Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term efficacy, safety and durability of Vabysmo® (faricimab-svoa) in wet, or neovascular, age-related macular degeneration (AMD), a leading cause of vision loss. Wet AMD affects nearly 1.1 million people in the U.S. and can require treatment with eye injections every one to two months. The

New Two-Year Data Confirm Genentech's Vabysmo Improves Vision With Fewer Treatments for People With Wet Age-Related Macular Degeneration

The street consensus anticipates 10.10% net profit and 6.77% free cash flow CAGR for Roche over the next 5 years. Ocrevus holds 20% of the global multiple sclerosis market share.

Roche: The Undervalued Swiss Pharma Giant

Bayer AG

BAYRY vs. RHHBY: Which Stock Is the Better Value Option?

Basel, 11 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the primary analysis of the phase III HAVEN 6 study, which show that Hemlibra® (emicizumab) continued to demonstrate a favourable safety profile and effective bleed control in people with moderate or mild haemophilia A, without factor VIII inhibitors.[1] The data will be presented at the 30th International Society on Thrombosis and Haemostasis (ISTH) Annual Congress, on 11 July 2022, in London, United Kingdom, and are planned to support a submission to the European Medicines Agency to update the label for Hemlibra to include non-severe haemophilia A patients. “We are proud that Hemlibra continues to redefine the standard of care for more people living with haemophilia A,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “The data presented at ISTH this year underscore Roche's commitment to addressing gaps in care for haemophilia A, thereby ensuring that broader populations can potentially benefit from Hemlibra.” In addition to HAVEN 6, data from the CHESS II (Cost of Haemophilia across Europe: a Socioeconomic Survey-II) and CHESS PAEDs studies will also be presented at ISTH 2022. These data show most adults with moderate or mild haemophilia A and more than half of children with moderate haemophilia A may not receive preventative treatments. This can result in worsened clinical burden, as more than 30% of adults and approximately 40% of children with moderate haemophilia A who were not taking preventative treatment in the study experienced at least three bleeds a year.[3] HAVEN 6 is a phase III, multicentre, open-label, single-arm study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of Hemlibra in people with moderate or mild haemophilia A without factor VIII inhibitors. The primary analysis included data from 72 participants (69 men and three women) who warranted prophylaxis; 21 had mild haemophilia A without factor VIII inhibitors and 51 had moderate haemophilia A without factor VIII inhibitors at a median follow-up of 55.6 weeks. At baseline, 37 participants were receiving factor VIII prophylactic treatment and 24 had target joints.[1] The data show that Hemlibra maintained low treated bleed rates across the study period, with 66.7% of participants experiencing no bleeds that required treatment, 81.9% experiencing no spontaneous bleeds that required treatment, and 88.9% experiencing no joint bleeds that required treatment.[1] Model-based annualised bleed rates (ABR) remained low throughout the evaluation period at 0.9 (95% CI: 0.55-1.52). The results also show that Hemlibra's safety profile was consistent with findings across various subpopulations of people with haemophilia A, from previous HAVEN and STASEY studies, with no new safety signals observed. The most common adverse event (AE) related to treatment occurring in 10% or more people in the HAVEN 6 study was local injection site reactions (ISRs) (16.7%). Fifteen people (20.8%) reported a Hemlibra-related AE, of which the majority were local ISRs. One participant experienced a grade one thromboembolic event unrelated to Hemlibra. There were no deaths or cases of thrombotic microangiopathy, reinforcing Hemlibra's favourable safety profile.[1] Hemlibra is approved to treat people with haemophilia A with factor VIII inhibitors in more than 110 countries worldwide and for people without factor VIII inhibitors in more than 95 countries worldwide, including the US and Japan for all severities of haemophilia A, and the EU for only severe haemophilia A. It has been studied in one of the largest clinical trial programmes in people with haemophilia A with and without factor VIII inhibitors, including eight phase III studies. About Hemlibra ® ( emicizumab ) Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once-weekly, every two weeks, or every four weeks (after an initial once-weekly dose for the first four weeks). Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech. It is marketed in the United States by Genentech as Hemlibra (emicizumab-kxwh), with kxwh as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration. About haemophilia A Haemophilia A is an inherited, serious disorder in which a person's blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Haemophilia A affects around 900,000 people worldwide, approximately 35-39% of whom have a severe form of the disorder. People with haemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their disorder, people with haemophilia A can bleed frequently, especially into their joints or muscles. These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility and long-term joint damage. A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies. Inhibitors are antibodies developed by the body's immune system that bind to and block the efficacy of replacement factor VIII, making it difficult, if not impossible, to obtain a level of factor VIII sufficient to control bleeding. About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematological diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

