LEIDEN, The Netherlands,
October 13, 2014 /PRNewswire/ --
Pharming to Directly Commercialise
Ruconest in Austria, Germany and Netherlands
Biotech company Pharming Group NV ("Pharming" or "the Company")
(EURONEXT: PHARM) and Swedish Orphan Biovitrum AB (publ) or "Sobi"
(SS: SOBI), today announced the amendment and extension of the
Ruconest® distribution agreement between Pharming and Sobi.
Effective immediately, Pharming will focus on direct
commercialization in Austria,
Germany and Netherlands, and Sobi will extend its
Ruconest® sales territory with the addition of Azerbaijan, Belarus, Georgia, Kazakhstan, Russia, Serbia and Ukraine.
Pharming has recently started the hiring of a small European
team of experienced HAE commercialisation and medical affairs
specialists to take-over the direct commercialization activities
from Sobi for Ruconest® in Austria, Germany and Netherlands. To ensure a seamless hand- over,
in particular to guarantee the continuous availability of Ruconest®
to patients and the drug safety monitoring and reporting of
Ruconest®, Sobi will continue to deliver Ruconest® as before and
will continue the drug safety monitoring and reporting during the
remaining months of 2014.
Sijmen de Vries, Pharming CEO commented, "This step forward into
direct commercialization of Ruconest® became possible as result of
our recently improved balance sheet and opens up new opportunities
for Pharming to not only grow revenues, but also, as those revenues
build, to put in place the right size of specialist commercial
infrastructure which could, over time, be leveraged through the
marketing of other products. This move is expected to, almost
immediately, have a positive impact on our financial performance as
we will be able to improve the margin from sales in the EU
territories with every vial of Ruconest® sold in Austria, Germany and Netherlands. In addition, the extension of the
Sobi territory will enable Sobi to continue growing Ruconest®
revenues further.
About Pharming Group NV:
Pharming Group NV is developing innovative products for the
treatment of unmet medical needs. Ruconest® (conestat alfa) is a
recombinant human C1 esterase inhibitor approved for the treatment
of angioedema attacks in patients with HAE in the USA, Israel,
all 27 EU countries plus Norway,
Iceland and Liechtenstein. Ruconest® is commercialized by
Pharming in Austria, Germany and Netherlands. Ruconest® is distributed by
Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU
countries and in Azerbaijan,
Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia and Ukraine.
Ruconest® is partnered with Salix Pharmaceuticals Inc. (NASDAQ:
SLXP) in North America.
The product is also being investigated in a randomized Phase II
clinical trial for prophylaxis of HAE and evaluated for various
additional follow-on indications. Pharming has a unique GMP
compliant, validated platform for the production of recombinant
human proteins that has proven capable of producing industrial
volumes of high quality recombinant human protein in a more
economical way compared to current cell based technologies. In
July 2013, the platform was partnered
with Shanghai Institute for Pharmaceutical Industry (SIPI), a
Sinopharm Company, for joint global development of new products.
Pre- clinical development and manufacturing will take place at SIPI
and are funded by SIPI. Pharming and SIPI initially plan to utilize
this platform for the development of rh-FVIII for the treatment of
Haemophilia-A. Additional information is available on the Pharming
website; http://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.
