LEIDEN, THE NETHERLANDS--(Marketwire - August 08, 2012) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that
it has
called the first tranche under the EUR10 million equity working capital
facility
previously announced on August 1, 2012.
Pharming has the option to draw from the working capital facility in
tranches in
exchange for ordinary shares in the capital of the Company, whereby both
the
timing and the amount of any tranche is determined by Pharming. The number
of
shares now issued by Pharming to the participating investors amounts to
15,088,368. The individual investors have an option to purchase up to 600%
of
the number of shares now issued during the 15 trading days pricing period;
the
total amount of cash paid for such shares to Pharming will depend on the
total
number of shares called by the investors and the development of the Volume
Weighted Average Price (VWAP) of the shares going forward during this 15
trading
days pricing period.
Following the issue of the 15,088,368 shares as per August 8, 2012, the
number
of outstanding shares increases from currently 724,248,676 shares to
739,337,044 shares.
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/1632516/523659.pdf
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originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1632516]
