Santarus and Pharming announce RHUCIN poster at American Academy of Allergy, Asthma & Immunology 2011 Annual Meeting
(Thomson Reuters ONE) -
SAN DIEGO and LEIDEN, The Netherlands (March 21, 2011) - Specialty
biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) and biotech company
Pharming Group NV (NYSE Euronext: PHARM) today announced new data on 62 patients
with Hereditary Angioedema (HAE) who received repeat treatment with the
investigational drug RHUCIN(®) (recombinant human C1 inhibitor) for 168 acute
angioedema attacks. The median time to beginning of relief of symptoms across
treatments for repeat attacks was approximately 60 minutes with response rates
that were consistently 90% or greater. This open-label study was an extension
of the randomized, double-blind, placebo-controlled study conducted by Pharming
in North America. The findings were presented Sunday, March 20, 2011 in a
poster session at the American Academy of Allergy, Asthma & Immunology (AAAAI)
2011 Annual Meeting in San Francisco.
"This larger open label experience supports the safety and efficacy results of
RHUCIN 50 U/kg for the treatment of HAE attacks as published last year, and
also indicates that this profile was sustained with repeated treatments" said
Dr. Rienk Pijpstra, Chief Medical Officer at Pharming.
The poster, Clinical outcomes with recombinant human C1 inhibitor in the repeat
treatment of acute attacks of hereditary angioedema in North American patients
(B Zuraw, et al) summarizes an open-label clinical study that was conducted to
assess the safety and efficacy of RHUCIN in the repeat treatment of acute
attacks of HAE in abdominal, peripheral, oro-facial-pharyngeal and/or laryngeal
and genito-urinary anatomical locations. Time to beginning of relief was
assessed by patients using a 100 mm visual analog scale (VAS). Of the 168
attacks, 90% were treated with a single dose of 50 U/kg of RHUCIN. More than
90% of the attacks responded within four hours of treatment. In addition, there
were no relapses of attacks (defined as symptom recurrence within 24 hours of
treatment) following treatments.
In the safety analysis of the adverse events (AEs), 39 (63%) of the patients
reported at least one AE; most of the AEs were considered mild to moderate in
severity and 7 patients experienced an AE that was considered severe. None of
the AEs were considered to be probably or definitely related to the study drug.
The overall incidence of AEs was similar to those in the placebo groups in
previously conducted clinical studies with RHUCIN. The frequency of adverse
events did not increase upon repeat administrations. Anti-C1 inhibitor antibody
results above the assay cut-off were sporadic and transient and did not
correlate with repeated treatment or time since last treatment. No neutralizing
antibodies were detected. Occasional presence of anti-C1 inhibitor or anti-host
related impurities (HRI) antibodies was not associated with adverse events.
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. Pharming is currently conducting a Phase IIIb clinical
study with RHUCIN for 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 Pharming's proprietary technology
in milk of transgenic rabbits and in Europe is approved under the name
RUCONEST((TM)) 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((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.
Santarus also has a diverse development pipeline with three late-stage product
candidates in Phase III clinical programs: 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 to other earlier-
stage development programs. More information about Santarus is available on the
company's 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 Pharming's
businesses, including, without limitation: whether the ongoing Phase IIIb study
for RHUCIN is completed in a timely manner and provides adequate support for the
approval of RHUCIN; 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 Pharming's
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(®) is a trademark 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((TM) )are
trademarks of Pharming Group NV.
# # #
SANTARUS CONTACTS: PHARMING CONTACT:
Martha L. Hough, VP Finance & Investor Relations Rienk Pijpstra
(858) 314-5824 Chief Medical Officer
Debra P. Crawford, Chief Financial Officer Tel: +31 650 123 946
(858) 314-5708 r.pijpstra(at)pharming.com
Lippert/Heilshorn & Associates, Inc. Karl Keegan
Jody Cain (jcain(at)lhai.com) Chief Financial Officer
Bruce Voss (bvoss(at)lhai.com) Tel: +31 (0)71 52 47 181
(310) 691-7100 k.keegan(at)pharming.com
Press release (PDF):
http://hugin.info/132866/R/1498422/434030.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(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#1498422]
Unternehmensinformation / Kurzprofil:
Datum: 21.03.2011 - 09:00 Uhr
Sprache: Deutsch
News-ID 52599
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