Roche to present data across broad and impactful

• First knowledge exhibiting OCREVUS therapy impact on incapacity development in non-active secondary progressive a number of sclerosis and additional knowledge in major progressive MS will likely be offered
• Evrysdi knowledge proceed to reveal long-term efficacy and security in a broad inhabitants of individuals with spinal muscular atrophy
• Longer-term efficacy and security for Enspryng in neuromyelitis optica spectrum dysfunction reinforce beforehand seen outcomes
• Further knowledge throughout neurological issues, together with Alzheimer’s illness, assist advance the scientific understanding of those situations and the potential influence of early therapy

Basel, 25 March 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) right now introduced new knowledge for its authorized and investigational medicines throughout neurological issues will likely be offered on the 74th American Academy of Neurology (AAN) Annual Assembly being held 02-07 April in Seattle and nearly 24-26 April 2022. These knowledge embrace twenty-four abstracts highlighting Roche’s expansive neuroscience portfolio throughout 5 therapeutic areas, together with OCREVUS® (ocrelizumab) in relapsing, secondary and first progressive a number of sclerosis (RMS, SPMS and PPMS), EVRYDSI™ (risdiplam) in spinal muscular atrophy (SMA), ENSPRYNG™ (satralizumab) in neuromyelitis optica spectrum dysfunction (NMOSD), together with knowledge from investigational applications in Alzheimer’s illness (AD) and Duchenne muscular dystrophy (DMD).

“The longer-term efficacy and security knowledge for OCREVUS, EVRYSDI and ENSPRYNG, in addition to findings from various and underrepresented populations, reveal the numerous influence of our increasing neuroscience portfolio,” stated Levi Garraway, M.D., Ph.D. Roche’s Chief Medical Officer and Head of World Product Growth. “We stay dedicated to advancing the science and bettering the lives of individuals dwelling with neurological situations.”

A number of Sclerosis
Roche will current 11 abstracts on MS and OCREVUS at AAN. New knowledge from the one-year interim evaluation of CONSONANCE, a first-of-its-kind open-label Part III trial, will present the therapy impact of OCREVUS within the full spectrum of progressive MS – SPMS and PPMS – with novel composite incapacity endpoints.

Moreover, an evaluation of a U.S. claims database will spotlight therapy disparities between Black and Hispanic/Latino-American sufferers and non-Hispanic white sufferers within the two years after prognosis. Addressing well being inequity and inclusion in analysis is central to Roche’s mission to enhance affected person well being outcomes. The insights from the information offered at AAN reinforce the significance of Roche’s CHIMES trial evaluating OCREVUS in Black and Hispanic sufferers with MS, which is now absolutely enrolled throughout websites within the U.S. and Kenya.

Spinal Muscular Atrophy
Roche will current encore knowledge from the medical improvement programme for EVRYSDI, together with 3-year knowledge from SUNFISH Half 1 and a pair of, highlighting the long-term efficacy and security of EVRYSDI in folks aged 2-25 years with Sort 2 or Sort 3 SMA. As well as, up to date interim efficacy knowledge from the RAINBOWFISH examine in presymptomatic infants with SMA will likely be offered. The medical improvement programme represents the broad real-world spectrum of individuals dwelling with SMA from new child infants to folks aged 60 years previous.

Roche will even share the design of the brand new MANATEE trial, a multi-centre, randomised, placebo-controlled, double-blind examine learning GYM329, an investigational anti-myostatin, together with EVRYSDI.

Neuromyelitis Optica Spectrum Dysfunction
Roche will current encore long-term efficacy and security knowledge from the ENSPRYNG SAkuraSky and SAkuraStar research. These knowledge reinforce the beforehand noticed efficacy and security of ENSPRYNG, the primary and solely authorized therapy designed to focus on and inhibit the IL-6 receptor exercise, and that may be administered subcutaneously each 4 weeks at residence after coaching from a healthcare supplier.

To extend the scientific understanding of NMOSD and enhance look after all folks dwelling with the situation, Roche has initiated SAkuraBONSAI, a multi-centre, Part IIIb, worldwide examine evaluating ENSPRYNG therapy for folks with AQP4-IgG seropositive NMOSD who’re therapy naïve, or the place prior rituximab (or biosimilar) therapy has failed*; SAkuraBONSAI will additional consider illness exercise and development utilizing complete imaging, biomarker and medical evaluation.

Alzheimer’s Illness
Roche will current updates from its AD medical programme, together with baseline traits of the Part III GRADUATE research in sufferers with early AD.

As well as, the design of the post-GRADUATE open label rollover examine evaluating the long-term security, tolerability and efficacy of gantenerumab in sufferers from the GRADUATE 1 and a pair of research will likely be offered.

For greater than twenty years, Roche has been learning and growing gantenerumab, a late-stage investigational subcutaneously-administered monoclonal antibody, for the therapy of AD. Information from the pivotal GRADUATE trials are anticipated within the fourth quarter of 2022. Gantenerumab can also be being evaluated within the Part III SKYLINE prevention trial to higher perceive the potential of the investigational remedy to sluggish illness development in folks with the earliest organic indicators of AD.

