26.07.2017 07:00:00

Kiadis Pharma proposes former Actelion COO Otto Schwarz as new Supervisory Board member

Regulatory News:

Kiadis Pharma N.V. ("Kiadis Pharma” or the "Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients suffering from blood cancers and inherited blood disorders, today announces that at its next General Meeting of Shareholders, the Kiadis Pharma Supervisory Board will nominate Dr. Otto Schwarz to be appointed as a new member of the Supervisory Board.

Dr. Otto Schwarz is a highly accomplished industry veteran, with significant operational and commercial leadership experience, including global launches of multiple major orphan and specialty care products. Most recently, Otto was Executive Vice-President, Chief Operating Officer and a member of the Actelion Executive Committee, up to the recent acquisition of Actelion by Johnson & Johnson. At Actelion, which he joined in 2008, Otto was responsible for global operations including marketing strategy & sales, medical affairs, manufacturing and supply chain, leading over 1300 people. Under Otto’s leadership, Actelion successfully launched the orphan products Opsumit, Uptravi and Veletri, growing total company sales to well over €2 billion. Prior to joining Actelion, he was Executive Vice-President Commercial Operations at Nycomed and an Executive Board Member at Altana Pharma. Prior to that he worked for almost 20 years at Schering-Plough and Eli Lilly in Austria, Switzerland, Canada, the US and Germany. Otto Schwarz is an Austrian citizen with a PhD in pharmaceutical chemistry from Vienna University.

Arthur Lahr, CEO of Kiadis Pharma, commented: "I am very pleased Otto has decided to join our Supervisory Board. As we prepare for the potential European commercial launch of ATIR101™ in 2019. Otto’s wealth of experience in launching and growing orphan and specialty care products, and in building a strong, fully integrated biotech company, will be incredibly valuable for Kiadis Pharma. With Otto’s support, we should be well positioned to make ATIR101™ widely available to patients and a commercial success.’’

Otto Schwarz added: "I am very happy to join the Kiadis Pharma Supervisory Board and am impressed by the Company’s investigational products and technology. I am committed to bring my 30 years of experience to support the further maturing of Kiadis Pharma as it enters the next important phases in its development, to help patients have safer and more effective bone marrow transplantations.’’

Mark Wegter, Chairman of the Supervisory Board of Kiadis Pharma, commented: "We are delighted to welcome Otto to our Supervisory Board. He is well respected with very relevant experience that will be invaluable in the next stage of our evolution, and he will help drive the commercial strategy for our products and continued transformation of the Company and our Board.”

About ATIR101™

For patients suffering from blood cancers and inherited blood disorders, an allogeneic hematopoietic stem cell transplantation (HSCT) can offer a cure, yet it has considerable risks. During an HSCT treatment, the patient’s diseased blood and immune system are destroyed and subsequently replaced by a healthy system from a donor. The key challenge with HSCT is that mature lymphocytes from the donor are required to provide immediate protection against infections and relapse, but may attack patient tissue, causing life threatening Graft-versus-Host-Disease (GVHD).

ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) provides for a single dose donor lymphocyte infusion, with functional, mature immune cells from a haploidentical family member, given as an adjunctive to a haploidentical HSCT. The lymphocytes in ATIR101™ are very potent in fighting infections and remaining tumor cells, yet do so with minimal risk of causing severe GVHD. To provide protection to patients without attacking patient tissue, ATIR101™ is manufactured by depleting patient specific alloreactive lymphocytes ex vivo from donor material. ATIR101™ offers a strong improvement in relapse rates and GVHD over literature for other HSCT protocols, such as the Post Transplant Cyclophosphamide (PTCy) or ‘Baltimore’ protocol.

About Kiadis Pharma

Kiadis Pharma is focused on cell-based immunotherapy products, as an adjunctive to a haploidentical hematopoietic stem cell transplantation (HSCT), for the treatment of blood cancers and inherited blood disorders. The Company’s product candidates have the potential to make allogeneic hematopoietic stem cell transplantations (HSCT) safer and more effective for patients.

Based on the positive results from the single dose Phase II trial with lead product ATIR101™ in patients with blood cancer, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101™ across the European Union as an adjunctive treatment in HSCT for malignant disease. In addition, Kiadis Pharma has received regulatory approval in various countries to start dosing patients in a Phase III trial with ATIR101™ that will be performed across Europe and North America. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.

The Company’s second product candidate, ATIR201™, will address beta thalassemia, an inherited blood disorder.

Kiadis Pharma was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the EMA.

The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels. For more information visit www.kiadis.com

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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