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
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.
Sijmen de Vries, CEO: T: +31-71-524-7400
FTI Consulting: Julia Phillips / Victoria Foster Mitchell, T: +44-203-727-1136
SOURCE Pharming Group N.V.