Pharming announces receipt of US$10 million milestone payment

Mon Nov 26, 2012 1:13am EST

* Reuters is not responsible for the content in this press release.

  LEIDEN, THE NETHERLANDS, Nov 26 (Marketwire) -- 
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE
Euronext: PHARM) today announced that following the announcement by
Pharming and Santarus on November 7, 2012 that the pivotal Phase III
clinical study of RUCONEST(R) (recombinant human C1 esterase inhibitor)
50 U/kg for the treatment of acute attacks of angioedema in patients with
Hereditary Angioedema (HAE) met its primary endpoint, and in accordance
with the terms of the license agreement between Pharming and Santarus, a
US$10 million milestone has now been paid to Pharming.

    An additional US$5 million milestone will be payable to Pharming upon U.S.
Food and Drug Administration (FDA) acceptance of the Biologics License
Application (BLA) for review. Pharming and Santarus expect to submit the
BLA for RUCONEST to the FDA in the first half of 2013.

    Sijmen de Vries, Pharming CEO, commented: "We are pleased to have received
this US$10 million milestone from our partner Santarus, which
significantly strengthens our balance sheet and signals the beginning of
a new chapter in the development of the Company."

    About RUCONEST(R) and Hereditary Angioedema

    RUCONEST(R) (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(R) is an investigational drug in the U.S. and has been granted
orphan drug designation for the treatment of acute attacks and
prophylaxis 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(R) (RHUCIN(R) in non-European territories)
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. Rhucin(R) is partnered with Santarus Inc
(NASDAQ: SNTS) in North America where the drug has completed Phase III
clinical development. The product is also being evaluated for various
follow-on indications. Pharming has a unique GMP compliant, validated
rabbit platform for the production of recombinant human proteins that,
with the EU approval of Pharming's rhC1 inhibitor, has proven capable of
producing industrial volumes of high quality recombinant human protein in
a significantly more economical way through low upfront capital
investment and manufacturing costs, compared to current cell based
technologies. Pharming now plans to utilise this platform for the
development of rhFVIII for the treatment of Haemophilia A.

    Additional information is available on the Pharming website,

    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):

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    Source: Pharming Group N.V. via Thomson Reuters ONE


Sijmen de Vries
T: +31 524 7400

FTI Consulting
Julia Phillips
John Dineen
T: +44 (0)207 269 7193

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