New data from phase III HAVEN 6 study reinforce favourable safety and efficacy profile of Roche's Hemlibra in people with moderate or mild haemophilia A

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the primary analysis of the Phase III HAVEN 6 study, which show that Hemlibra® (emicizumab-kxwh) continued to demonstrate a favorable safety profile and effective bleed control in people with moderate or mild hemophilia A, without factor VIII inhibitors. The data will be presented at the 30th International Society on Thrombosis and Haemostasis (ISTH) An

New Data From Phase III HAVEN 6 Study Reinforce Favorable Safety and Efficacy Profile of Genentech's Hemlibra (emicizumab-kxwh) in People With Moderate or Mild Hemophilia A

Roche's (RHHBY) BLA application seeking approval for the use of Lunsumio for relapsed or refractory follicular lymphoma has been granted priority review in the United States.

Roche's (RHHBY) Lunsumio Application Gets Priority Review

Basel, 6 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) and granted Priority Review for Lunsumio® (mosunetuzumab), a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. FL is the most common indolent (slow growing) form of non-Hodgkin lymphoma (NHL), a type of blood cancer, which often returns after initial therapy. The FDA is expected to make a decision on approval of this novel cancer immunotherapy by 29 December 2022.

FDA grants Priority Review to Roche's Lunsumio for people with relapsed or refractory follicular lymphoma

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 Biologics License Application (BLA) and granted Priority Review for mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic the

FDA Grants Priority Review to Genentech's Mosunetuzumab for People With Relapsed or Refractory Follicular Lymphoma

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Health care investors would be wise to keep tabs on the results of numerous drug trials scheduled to be revealed in the third quarter. Trial data can impact the stock price of a pharmaceutical company, sometimes sending it up, sometimes down.

3rd-Quarter Clinical Trial Data Could Shake Up Pharma Stocks

This marks an underperformance compared to some of its peers and the broader markets, with Johnson & Johnson stock rising 22%, Pfizer stock rising 41%, Merck stock up 5%, and the S&P 500 index rising 17% over the same period.

Should You Buy, Sell, Or Hold Roche Stock At $42?

Basel, 29 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the BenchMark ULTRA PLUS system, its newest advanced tissue staining platform. The system enables quick and accurate test results so clinicians can make timely decisions regarding a patient's care journey.

Roche launches new BenchMark ULTRA PLUS system for cancer diagnostics enabling timely, targeted patient care

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Investors who are sweating the loss of patent protection for some of Big Pharma's top-selling drugs should relax.

