Strengthens Senior Management Team with Chief Human Resources Officer and General Counsel and Company Secretary
Amsterdam, The Netherlands, September 6, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces that Mr. Mark Schaefer has been appointed Chief Human Resources Officer and Mr. James Joy has been appointed General Counsel and Company Secretary. Mr. Schaefer and Mr. Joy will be members of the Senior Management Team at Kiadis Pharma, report to the Chief Executive Officer, and are both based in Amsterdam, The Netherlands.
Arthur Lahr, CEO of Kiadis Pharma, commented: “I am delighted to welcome Mark Schaefer and James Joy to Kiadis. Mark’s 25 years of global Human Resources experience building manufacturing and commercial operations will help us in expanding and strengthening the organization as we prepare for EU launch and scale up. James brings with him significant experience as corporate lawyer and general counsel and has an excellent track record in corporate finance. Building a biotech company requires highly experienced people across all disciplines. These appointments clearly show and reinforce our ability to attract seasoned senior executives and specialized staff to deliver on our strategy.”
Mr. Mark Schaefer has 25 years of HR experience and joins from Aenova Holding, where he was Senior Vice President of Global HR. The Aenova Group is a global leader in the pharmaceutical and healthcare industries and one of the leading contract manufacturers in Europe. Prior to this Mr. Schaefer worked in senior global HR roles at West Pharmaceuticals, 3M, Sony and GE. He holds a BA in Economics and Commerce as well as a Master’s degree in Industrial Relations from the University of Toronto. Mr. Schaefer is a Canadian citizen.
Mr. James Joy has over 20 years of legal and corporate finance experience. Mr. Joy served as General Counsel respectively VP Legal at leading multinational companies TomTom N.V. and Royal Ahold N.V. Previously, Mr. Joy practiced as international corporate lawyer in New York and London with Latham & Watkins and Norton Rose Fulbright where he advised on corporate finance and mergers and acquisitions. Mr. Joy holds a bachelor’s degree in Economics from Heriot-Watt University and a Juris Doctor degree from Tulane Law School. Mr. Joy is a member of the New York State Bar. Mr. Joy is a British citizen.
For more information, please contact:
Karl Hård, Head of Investor Relations & Communications
Tel. +31 611 096 298
Optimum Strategic Communications:
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 714 1789
David Brilleslijper (Amsterdam)
Tel: +31 610 942 514
About Kiadis Pharma
Kiadis Pharma is initially developing its lead product candidate, ATIR101, for use in conjunction with haploidentical HSCT for adult blood cancers to address key limitations of haploidentical HSCT, without prophylactic immunosuppression and its associated morbidity and mortality. Based on the positive results from the single dose Phase II CR-AIR-007 study, the Company submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, in April 2017 for approval of ATIR101 as an adjunctive treatment in haploidentical HSCT for high risk adult hematological malignancies. Kiadis Pharma submitted responses to the EMA’s Day 180 List of Issues in August 2018. The Company expects a Committee for Medicinal Products for Human Use, or CHMP, opinion in the fourth quarter of 2018 which, if positive, would enable it to receive a conditional marketing approval from the European Commission as early as in the first quarter of 2019. If then conditionally approved, Kiadis Pharma intends to launch ATIR101 in selected countries in Europe through its own commercial organization starting in the second half of 2019.
In December 2017, Kiadis Pharma commenced an international, multicenter, randomized and controlled Phase III clinical trial of ATIR101 against the Post-Transplant Cyclophosphamide, or PTCy protocol, the main protocol used to perform a haploidentical HSCT. The trial will be performed in 250 patients with acute leukemia and myelodysplastic syndrome, or MDS, at approximately 50 sites in the United States, Canada, Europe and certain additional countries. The trial’s primary endpoint is GVHD-Free and Relapse-Free Survival, or GRFS, which is defined as survival without acute GVHD grade III/IV, without chronic GVHD requiring systemic immunosuppression, and without relapse, and is a composite endpoint widely used in HSCT trials that captures survival, quality of life and future prognosis. The first patient was enrolled in December 2017. If successful, the Company intends to use data from this Phase III trial as a basis for the filing of a Biologics License Application, or BLA, with the U.S. Food and Drug Administration, or FDA. The Company also plans to use data from the Phase III trial to support the conversion of the anticipated conditional marketing approval of ATIR101 in Europe into a standard marketing approval. ATIR101 received regenerative medicine advanced therapy, or RMAT, designation from the FDA in September 2017, which provides benefits that are materially equivalent to a breakthrough designation from the FDA. In addition, ATIR101 has been granted multiple orphan drug designations both in the European Union and the United States.
The Company’s shares are listed on Euronext Amsterdam and Brussels under the ticker KDS.
Forward Looking Statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharma’s or, as appropriate, Kiadis Pharma’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis Pharma expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis Pharma nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.