Kiadis Pharma on track with European regulatory review for ATIR101
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:
| Kiadis Pharma: |
Karl Hård, Head of IR & Communications
Tel. +31 (0) 611 096 298
| Optimum Strategic Communications: |
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 714 1787
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.
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.
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Source: Kiadis Pharma N. V. via GlobeNewswire