Santarus Announces UCERIS (budesonide) Poster Presentations at Digestive
Disease Week Meeting
SAN DIEGO -- May 17, 2013
Santarus, 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 breastfeed.
*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 arms.
*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
*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
*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
*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
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
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 and ZEGERID^® (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
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
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 31, 2013.
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
Santarus^®, FENOGLIDE^®, 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
VP Finance & Investor Relations
Debra P. Crawford, 858-314-5708
Chief Financial Officer
Westwicke Partners, LLC
Stefan Loren, Ph.D., 858-356-5930
Robert Uhl, 858-356-5932
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