Investors Need Not Be Alarmed by Drug Patent Expirations

Basel, 28 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE launch of the next-generation VENTANA DP 600 slide scanner (CE-IVD marked). This high-capacity slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab. “The VENTANA DP 600 slide scanner is an important tool in the advancement of personalised healthcare. In combination with our innovative AI image analysis algorithms, this solution can help ensure that each patient receives the most effective treatment plan possible,” said Thomas Schinecker, CEO of Roche Diagnostics. “It also creates opportunities for better collaboration and remote diagnosis, which can be lifesaving in areas with limited access to pathologists.” The VENTANA DP 600 slide scanner is an important addition to the Roche Digital Pathology portfolio, which provides innovative, high-quality digital solutions that automate tissue diagnostics and empower pathologists to provide faster and more comprehensive diagnostic results to healthcare providers and their patients. Digital Pathology refers to the digitalisation of the traditional pathology workflow starting from slide scanning to visualisation to analysis. Digital Pathology is transforming traditional histopathology by improving efficiency, depth of analysis, and opportunity for collaboration in pathology workflows. For example, once the slide scanner captures and converts stained tissue on glass slides to digital images, these images can be managed, shared, and analysed by pathologists and can help determine a cancer patient's treatment. This new 240-slide scanner, which builds on the success of the 6-slide VENTANA DP 200 scanner, will help anatomic pathology laboratories accelerate the digitalisation of their pathology workflow. Both scanners feature the same innovative optics and dynamic focus technology for high-resolution, high-quality colour images that accurately reproduce the image quality that pathologists see under microscopes. About Roche Digital Pathology Built by pathologists, for pathologists, the end-to-end Roche Digital Pathology solution focuses on maximising the pathologists' unique training, skills, and vision. The Roche Digital Pathology solution is an integrated solution that combines innovative slide scanners, patient-centric pathology workflow software and image analysis algorithms, working in integrated harmony with the full Roche tissue diagnostics portfolio. The newest addition to the Roche Digital Pathology portfolio is the 240-slide, high-capacity brightfield VENTANA DP 600 slide scanner that offers workflow flexibility to suit a variety of anatomical pathology labs. VENTANA slide scanners use tray-based systems engineered with minimal moving parts. The slides move through the system on the tray without interference by a robotic mechanism, allowing for a high quality scan even if the slides are wet, frozen, or if cover slips are slightly off centre. The tray based system eliminates slide-handling errors such as breakage and loss of slides. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

Roche launches the VENTANA DP 600 slide scanner for digital pathology, enhancing patient care with precision diagnostics

Everyone appears to be "rivaling each other to get the headlines and say the most awful things about the world," says veteran strategist David Roche.

The world can avoid a recession but it won't think it can until it does, says David Roche

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Roche Alzheimer's Candidate Failure Hurts Lilly, Biogen

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If you have the discipline to think long-term as an investor, this is the time to take advantage of the steep discounts on great biotechnology companies.

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Roche's (RHHBY) study evaluating crenezumab in autosomal dominant Alzheimer's disease did not slow or prevent cognitive decline in people with a specific genetic mutation that causes its early onset.

Roche (RHHBY) Alzheimer's Disease Drug Data Disappoints

Roche Holdings AG (OTC: RHHBY) said its Alzheimer's medicine crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation that causes early-onset disease. Crenezumab did not show a statistically significant clinical benefit in its co-primary.

Roche-AC Immune's Crenezumab Fails To Show Benefit In Sub-Set Of Alzheimer's Patients

Basel, 16 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of a human papillomavirus (HPV) self sampling solution in countries accepting the CE mark. This new solution enables a patient to privately collect her sample for HPV screening while at a healthcare facility, following instructions provided by a healthcare worker. The clinically-validated vaginal sample is analysed with the Roche cobas® HPV test on a Roche molecular instrument. Screening for human papillomavirus (HPV) can help identify women who are at risk of developing cervical cancer, so that the disease can be found and treated early before it has a chance to develop. There are many drivers that contribute to women not participating in cervical cancer screening programs, including limited access to testing, past experiences, embarrassment and cultural influences. Roche's self sampling solution helps reduce these barriers by offering women an alternative to more invasive clinician collection procedures, while also providing accurate and reliable results enabling clinicians to make patient care decisions. “The elimination of cervical cancer is within reach. Reducing barriers to HPV screening by enabling women to self-collect their own specimen for HPV testing is a critical tool in the fight against cervical cancer,” said Thomas Schinecker, CEO Roche Diagnostics. In low- and middle-income countries, women are often diagnosed with cervical cancer at a more advanced stage, where the opportunity for cure is low. By broadening access through removing barriers and enabling screening in additional healthcare environments, Roche highlights its commitment to achieving the World Health Organisation's global strategy to eliminate cervical cancer and reduce the overall mortality rate.3 About the cobas HPV test The cobas HPV test is indicated for use for routine cervical cancer screening as per professional medical guidelines, including HPV primary screening, co-testing (or adjunctive screen) with cytology, and for triage of women with abnormal cytology, to assess the risk for cervical precancer and cancer. Test performance for this new sampling method demonstrates that self-collected vaginal specimens tested using a molecular technology are fully adequate, and provide results that are comparable to clinician-collected cervical samples. Cervical cancer screening using the cobas HPV test is clinically validated in large, FDA registrational trials for use on cobas systems, and the assay individually identifies the presence of the DNA of HPV genotypes 16 and 18 – the two genotypes responsible for about 70 percent of all cervical cancers4 – and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. More information about the cobas HPV tests is available at diagnostics.roche.com/cervicalcancer or cervicalcancer-screening.com. The fully automated cobas 6800/8800 Systems offer the fastest time to results, providing up to 96 results in about three hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. Learn more now: http://diagnostics.roche.com. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

