Roche announces new data at the ISTH 2020 Congress, demonstrating ongoing commitment to advancing care for people with haemophilia A

Spark Therapeutics will present data from the initial dose cohorts of its phase I/II SPK-8011 gene therapy study, showing stable and durable factor VIII expression, substantial improvement in annualised bleed rate for more than two years, and an acceptable safety profile after more than two years of follow-up¹Roche will present second interim analysis results from the phase IIIb STASEY study, reinforcing the safety and efficacy profile of Hemlibra in people with haemophilia A with factor VIII inhibitors seen in phase III HAVEN studies^2,3,4First clinical data from the phase III HAVEN 5 study in people with haemophilia A in the Asia-Pacific region, demonstrating that Hemlibra prophylaxis resulted in a statistically significant reduction in treated bleeds compared to no prophylaxis⁵Preliminary analysis from CHESS II, a socioeconomic survey, providing insights into the clinical outcomes and burdens of living with haemophilia ABasel, 29 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its haemophilia A clinical programme will be presented at the International Society on Thrombosis and Haemostasis (ISTH) 2020 Congress on 12-14 July 2020. Data will include updated safety results from the phase IIIb STASEY study of Hemlibra® (emicizumab) and new results from the phase III HAVEN 5 study of Hemlibra. Data will also include insights into the impact of living with haemophilia A. Spark Therapeutics (a member of the Roche Group) will also present data from the initial dose cohorts of its phase I/II SPK-8011 gene therapy study.About Hemlibra® (emicizumab)
Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once-weekly, every two weeks or every four weeks (after an initial once weekly dose for the first four weeks). Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech. It is marketed in the United States by Genentech as Hemlibra (emicizumab-kxwh), with kxwh as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the US Food and Drug Administration.Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
– Nicolas Dunant (Head)
– Patrick Barth
– Daniel Grotzky
– Karsten Kleine
– Nathalie Meetz
– Barbara von Schnurbein Attachment29062020_MR_ISTH Curtain Raiser_EN