DNase1-Fc

Phase III OCARINA II trial met primary and secondary endpoints Ocrevus 10-minute injection has the potential to further improve the treatment experience and expand Ocrevus® usage in MS centers with IV capacity limitations or without IV infrastructure Ocrevus remains the first and only therapy approved for both RMS and PPMS, and more than 300,000 people have been treated globally SOUTH SAN FRANCISCO, CA, USA I July 12, 2023 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase III OCARINA II trial evaluating Ocrevus ® (ocrelizumab) as a twice a year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of MS or primary progressive MS (RMS or PPMS). Ocrevus subcutaneous injection was shown to be non-inferior to Ocrevus given by intravenous infusion (IV), as measured by pharmacokinetics (levels in the blood) over 12 weeks. Ocrevus subcutaneous injection was also comparable with Ocrevus IV in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks. The safety profile of Ocrevus subcutaneous injection was consistent with that of Ocrevus IV. The Ocrevus 10-minute injection is designed to be administered without the need for IV infrastructure so it has the potential to expand the usage of Ocrevus in MS centers without IV infrastructure or those with IV capacity limitations. It also retains the twice-yearly dosing regimen of Ocrevus IV that has shown high persistence and adherence since becoming a standard of care MS treatment. 1 This provides an additional delivery option so that the administration of Ocrevus can be matched to the individual needs of patients and healthcare professionals. “These results give people living with MS the possibility to receive the transformational benefits of Ocrevus in the way best suited to their lives while freeing up time and healthcare resources,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “This new subcutaneous injection will allow Ocrevus to be administered in 10 minutes twice a year, helping people living with MS to spend less time in treatment for this disease.’’ Detailed results from the trial will be presented at an upcoming medical meeting and submitted to health authorities around the world. Roche is committed to advancing innovative clinical research programs to broaden the scientific understanding of MS, further reduce disability progression in RMS and PPMS and improve the treatment experiences for those living with the disease. About the OCARINA II study OCARINA II is a Phase III, global, multicentre, randomized study evaluating the pharmacokinetics, safety and radiological and clinical effects of the subcutaneous formulation of Ocrevus compared with Ocrevus intravenous (IV) infusion in 236 patients with relapsing MS (RMS) or primary progressive MS (PPMS). The primary endpoint is non-inferiority in serum area under the curve (AUC) from day 1 to 12 weeks after subcutaneous injection compared to IV infusion. Secondary endpoints include maximum serum concentration (Cmax) of Ocrevus, the total number of active, gadolinium-enhancing T1 lesions at 8 and 12 weeks, and new or enlarging T2 lesions at 12 and 24 weeks, as well as safety and immunogenicity outcomes. Exploratory endpoints include patient-reported outcomes. About the subcutaneous formulation of Ocrevus (ocrelizumab) The investigational subcutaneous formulation combines Ocrevus with Halozyme Therapeutics’ Enhanze ® drug delivery technology. 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. The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for large molecules like Ocrevus to enter, and enables the subcutaneous formulation to be rapidly dispersed and absorbed into the bloodstream. Ocrevus IV is the first and only therapy approved for the treatment of adults with either RMS (including relapsing-remitting MS [RRMS] and active secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS]) and PPMS. Ocrevus IV 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 multiple sclerosis Multiple sclerosis (MS) is a chronic disease that affects more than 2.8 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults. People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their clinical symptoms aren’t apparent or don’t appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent disease activity and progression as early as possible. Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include RRMS, CIS and SPMS with clinical or MRI activity. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS. 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 https://www.Ocrevus.com or call 1-844-627-3887. For additional safety information, please see the full Prescribing Information and Medication Guide . 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 Genentech 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 . References 1 Engmann NJ, Sheinson D, Bawa K, Ng CD, Pardo G. Persistence and adherence to ocrelizumab compared with other disease-modifying therapies for multiple sclerosis in U.S. commercial claims data. J Manag Care Spec Pharm. 2021;27(5):639-649. SOURCE: Genentech

Acceptance based on two Phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to aflibercept Application was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid If approved, RVO would be the third indication for Vabysmo in addition to wet age-related macular degeneration (AMD) and diabetic macular edema (DME) Vabysmo is currently approved in 60 countries to treat wet AMD and DME, with nearly one million doses distributed globally SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). The sBLA is based on results from the Phase III BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. Vabysmo’s safety pro consistent with previous trials. “This acceptance brings us one step closer to delivering Vabysmo as a treatment for retinal vein occlusion, a disease that affects more than one million people in the United States and can cause severe and sudden vision loss,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “If approved, this would be the third indication for Vabysmo, the first bispecific antibody available for the treatment of retinal conditions that can cause blindness.” The data from the BALATON and COMINO studies will be submitted to other health authorities around the world, including the European Medicines Agency, for approval for the treatment of macular edema following RVO. The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months. Vabysmo is the first bispecific antibody approved for the eye and was approved in the United States for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME) in January 2022. Vabysmo is approved in 60 countries, including Japan, the United Kingdom, and in the European Union, for wet AMD and DME. Wet AMD, DME, and RVO together affect around three million people in the United States and are among the leading causes of vision loss. Vabysmo’s efficacy and safety pro wet AMD and DME is supported by four large, global studies involving more than 3,000 participants and extensive real world experience, with nearly one million doses distributed globally. Vabysmo is the only injectable eye medicine approved for wet AMD and DME by the U.S. Food and Drug Administration (FDA) with the option for treatments from one to four months apart in the first year following four initial monthly loading doses, based on evaluation of the patient’s anatomy and vision outcomes. