Responses submitted to EMA Day 120 list of questions
Amsterdam, The Netherlands, March 28, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) in hematopoietic stem cell transplantations (HSCT), today confirms it has submitted its responses to the European Medicines Agency’s (EMA) Day 120 List of Questions for its lead product candidate ATIR101 within the timeline that had been agreed with EMA and announced in September 2017.
Arthur Lahr, CEO of Kiadis Pharma, commented: “We are pleased to have submitted our responses to EMA’s Day 120 List of Questions in a timely manner. We believe we have adequately addressed the questions and remain on track to potentially obtain a positive CHMP opinion for ATIR101 in Q4 2018 and (conditional) approval from the European Commission in Q1 2019, which would allow for a European launch in H2 2019.
For more information, please contact:
Karl Hård, Head of IR & Communications
Tel. +31 611 096 298
Optimum Strategic Communications:
Mary Clark, Supriya Mathur, Hollie Vile
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About Kiadis Pharma
Kiadis Pharma’s allodepleted T-cell immunotherapy product candidate, given after a haploidentical hematopoietic stem cell transplantation (HSCT), is designed to reduce Graft versus Host Disease (GVHD). Single dose Phase 2 data with lead product candidate ATIR101 in patients with blood cancer shows a strong and clinically very relevant improvement over literature for the Baltimore protocol, with reduced risk of GVHD. Based on the positive results from the Phase 2 trial, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101 across the EU as an adjunctive treatment in HSCT for malignant disease. Kiadis Pharma received Day 120 questions in September 2017 and is on track for potential (conditional) approval in Q4 2018 and launch in H2 2019. Kiadis Pharma is conducting a Phase 3 trial with ATIR101 across Europe and North America (head to head against the Baltimore protocol). The first patient was enrolled in December 2017.
In September 2017 the US Food and Drug Administration (FDA) granted ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) designation. ATIR101 has been granted Orphan Drug Designations both in the US and Europe.
The Company’s shares are listed on Euronext Amsterdam and Brussels under the ticker KDS.
Company presentation: http://www.kiadis.com/company-presentation/
Forward Looking Statements
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