LEIDEN, NETHERLANDS--(Marketwire - May 23, 2011) -
Pharming Group NV ("Pharming" or "the
Company") (NYSE Euronext: PHARM) announced today that new clinical data
from
open-label studies on their recombinant human C1 inhibitor (rhC1INH;
conestat
alfa; Ruconest™ in Europe, Rhucin® in other countries) was
presented during
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
fixed
dose of one vial (2100 U) or more at the investigator's discretion,
in 57
patients with acute Hereditary Angioedema (HAE) attacks. This open-label
study
was an extension of one of the two pivotal randomized controlled studies
which
formed the basis for approval in Europe. The majority of acute
Angioedema
attacks (63%) were treated with a single dose of Ruconest (2100 U). Use of
more
than one dose was more common during attacks at oro-facial-pharyngeal-
laryngeal
locations (57%) than during abdominal (26%) and peripheral (37%) attacks.
The
median time to the beginning of relief of symptoms across
treatments, was
approximately 60 minutes with an overall response rate of 87% and no
relapses.
No product related adverse reactions were observed during this study.
Results were also presented for 53 potentially life threatening acute
angioedema
attacks involving the upper airways. The median time to the beginning of
relief
of symptoms for these upper airway attacks was 76 minutes (95%
confidence
interval, 62; 120 min) and the median time to the beginning of
relief of
symptoms was 265 minutes (95% confidence interval, 240; 720 min). These
results
are consistent with previously reported results for other anatomical
locations.
The overall response rate in treating these severe attacks was 100%. There
were
no treatment failures, nor relapses reported, and Ruconest was generally
safe
and well tolerated. The safety dataset of Ruconest / Rhucin now includes a
total
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
acute
HAE attacks, including those potentially life-threatening attacks involving
the
upper airways. In addition, the European open label efficacy data suggest
that
although a 50 U/kg dose is recommended to achieve optimal efficacy, many
attacks
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
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, and is distributed in the EU by Swedish Orphan Biovitrum
(STO: SOBI). 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.
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.
Press release (PDF):
http://hugin.info/132866/R/1517766/454313.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#1517766]
