Roche announces new OCREVUS (ocrelizumab) data on long-term disability benefits in primary progressive multiple sclerosis and initiation of two global studies in progressive multiple sclerosis

• OCREVUS may delay the need for a wheelchair by seven years for people with primary progressive multiple sclerosis (PPMS)
• Longer-term efficacy and safety data are consistent with OCREVUS’ favourable benefit-risk profile for both PPMS and relapsing MS (RMS)
• Two new Phase IIIb studies for OCREVUS in progressive MS will use novel endpoints to evaluate upper-limb function and disability progression
• OCREVUS approved in more than 60 countries, with 50,000 patients treated globally to date

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new OCREVUS (ocrelizumab) data will be presented at the 4th Congress of the European Academy of Neurology (EAN) from 16 June to 19 June in Lisbon, Portugal. The new Phase III data analyses show OCREVUS may provide meaningful disability benefits such as delay in the need for a wheelchair for people with primary progressive multiple sclerosis (PPMS). Roche continues its commitment to people with progressive forms of MS by initiating two new global Phase IIIb studies that will evaluate the efficacy of OCREVUS in a broad range of people with progressive forms of MS.

In a new exploratory analysis from the extended control period of the Phase III ORATORIO study in PPMS, OCREVUS may significantly delay the time to need a wheelchair by seven years, as measured by the length of time until a person reaches Expanded Disability Status Scale seven or greater (EDSS≥7) using 24-week confirmed disability progression (CDP). People treated with OCREVUS had a 46 percent reduction in the risk of progressing to a wheelchair compared to the placebo-treated group (6.2 percent vs. 9.8 percent risk, respectively, p=0.022). When these results were extended (extrapolated) to calculate the median time-to-wheelchair, the data suggest OCREVUS treatment may delay the need for a wheelchair by seven years (19.2 years for OCREVUS vs. 12.1 years for placebo).

“To a person living with primary progressive MS, for whom disability accumulates twice as fast as in relapsing MS, seven more years without the need for a wheelchair could extend the time they can live independently in their home, continue working or looking after their families,” said Helmut Butzkueven, Professor and Chair of MS and Neuroimmunology Research at Central Clinical School, Monash University, Head of MS and Neuroimmunology Service at Alfred Health and Director of MS Service at Eastern Health. “The data at EAN show the significant impact that OCREVUS, the first disease-modifying medicine for PPMS approved in more than 60 countries around the world, can have on people with MS with the greatest unmet need.”

Additionally, the analysis showed that the placebo-treated patient population studied in ORATORIO had similar disability progression rates to an untreated real-world PPMS population. The extrapolated median time to wheelchair (EDSS≥7) for placebo-treated people in the ORATORIO study was 12.1 years compared to 12.4 years for people with PPMS in the real-world MSBase registry.

Longer-term safety data presented at EAN representing 3,778 RMS and PPMS patients and 9,474 patient years of exposure to OCREVUS, across all OCREVUS clinical trials, remain consistent with the medicine’s favourable benefit-risk profile. As of June 2018, over 50,000 people have been treated globally with OCREVUS.

In parallel to EAN and following the success of Roche’s first MS Forum in 2017, Roche will be hosting a live MS Forum: ‘Maintaining Independence in Progressive Multiple Sclerosis’ on Monday 18 June at 4.00 – 5.00pm CEST. Registration can be made here: http://livestream.videum.com/roche/ms/.

Follow Roche on Twitter via @Roche and keep up to date with EAN 2018 news and updates by using the hashtag #EAN2018.

OCREVUS is now approved in over 60 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.

New progressive MS studies initiating in 2018

Many people with progressive MS eventually transition into a wheelchair, which means that maintaining the ability to use their hands and arms is important, especially in later stages of the disease. To advance the clinical understanding of MS progression and the importance of maintaining upper-limb function in people with progressive MS, Roche will be initiating two new Phase IIIb studies of OCREVUS in 2018.

A first-of-its-kind study, ORATORIO-HAND, will evaluate the long-term safety and efficacy of OCREVUS in people with PPMS later in their disease course (with an EDSS score three to eight) and the Nine-Hole Peg Test (9-HPT) — a measure of arm, wrist and hand function — will be used as the primary efficacy outcome. A key secondary endpoint is 12-week CDP. This multicentre, randomised, placebo-controlled, double-blind study is planned to start before the end of 2018 and will enrol approximately 1,000 people with PPMS.

“Addressing the needs of people with progressive MS, who are typically more advanced in their disease course, is one of the major frontiers in MS research. Around a third of people living with progressive MS may already be confined to a wheelchair, so maintaining hand and arm function is essential for them to stay independent and lead active lives,” said lead trial investigator Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London. “For a number of years, through our #ThinkHand campaign, we have been urging industry to conduct a study looking at upper limb function in people with advanced MS. We’re pleased that in collaboration with Roche, we will conduct a clinical trial that uses hand function as a primary outcome for the first time.”

The second study, named CONSONANCE, will evaluate the efficacy of OCREVUS in the complete spectrum of progressive MS (PPMS and secondary progressive MS (SPMS)). The CONSONANCE study will measure the long-term effectiveness of OCREVUS in progressive MS with novel composite disability endpoints, including No Evidence of Progression (NEP) and No Evidence of Progression or Active Disease (NEPAD), in addition to a wide range of patient-relevant measures and advanced MRI outcomes. The four-year, Phase IIIb study is currently enrolling 600 people with PPMS or SPMS (in a 1:1 ratio) from across 26 countries. The study will also explore whether technology-enabled, continuous sensor-based and self-administered measures may detect changes in disability progression earlier than conventional clinical measures.

Roche presentations at EAN 2018

Leading investigators will present the following oral and poster presentations at EAN 2018:

About OCREVUS® (ocrelizumab)

OCREVUS is a humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with multiple sclerosis (MS). Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

OCREVUS is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

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.

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