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.

Basel, 08 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data on its investigational T-cell engaging bispecific antibodies, mosunetuzumab, glofitamab and cevostamab, were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, from 5-8 December 2020, showing encouraging activity across multiple types of blood cancer. These antibodies work by binding to two different targets, on two different cells, simultaneously: one on the surface of cancer cells and one on the surface of immune cells called T-cells. This dual targeting approach activates a patient's existing T-cells to engage and eliminate target cancer cells, offering an innovative approach for the treatment of blood cancers including non-Hodgkin lymphoma (NHL) and multiple myeloma (MM); diseases where treatment options are currently limited, and resistance to, or relapse following, treatment is common. These bispecifics are just one of the novel ‘off-the-shelf' technologies Roche is exploring, in its quest to improve patient outcomes. “The data suggest that our novel bispecific antibodies have potential across multiple types of blood cancers, and supports broad exploration of these new immunotherapy approaches across different patient populations and treatment lines,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Lymphoma and multiple myeloma are challenging cancers to treat, especially when patients present with aggressive subtypes or experience multiple relapses, but ‘off-the-shelf' therapies like these could provide new options that may potentially enable patients to be treated quickly.” Promising responses with mosunetuzumab and glofitamab in non-Hodgkin lymphoma To date in clinical trials, Roche's two CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, have shown promising responses across multiple types of NHL, including relapsed or refractory (R/R) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). This is reinforced by the latest results from the phase I/Ib GO29781 study in R/R FL, which show that 51.6% of patients (n=32/62) achieved a complete response (CR) when treated with mosunetuzumab.[1] High response rates also continue to be seen with glofitamab. For example, new data from the phase I/Ib NP30179 study in R/R NHL show a CR rate of 53.6% in aggressive NHL (n=15/28).[2] Additionally, both bispecific antibodies have proven to have manageable safety profiles. One of the most common adverse events (AEs) observed with bispecific antibodies is cytokine release syndrome (CRS), which involves the over activation of immune cells, and is a known risk associated with immunotherapies that activate the body's own immune system. [3] Based on studies so far, CRS events with mosunetuzumab and glofitamab are largely low-grade (mainly Grade 1-2), occur in early treatment cycles, and are mostly reversible.[1,2] Beyond the R/R setting, mosunetuzumab and glofitamab are also being investigated in earlier treatment lines, including first-line DLBCL. Initial data with single-agent mosunetuzumab in the phase I/II GO40554 study, show a CR rate of 45.5% (n=10/22) in elderly or unfit patients who are unable to tolerate full-dose immunochemotherapy. Additionally, when mosunetuzumab was combined with chemotherapy in the phase Ib/II GO40515 study, the CR rate was 79.4% (n=27/34). These are the first bispecific antibody studies in 1L DLBCL to report data, and while early, these results support the potential for mosunetuzumab to provide a new, much-needed treatment option for these patients.[4,5] Robust development programmes are ongoing for mosunetuzumab and glofitamab, investigating the treatments as monotherapies and in combination with other molecules, as well as more convenient forms of administration such as subcutaneous administration, with several phase III trials planned in the near future. Encouraging activity with cevostamab in heavily pre-treated patients with multiple myeloma The third of Roche's bispecific antibodies in malignant haematology, and latest addition to its pipeline, is cevostamab, a first-of-its kind FcRH5xCD3 bispecific antibody targeting FcRH5 on myeloma cells and CD3 on T-cells. FcRH5 is a unique and differentiated target and is expressed on nearly 100% of myeloma cells. Cevostamab is currently being investigated in the ongoing phase I GO39775 dose-escalation and expansion study in heavily pre-treated patients with MM (with a median of six prior lines of therapy); a population for whom new treatment options are urgently needed. First clinical safety and efficacy data presented at ASH, showed an encouraging overall response rate of 53% (n=18/34) at active doses. Notably, responses were seen in high-risk patients, including those refractory to five different classes of drug (penta-drug refractory) and those with prior exposure to anti-BCMA therapy. Safety of cevostamab was manageable with the most common treatment-related AE being CRS (76%). The majority of CRS events were Grade 1–2 (Grade 1; 34% and Grade 2; 40%) and occurred in cycle 1. One patient experienced Grade 3 CRS (2%) and no Grade 4 or 5 CRS events were observed.