Roche launches human papillomavirus (HPV) self-sampling solution, expanding cervical cancer screening options

Basel, 16 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY), together with Banner Alzheimer's Institute, today announced results from the Alzheimer's Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial. The study evaluated the potential of crenezumab, an investigational medicine, to slow or prevent Alzheimer's disease in cognitively unimpaired people who carry a specific genetic mutation which causes early-onset Alzheimer's disease. The trial did not demonstrate a statistically significant clinical benefit in either of its co-primary endpoints assessing the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index, respectively. Small numerical differences favouring crenezumab were observed across the co-primary and multiple secondary and exploratory endpoints, but these were not statistically significant. No new safety issues were identified with crenezumab during the study. Further analyses of data are ongoing. Initial data will be presented at the Alzheimer's Association International Conference (AAIC) on August 2, 2022. “We're disappointed that the treatment did not demonstrate a statistically significant clinical benefit,” said Eric M. Reiman, M.D., Banner Alzheimer's Institute executive director and one of the study leaders. “At the same time, we're proud of the impact that this precedent-setting trial has had in shaping a new era in Alzheimer's prevention research and we're extremely grateful to our research participants and their families. This trial, the data, samples and findings that we'll share with the research community, and the related work that we and others are doing promise to further accelerate the evaluation and approval of future prevention therapies.” The trial enrolled 252 people who are members of the world's largest extended family with ADAD in Colombia, with 94% of participants completing the study. Two-thirds of participants carried the Presenilin 1 E280A mutation which typically causes cognitive impairment due to Alzheimer's disease around age 44. Participants were randomised to receive crenezumab, an investigational treatment discovered by AC Immune SA, or placebo over five to eight years. During the trial, the dose of crenezumab was increased as knowledge about potential treatment approaches for Alzheimer's disease evolved. “While this is a disappointing result, we would like to thank the participants and their families - they have made an enormous contribution to advancing both understanding and the search for new treatments for familial Alzheimer's disease,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We remain committed to contributing further scientific evidence to advance how Alzheimer's disease is understood, diagnosed and treated.” The study, which was supported by the National Institute on Aging, generous philanthropic contributions to Banner Alzheimer's Foundation, and Roche, has generated a wealth of data that will advance the early detection, tracking and study of Alzheimer's disease and inform the design of future Alzheimer's prevention trials. Within its Alzheimer's pipeline, Roche is also evaluating the potential of gantenerumab in autosomal dominant Alzheimer's disease, as well as for the prevention of sporadic Alzheimer's and treatment of early Alzheimer's in late stage clinical trials. Results from the phase III GRADUATE studies of gantenerumab in early Alzheimer's are expected in Q4, 2022. About Banner Alzheimer's Institute Since its inception in 2006, Banner Alzheimer's Institute (BAI) has sought to find effective Alzheimer's disease prevention therapies without losing another generation, establish a new model of dementia care for patients and family caregivers, and forge new models of collaboration in biomedical research. It has made groundbreaking contributions to the unusually early detection, tracking, diagnosis and study of Alzheimer's, and aims to find an effective prevention therapy by 2025. It includes the pioneering Alzheimer's Prevention Initiative (API), an extensive profile of research studies and clinical trials, comprehensive clinical, family and community service programs, a leading brain imaging research program, and strategic partnerships with numerous public and private research organisations around the world. About the Alzheimer's Prevention Initiative (API) and the API ADAD (Colombia) Trial The Alzheimer's Prevention Initiative (API) is an international collaborative formed in 2009 to launch a new era of Alzheimer's prevention research. Led by the Banner Alzheimer's Institute, the API conducts prevention trials in cognitively healthy people at increased risk for