Pharming announces EMA approval of new manufacturing site for Ruconest(R)

Pharming announces EMA approval of new manufacturing site for Ruconest(R) 
LEIDEN, THE NETHERLANDS -- (Marketwire) -- 03/28/13 --  Leiden, the
Netherlands, March 28th, 2013. Biotech company Pharming Group NV
("Pharming") (EURONEXT BRUSSELS: 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(R)  at their Aramon
(France) site. Sanofi Chimie is acting
as Pharming's Contract Manufacturing Organization, 
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 indications. 
Bruno Giannetti, COO of Pharming, said: "The approval from the EMA to
manufacture Ruconest(R) 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(R) 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(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,
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. 
# # # 
Press release (PDF): http://hugin.info/132866/R/1688803/554162.pdf 
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants
that: 
(i) the releases contained herein are protected by copyright and    
other applicable laws; and 
(ii) they are solely responsible for the content, accuracy and     
originality of the information contained therein. 
Source: Pharming Group N.V. via Thomson Reuters ONE 
[HUG#1688803] 
Contact
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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