Santarus Announces FDA Extension of UCERIS New Drug Application Target Action Date to January 16, 2013
SAN DIEGO--(BUSINESS WIRE)--
Inc. (NASDAQ: SNTS) today announced that the U.S. Food and Drug
Administration (FDA) has extended the Prescription Drug User Fee Act
(PDUFA) target action date for the review of the New Drug Application
(NDA) for UCERIS™ (budesonide) tablets 9 mg for the induction
of remission of mild to moderate active ulcerative colitis from October
16, 2012 to January 16, 2013. The three-month extension is a standard
On August 3, 2012, following the FDA's request, Santarus submitted
additional information for the Office of Scientific Investigations,
which is the division of the FDA responsible for ensuring compliance
with Good Clinical Practices (GCP), in connection with U.S. and ex-U.S.
pre-approval inspections. On August 10, 2012, the company received a
communication from the FDA that the submission has been classified as a
major amendment to the NDA. Since the submission was received within
three months of the target action date, the FDA is extending the PDUFA
date by three months to provide time for a full review of the submitted
The FDA also indicated that if major deficiencies are not identified
during the review of the NDA, the FDA plans to communicate proposed
labeling and, if necessary, any postmarketing requirement/commitment
requests to Santarus by December 12, 2012. Assuming FDA approval,
Santarus anticipates that it will be in a position to commence the
launch of UCERIS approximately two months following the determination of
the final product label.
UCERIS is an investigational drug that is a locally acting, non-systemic
corticosteroid in a novel, patented, oral tablet formulation that
utilizes proprietary MMX® multi-matrix system technology,
which 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 corticosteroids. UCERIS is being
developed in collaboration with Cosmo Technologies Limited, a subsidiary
of Cosmo Pharmaceuticals S.p.A.
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 has a diverse product development pipeline. A New Drug
Application for UCERIS™ (budesonide) tablets for induction of
remission of mild to moderate active ulcerative colitis is under review
by the U.S. Food and Drug Administration with a response expected in
January 2013. The pipeline also includes two late-stage investigational
drugs in Phase III clinical studies: RUCONEST® (recombinant
human C1 inhibitor) for treatment of acute attacks of hereditary
angioedema and rifamycin SV MMX® for treatment of travelers'
diarrhea. In addition, the company's investigational monoclonal
antibody, SAN-300, is being evaluated in a Phase I clinical program.
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
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, whether the extended use study,
which evaluated UCERIS 6 mg, provides adequate data to support approval
of UCERIS 9 mg, and the outcome of the Office of Scientific
Investigations' evaluation and U.S. and ex-U.S. pre-approval
inspections; whether the FDA requires completion of additional clinical
studies or other development programs before approving UCERIS; the
timing for UCERIS launch following receipt of regulatory approval; and
other risks detailed in Santarus' prior press releases and 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. RUCONEST®
is a trademark of Pharming Group N.V.
Martha L. Hough
Finance & Investor Relations
Chief Financial Officer
Westwicke Partners, LLC
Stefan Loren, Ph.D.,
Source: Santarus, Inc.
News Provided by Acquire Media
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