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). About the BALATON and COMINO Studies BALATON (NCT04740905) and COMINO (NCT04740931) are two randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of Vabysmo®️ (faricimab-svoa) compared to aflibercept. For the first 20 weeks, patients are randomized 1:1 to receive six monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From weeks 24 to 72, all patients receive Vabysmo (6.0 mg) up to every four months – according to a personalized treatment interval dosing regimen – using a treat-and-extend approach. The BALATON study is being conducted in 553 patients with branch retinal vein occlusion. The COMINO study is being conducted in 729 patients with central retinal or hemiretinal vein occlusion. The primary endpoint of each study is the change in best-corrected visual acuity (BCVA) from baseline at 24 weeks. Secondary endpoints include change in central subfield thickness (CST) from baseline over time up to 24 weeks. Both studies met their primary endpoint, with Vabysmo showing non-inferior visual acuity gains compared to aflibercept. The average vision gains from baseline were comparable between the two treatments in both studies. In BALATON, vision gains were +16.9 eye chart letters in the Vabysmo arm and +17.5 letters in the aflibercept arm at 24 weeks. In COMINO, vision gains were +16.9 letters in the Vabysmo arm and +17.3 letters in the aflibercept arm at 24 weeks. A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid, as measured by reduction in CST from baseline. In both studies, reductions in CST were comparable across treatment arms. In BALATON, CST reductions from baseline at 24 weeks were 311.4 μm in the Vabysmo arm and 304.4 μm in the aflibercept arm. In COMINO, CST reductions from baseline at 24 weeks were 461.6 μm in the Vabysmo arm and 448.8 μm in the aflibercept arm. Additionally, both studies showed that more Vabysmo patients had an absence of blood vessel leakage in the retina compared to aflibercept patients as seen in a pre-specified exploratory endpoint. Blood vessel leakage in the macula may lead to more retinal fluid, which can cause swelling and blurry vision. In BALATON, one-third of patients (34%) treated with Vabysmo had an absence of macular leakage compared to one-fifth (21%) of aflibercept patients at 24 weeks. In COMINO, the rates were 44% for Vabysmo patients versus 30% for aflibercept patients at 24 weeks. In both studies, Vabysmo’s safety pro consistent with previous trials. The most common adverse reaction was conjunctival hemorrhage (3%). Safety results were consistent across study arms. The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months. About Retinal Vein Occlusion Retinal vein occlusion (RVO) is the second most common cause of vision loss due to retinal vascular diseases. It affects more than one million people in the U.S., mainly those aged 50 or older, and can lead to severe and sudden vision loss. RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage, and retinal swelling called macular edema. Currently, macular edema due to RVO is typically treated with repeated intravitreal injection of anti-vascular endothelial growth factor therapies. There are two main types of RVO: branch retinal vein occlusion (BRVO), which affects an estimated 887,000 people in the U.S. and occurs when one of the four smaller “branches” of the main central retinal vein becomes blocked; and central retinal vein occlusion (CRVO), which is less common, affecting an estimated 265,000 people in the U.S., and occurs when the eye’s central retinal vein becomes blocked. About the Vabysmo® (faricimab-svoa) Clinical Development Program Genentech has a robust Phase III clinical development program for Vabysmo. The program includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in wet, or neovascular, macular degeneration (AMD), and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME). In addition, Genentech is investigating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion (RVO) in two Phase III studies, BALATON and COMINO. Genentech has also initiated several Phase IV studies, including the Elevatum study of Vabysmo in underrepresented patient populations with DME, the SALWEEN study of Vabysmo in a subpopulation of wet AMD highly prevalent in Asia, as well as the VOYAGER study, a global real-world data collection platform. About Vabysmo® (faricimab-svoa) Vabysmo (faricimab-svoa) is the first bispecific antibody approved for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. Vabysmo U.S. Indications Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age‑related macular degeneration (AMD) and diabetic macular edema (DME). Important Safety Information Contraindications Vabysmo is contraindicated in patients who have an infection in or around their eye, have active swelling around their eye that may include pain and redness, or are allergic to Vabysmo or any of the ingredients in Vabysmo. Warnings and Precautions Injections like the one for Vabysmo can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Patients should seek medical care if they experience increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye. Vabysmo may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs 60 minutes after the injection. Although not common, Vabysmo patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies for wet AMD during the first year, 7 out of 664 patients treated with Vabysmo reported such an event. In DME studies from baseline to week 100, 64 out of 1,262 patients treated with Vabysmo reported such an event. Adverse Reactions The most common adverse reactions (≥5%) reported in patients receiving Vabysmo were cataract (15%) and blood on the white of the eye (conjunctival hemorrhage, 7%). These are not all the possible side effects of Vabysmo. Pregnancy, Lactation, Females and Males of Reproductive Potential Based on how Vabysmo interacts with your body, there may be a potential risk to an unborn baby. Patients should use birth control before their first injection, during their treatment with Vabysmo, and for 3 months after their last dose of Vabysmo. It is not known if Vabysmo passes into breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if they receive Vabysmo. Patients may report side effects to the FDA at (800) FDA-1088 or . Patients may also report side effects to Genentech at (888) 835-2555. Please see additional Important Safety Information in the full Vabysmo Prescribing Information or visit . About Genentech in Ophthalmology Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases. About Genentech 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 . View source version on businesswire.com: Contacts Media Contact: Shirley Dang (650) 467-6800 Advocacy Contact: Danielle Haney (240) 805-4810 Investor Contacts: Loren Kalm (650) 225-3217 Bruno Eschli +41 61 687 5284 Source: Genentech View this news release online at: