LEIDEN, THE NETHERLANDS--(Marketwire - August 01, 2012) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that
it has
secured an equity working capital facility of up to EUR10 million for a
two year
term, with Kingsbrook Opportunities Master Fund LP as lead investor and
other
institutional investors ("the Investors").
The working capital facility should enable Pharming's cash runway to
reach the
anticipated read out of Study 1310 for Ruconest in the US and the
associated
US$10 million milestone payment (upon successful read out of the study)
and a
further US$5 million upon acceptance of the BLA by the FDA from US
partner,
Santarus, Inc.
Pharming will have the option to draw from the working capital
facility in
tranches in exchange for ordinary shares in the capital of the Company.
Pharming
will retain control of the timing and amount of any funds draw down.
Pharming
must give notice to the Investors (a "Draw Down Notice") prior to drawing
down
funds. Each Draw Down Notice will state the number of ordinary shares
Pharming
wishes to sell to the Investors ("the Draw Down Amount"). The Investors
have the
option to purchase up to 600% of the Draw Down Amount.
On signing, the Investors will receive warrants to purchase up to an
aggregate
of 16,500,000 ordinary shares in the capital of the Company. When draw
downs
have exceeded a total of EUR2,500,000 and for every subsequent
EUR2,500,000 drawn,
the Investors will receive additional warrants to purchase up to an
additional
16,500,000 ordinary shares. The warrants have an exercise period of five
years
and are exercisable at a strike price equal to 110% of the average of the
volume
weighted average price of the ordinary shares on the market for the 10
trading
days prior to the signing of this agreement.
Sijmen de Vries, CEO, said "Pharming is very pleased to have secured
this
facility against a backdrop of extremely difficult conditions in the
capital
markets. The facility can be used at Pharming's option and should
enable
Pharming to reach the unblinding of Study 1310. This financing has been
achieved
as part of the ongoing strategic review and is a key component of
strengthening
the Company's cash position".
Roth Capital Partners LLC acted as sole placement agent in this
transaction.
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/1631005/522787.pdf
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originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1631005]