Date: Dec 16, 2011 Source: (
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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, www.pharming.com.
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.
Contact
Pharming
Sijmen de Vries, CEO: T: +31 524 7400
Karl Keegan, CFO: T: +31 6 3168 0465
Renova Life
Dr. Fuliang DU
www.renovalife.com
FTI Consulting
Julia Phillips/ John Dineen, T: +44 (0)207 269 7193
