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.
