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
pivotal Phase III clinical study of RUCONEST® (recombinant human C1
inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in
with Hereditary Angioedema (HAE) met its primary endpoint, and in
with the terms of the license agreement between Pharming and Santarus, a
million milestone has now been paid to Pharming.
An additional US$5 million milestone will be payable to Pharming upon U.S.
and Drug Administration (FDA) acceptance of the Biologics License
(BLA) for review. Pharming and Santarus expect to submit the BLA for
the FDA in the first half of 2013.
Sijmen de Vries, Pharming CEO, commented: "We are pleased to have received
US$10 million milestone from our partner Santarus, which
strengthens our balance sheet and signals the beginning of a new chapter
development of the Company."
About RUCONEST® and Hereditary Angioedema
RUCONEST® (INN conestat alfa) is a recombinant version of the human
inhibitor (C1INH). RUCONEST is produced through Pharming's
technology in milk of transgenic rabbits and is approved in Europe for
of acute angioedema attacks in patients with HAE.
RUCONEST® is an
investigational drug in the U.S. and has been granted orphan drug
for the treatment of acute attacks and prophylaxis of HAE, a genetic
which the patient is deficient in or lacks a functional plasma
inhibitor, resulting in unpredictable and debilitating episodes of
swelling of the extremities, face, trunk, genitals, abdomen and upper
The frequency and severity of HAE attacks vary and are most serious when
involve laryngeal edema, which can close the upper airway and cause
asphyxiation. According to the U.S. Hereditary Angioedema
epidemiological estimates for HAE range from one in 10,000 to one in
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
Rhucin® is partnered with Santarus Inc (NASDAQ: SNTS) in North
the drug has completed Phase III clinical development. The product is also
evaluated for various follow-on indications. Pharming has a unique
compliant, validated rabbit platform for the production of recombinant
proteins that, with the EU approval of Pharming's rhC1 inhibitor, has
capable of producing industrial volumes of high quality recombinant
protein in a significantly more economical way through low upfront
investment and manufacturing costs, compared to current cell based
Pharming now plans to utilise this platform for the development of
the treatment of Haemophilia A.
Additional information is available on the Pharming website,
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