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Friday 16 December, 2011

Pharming Group N.V.

Pharming announces agreement with Renova Life targeting factor VIII for the treatment of haemophilia A

Leiden, The Netherlands, December 16, 2011. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it has
signed a service agreement with Renova Life, Inc, (RLI) a biotech company based
in Maryland, USA. The agreement covers the development and supply of founder
transgenic rabbits from RLI to Pharming. The founder rabbits will enable
Pharming to start the commercial production breeding process. The first protein
to be expressed in the rabbits will be recombinant human Factor VIII (rhFVIII)
for the treatment of haemophilia A.

RLI recently announced the birth of rhFVIII transgenic rabbits through their
Chinese subsidiary, Lannuo Biotechnologies (Wuxi, China) and have previously had
successful functional expression of rhFVIII in mice. Pharming will leverage its
proprietary and validated rabbit platform for the production of recombinant
human proteins to develop rhFVIII.

The recent European approval of Pharming's rh C1 inhibitor (Ruconest®) has
demonstrated Pharming's ability to produce industrial volumes of high quality
recombinant human protein through a method which requires significantly lower
upfront capital investment and manufacturing costs compared to current cell
based technologies.

Haemophilia A is an X chromosome linked hereditary disorder caused by defects in
the Factor VIII (FVIII) gene that lead to lower levels of the functional FVIII
protein. Lack of functional FVIII diminishes the body's clotting ability, which
in turn can lead to damaging or fatal bleeding episodes. The global rhFVIII
market was estimated to worth US$3.8 billion in 2009, with 90% of sales in the
developed markets and very high unmet medical needs in the developing markets,
such as China. In addition, only approximately 50% of the world-wide estimated
haemophilia market can currently be supplied with appropriate FVIII therapy.
Hence, there is still a high unmet medical need in this field with an estimated
total market potential of US$10 billion.

Dr Fuliang Du, President of RLI, commented: "RLI is very excited to combine our
recent technological successes of expressing significant quantities of active
rhFVIII in mice and the subsequent birth of our first FVIII transgenic rabbits
with Pharming's validated and industrialised transgenic platform."

Bruno Giannetti, COO of Pharming, stated: "Pharming is pleased to have taken
this first step towards developing recombinant transgenic Factor VIII and
addressing the current demands and unmet needs of the global haemophilia market.
This agreement is in line with Pharming's stated strategy of leveraging the
embedded value of our proprietary transgenic platform through licensing and co-
development agreements, to develop protein therapeutics targeting unmet medical
needs and commercially attractive markets."

About Pharming Group N.V.
Pharming Group NV is developing innovative products for the treatment of unmet
medical needs. RUCONEST(®) (RHUCIN(®) 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(®) 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
platforms for the production of protein therapeutics, technology and processes
for the purification and formulation of these products. Additional information
is available on the Pharming website,

About Renova Life, Inc.
Renova Life, Inc is dedicated to research and innovations in
animal reproductive biotechnologies. RLI scientists have made significant
contributions to the animal embryo biotechnology field, particularly with rabbit
models. Early in the 1980s, they participated in the pioneer work to generate
transgenic rabbit via DNA microinjection (China), and rabbit cloning
using embryonic blastomere cells (China). RLI scientists constantly achieve over
20% of transgenic rates via DNA and/or RNA pronuclear injection in rabbits.

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.

Sijmen de Vries, CEO: T: +31 524 7400
Karl Keegan, CFO: T: +31 6 3168 0465

Renova Life
Dr. Fuliang DU

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

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Press release (PDF) :

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


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