Monday, Apr 24, 2023
Roche, Genentech and partners embark on global prevalence research, trend-spotting with digital analysis, and telehealth initiatives to assess & address deterrents to brain health to better understand holistic health journeys of patients with neurologic diseases
Long-term data to be presented demonstrate delayed MS disability with Ocrevus; reduced disease activity with Enspryng in NMOSD and with Evrysdi in SMA
Data from late-stage neuroscience pipeline to be presented, including efficacy and safety results from Phase II prasinezumab study in early Parkinson’s Disease
South San Francisco, CA -- April 24, 2023 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is announcing three new partnerships focused on improving brain health outcomes. These industry-leading initiatives are designed to quantify and assess the complexity, economic impact and patient and care partner burden of brain health conditions, and generate robust data around the nuanced dynamics of neurologic care. Conditions affecting the brain and nervous system cause more death and illness globally than cardiovascular disease, cancers, and all other conditions.1 Genentech is proud to partake in this groundbreaking collaboration with the University of Washington, Institute for Health Metrics and Evaluation (IHME), PicnicHealth and Cleveland Clinic, and insights from these partnerships will be further discussed as part of Genentech’s presence at the 75th American Academy of Neurology (AAN) Annual Meeting being held April 22-27 in Boston.
Roche and Genentech will also present 33 data abstracts spanning Ocrevus® (ocrelizumab) in multiple sclerosis (MS), Enspryng® (satralizumab-mwge) in neuromyelitis optica spectrum disorder (NMOSD) and Evrysdi® (risdiplam) in spinal muscular atrophy (SMA), as well as from its broad pipeline of medicines being investigated in neuroimmunologic and neurodegenerative diseases, and neuroscience digital health and telehealth interventions.
“Diseases affecting the brain and central nervous system are associated with loss of more disability-adjusted life-years than almost any other condition,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “With that in mind, we are committed to developing and delivering new medicines that address areas of highest need in neuroscience. Accordingly, we have more than a dozen investigational medicines that span a range of neurological conditions, with the ultimate goal of slowing progression and delaying disability for as long as possible.”
Commitment to Advancing Understanding of Brain Health and Neurological Disorders
Roche and Genentech are the number one investor in R&D among all healthcare companies, with $14.7 billion invested in 2022 alone, of which more than 20% was dedicated to evaluating therapeutic, diagnostic and digital technology interventions to discover and potentially address brain health disorders. As part of Roche and Genentech’s commitment to brain health, we have embarked on substantial new initiatives and expanded partnerships that aim to realize the full value of innovation to reduce disease burden, improve lives and help build more resilient and responsive health systems to meet current and future needs across the spectrum of brain health, including:
University of Washington, Institute for Health Metrics and Evaluation (IHME) Brain Health Initiative
Roche and Genentech are proud to support IHME as a founding member in their newly launched Brain Health Collaborative. The multi-year effort will develop a view of the current and future burden of brain health conditions (mental, neurological and cerebrovascular) and create publicly available, interactive research tools including the Brain Health Atlas, which illustrates the global burden of health conditions measured over time and geographies, exploring the full economic impact of brain disorders globally, including analysis on total economic and social costs. This initiative will be featured as part of AAN’s Practice and Policy Hub session, featuring experts from Roche, IHME and other leaders on the emerging science and technologies of brain health on Wednesday, April 26 from 7:45-8:45 a.m. ET. See here for additional details.
PicnicHealth “BrainPower” Pan-Neuroscience Patient Experience Research
Genentech is initiating a neuroscience research study called BrainPower (Brain Patient Outcomes With Experience Research), an expansion of our five-year partnership with a patient-centered medical records healthcare technology company, PicnicHealth, to analyze longitudinal, real-world clinical data of people living with neurologic diseases, such as Alzheimer’s disease (AD) and related dementias (EMPOWER AD), Myasthenia gravis (MG), and MS to identify common data trends and understand shared patient challenges across neurological disorders. This further builds on previously announced neuroscience partnerships in MS and Huntington’s disease. Details on the EMPOWER AD study with PicnicHealth will be shared in an oral presentation on Monday, April 24 at 8:00 a.m. ET.
“Social determinants of health impact quality of life, outcomes and overall health, and we are acutely aware of the disparities and inequities they perpetuate across neurological disorders -- particularly in the United States. We are partnering with the leading minds in healthcare technology, telehealth, inclusive research and evidence generation to identify barriers and co-create solutions with the neurology community to facilitate equitable healthcare delivery,” said Gregory A. Rippon, M.D., M.S., F.A.A.N., Vice President and Chief Medical Partner, Neurology. “Our hope is to help people living with neurological disorders preserve their health, independence, and what makes them uniquely who they are – and that will only be possible when every person not only receives a transformative treatment, but also receives the same quality of care, regardless of their zip code, income or background.”
Cleveland Clinic Neurology Telehealth Pilot
Telehealth is an accessible option for a variety of patients, including those living in rural areas, facing barriers to healthcare access, who are immunocompromised or could face issues with an in-person setting (e.g., due to financial or mobility challenges). Neurology practices saw one of the highest uptake rates for ambulatory telemedicine (nearly half of total visits) during the early part of the COVID-19 pandemic. Cleveland Clinic and Genentech established a research collaboration in 2022 to better understand the utilization of telehealth in nearly 200,000 people living with neurological conditions (MS, Alzheimer’s, Parkinson’s), and impact on access to care, clinical outcomes, and healthcare resource utilization within Cleveland Clinic’s health system. We hope to understand patient barriers to facilitate more equitable healthcare delivery, particularly among underserved minority communities, older and lower socioeconomic status individuals and people living in rural areas. See AAN oral presentation details on Genentech’s telehealth pilot with Cleveland Clinic here, Tuesday, April 25 at 3:54 p.m. ET.
