LEIDEN, NETHERLANDS--(Marketwire - May 23, 2011) -
Pharming Group NV ("Pharming" or "the
Company") (NYSE Euronext: PHARM) announced today that new clinical data
open-label studies on their recombinant human C1 inhibitor (rhC1INH;
alfa; Ruconest™ in Europe, Rhucin® in other countries) was
the 7(th) C1INH deficiency workshop in Budapest, Hungary, 20-22 May 2011.
New data was presented on 194 treatments with Ruconest / Rhucin using a
dose of one vial (2100 U) or more at the investigator's discretion,
patients with acute Hereditary Angioedema (HAE) attacks. This open-label
was an extension of one of the two pivotal randomized controlled studies
formed the basis for approval in Europe. The majority of acute
attacks (63%) were treated with a single dose of Ruconest (2100 U). Use of
than one dose was more common during attacks at oro-facial-pharyngeal-
locations (57%) than during abdominal (26%) and peripheral (37%) attacks.
median time to the beginning of relief of symptoms across
approximately 60 minutes with an overall response rate of 87% and no
No product related adverse reactions were observed during this study.
Results were also presented for 53 potentially life threatening acute
attacks involving the upper airways. The median time to the beginning of
of symptoms for these upper airway attacks was 76 minutes (95%
interval, 62; 120 min) and the median time to the beginning of
symptoms was 265 minutes (95% confidence interval, 240; 720 min). These
are consistent with previously reported results for other anatomical
The overall response rate in treating these severe attacks was 100%. There
no treatment failures, nor relapses reported, and Ruconest was generally
and well tolerated. The safety dataset of Ruconest / Rhucin now includes a
of 714 administrations in 190 subjects.
Dr. Pijpstra, Chief Medical Officer at Pharming commented: "These new data
support that Ruconest is an effective novel therapy for the treatment of
HAE attacks, including those potentially life-threatening attacks involving
upper airways. In addition, the European open label efficacy data suggest
although a 50 U/kg dose is recommended to achieve optimal efficacy, many
respond well to a single vial dose of 2100 U."
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of
medical needs. Ruconest™ (Rhucin® in non-European
territories) is a
recombinant human C1 inhibitor approved for the treatment of angioedema
in patients with HAE in all 27 EU countries plus Norway, Iceland
Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum
(STO: SOBI). The product is also under development for follow-on indications,
antibody-mediated rejection (AMR) and delayed graft function (DGF)
kidney transplantation. The advanced technologies of the Company
innovative platforms for the production of protein therapeutics,
processes for the purification and formulation of these products.
information is available on the Pharming website,www.pharming.com.
This press release contains forward looking statements that involve
unknown risks, uncertainties and other factors, which may cause the
results, performance or achievements of the Company to be materially
from the results, performance or achievements expressed or implied by
forward looking statements.
Press release (PDF):
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Source: Pharming Group N.V. via Thomson Reuters ONE