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8-K - FORM 8-K - SANTARUS INC | a58822e8vk.htm |
Exhibit 99.1
SANTARUS CONTACTS:
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PHARMING CONTACT: |
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Martha L. Hough, VP Finance & Investor Relations
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Rienk Pijpstra |
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(858) 314-5824
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Chief Medical Officer |
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Debra P. Crawford, Chief Financial Officer
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Tel: +31 650 123 946 |
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(858) 314-5708
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r.pijpstra@pharming.com |
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Lippert/Heilshorn & Associates, Inc.
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Karl Keegan |
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Jody Cain (jcain@lhai.com)
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Chief Financial Officer |
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Bruce Voss (bvoss@lhai.com)
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Tel: +31 (0)71 52 47 181 |
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(310) 691-7100
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k.keegan@pharming.com |
For Immediate Release
SANTARUS AND PHARMING ANNOUNCE RECEIPT OF FDA REFUSAL TO FILE LETTER
FOR RHUCIN BIOLOGICS LICENSE APPLICATION
FOR RHUCIN BIOLOGICS LICENSE APPLICATION
SAN DIEGO and LEIDEN, The Netherlands (February 28, 2011) Specialty biopharmaceutical company
Santarus, Inc. (NASDAQ: SNTS) and biotech company Pharming Group NV (NYSE Euronext: PHARM) today
announced the receipt of a refusal to file letter from the U.S. Food and Drug Administration
(FDA) for the RHUCIN® (recombinant human C1 inhibitor) Biologics License Application
(BLA) submitted by Pharming. In the letter the FDA indicated that the BLA was not sufficiently
complete to enable a critical medical review.
In reaching its conclusion, the FDA indicated that the previously conducted studies evaluating
RHUCIN for the treatment of acute attacks of Hereditary Angioedema (HAE) did not provide data for a
sufficient number of subjects to support the proposed dose of 50 U/kg and lacked prospective
validation of the visual analog scale used in measuring the clinical effects of RHUCIN. The FDA
also provided other comments on the prior clinical studies and indicated that they will provide
additional feedback on the design of the ongoing Phase IIIb clinical study, which had been
initiated based on previous discussions with the FDA. In addition, the FDA requested that the
results of the Phase IIIb clinical study be included in any future BLA submission for RHUCIN.
The FDA has the ability to formally file or refuse to file an application within 60 days of the
completion of the submission, which occurred in late December 2010. Both companies intend to meet
with the FDA at the earliest opportunity to discuss the issues raised in the FDA letter and to
reach a more comprehensive understanding of what would be required for the BLA to be accepted for
review.
Santarus has licensed certain exclusive rights from Pharming to commercialize RHUCIN in North
America for the treatment of acute attacks of HAE and other future indications. Under the terms of
the license agreement, Pharming is responsible for conducting and paying for the current Phase IIIb
clinical study with RHUCIN in the treatment of acute attacks of angioedema in patients with HAE.
About RHUCIN (RUCONEST in European countries) and Hereditary Angioedema
RHUCIN (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH).
RHUCIN is produced through Pharmings proprietary technology in milk of transgenic rabbits and in
Europe is approved under the name RUCONEST for treatment of acute angioedema attacks in patients
with HAE. RHUCIN was granted orphan drug designation for the treatment of acute attacks of HAE, a
genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1
inhibitor, resulting in
unpredictable and debilitating episodes of intense swelling of the
extremities, face, trunk, genitals, abdomen
and upper airway. The frequency and severity of HAE attacks vary and are most serious when they
involve laryngeal edema, which can close the upper airway and cause death by asphyxiation.
According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range
from one in 10,000 to one in 50,000 individuals.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs.
RUCONEST (RHUCIN® in non-European territories) is a recombinant human C1
inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU
countries plus Norway, Iceland and Liechtenstein. The product is also under development for
follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF)
following kidney transplantation. Pharmings advanced technologies include innovative platforms
for the production of protein therapeutics, technology and processes for the purification and
formulation of these products. Additional information is available on the Pharming website,
www.pharming.com.
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 companys 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.
Santarus also has a diverse development pipeline with three late-stage product candidates in Phase
III clinical programs: ULTESA (budesonide MMX®) 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, Santarus plans to initiate a Phase I clinical study in March/April 2011
with SAN-300, its anti-VLA-1 antibody, which the company expects to investigate for the treatment
of rheumatoid arthritis. More information about Santarus is available on the companys website at
www.santarus.com.
Santarus and Pharming caution 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 or Pharming 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 and Pharmings businesses,
including, without limitation: whether the FDA accepts a future BLA submission for RHUCIN and
ultimately approves RHUCIN in a timely manner or at all; whether the ongoing Phase IIIb study is
completed in a timely manner and provides adequate support for the approval of RHUCIN; whether the
FDAs feedback on the design of the Phase IIIb study is received in a timely manner and whether the
feedback requires changes to the design of the ongoing study; whether additional clinical studies
and/or development programs beyond the ongoing Phase IIIb study are required to support approval of
RHUCIN; risks related to the license and supply arrangements between Santarus and Pharming,
including the potential for termination of the arrangements; other difficulties or delays in
development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory
approvals for, Santarus and Pharmings products; and other risks detailed in prior press releases
as well as in 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 neither Santarus nor Pharming undertakes any 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®
and ULTESA 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®
and RUCONEST are
trademarks of Pharming Group NV.
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