LEIDEN, THE NETHERLANDS--(Marketwire - Aug 13, 2012) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces
investors have increased the first call under the facility by 13,000,000
from 32,808,442 to 45,808,442.
Under the first call of 15,088,368 shares made by the Company as
August 8, 2012, the individual investors have an option to purchase
limited to up to 600% of these 15,088,368 shares during the 15 trading
this call. The investors have now called for another 13,000,000
addition to 17,720,074 shares previously issued under their option.
the issue of these 13,000,000 shares as per August 13, 2012, the
outstanding shares increases from currently 757,057,118 shares to
Pharming's CEO, Sijmen de Vries commented: "We are very pleased
development of this call as it supports our ongoing discussions with
partners and investors as part of our strategic review. At the same time,
moving closer to the conclusion of our US pivotal Phase III study (Study
as of today, 62 of the 75 patients were either treated for a subsequent
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
Special Protocol Assessment (SPA) that is intended to support the
a Biologics License Application (BLA) to the U.S. Food and Drug
(FDA). RUCONEST is being evaluated for the treatment of acute attacks of
angioedema in patients with HAE in an international, multicenter,
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
North America for the treatment of acute attacks of HAE and other future
indications. Under the terms of the license agreement, a $10 million
is payable to Pharming upon successful achievement of the primary endpoint
the Phase III clinical study. The study is expected to be completed by the
of the third quarter of 2012.
About RUCONEST® and Hereditary Angioedema
RUCONEST® (INN conestat alfa) is a recombinant version of the human
inhibitor (C1INH). RUCONEST is produced through Pharming's proprietary
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 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
extremities, face, trunk, genitals, abdomen and upper airway. The frequency
severity of HAE attacks vary and are most serious when they involve
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
medical needs. RUCONEST® is a recombinant human C1 inhibitor approved
treatment of angioedema attacks in patients with HAE in all 27 EU countries
Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish
Orphan Biovitrum (OMX: SOBI). RUCONEST® is partnered with Santarus,
(NASDAQ: SNTS) in North America where the drug is undergoing Phase III
development. The product is also being evaluated for follow-on indications
the areas of transplantation and reperfusion injury. The advanced
of the Company include innovative and validated platforms for the
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
for the treatment of Haemophilia A is underway with partner Renova Life,
Additional information is available on the Pharming website,
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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.
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Source: Pharming Group N.V. via Thomson Reuters ONE