Santarus Announces FDA Acceptance of UCERIS New Drug Application for Induction of Remission of Active Ulcerative Colitis
FDA action date in October 2012
SAN DIEGO--(BUSINESS WIRE)--
Santarus, Inc. (NASDAQ: SNTS) today announced that the U.S. Food
and Drug Administration (FDA) has accepted for filing the company's New
Drug Application (NDA) for UCERIS™ (budesonide) tablets 9 mg.
Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus
expects the FDA will complete its review or otherwise respond to the
UCERIS NDA by mid-October, 2012. Santarus is seeking marketing approval
in the U.S. of UCERIS 9 mg for the induction of remission of mild to
moderate active ulcerative colitis.
"Ulcerative colitis is a serious, chronic disease that typically starts
to manifest in young adults with a long-term negative impact on the
patient," said Gerald T. Proehl, president and chief executive officer.
"We look forward to the potential to offer what we believe will be an
important new therapeutic option to physicians and their patients to
manage the symptoms of active ulcerative colitis."
UCERIS is an investigational drug that is a locally acting
(non-systemic) corticosteroid in a novel, patented, oral tablet
formulation, which utilizes proprietary MMX® multi-matrix
system technology and is designed to result in the controlled release
and distribution of budesonide throughout the length of the colon.
Budesonide has topical anti-inflammatory activity and due to an extended
first pass effect, has less systemic absorption than other
UCERIS is being developed in collaboration with Cosmo Technologies
Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. With FDA
acceptance for review of the NDA for UCERIS tablets, $4 million is
payable to Cosmo Technologies in cash or Santarus common stock, at
The NDA for UCERIS was filed as a section 505(b)(2) NDA, referencing
data generated for Entocort® EC (budesonide). In connection
with the FDA's acceptance for filing of the UCERIS NDA, Santarus is
providing notice to the NDA holder and the patent owner that UCERIS 9 mg
does not infringe any claims of the one unexpired patent listed in the
Orange Book for Entocort EC or that the claims in the patent are invalid.
About Ulcerative Colitis
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that
produces inflammation and ulcers along the inside of the colon. The
inflammation can interfere with the normal function of the colon, often
causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and
frequent bowel movements, which may also strongly affect quality of
life. According to the Crohn's & Colitis Foundation of America, IBD
affects an estimated 1.4 million Americans.
Ulcerative colitis is a chronic relapsing-remitting illness for which
there is no known cure, but with appropriate treatment patients can
manage their symptoms. However, it is estimated that up to 30% of
patients with mild or moderate ulcerative colitis require add-on therapy
to 5-ASA drugs. Patients refractive to treatment with 5-ASA drugs
typically receive a course of an oral, systemically absorbed
corticosteroid, the success of which may be limited by significant side
effects. For moderate to severe cases of ulcerative colitis,
immunosuppressant drugs or biologic drugs may be prescribed. If the
condition does not respond to pharmaceutical therapy and the symptoms
are severe, the patient may be referred for surgery.
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 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 on FENOGLIDE®
(fenofibrate) tablets, which is indicated as an adjunct to diet to
reduce high cholesterol.
Santarus also has a diverse pipeline, including three investigational
drugs in late-stage clinical development: UCERIS™
(budesonide) tablets for induction of remission of active ulcerative
colitis, RHUCIN® (recombinant human C1 inhibitor) for
treatment of acute attacks of hereditary angioedema and rifamycin SV MMX®
for treatment of travelers' diarrhea, in addition to other earlier-stage
development programs. 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: whether
Santarus obtains regulatory approval for UCERIS in a timely manner or at
all, including whether the FDA agrees with the statistical analysis plan
for the UCERIS Phase III studies, the clinical interpretation of the
results and the conduct of the studies and whether the extended use
study, which evaluated UCERIS 6 mg, provides adequate data to support
approval of UCERIS 9 mg; whether the FDA requires completion of
additional clinical studies or other development programs before
approving UCERIS; whether the ongoing Phase IIIb clinical study will be
completed in a timely manner with a positive outcome; risks associated
with the paragraph IV certification concerning Entocort EC, including
the potential for litigation and a 30-month stay of approval for the
UCERIS NDA; risks associated with the collaboration with Cosmo relating
to the MMX product candidates, including the potential for termination
of the collaboration; competition from other products; 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.
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.
and UCERIS™ 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. RHUCIN®
is a trademark of Pharming Group NV. All other trademarks are the
property of their respective owners.
Martha L. Hough
Finance & Investor Relations
Chief Financial Officer
Jody Cain (firstname.lastname@example.org)
Source: Santarus, Inc.
News Provided by Acquire Media
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