Santarus Announces Commercial Launch of UCERIS (budesonide) Extended Release Tablets
New treatment for the induction of remission of active, mild to
moderate ulcerative colitis
SAN DIEGO--(BUSINESS WIRE)--
Santarus,
Inc. (NASDAQ: SNTS) announced today the U.S. commercial launch of
UCERIS™ (budesonide) extended release tablets for the
induction of remission in patients with active, mild to moderate
ulcerative colitis. UCERIS was approved by the U.S. Food and Drug
Administration on January 14, 2013.
UCERIS contains budesonide, a locally acting glucocorticosteroid, in a
novel oral tablet formulation that utilizes proprietary MMX®
multi-matrix system colonic delivery technology. The approved dosing
regimen for adult patients is one 9 mg tablet taken orally once daily in
the morning for up to 8 weeks.
"We believe that UCERIS fills an important therapeutic gap as a new
prescription option available to physicians treating patients in the
active phase of mild to moderate ulcerative colitis," said Wendell
Wierenga, Ph.D., executive vice president of research and development.
"In our pivotal clinical studies, three times more patients achieved
clinical remission and mucosal healing with UCERIS compared with
patients taking placebo, and no clinically significant differences in
glucocorticosteroid side effects were seen versus placebo after eight
weeks of treatment."
William C. Denby, senior vice president of commercial operations said,
"For the commercial launch of UCERIS we have added 85 new sales
representatives, increasing our total number of sales reps to 235. We
will use the entire sales organization to promote UCERIS and ZEGERID®
(omeprazole/sodium bicarbonate) to gastroenterologists, while also
continuing to promote our three diabetes/metabolic products to
endocrinologists and other physicians."
Mr. Denby added, "In addition to our physician outreach, we recognize
that informing patients with ulcerative colitis about UCERIS is key to
motivating them to seek treatment for the active phase of their disease.
To that end, we are implementing patient education programs through
social media and medical information websites to provide patients with
helpful information about treatment options."
UCERIS was developed in collaboration with Cosmo Technologies Limited, a
subsidiary of Cosmo Pharmaceuticals S.p.A. Upon first commercial sale of
UCERIS, $7 million is payable to Cosmo in cash or Santarus common stock,
at Cosmo's option.
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 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 healthcare provider and see the Full Prescribing
Information including Patient Labeling, available at www.santarus.com.
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.
About Santarus
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 are available at www.santarus.com.
Santarus' product development pipeline includes the investigational drug
RUCONEST® (recombinant human C1 esterase inhibitor) for
treatment of acute attacks of hereditary angioedema. The company expects
to submit a biologics license application (BLA) to the U.S. Food and
Drug Administration for RUCONEST in the first half of 2013. Santarus is
also developing rifamycin SV MMX®, which is in Phase III
clinical testing for treatment of travelers' diarrhea. In addition,
enrollment has been completed in a Phase I clinical program with
SAN-300, the company's 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. These forward-looking statements include statements
regarding the timing and outcome of various matters relating to
Santarus' development products, including the submission of a BLA for
RUCONEST.
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: Santarus' ability to
successfully launch UCERIS and generate revenues from UCERIS, ZEGERID,
GLUMETZA and its other currently promoted commercial products and its
authorized generic ZEGERID product; Santarus' ability to successfully
advance the development of, obtain regulatory approval for and
ultimately commercialize, its development-stage products, including the
timing and outcome of the UCERIS Phase IIIb clinical study, the
submission of the RUCONEST BLA and the second Phase III clinical study
for rifamycin SV MMX; Santarus' ability to maintain patent protection
for its products, including the difficulty in predicting the timing and
outcome of ongoing patent litigation; Santarus' ability to achieve
continued progress under its strategic alliances, and the potential for
early termination of these agreements; Santarus' dependence on strategic
partners for certain aspects of its development programs, including
risks related to their financial stability; adverse side effects,
inadequate therapeutic efficacy or other issues related to Santarus'
products that could result in product recalls, market withdrawals or
product liability claims; competition from other pharmaceutical or
biotechnology companies and evolving market dynamics; other difficulties
or delays relating to the development, testing, manufacturing and
marketing of, and obtaining and maintaining regulatory approvals for,
Santarus' products; fluctuations in quarterly and annual results;
Santarus' ability to obtain additional financing as needed to support
its operations or future product acquisitions; and other risks detailed
in Santarus' prior press releases as well as in prior public periodic
filings with the Securities and Exchange Commission.
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.
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.
Company Contact:
Santarus, Inc.
Martha L. Hough
VP
Finance & Investor Relations
858-314-5824
or
Debra P.
Crawford
Chief Financial Officer
858-314-5708
or
Investor
Contact:
Westwicke Partners, LLC
Stefan Loren, Ph.D.
858-356-5930
sloren@westwicke.com
or
Robert
Uhl
858-356-5932
robert.uhl@westwicke.com
Source: Santarus, Inc.
News Provided by Acquire Media
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