2013-03-28 07:05:58 -
Leiden, the Netherlands, March 28th, 2013. Biotech company Pharming Group NV
("Pharming") (NYSE Euronext: PHARM) announced today that it has received
approval from the European Medicines Agency (EMA) for Sanofi Chimie to
manufacture drug substance for Pharming's product Ruconest® at their Aramon
(France) site. Sanofi Chimie is acting as Pharming's Contract Manufacturing
Sanofi Chimie's Aramon site is recognized for its industrial excellence in the
production of biologics. The site reaches high quality standards and its team
has a very good track record with health authorities.
The approval of the production site by EMA (European Medicines Agency), which
was achieved through a Type II variation, allows Pharming to supply the European
market with drug substance from Sanofi Chimie.
Pharming's ability to leverage the manufacturing process for Ruconest, a
recombinant human C1 inhibitor approved
for the treatment of angioedema attacks
in patients with HAE (Hereditary Angioedema), represents a significant
competitive advantage over manufacturers of plasma- (blood) derived products,
which are dependent on blood donations.
The Contract Manufacturing process requires a highly complex purification
process. Three different chromatography steps are necessary to obtain a robust
high quality profile of drug substance. All essential sophisticated analytical
methods involved have been also successfully implemented and validated.
This approval will enable significant improvements in Ruconest's competitiveness
and will allow Pharming to meet future global demands with a secure supply chain
agreement on the long term for the treatment of HAE as well as follow-up
Bruno Giannetti, COO of Pharming, said: "The approval from the EMA to
manufacture Ruconest(®) at the Sanofi Aramon (France) site is an important
development for Pharming as it will allow us to scale up manufacturing of
Ruconest ahead of future market demand, particularly as we progress towards US
approval of Ruconest with our partner, Santarus. Importantly, this approval
significantly enhances Ruconest's competitive profile, as it enables us to ramp-
up manufacturing of Ruconest and optimizing the cost of goods for the product".
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. RUCONEST(®) 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, www.pharming.com.
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 71 524 7400
FTI Consulting: Julia Phillips/ John Dineen, T: +44 (0)207 269 7193
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Source: Pharming Group N.V. via Thomson Reuters ONE