- Pharming will take control of commercial rights to its product RUCONEST® in all 36 remaining countries
- Pharming will pay a total of EUR7.5 million in two tranches for a smooth transition of the existing activity and to terminate the license early
- The transaction will be accretive to earnings immediately
LEIDEN, Netherlands, Dec. 30, 2019 /PRNewswire/ -- Pharming Group N.V. today announced it has entered into a definitive agreement with Swedish Orphan Biovitrum AB (publ) ("Sobi") to reacquire the commercial rights to Pharming's product, RUCONEST®, in all remaining territories, which includes all remaining EU markets. Under the agreement, the license is being terminated with effect from 1 January 2020 in all 36 countries with a smooth handover planned in the countries where Sobi has sales activities. Pharming will pay Sobi EUR7.5 million in two tranches.
Following the strategic decision to reaquire the North American commercial rights for RUCONEST® in December 2016 from its licensee Valeant Pharmaceuticals International (now "Bausch Health"), Pharming has increased US sales significantly. It is anticipated that, while not of the same commercial scale as the US, a growth increase in the additional 36 territories can be expected. The transaction will be accretive to earnings immediately.
RUCONEST® has been licensed for a total of 60 different countries in this region since 2010, and was launched in a number of these countries. Commercialization rights for RUCONEST® in 24 of the 60 countries have been returned to Pharming in previous years.
In order to ensure that existing RUCONEST® patients can continue to receive their therapy, Pharming will be cooperating with Sobi to replace all contracts for distribution and other services as quickly as possible, and to transfer existing reimbursement approvals where possible. While Pharming will be responsible for the distribution of RUCONEST® in the 36 reaquired territories from the 1 January 2020, it may be some time before all activities and full control have been transferred. No personnel will be transferring between the two companies.
Sijmen de Vries, Chief Executive of Pharming, said:
"Our strategic decision to reacquire the commercial rights to RUCONEST® from SOBI builds on the commercial success of the product in the US and now means we own commerical rights to our lead asset for the treatment of HAE in all countries, except some markets in Latin America, Israel and South Korea. The transaction will enable us to drive further growth of RUCONEST® and will be accretive to earnings immediately. In addition, we will expand our existing commercial infrastructure in Europe to support the expected launch of future new products from our pipeline, including the recently in-licensed, late-stage compound, leniolisib, for the treatment of APDS."
Under the terms of the agreement, Pharming will pay a total payment of EUR7.5 million in two tranches, the larger part upfront with a final payment once all transition activities are complete or underway. There are no further future payments under this agreement.
About Pharming Group N.V.
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, Israel and South Korea. The product is available on a named-patient basis in other territories where it has not yet obtained marketing authorization.
RUCONEST® is distributed by Pharming in Austria, France, Germany, Luxembourg, the Netherlands, the United Kingdom and the United States of America. Pharming holds commercialisation rights in Algeria, Andorra, Bahrain, Belgium, Ireland, Jordan, Kuwait, Lebanon, Morocco, Oman, Portugal, Qatar, Syria, Spain, Switzerland, Tunisia, United Arab Emirates and Yemen. In some of these countries distribution is made in association with the HAEi Global Access Program (GAP). As of 1 January 2020 RUCONEST® will also be distributed by Pharming in the other EU countries as well as Serbia and Norway, and Pharming will hold commercialization rights in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Russia, Serbia and Ukraine and the remaining countries in the Middle East region. Before 1 January 2020 these territories were licenced to Sobi.
RUCONEST® is distributed in Argentina, Colombia, Costa Rica, the Dominican Republic, Panama, and Venezuela by Cytobioteck, in South Korea by HyupJin Corporation and in Israel by Kamada.
RUCONEST® is also being examined for approval 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 being explored at an early stage at present.
Pharming has a long-term partnership with the China State Institute of Pharmaceutical Industry ("CSIPI"), 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 CSIPI and are funded by CSIPI. Clinical development will be shared between the partners with each partner taking the costs for their territories under the partnership.
Additional information is available on the Pharming website: www.pharming.com [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.
For further public information, contact
Sijmen de Vries, CEO: T: +31 71 524 7400 Robin Wright, CFO: T: +31 71 524 7400
FTI Consulting Victoria Foster Mitchell, T: +44 203 727 1136
LifeSpring Life Sciences Communication, Amsterdam, The Netherlands Leon Melens, Tel: +31 6 53 81 64 27