Author: Willem van Lawick

Woensdag 24 juni 2015, AMSTERDAM (Dow Jones)–Kiadis Pharma nv (KDS.AE) maakt woensdag bekend dat het orderboek voor de geplande beursgang van het biofarmaceutische concern uit Amsterdam gevuld is.
In totaal is ingetekend op 2.272.727 aandelen, aldus Kiadis in een persbericht. Dit aantal kan eventueel met maximaal 15% worden uitgebreid tot 2,61 miljoen stuks. Daarnaast is er nog de overtoewijzingsoptie, waarmee nog eens 15% van het aantal nieuwe aandelen kan worden uitgegeven. (more…)

SAN RAFAEL, Calif., June 8, 2015 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for drisapersen, an investigational antisense oligonucleotide drug candidate for the treatment of the largest subset of Duchenne muscular dystrophy (DMD) amenable to single exon skipping. DMD is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in every 3,500 live male births with about 20,000 new cases diagnosed globally each year. In Europe, it is estimated there are 23,000 boys with Duchenne Muscular Dystrophy, and approximately 3,000 of those would be candidates for drisapersen. In BioMarin’s commercial territories, approximately 85 percent of Duchenne patients are located outside of the United States, including Western Europe, Middle East, Eastern Europe, Latin America and Japan. Western Europe has the largest patient population among those areas, exceeding the United States by around 30 percent. (more…)

Amsterdam, The Netherlands, June 3, 2015 – Kiadis Pharma B.V. (“Kiadis Pharma”, “Kiadis” or “the Company”), a clinical stage biopharmaceutical company developing innovative cellbased immunotherapy treatments, announces today its intention to raise new funds through an Initial Public Offering and listing of the entire share capital of a newly incorporated holding company on Euronext Amsterdam and Euronext Brussels.

Company highlights
Innovative cell-therapy for HSCT: Kiadis Pharma develops ATIR™, an innovative cell-therapy for allogeneic hematopoietic stem cell transplantation (HSCT). HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders, yet not a viable option for many patients given the risks and limitations of current HSCT treatments.
Meets significant unmet medical need: ATIR™ addresses the key risks and limitations of current HSCT treatments in blood cancers and inherited blood disorders, being: opportunistic infections, graft-versus-host-disease (GVHD), cancer relapse and limited donor availability. Consequently, ATIR™ enables the safer use of partially matched (haploidentical) family members as stem cell donors for those patients that would otherwise not find a matching donor in time, thereby meeting a significant unmet medical need.
Phase II trial for leukaemia: The Company’s lead product, ATIR™101, is currently in an international Phase II trial for leukaemia. The trial is being conducted in hospitals in Belgium, Canada, Germany and the UK. Trial results are expected at the beginning of 2016.
Obtained positive Phase II interim data: Positive interim data from the ongoing Phase II clinical trial for ATIR™101 were announced in December 2014, supporting the safety profile and showing efficacy of ATIR™101.
Market potential: Kiadis Pharma believes that ATIR™101 has the potential to provide a lifesaving therapy to approximately 19,000 patients in key countries worldwide, with a substantial expanding primary market and complementary product trends.
Second product for thalassemia: Kiadis Pharma’s second product, ATIR™201, is expected to be developed for inherited blood disorders with an initial focus on thalassemia.
Granted EMA manufacturing quality certificate: The Company has a robust, GMP-compliant manufacturing process in use in North America and Europe. It is one of five companies to have ever been issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA). (more…)

Amsterdam, The Netherlands, May 13, 2015 – Kiadis Pharma B.V. (“Kiadis Pharma” or “the Company”), a clinical stage biopharmaceutical company developing innovative immunotherapy treatments, today announces that its lead product ATIR™ for blood cancers has been granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA). The granted ATMP certificate was issued on a recommendation from the Committee for Advanced Therapies of the EMA recognizing that the data generated for ATIR™ is meeting the stringent standards imposed by the agency. As of 2009, only five such ATMP certificates have been issued by the EMA. (more…)

Amsterdam, The Netherlands, May 7, 2015 – Kiadis Pharma B.V. (“Kiadis Pharma” or “the Company”), a clinical stage biopharmaceutical company developing innovative immunotherapy treatments, today announces the appointment of Dr. Vincent Brichard as an independent member of its Supervisory Board.
Dr. Brichard has more than 25 years’ experience in the oncology and immunology field, including almost 15 years at GlaxoSmithKline (“GSK”) where he was Senior Vice-President and had responsibility for the Immunotherapeutics Business Unit, which covered a broad, integrated approach to immunotherapy – from bench discovery through clinical development and operations to regulatory and commercial activities. In addition to this position, he served as a member of the Board of Directors at GSK Biologicals. Dr. Brichard is a physician by training and holds a PhD in tumor immunology. He began his academic career at the Ludwig Institute for Cancer Research, Brussels Branch, followed by positions at the Institut Curie Cancer Center, Paris, and at the University of Louvain, Brussels. He further holds an MBA from the Harvard Business School. (more…)