Alzheimer's disease. API continues to establish brain imaging, fluid biomarker and cognitive endpoints needed to rapidly test promising prevention therapies. It also leads participant recruitment registries to accelerate enrollment into Alzheimer's-focused studies. API is intended to provide the scientific means, accelerated approval pathway and enrollment resources needed to evaluate the range of promising Alzheimer's prevention therapies and find ones that work without losing another generation. First proposed by investigators from BAI, the API ADAD trial (NCT01998841) was a prospective, randomised, double-blind, placebo-controlled, parallel-group label enabling Phase II study of the efficacy of crenezumab versus placebo in cognitively unimpaired individuals who have no clinical symptoms of Alzheimer's disease and carry the PSEN1 E280A autosomal dominant mutation. Participants who are mutation carriers were randomised in a 1:1 ratio to receive either crenezumab or placebo for at least 260 weeks. Crenezumab was initially administered subcutaneously 300 mg every two weeks. Dosing was amended in 2015 to 720 mg subcutaneously every two weeks and in 2019 the option to increase the dose to 60 mg/kg, delivered intravenously every four weeks, was offered to participants. A cohort of participants (non-mutation carriers) were also enrolled and dosed solely on placebo. The trial, which was supported by National Institute on Aging (NIA) generous philanthropic contributions to Banner Alzheimer's Foundation and Roche, was the first NIH-supported prevention trial of an experimental prevention therapy in cognitively unimpaired persons at known risk for the disease. For more information, go to https://alzheimerspreventioninitiative.com/ . About Autosomal Dominant Alzheimer's Disease Autosomal dominant Alzheimer's Disease (ADAD; also known as familial AD or dominantly-inherited AD [DIAD]) is a rare, inherited form of Alzheimer's disease caused by single gene mutations in the APP, PSEN1 or PSEN2 genes. Less than 1% of all Alzheimer's cases worldwide are thought to be caused by genetic mutations. It usually has a much earlier onset than the more common sporadic Alzheimer's disease, with symptoms developing in people in their 30s to 60s. If an individual has one of these mutations they are nearly certain to develop Alzheimer's and there is a 50% chance they will pass it on to each of their children. About the PSEN1 E280A mutation and the Antioquia kindreds The PSEN1 E280A or ‘Paisa' mutation virtually guarantees that carriers will develop Alzheimer's at the average age of 44 and dementia at the average age of 49. The Colombian PSEN1 E280A kindred are the world's largest extended family with ADAD, with ~6,000 family members and ~1,200 with the mutation. The API ADAD trial was conducted in collaboration with neurologist Francisco Lopera and his team, Grupo de Neurociencias de Antioquia (GNA), at the University of Antioquia in Medellín, Colombia. Dr Lopera followed the kindred for three decades prior to the start of the trial and has established a close relationship with many members. About crenezumab Crenezumab is an investigational, monoclonal antibody designed to neutralise neurotoxic oligomers, a form of beta-amyloid. Crenezumab has an antibody backbone (IgG4) designed to minimise the inflammatory response in the brain, which may result in a lower risk of certain MRI (magnetic resonance imaging) abnormalities known as ARIA (Amyloid-Related Imaging Abnormalities). The investigational medicine was discovered by Swiss biotechnology company AC Immune SA. About Roche in Neuroscience Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer's disease, Huntington's disease, Parkinson's disease and Duchenne muscular dystrophy. 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 Roche Founded in1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. 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 . All trademarks used or mentioned in this release are protected by law. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche provides update on Alzheimer's Prevention Initiative study evaluating crenezumab in autosomal dominant Alzheimer's disease

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), together with Banner Alzheimer's Institute, today announced results from the Alzheimer's Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial. The study evaluated the potential of crenezumab, an investigational medicine, to slow or prevent Alzheimer's disease in cognitively unimpaired people who carry a specific genetic mutation which causes earl

Genentech Provides Update on Alzheimer's Prevention Initiative Study Evaluating Crenezumab in Autosomal Dominant Alzheimer's Disease

