LEIDEN, THE NETHERLANDS--(Marketwire - November 26, 2012) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that
following the announcement by Pharming and Santarus on November 7, 2012
that the
pivotal Phase III clinical study of RUCONEST® (recombinant human C1
esterase
inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in
patients
with Hereditary Angioedema (HAE) met its primary endpoint, and in
accordance
with the terms of the license agreement between Pharming and Santarus, a
US$10
million milestone has now been paid to Pharming.
An additional US$5 million milestone will be payable to Pharming upon U.S.
Food
and Drug Administration (FDA) acceptance of the Biologics License
Application
(BLA) for review. Pharming and Santarus expect to submit the BLA for
RUCONEST to
the FDA in the first half of 2013.
Sijmen de Vries, Pharming CEO, commented: "We are pleased to have received
this
US$10 million milestone from our partner Santarus, which
significantly
strengthens our balance sheet and signals the beginning of a new chapter
in the
development of the Company."
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 and prophylaxis 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® (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.
Rhucin® is partnered with Santarus Inc (NASDAQ: SNTS) in North
America where
the drug has completed Phase III clinical development. The product is also
being
evaluated for various follow-on indications. Pharming has a unique
GMP
compliant, validated rabbit platform for the production of recombinant
human
proteins that, with the EU approval of Pharming's rhC1 inhibitor, has
proven
capable of producing industrial volumes of high quality recombinant
human
protein in a significantly more economical way through low upfront
capital
investment and manufacturing costs, compared to current cell based
technologies.
Pharming now plans to utilise this platform for the development of
rhFVIII for
the treatment of Haemophilia A.
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/1660435/537717.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#1660435]
