Amsterdam-Duivendrecht, The Netherlands, December 6, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative cell therapy products to make bone marrow transplantations safer and more effective for patients, today announces that it has entered into an agreement to lease an existing commercial manufacturing facility, which includes process development and quality control laboratories, as well as space for the Kiadis Pharma headquarters in Amsterdam, The Netherlands. The facility is located at Paasheuvelweg 25A in Amsterdam, The Netherlands.
The in-house manufacturing capability will allow the Company to enhance flexibility and expand capacity, and will not affect the ongoing contract manufacturing collaborations.
Arthur Lahr, CEO of Kiadis Pharma, commented: “As we continue to prepare for European launch in 2019, this provides Kiadis with a unique opportunity to obtain access to a recently established state-of-the-art commercial manufacturing facility in Amsterdam without spending capital and time on a construction project. Also, we can now locate all our activities at a single site.”
About Kiadis Pharma
Kiadis Pharma’s cell-based immunotherapy products can make haploidentical hematopoietic stem cell transplantations (HSCT) safer and more effective. Single dose Phase 2 data with lead product ATIR101™ in patients with blood cancer shows a strong and clinically very relevant improvement over literature for the Baltimore protocol. 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 H2 2018 and launch in 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/
For more information, please contact:
Head of IR & Communications
Tel. +31 611 096 298
|Consilium Strategic Communications:
Mary-Jane Elliott, Philippa Gardner, Lindsey Neville, Hendrik Thys
Tel: +44 203 709 5708
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.