Kiadis Pharma to lease exist­ing com­mer­cial man­u­fac­tur­ing facil­i­ty in The Netherlands

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.