Pharming and Swedish Orphan announce publication of randomized clinical trial results with Pharming's recombinant human C1 inhibitor
(Thomson Reuters ONE) -
Leiden, The Netherland and Stockholm, Sweden, October 5, 2010. Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) and Swedish Orphan
Biovitrum (STO: SOBI) announced today the publication of the integrated analysis
of Pharming's randomized placebo-controlled clinical trials with recombinant
human C1 esterase inhibitor (rhC1INH; conestat alfa; Ruconest(TM) in Europe;
Rhucin® in other countries) for treatment of acute angioedema attacks in
patients with Hereditary angioedema (HAE) in the October issue of the peer-
reviewed Journal of Allergy and Clinical Immunology.
In the publication, Zuraw et al report the results of two similar but
independent, randomized, placebo-controlled studies that were conducted in 70
HAE patients in total to evaluate the efficacy and safety of 50 and 100 U/Kg of
rhC1INH for the treatment of acute angioedema attacks. In the European study,
32 patients were randomized (16 patients received rhC1INH 100U/kg and 16
patients saline) and 38 patients in the North American study (13 patients
received 100 U/kg rhC1INH, 12 patients 50 U/kg and 13 patients saline).
Both doses of rhC1INH (50U/kg and 100U/kg) significantly reduced the time to
beginning of relief of symptoms for all anatomical locations studied (abdominal,
genitourinary, facial-laryngeal or peripheral) compared to placebo and resulted
in high response rate for rhC1INH (>90%). Adverse events occurred less
frequently in the rhC1INH arm than in the placebo arm. No antibody responses
against rhC1INH or host-related impurities were observed. The authors conclude
that rhC1INH constitutes a highly effective alternative to plasma derived C1INH
for the treatment of acute angioedema attacks in HAE patients.
Lead author Bruce Zuraw, MD, said: "The publication of the results from these
randomized controlled trials is an important step in educating the medical
community about recombinant human C1INH for HAE patients with acute angioedema."
Dr. Zuraw is a leading authority on HAE and is Professor of Medicine and Chief,
Section of Allergy & Immunology in the Department of Medicine, University of
California, San Diego and Research Scientist at the San Diego VA Healthcare, La
Jolla, CA.
"The publication in this peer-reviewed journal provides a solid background for
us to build ahead of the anticipated European market launch in the fourth
quarter of this year," said Dr Rienk Pijpstra, Chief Medical Officer at
Pharming.
"We are excited about the data and clinical efficacy of Ruconest and are very
much looking forward to spearhead the launch of Ruconest in most countries in
Europe," said Kennet Rooth, Vice President, Marketing and Sales at Swedish
Orphan Biovitrum. "Ruconest will help many patients and make life much easier
for them."
About HAE and C1 esterase inhibitor
Pharming's rhC1INH is a human protein developed through Pharming's proprietary
technology where the human protein is expressed in milk of transgenic rabbits.
HAE is a human genetic disorder in which the patient is deficient in or lacks a
functional plasma protein C1 inhibitor, resulting in an overreaction of the
immune system. The disease is characterized by unpredictable and debilitating
episodes of intense swelling of the extremities, face, trunk, genitals, abdomen
and upper airway, which may last up to five days when untreated. In addition to
the life-threatening nature of the disease in case of laryngeal attacks, quality
of life for individuals with the disease may be seriously impaired.
Approximately one in 30,000 individuals (1:10,000 - 1:50,000) suffers from HAE
with an average of approximately eight acute attacks per year.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic
disorders, specialty products for surgical indications, and nutritional
products. On June 24, the European Medicines Agency adopted a positive opinion
for Ruconest(TM) (Rhucin® in non-EU territories) for the treatment of angioedema
attacks. Market Authorization in the European Economic Area is therefore
expected imminently with an anticipated market launch in the fourth quarter
2010. The product is also under development for follow-on indications, i.e.
antibody-mediated rejection (AMR) and delayed graft function (DGF) following
kidney transplantation. The advanced technologies of the Company 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 Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty pharmaceutical
company with an international market presence. The company is focused on
providing and developing specialist pharmaceuticals for rare disease patients
with high medical needs. The portfolio consists of about 60 marketed products
and an emerging late stage clinical development pipe-line. Our focus areas are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer
supportive care and inherited metabolic disorders. Swedish Orphan Biovitrum had
pro-forma revenues 2009e of about 2 BSEK and approximately 500 employees. The
head office is located in Sweden and the share (STO: SOBI) is listed on NASDAQ
OMX Stockholm. For more information please visitwww.sobi.com.
This press release contains forward looking statements that involve known and
unknown risks, uncertainties and other factors, which may cause the actual
results, performance or achievements of the Company to be materially different
from the results, performance or achievements expressed or implied by these
forward looking statements.
Contact:
Pharming:
Marjolein van Helmond, Manager Corporate Communication, T: +31 (0)71 52 47 431
or +31 (0)6 109 299 54
Swedish Orphan Biovitrum
Kennet Rooth, VP and Head of Sales & Marketing, T +46 (0) 8 697 20 00
[HUG#1449016]
Press release (PDF):
http://hugin.info/132866/R/1449016/391044.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
Unternehmensinformation / Kurzprofil:
Datum: 05.10.2010 - 08:00 Uhr
Sprache: Deutsch
News-ID 44112
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