Pharming Group N.V. : Pharming announces EMA approval of new manufacturing site for Ruconest®

  Pharming Group N.V. : Pharming announces EMA approval of new manufacturing
                              site for Ruconest®

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
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^® 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.

Contact
Sijmen de Vries, CEO: T: +31 71 524 7400
FTI Consulting: Julia Phillips/ John Dineen, T: +44 (0)207 269 7193

                                    # # #

Press release (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
 
Press spacebar to pause and continue. Press esc to stop.