Investor Update

Basel, 16 April 2018

Roche to present new data at AAN highlighting extensive research for OCREVUS and expanding neuroscience pipeline

  • Breadth of data will reinforce efficacy and safety of OCREVUS in relapsing and primary progressive multiple sclerosis and demonstrate its benefits in slowing disability progression, including new cognitive and biomarker results
  • Important research in Alzheimer’s disease, Huntington’s disease, Spinal Muscular Atrophy and Duchenne Muscular Dystrophy will highlight the strength of Roche’s neuroscience pipeline

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data on its approved and investigational medicines for neurological conditions will be presented during the 70th American Academy of Neurology (AAN) Annual Meeting from 21-27 April in Los Angeles, California. These data will reinforce the efficacy and safety of OCREVUS® (ocrelizumab) and expand the clinical understanding of disability progression in multiple sclerosis (MS). They will also represent investigational research from the Roche neuroscience pipeline in Alzheimer’s disease, Huntington’s disease, spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD).

“Our neuroscience pipeline is one of the deepest and most diverse in the industry, spanning both common and rare neurological conditions with the greatest unmet need,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “OCREVUS is now approved in over 55 countries with more than 40,000 people treated. We remain committed to continuing our research and development to understand MS progression further and help those living with MS and their physicians.”

OCREVUS data will show significant and sustained efficacy as well as benefits in cognition in people with relapsing MS (RMS). The early impact of OCREVUS on biomarkers of inflammation and neurodegeneration in people with RMS and primary progressive MS (PPMS) will be shared for the first time through the OBOE (Ocrelizumab Biomarker Outcome Evaluation) study.

Additional notable MS presentations include updated safety analyses for OCREVUS, which will further inform and reinforce its continued favourable benefit-risk profile. New data from the FLOODLIGHT pilot study, which support mobile technology as a complement to in-clinic testing to provide a more complete and real-time picture of a patient’s underlying disease activity, will also be presented.

Encouraging data from other investigational medicines in Roche’s neuroscience pipeline will also be presented:

  • Alzheimer’s disease is an important area of focus for Roche. Four presentations on investigational anti-amyloid beta antibodies crenezumab and gantenerumab show promise in Roche’s Alzheimer’s disease pipeline and the findings have informed the design for both the CREAD and GRADUATE pivotal Phase III trial programmes, respectively. In a platform session, data on gantenerumab will be presented showing a significant reduction in brain amyloid beta plaques with a higher dosing regimen (1200mg) in two Phase III, open label extension studies. Data from these two studies guided the dose and titration regimen selection for the recently initiated Phase III GRADUATE pivotal programme investigating gantenerumab for the treatment of early Alzheimer’s disease. Two posters on crenezumab will be presented; one will focus on preclinical data and will discuss its proposed mechanism of action, including data supporting its preferential binding to neurotoxic amyloid beta oligomers. A second poster will describe the results from a safety, tolerability and pharmacokinetics Phase Ib study in doses up to 120mg. Data from this study were used to determine an optimal dose now used in the ongoing CREAD pivotal programme investigating crenezumab for the treatment of early Alzheimer’s disease.
  • Data from a Phase I/IIa multiple-ascending dose study of RG6042 (formerly known as IONIS HTTRx) in Huntington’s disease will be presented in a plenary session. These data will highlight the safety and tolerability of this investigational medicine over four monthly doses, demonstrate dose-dependent lowering of the mutant huntingtin protein (mHTT), and show additional exploratory analyses from this first-in-human study. These results for RG6042 are the first data demonstrating lowering of mHTT, the disease-causing protein in people with Huntington’s disease.
  • The SMA presentations include late-breaking interim data on the increase in survival of motor neuron (SMN) protein levels following treatment with RG7916 in infants with Type 1 SMA. SMA, the leading genetic cause of mortality in infants and toddlers, is a rare neuromuscular disease caused by a deficiency of SMN protein. RG7916 is an investigational oral SMN2 splicing modifier being developed in collaboration with PTC Therapeutics, Inc. and the SMA Foundation.
  • Results from a Phase Ib/II study of the investigational adnectin fusion protein RG6206 in young male adolescents with DMD will also be presented. These data will highlight the myostatin suppression levels achieved and its potential effect in increasing lean body mass volume.

Investigators will present the following plenary, platform and poster presentations:

Full session details and data presentation listings for the 2018 AAN Annual Meeting can be found at the meeting website: https://www.aan.com/conferences-community/annual-meeting/.

OCREVUS is now approved in over 55 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union. Marketing applications are currently under review in more than 20 countries across the world.

Follow Roche on Twitter via @Roche and keep up to date with AAN 2018 Annual Meeting news and updates by using the hashtag #AANAM.

About Roche in neuroscience

Neuroscience is a major focus of research and development at Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.