LEIDEN, THE NETHERLANDS--(Marketwire - August 02, 2012) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced a
restructuring plan of its Dutch operations designed to accelerate the
path to sustainability and future profitability. The proposed plan, which
necessitates a request for "collective redundancies", was filed with the Dutch
authorities (UWV Werkbedrijf, in accordance with the "Wet Melding Collectief
Ontslag"). The process entails a formal procedure, required when there is a
for downsizing of an organisation by 20 staff or more. The plan continues the
restructuring initiated in June by the closure and subsequent sale of
Post the completion of this restructuring, the organisation will have
full capabilities to execute technology transfers of platform technology and
product processes as well as retaining all product development associated
know-how. Furthermore, Pharming will continue to participate in existing
collaborative product development and to pursue potential partnerships in the
The Company will thus maintain sufficient personnel to achieve these strategic
objectives by aligning the staffing resources and potential partnering
requirements of the organisation with its strategic needs post the anticipated
finish of Study 1310 (our US pivotal trial) and submission of the Ruconest
to the FDA .
As a result of the restructuring, the Company aims to reduce costs by
approximately EUR 3.5-5 million annually over the coming 12-18 months. The
of the plan will be influenced by external (e.g. authorities and business
development activities) and internal influences (operational deliverables).
Pharming's Works Council has yet to advise on the restructuring plan,
to the Works Councils Act art 25. Following the decision of the authorities
the advice of the Works Council, the plan will be implemented.
"This restructuring will allow Pharming to implement the next steps in its
business strategy: transitioning from a mainly internal research driven model
a market driven, externally focused, collaborative research and development
model", said Sijmen de Vries, CEO. "It is clear that Pharming must adopt a
leaner, more cash efficient business model if it is to survive in the longer
term and we firmly believe that these actions will help to re-position
to create value for our stakeholders."
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
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
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 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
extremities, face, trunk, genitals, abdomen and upper airway. The frequency
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
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, Inc
(NASDAQ: SNTS) in North America where the drug is undergoing Phase III
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
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, Inc.
Additional information is available on the Pharming website, www.pharming.com.
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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.
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Source: Pharming Group N.V. via Thomson Reuters ONE