Leiden, The Netherlands--(Marketwire - July 05, 2012) - Biotech company Pharming Group
NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that
it has
reached full recruitment of its ongoing US pivotal Phase III clinical
study
(Study 1310) evaluating the investigational drug RUCONEST®
(recombinant human C1
inhibitor) for the treatment of acute attacks of angioedema in patients
with
Hereditary Angioedema (HAE). 75 randomized patients are in the study
and no
further patients will be entered.
Study 1310 will now continue until such time that either all of the
treated
patients have received an open label treatment for a subsequent HAE
attack, or
until 90 days have lapsed since their randomized attack. This will be
followed
by the analysis of the results. Positive results of the study will trigger
a US$
10 million milestone payment to Pharming from its US partner Santarus Inc.
Currently 53 of the 75 patients have experienced a repeat attack or
achieved a
90 day attack free period.
Bruno Giannetti, COO of Pharming, said, "Completion of recruitment into
this
clinical study is an important milestone for Pharming. As previously
stated, the
final step to completion of the trial consists of an additional follow up
period
of up to 90 days, depending on when patients experience a subsequent
attack.
However, it is a generally accepted assumption that approximately one
to two
attacks occur per month in otherwise untreated HAE patients, suggesting
that
those individuals in our study may typically experience a subsequent
attack
significantly sooner than 90 days post their randomized attack."
About RUCONEST® and Hereditary Angioedema
RUCONEST® (INN conestat alfa) is a recombinant version of the human
protein C1
inhibitor (C1INH). RUCONEST is produced through Pharming's
proprietary
technology in milk of transgenic rabbits and is approved in Europe for
treatment
of acute angioedema attacks in patients with HAE. RUCONEST®
is an
investigational drug in the U.S. and has been 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® 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 (OMX: SOBI). RUCONEST® is partnered with
Santarus, Inc
(NASDAQ: SNTS) in North America where the drug is undergoing Phase III
clinical
development. The product is also being evaluated for follow-on
indications in
the areas of transplantation and reperfusion injury. The advanced
technologies
of the Company include innovative and validated platforms for the
production of
protein therapeutics, technology and processes for the purification
and
formulation of these products. A feasibility study, using the
validated
transgenic rabbit platform, aimed at the development of recombinant Factor
VIII
for the treatment of Haemophilia A is underway with partner, Renova Life,
Inc.
Additional information is available on the Pharming website,
www.pharming.com.
To download the Pharming Group Investor Relations App, click here.
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/1624333/519415.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#1624333]
