Inc. (NASDAQ: SNTS) today announced that additional data from two
pivotal clinical studies with UCERIS® (budesonide) extended
release tablets will be featured in two poster presentations at the
Digestive Disease Week® (DDW®) Meeting being held
in Orlando, Fla. from May 18 - 21, 2013.
The two UCERIS poster presentations are scheduled to take place on
Saturday, May 18, 2013 from 8:00 a.m. to 5:00 p.m. Eastern time at the
Orange County Convention Center, Hall West A1.
Su1219 - Sandborn W, et al, Efficacy of Budesonide MMX®
in Reduction of Symptoms in Patients with Mild-to-Moderately Active
Ulcerative Colitis: A Pooled Analysis of the CORE I and CORE II Studies
Su1220 - Lichtenstein G R, et al, Budesonide MMX®
9 mg Induces Remission in Mild-to-Moderately Active Ulcerative Colitis
Patients Regardless of Prior History of 5-ASA Therapy
Important Safety Information About UCERIS
UCERIS is a prescription corticosteroid medicine used to help get mild
to moderate ulcerative colitis under control. UCERIS is taken once daily
in the morning with or without food for up to 8 weeks.
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.
The Important Safety Information does not include all the information
needed to use UCERIS safely and effectively. For additional information,
talk to your healthcare provider and see the Full Prescribing
Information including Patient Labeling available at www.uceris.com
or by contacting Santarus at 888-778-0887.
About Ulcerative Colitis
Ulcerative colitis is a form of chronic inflammatory bowel disease (IBD)
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.
Digestive Disease Week® (DDW®) is the largest
international gathering of physicians, researchers and academics in the
fields of gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the Study of
Liver Diseases (AASLD), the American Gastroenterological Association
(AGA) Institute, the American Society for Gastrointestinal Endoscopy
(ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW
takes place May 18 - 21, 2013, at the Orange County Convention Center in
Orlando. The meeting showcases more than 5,000 abstracts and hundreds of
lectures on the latest advances in GI research, medicine and technology.
More information can be found at www.ddw.org.
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.
Santarus' product development pipeline includes the investigational drug
RUCONEST® (recombinant human C1 esterase inhibitor). A
Biologics License Application for RUCONEST was submitted to the FDA in
April 2013 for the treatment of acute angioedema attacks in patients
with hereditary angioedema. Santarus is also developing rifamycin SV MMX®,
which is in Phase III clinical testing for the 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;
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, except as may be required by applicable law. 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
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, 858-314-5824
& Investor Relations
Debra P. Crawford, 858-314-5708
Stefan Loren, Ph.D., 858-356-5930