LEIDEN, THE NETHERLANDS--(Marketwire - Aug 13, 2012) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces
that the
investors have increased the first call under the facility by 13,000,000
shares
from 32,808,442 to 45,808,442.
Under the first call of 15,088,368 shares made by the Company as
announced on
August 8, 2012, the individual investors have an option to purchase
that is
limited to up to 600% of these 15,088,368 shares during the 15 trading
days of
this call. The investors have now called for another 13,000,000
shares in
addition to 17,720,074 shares previously issued under their option.
Following
the issue of these 13,000,000 shares as per August 13, 2012, the
number of
outstanding shares increases from currently 757,057,118 shares to
770,057,118
shares.
Pharming's CEO, Sijmen de Vries commented: "We are very pleased
about the
development of this call as it supports our ongoing discussions with
potential
partners and investors as part of our strategic review. At the same time,
we are
moving closer to the conclusion of our US pivotal Phase III study (Study
1310);
as of today, 62 of the 75 patients were either treated for a subsequent
attack
of HAE or reached the Day 90 endpoint of the study."
RUCONEST® Phase III Study
Pharming is conducting a Phase III clinical study with RUCONEST® under
a
Special Protocol Assessment (SPA) that is intended to support the
submission of
a Biologics License Application (BLA) to the U.S. Food and Drug
Administration
(FDA). RUCONEST is being evaluated for the treatment of acute attacks of
angioedema in patients with HAE in an international, multicenter,
randomized,
placebo-controlled Phase III study at a dosage strength of 50 U/kg with a
primary endpoint of time to beginning of relief of symptoms. Santarus has
licensed certain exclusive rights from Pharming to commercialize RUCONEST
in
North America for the treatment of acute attacks of HAE and other future
indications. Under the terms of the license agreement, a $10 million
milestone
is payable to Pharming upon successful achievement of the primary endpoint
of
the Phase III clinical study. The study is expected to be completed by the
end
of the third quarter of 2012.
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/1633420/524195.pdf
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originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1633420]