LEIDEN, the Netherlands,
July 14, 2016 /PRNewswire/ --
Pharming To Directly Commercialise
RUCONEST in 21 Additional Western European, North African And
Middle-Eastern Markets
Pharming Group NV ("Pharming" or "the Company") (EURONEXT:
PHARM) and Swedish Orphan Biovitrum AB (publ) or "Sobi" (SS: SOBI),
today announced an amendment of the RUCONEST® distribution
agreement signed in 2009 with Swedish Orphan Biovitrum AB (publ)
(Sobi).
In addition to Austria,
Germany and Netherlands, Pharming will market RUCONEST®
directly into an additional 21 countries, effective 1 October 2016. These countries include
Algeria, Andorra, Bahrain, Belgium, France, Ireland, Jordan, Kuwait, Lebanon, Luxembourg, Morocco, Oman, Portugal, Qatar, Syria,
Spain, Switzerland, Tunisia, United Arab
Emirates, United Kingdom
and Yemen.
To support the commercialization, Pharming will expand the
current small European team of experienced HAE marketing and
medical affairs specialists.
To ensure a seamless hand-over and guarantee the continuous
availability of RUCONEST® to patients, Sobi will continue to
deliver RUCONEST® and continue the drug safety monitoring and
reporting, until 1 October 2016.
Sijmen de Vries, Pharming's CEO, commented, "Extension of our
direct commercialization of RUCONEST® into these additional 21
markets is a further step towards our goal of becoming a specialty
pharma company with significant commercial infrastructure to be
able to fully benefit from the added value of bringing our products
to patients. Despite RUCONEST® sales in these important markets
being modest, this move is expected to have a positive impact on
our financial performance as we will be able to improve the margin
from sales with every vial of RUCONEST® sold.
About Pharming Group NV
Pharming is a specialty pharmaceutical company developing
innovative products for the safe, effective treatment of rare
diseases and unmet medical needs. Pharming's lead product,
RUCONEST® (conestat alfa) is a recombinant human C1 esterase
inhibitor approved for the treatment of acute Hereditary Angioedema
("HAE") attacks in patients in Europe, the US and rest of the world. The
product is available on a named-patient basis in other territories
where it has not yet obtained marketing authorization.
RUCONEST® is commercialized by Pharming in Austria, Germany and The
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® will after the amendment continue to be distributed by
Swedish Orphan Biovitrum AB (publ) in Albania, Azerbaijan, Belarus, Bosnia
& Herzegovina, Bulgaria, Croatia, Cyprus, the Czech
Republic, Denmark,
Estonia, Finland, Georgia, Greece, Hungary, Iceland, Iran, Iraq,
Italy, Kazakhstan, Kosovo, Latvia, Lithuania, Malta, Macedonia, Montenegro, Moldova, Norway, Poland, Romania, Russia, Saudi
Arabia, Serbia, Slovakia,
Slovenia, Sweden, Ukraine
RUCONEST® is distributed in North
America, Canada and
Mexico by Valeant Pharmaceuticals
International, Inc. (NYSE: VRX/TSX: VRX), following Valeant's
acquisition of Salix Pharmaceuticals, Ltd.
RUCONEST® is distributed in Argentina, Colombia, Costa
Rica, the Dominican
Republic, Panama and
Venezuela, by Cytobioteck.
RUCONEST® is distributed in South
Korea by HyupJin Corporation and in Israel by Megapharm.
RUCONEST® is being investigated in a Phase II randomized, double
blind placebo-controlled clinical trial for prophylactic treatment
of HAE and is being evaluated for other indications as well. The
Phase II study was fully recruited shortly after the year-end.
RUCONEST® is also being investigated in a Phase II clinical
trial for the treatment of HAE in young children (2-13 years of
age) and evaluated for various additional follow-on
indications.
Pharming's technology platform includes a unique, GMP-compliant,
validated process for the production of pure recombinant human
proteins that has proven capable of producing industrial quantities
of high quality recombinant human proteins in a more economical and
less immunogenetic way compared with current cell-line based
methods. Leads for enzyme replacement therapy ("ERT") for Pompe and
Fabry's diseases are being optimized at present, with additional
programs not involving ERT also at an early stage of
development.
Pharming has a long term partnership with the Shanghai Institute
of Pharmaceutical Industry ("SIPI"), a Sinopharm company, for joint
global development of new products, starting with recombinant human
Factor VIII for the treatment of Haemophilia A. Pre-clinical
development and manufacturing will take place to global standards
at SIPI and are funded by SIPI. Clinical development will be shared
between the partners with each partner taking the costs for their
territories under the partnership.
Pharming has declared that the
Netherlands is its "Home Member State" pursuant to the
amended article 5:25a paragraph 2 of the Dutch Financial
Supervision Act.
Additional information is available on the Pharming website:
http://www.pharming.com
Forward-looking statements
This press release of Pharming Group N.V. and its subsidiaries
(“Pharming”, the “Company” or the “Group”) may contain
forward-looking statements including without limitation those
regarding Pharming’s financial projections, market expectations,
developments, partnerships, plans, strategies and capital
expenditures.
The Company cautions that such forward-looking statements may
involve certain risks and uncertainties, and actual results may
differ. Risks and uncertainties include without limitation the
effect of competitive, political and economic factors, legal
claims, the Company’s ability to protect intellectual property,
fluctuations in exchange and interest rates, changes in taxation
laws or rates, changes in legislation or accountancy practices and
the Company’s ability to identify, develop and successfully
commercialise new products, markets or technologies.
As a result, the Company’s actual performance, position and
financial results and statements may differ materially from the
plans, goals and expectations set forth in such forward-looking
statements. The Company assumes no obligation to update any
forward-looking statements or information, which should be taken as
of their respective dates of issue, unless required by laws or
regulations.
Contact
Sijmen de Vries, CEO: T: +31-71-524-7400
FTI Consulting: Julia Phillips /
Victoria Foster Mitchell, T:
+44-203-727-1136