Pharming and Santarus announce submission of Rhucin Biologics License Application to FDA
(Thomson Reuters ONE) -
Leiden, The Netherlands and San Diego, US, December 28, 2010. Biotech company
Pharming Group NV (NYSE Euronext: PHARM) and specialty biopharmaceutical company
Santarus, Inc (NASDAQ: SNTS) today announced the submission of a Biologics
License Application (BLA) to the US Food and Drug Administration (FDA) to obtain
marketing approval for Rhucin(®) (recombinant human C1 inhibitor) for the
treatment of acute angioedema attacks in patients with Hereditary Angioedema
(HAE).
The safety and efficacy of Rhucin for the treatment of HAE attacks were
evaluated in two randomized placebo-controlled studies and are supported by four
open label treatment studies. Both placebo-controlled clinical studies showed
statistically significant and clinically relevant improvement in the primary
endpoint of time to beginning of relief of symptoms at Rhucin dosage strengths
of 50 U/kg and 100 U/kg compared to placebo. In October 2010, Pharming received
Marketing Authorization for Ruconest((TM) )(Rhucin in non-European countries)
for the treatment of acute HAE in the European Union. Pharming has updated the
clinical dataset reviewed and approved by the European Medicines Agency with
additional patient data and analyses. In total, the BLA dossier includes nine
clinical studies covering 714 administrations in 190 subjects.
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, a $5 million
milestone is payable to Pharming upon FDA acceptance for review of the BLA for
Rhucin.
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 Pharming's 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. The FDA has
granted Orphan Drug and Fast Track Status to Rhucin 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 US Hereditary
Angioedema Association, epidemiological estimates for HAE range from one in
10,000 to one in 50,000 individuals. Based on prior discussions with the FDA,
Pharming is planning to initiate an additional randomized placebo-controlled,
clinical study with Rhucin in approximately 50 patients to provide additional
data in support of the 50 U/kg dose. Data from the placebo-controlled study
will also be used to provide additional validation of the visual analog scale
used in measuring the clinical effects of Rhucin.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet
medical needs. Ruconest(TM) (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. Pharming's 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 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. CYCLOSET was commercially launched in November 2010.
Santarus also has a diverse development pipeline with three late-stage product
candidates in Phase III clinical programs: ULTESA(TM) (budesonide MMX(®)) for
induction of remission of active ulcerative colitis, rifamycin SV MMX(®) for
treatment of travelers' diarrhea and RHUCIN(®) (recombinant human C1 inhibitor)
for treatment of acute attacks of hereditary angioedema. In addition, Santarus
plans to initiate a Phase I clinical study in the first half of 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 company's website at www.santarus.com.
Pharming and Santarus caution 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 potential
attributes of the RHUCIN (recombinant human C1 inhibitor) development product
and its potential to treat HAE or other indications. The inclusion of forward-
looking statements should not be regarded as a representation by Pharming or
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 Pharming's and Santarus' businesses, including,
without limitation: whether the FDA accepts the BLA submission and approves
RHUCIN in a timely manner or at all; risks related to the timing and success of
planned development programs for RHUCIN, including the planned clinical study
designed to provide additional data in support of the 50 U/kg dose; Santarus'
ability to generate market demand and sales of RHUCIN, if approved; competition
from other products, unexpected adverse side effects or inadequate therapeutic
efficacy of RHUCIN; the ability to ensure continued supply of RHUCIN; the scope
and validity of patent protection or other regulatory exclusivity for RHUCIN;
risks related to the license and supply arrangements between Pharming and
Santarus, 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, Pharming's and Santarus'
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 Pharming nor Santarus 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((TM)) are trademarks of Santarus, Inc. GLUMETZA(®) is a
registered trademark of Biovail Laboratories International S.r.l. licensed
exclusively in the United States to Depomed, Inc. CYCLOSET(®) is a registered
trademark of VeroScience LLC. MMX(®) is a registered trademark of Cosmo
Technologies Limited. RHUCIN(®) and RUCONEST(TM) are trademarks of Pharming
Group NV.
Contact:
Pharming:
Marjolein van Helmond, Manager Corporate Communication, T: +31 (0)71 52 47 431
or +31 (0)6 109 299 54 or E:m.helmond(at)pharming.com
Santarus:
Martha L. Hough, VP Finance & Investor Relations, T: (858) 314-5824 or
E:mhough(at)santarus.com
Debra P. Crawford, Chief Financial Officer, T: (858) 314-5708
Press release (PDF):
http://hugin.info/132866/R/1475839/411934.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1475839]
Unternehmensinformation / Kurzprofil:
Datum: 28.12.2010 - 14:00 Uhr
Sprache: Deutsch
News-ID 50090
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contact information:
Town:
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Kategorie:
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