Longer-term data to be presented at AAN to reinforce importance of early treatment and slowing disease activity and progression in MS, NMOSD and SMA
Across neurological disorders the main goal of treatment is to prevent disease progression to ultimately preserve function. Genentech will present 33 abstracts, including new long-term data for market leading Ocrevus in MS and Evrysdi in SMA, including:
Broad Neuroscience Pipeline & Areas of Focus
As global populations continue to grow and age, their impact is set to increase, creating new challenges for families, carers, health systems, employers, and economies. To meet the needs of people living with brain health conditions, Genentech is continuing to grow and advance its pipeline, with key areas of focus in neuroimmunologic, neuromuscular, neurodegenerative and neurodevelopmental diseases. In addition to the Phase II PASADENA trial, evaluating prasinezumab in people with early Parkinson’s, data being featured at AAN, Genentech’s later-stage neuroscience programs include tenecteplase for acute ischemic stroke, fenebrutinib for MS, prasinezumab in Parkinson’s, tominerson in Huntington's disease, rugonersen in angelman syndrome, satralizumab in MG and trontinemab, utilizing Roche’s Brain Shuttle technology for Alzheimer’s. Genentech’s late-stage pipeline is available here.
The full range of data from Genentech’s clinical development program in neuroscience being presented at AAN 2023 can be found at https://aan.com/events/annual-meeting.
About Genentech in Neuroscience
Neuroscience is a major focus of research and development at Genentech. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.
Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including MS, SMA, NMOSD, Alzheimer’s, Huntington’s, Parkinson’s, Acute ischemic stroke, Duchenne muscular dystrophy and Angelman syndrome. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.
About Ocrevus® (ocrelizumab)
Ocrevus is the first and only therapy approved for both RMS (including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS. Ocrevus is a humanized monoclonal antibody designed to 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 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, suggesting that 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 Enspryng® (satralizumab-mwge)
Enspryng, which was designed by Chugai, a member of the Roche Group, is a humanized monoclonal antibody that targets interleukin-6 (IL-6) receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD disease processes, triggering the inflammation cascade and leading to damage and disability. Enspryng was designed using novel recycling antibody technology. When compared to conventional antibodies, Enspryng’s recycling antibody technology enables the medicine to remain in the bloodstream for a longer period of time and bind repeatedly to its target (the IL-6 receptor) - maximally sustaining IL-6 suppression in a chronic disease like NMOSD and enabling subcutaneous dosing every four weeks.
Positive Phase III results for Enspryng, as both monotherapy and in combination with baseline immunosuppressive therapy, suggest that IL-6 inhibition is an effective therapeutic approach for NMOSD who are AQP4-IgG seropositive. The Phase III clinical development program for Enspryng includes two studies: SAkuraStar and SAkuraSky.
Enspryng is currently approved in 80 countries, including the United States, Canada, Japan, South Korea and the European Union.
Enspryng has been designated as an orphan drug in the United States, Europe, Japan and Russia. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018, which is given to treatments that may demonstrate substantial improvement over other available options.
About Evrysdi® (risdiplam)
Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.
Evrysdi is designed to treat SMA by increasing and sustaining the production of SMN protein in the central nervous system (CNS) and peripheral tissues as demonstrated in animal models. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.
Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S. Food and Drug Administration in 2017. In 2021, Evrysdi was awarded Drug Discovery of the Year by the British Pharmacological Society as well as the Society for Medicines Research award for Drug Discovery. Evrysdi is currently approved in more than 90 countries and the dossier is under review in a further 16 countries.
Evrysdi is currently being evaluated in five multicenter trials in people with SMA:
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
Indications and Important Safety Information
What is Ocrevus?
Ocrevus is a prescription medicine used to treat:
It is not known if Ocrevus is safe or effective in children.
Who should not receive Ocrevus?
Do not receive Ocrevus if you have an active hepatitis B virus (HBV) infection.
Do not receive Ocrevus if you have had a life threatening allergic reaction to Ocrevus. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past.
What is the most important information I should know about Ocrevus?
Ocrevus can cause serious side effects, including:
These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion.
If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.
Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of Ocrevus?
Ocrevus may cause serious side effects, including:
Most common side effects include infusion reactions and infections.
These are not all the possible side effects of Ocrevus.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
For more information, go to http://www.Ocrevus.com or call 1-844-627-3887.
What is Evrysdi?
Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in children and adults.
Important Safety Information
These are not all of the possible side effects of Evrysdi. For more information on the risk and benefits profile of Evrysdi, ask your healthcare provider or pharmacist.
You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Indications and Important Safety Information
Patients should not take Enspryng if they:
Enspryng may cause serious side effects including:
Before taking Enspryng, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
The most common side effects of Enspryng include:
For more information about the risk and benefit profile of Enspryng, patients should ask their healthcare provider.
Patients may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at 1-888-835-2555.
Please see the full Prescribing Information for additional Important Safety Information.
References1Brain Health Atlas. https://brainhealthatlas.org/