Basel, 15 June 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the cobas SARS-CoV-2 Duo for use on the fully automated cobas 6800/8800 Systems, expanding the Roche COVID-19 portfolio. This is the first automated, real-time RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. "With the SARS-CoV-2 Duo test, we are now able to detect the COVID-19 virus and simultaneously measure the viral load in an individual,” said Thomas Schinecker, CEO Roche Diagnostics. “The test's performance suggests that, by earlier and more accurately identifying infected patients, the results may open the path for healthcare providers to more efficiently organise their therapeutic and monitoring interventions.” The quantitative result is traceable to the World Health Organization (WHO) International Standard for SARS-CoV-2 RNA. The potential benefits from reporting a standardized viral load along with the qualitative result may help clinicians in the assessment and monitoring of infected patients across laboratories and over time. Roche continues to add a range of diagnostic solutions to our global portfolio to help in the fight against COVID-19. For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page. The test will be available in the United States by Q2 2022. About the cobas SARS-CoV-2 Duo test The cobas SARS-CoV-2 Duo test received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) on June 14, 2022. The cobas SARS-CoV-2 Duo for use on the cobas® 6800/8800 Systems is an automated real-time RT-PCR assay for the qualitative detection of SARS-CoV-2 RNA in healthcare provider instructed self-collected nasal swab specimens (collected on site), and healthcare provider-collected nasal and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. This assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of cobas® SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Roche receives FDA EUA for cobas SARS-CoV-2 Duo, the first PCR test to simultaneously detect COVID-19 and quantitatively measure viral load levels of COVID-19

Basel, 10 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it is presenting new long-term follow-up results and subanalyses from clinical trials of its approved therapies, as well as data on investigational medicines from its broad blood cancer portfolio, at the European Hematology Association (EHA) 2022 Congress in Vienna. Data include five-year results from the phase III CLL14 study of fixed-duration Venclexta®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® (obinutuzumab) in previously untreated chronic lymphocytic leukaemia (CLL); the final analysis of the phase III GALLIUM study of Gazyva/Gazyvaro plus chemotherapy in people with previously untreated advanced-stage follicular lymphoma (FL); and subanalyses from the phase III POLARIX study of Polivy® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Roche will also present data from its T-cell engaging bispecific antibody development programmes including Lunsumio® (mosunetuzumab) and glofitamab in patients receiving later lines of therapy for non-Hodgkin lymphoma (NHL) and investigational medicines cevostamab and RG6234 in relapsed or refractory (R/R) multiple myeloma (MM). “Blood cancers remain challenging to treat at all stages, but by improving frontline treatment options we aim to increase the likelihood of meaningful clinical outcomes for these patients,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “With these new long-term data and other studies of fixed-duration therapies in our portfolio, we are working to lessen the treatment burdens associated with long-term cancer care.” Improv ing clinical outcomes with effective frontline treatment options Five-year results of phase III CLL14 study of Venclexta/Venclyxto plus Gazyva/Gazyvaro ( Abstract #S148 ) After a median of 65.4 months following treatment with Venclexta/Venclyxto plus Gazyva/Gazyvaro, results confirm the combination continues to be an effective fixed-duration and chemotherapy-free option for patients with previously untreated CLL and coexisting conditions. The estimated investigator-assessed progression-free survival (PFS) rate at this follow-up was 62.6% with Venclexta/Venclyxto plus Gazyva/Gazyvaro and 27.0% with Gazyva/Gazyvaro plus chlorambucil, and the estimated overall survival (OS) rate was 81.9% versus 77.0% (HR 0.72; 95% CI: 0.48-1.09; p=0.12). In addition, the analysis found that 72.1% of patients in the Venclexta/Venclyxto plus Gazyva/Gazyvaro arm did not require another treatment for CLL in the five years following initial treatment (HR 0.42; 95% CI: 0.31-0.57; p

Roche announces positive data from broad blood cancer portfolio at European Hematology Association Annual Meeting

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it is presenting new long-term follow-up results and subanalyses from clinical trials of its approved therapies, as well as data on investigational medicines from its broad blood cancer portfolio, at the European Hematology Association (EHA) 2022 Congress in Vienna. Data include five-year results from the Phase III CLL14 study of fixed-duration Venclexta® (vene

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