the skin of your abdomen, thighs, breasts, and
When UCERIS is taken for a long period of time, the adrenal glands do
not make enough steroid hormones. Tell your doctor if you are under
stress or have any symptoms of adrenal suppression during treatment
with UCERIS, including tiredness, weakness, nausea and vomiting, and
low blood pressure.
UCERIS weakens your immune system. Taking medicines that weaken your
immune system makes you more likely to get infections. Avoid contact
with people who have contagious diseases such as chickenpox or measles
while taking UCERIS. Tell your doctor about any signs or symptoms of
infection, including fever, pain, aches, chills, feeling tired, or
nausea and vomiting.
If you take certain other corticosteroid medicines to treat allergies
(e.g., eczema, rhinitis), switching to UCERIS may cause your allergies
to come back. Tell your doctor if any of your allergies become worse
while taking UCERIS.
The most common side effects with UCERIS are headache, nausea,
decreased blood cortisol levels, stomach-area pain, tiredness, stomach
or intestinal gas, bloating, acne, urinary tract infection, joint
pain, and constipation.
UCERIS is available by prescription only. For additional
information, talk to your doctor and see Full Prescribing Information
including Patient Labeling, which is available at www.santarus.com
or by contacting Santarus at (888) 778-0887.
About Ulcerative Colitis
Ulcerative colitis is a form of chronic inflammatory bowel disease that
produces inflammation and ulcers along the inside of the colon, which
can interfere with the normal function of the colon. The disease
typically starts to manifest in patients as young adults. Ulcerative
colitis is an intermittent disease with periods of exacerbated symptoms,
or flares, and periods that are relatively symptom-free. Although the
symptoms of ulcerative colitis may resolve without treatment, the
disease usually requires medication to go into remission. According to
the Crohn's and Colitis Foundation of America, as many as 700,000 people
in the U.S. suffer from ulcerative colitis.
Santarus, Inc. is a specialty biopharmaceutical company focused on
acquiring, developing and commercializing proprietary products that
address the needs of patients treated by physician specialists. The
company's current commercial efforts are focused on five products. UCERIS®(budesonide) extended release tablets for the induction of
remission in patients with active, mild to moderate ulcerative colitis
(omeprazole/sodium bicarbonate) for the treatment of certain upper
gastrointestinal disorders are promoted to gastroenterologists. GLUMETZA®
(metformin hydrochloride extended release tablets) and CYCLOSET®
(bromocriptine mesylate) tablets, which are indicated as adjuncts to
diet and exercise to improve glycemic control in adults with type 2
diabetes, and FENOGLIDE®
(fenofibrate) tablets, which is indicated as an adjunct to diet to
reduce high cholesterol, are promoted to endocrinologists and other
physicians who treat patients with type 2 diabetes. Full prescribing and
safety information for Santarus' products is available at www.santarus.com
or by contacting Santarus at 1-888-778-0887.
Santarus' product development pipeline includes the investigational drug
RUCONEST® (recombinant human C1 esterase inhibitor). A
Biologics License Application for RUCONEST for the treatment of acute
angioedema attacks in patients with hereditary angioedema is under
review by the U.S. Food and Drug Administration with a response expected
in April 2014. Santarus is also developing rifamycin SV MMX®,
which is in Phase III clinical testing for treatment of travelers'
diarrhea. In addition, the company has completed a Phase I clinical
program with SAN-300, an investigational monoclonal antibody. More
information about Santarus is available at www.santarus.com.
Santarus cautions you that statements included in this press release
that are not a description of historical facts are forward-looking
statements. The inclusion of forward-looking statements should
not be regarded as a representation by Santarus that any of its plans or
objectives will be achieved. Actual results may differ materially
from those set forth in this release due to the risks and uncertainties
inherent in Santarus' business, including, without limitation:
unexpected adverse side effects or inadequate therapeutic efficacy of
Santarus' products and product candidates; the scope and validity of
patent protection for Santarus' products and product candidates; and
other difficulties or delays relating to the development, testing,
manufacturing and marketing of, and obtaining and maintaining regulatory
approvals for, Santarus' products and product candidates; and other
risks detailed in Santarus' prior press releases as well as in prior
public periodic filings with the Securities and Exchange Commission,
including its Quarterly Report on Form 10-Q for the quarter ended March
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement and Santarus undertakes no obligation to revise or
update this news release to reflect events or circumstances after the
date hereof. This caution is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation Reform
Act of 1995.
UCERIS® and ZEGERID®
are registered trademarks of Santarus, Inc. GLUMETZA®
is a trademark of Biovail Laboratories International S.r.l. licensed
exclusively in the United States to Depomed, Inc. CYCLOSET®
is a trademark of VeroScience LLC. MMX®
is a trademark of Cosmo Technologies Limited. RUCONEST®
is a trademark of Pharming Group N.V.
Martha L. Hough
VP Finance & Investor
Debra P. Crawford
Stefan Loren, Ph.D. (firstname.lastname@example.org)
Robert Uhl (email@example.com)