Pharming responds to press speculation

  • Pharming categorically denies having had any involvement in the alleged abstraction of proprietary information by Dr Joseph Chiao from his former employer CSL
Leiden, the Netherlands – 16 October 2019

Pharming Group N.V. (Euronext Amsterdam: PHARM) today confirmed it has been included in an injunction in the US obtained by CSL Behring, a subsidiary of CSL Limited of Australia (“CSL”), to prevent possible transmission of proprietary documents and data to Pharming which CSL claims have been removed from its systems by Dr Joseph Chiao, who was hired recently by Pharming to be a medical director.

The injunction is aimed at giving CSL time and opportunity to investigate how and what was taken, and whether or not Pharming was involved and/or has received any of the abstracted data or documents.

Pharming is issuing this release to state for the record that Pharming did not induce or encourage Dr Chiao to breach any rules or contract terms or in any way to remove any data from his former employer. Furthermore, Pharming has not received or seen any proprietary CSL information from Dr Chiao or any other source.

Pharming is cooperating with CSL in the cyber-interrogation of all of Pharming’s systems and with US judiciary authorities to demonstrate its innocence of any wrongdoing. In accordance with the injunction, Dr Chiao has been suspended pending the outcome of the court hearing.

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).

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 distributed in 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.

Leniolisib is in final stage clinical development for Activated Phosphoinositide 3-kinase Delta Syndrome (“APDS”). Leniolisib is a small molecule phosphoinositide 3-kinase delta (“PIK3δ”) inhibitor developed by Nopvartis. Global rights to the product were obtained from Novartis in August 2019. Development of the compound through its current registration-enabling trial will be continued by Novartis and Pharming in partnership. Pharming will commercialise the treatment if it obtains approval from regulators.

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

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 commercialize 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

Pharming Group N.V.

Sijmen de Vries, CEO
Tel: +31 71 524 7400

FTI Consulting, London, UK:

Julia Phillips / Victoria Foster Mitchell / Brett Pollard
Tel: +44 203 727 1136

LifeSpring Life Sciences Communication, Amsterdam, The Netherlands:

Leon Melens
Tel: +31 6 53 81 64 27

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