The complete vary of information from Roche’s medical improvement programme in neuroscience being offered at 2022 AAN embrace:

About OCREVUS® (ocrelizumab)
OCREVUS is the primary and solely remedy authorized for each RMS (together with RRMS and energetic, or relapsing, SPMS and CIS within the U.S.) and PPMS, with six-month dosing. OCREVUS is a humanised monoclonal antibody designed to focus on CD20-positive B cells, a particular kind of immune cell considered a key contributor to myelin (nerve cell insulation and assist) and axonal (nerve cell) injury. This nerve cell injury can result in incapacity in folks with MS. Based mostly on preclinical research, OCREVUS binds to CD20 cell floor proteins expressed on sure B cells, however not on stem cells or plasma cells, suggesting that necessary features of the immune system could also be preserved. OCREVUS is run by intravenous infusion each six months. The preliminary dose is given as two 300 mg infusions given two weeks aside. Subsequent doses are given as single 600 mg infusions.

About EVRYSDI™ (risdiplam)
EVRYSDI is a survival of motor neuron 2 (SMN2) splicing modifier designed to deal with SMA by rising and sustaining the manufacturing of the survival motor neuron (SMN) protein within the central nervous system (CNS) and peripheral tissues. SMN protein is discovered all through the physique and is crucial for sustaining wholesome motor neurons and motion. EVRYSDI is run each day at residence in liquid type by mouth or by feeding tube.

The U.S. Meals and Drug Administration (FDA) authorized EVRYSDI for the therapy of SMA in adults and youngsters 2 months of age and older. EVRYSDI was granted PRIME designation by the European Medicines Company (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Presently, EVRYSDI has been authorized in 76 international locations and submitted in an additional 29 international locations.

About ENSPRYNGTM (satralizumab)
ENSPRYNG, which was designed by Chugai, a member of the Roche Group, is a humanized monoclonal antibody that targets interleukin-6 (IL-6) receptor exercise. The cytokine IL-6 is believed to be a key driver in NMOSD illness processes, triggering the irritation cascade and main to break and incapacity. ENSPRYNG was designed utilizing novel recycling antibody know-how. When in comparison with standard antibodies, ENSPRYNG’s recycling antibody know-how permits the medication to stay within the bloodstream for an extended time period and bind repeatedly to its goal (the IL-6 receptor) – maximally sustaining IL-6 suppression in a power illness like NMOSD and enabling subcutaneous dosing each 4 weeks.

Constructive Part III outcomes for ENSPRYNG, as each monotherapy and together with baseline immunosuppressive remedy, reveal that IL-6 inhibition is an efficient therapeutic method for sufferers with NMOSD who’re AQP4-IgG seropositive. The Part III medical improvement program for ENSPRYNG contains two research: SAkuraStar and SAkuraSky.

ENSPRYNG is at present authorized in 63 international locations, together with the USA, Canada, Japan, South Korea and the European Union.

ENSPRYNG has been designated as an orphan drug in the USA, Europe, Japan and Russia. As well as, it was granted Breakthrough Remedy Designation for the therapy of NMOSD by the FDA in December 2018, which is given to remedies that will reveal substantial enchancment over different obtainable choices.

About Roche in neuroscience
Neuroscience is a significant focus of analysis and improvement at Roche. Our objective is to pursue groundbreaking science to develop new remedies that assist enhance the lives of individuals with power and doubtlessly devastating illnesses.

Roche is investigating greater than a dozen medicines for neurological issues, together with a number of sclerosis, Alzheimer’s illness, Huntington’s illness, Parkinson’s illness, Duchenne muscular dystrophy and autism spectrum dysfunction. Along with our companions, we’re dedicated to pushing the boundaries of scientific understanding to unravel a number of the most tough challenges in neuroscience right now.

About Roche
Based in 1896 in Basel, Switzerland, as one of many first industrial producers of branded medicines, Roche has grown into the world’s largest biotechnology firm and the worldwide chief in in-vitro diagnostics. The corporate pursues scientific excellence to find and develop medicines and diagnostics for bettering and saving the lives of individuals all over the world. We’re a pioneer in personalised healthcare and wish to additional remodel how healthcare is delivered to have a fair better influence. To supply the most effective look after every particular person we associate with many stakeholders and mix our strengths in Diagnostics and Pharma with knowledge insights from the medical observe.

In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named probably the most sustainable firms within the prescribed drugs trade by the Dow Jones Sustainability Indices for the thirteenth consecutive 12 months. This distinction additionally displays our efforts to enhance entry to healthcare along with native companions in each nation we work.

Genentech, in the USA, is an entirely owned member of the Roche Group. Roche is almost all shareholder in Chugai Pharmaceutical, Japan.

For extra info, please go to www.roche.com.

*It is very important word, rituximab (or any biosimilar) just isn’t authorized by regulatory authorities for the therapy of NMOSD.

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