[6] Additional biomarker analyses presented at the congress are also helping to further understand the potential of cevostamab in MM and inform its future development, including strategies to mitigate the risk of CRS.[7] Roche is excited about the ongoing development of its three bispecific antibodies in malignant haematology and eager to understand their full potential in patients with blood cancers. About Roche's CD20xCD3 bispecific antibodies Roche is currently developing two T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and re-directs a patient's existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. Mosunetuzumab and glofitamab differ in their structures, and both are being developed by Roche as part of our ongoing haematology research and development strategy to explore multiple bispecific formats, to identify those that may maximise clinical benefits for patients. Mosunetuzumab has a structure similar to that of a natural human antibody in that it has two ‘Fab' regions, but is different from naturally-occurring antibodies in that one ‘Fab' region targets CD20 and the other ‘Fab' region targets CD3. Glofitamab is based on a novel structural format which we call ‘2:1', which refers to the structure of the antibody. It is engineered to have two ‘Fab' regions which bind to CD20, and one ‘Fab' region which binds to CD3. The clinical development programmes for mosunetuzumab and glofitamab include ongoing investigations of these molecules as monotherapies and in combination with other medicines, for the treatment of people with CD20-positive B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma, and other blood cancers. About cevostamab (FcRH5xCD3 bispecific antibody) Cevostamab (BFCR4350A) is an FcRH5xCD3 T-cell engaging bispecific antibody designed to target FcRH5 on myeloma cells and CD3 on T-cells. FcRH5 is a unique and differentiated target, expressed on nearly 100% of myeloma cells.[8] Cevostamab has a structure similar to that of a natural human antibody in that it has two ‘Fab' regions, but is different from naturally-occurring antibodies in that one ‘Fab' region targets FcRH5 and the other ‘Fab' region targets CD3. This dual targeting activates and re-directs a patient's existing T-cells to engage and eliminate target FcRH5-expressing myeloma cells by releasing cytotoxic proteins into the myeloma cells. About the GO29781 study The GO29781 study [ NCT02500407 ] is a phase I/Ib, multicentre, open-label, dose-escalation study evaluating the safety and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include best objective response rate by revised International Working Group criteria, maximum tolerated dose and tolerability. About the GO40554 study The GO40554 study [ NCT03677154 ] is a phase I/II, multicentre, open-label, randomised study evaluating the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy, or in participants with previously untreated DLBCL who are unable to tolerate full-dose, first-line immunochemotherapy. Primary objectives include complete response rate at time of primary response assessment, as measured by PET-CT, according to Lugano 2014 Response Criteria, and safety. Secondary objectives include assessment of pharmacokinetics, objective response rate, duration of response and progression-free survival. About the NP30179 study The NP30179 study [ NCT03075696 ] is a phase I/Ib, multicentre, open-label, dose-escalation study, evaluating the efficacy, safety, tolerability and pharmacokinetics of glofitamab. In this study, glofitamab is assessed as a single-agent and in combination with Gazyva®/Gazyvaro® (obinutuzumab), following pre-treatment with a one-time, fixed-dose of Gazyva/Gazyvaro, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include overall response rate, complete response rate per Lugano 2014 criteria, maximum tolerated dose and tolerability. About the GO39775 study The GO39775 study [ NCT03275103 ] is a phase I, multicentre trial evaluating the safety and activity of cevostamab (BFCR4350A) monotherapy in adult patients with relapsed or refractory multiple myeloma for which no established therapies are available, appropriate or tolerable. Prior exposure to CAR T-cells, T-cell engaging bispecific antibodies, bispecific T-cell engagers (BiTEs) and antibody-drug conjugates, including those targeting BCMA, is allowed. Primary objectives are to evaluate safety (including the maximum tolerated dose and dose-limiting toxicities) and to identify a recommended phase II dose. Secondary objectives include assessment of pharmacokinetics, activity, immunogenicity and pharmacodynamic biomarkers. 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 haematologic 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 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. More than 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. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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 . All trademarks used or mentioned in this release are protected by law.

Roche presents new data from its bispecific antibody portfolio across a range of blood cancers

Roche's ADR is up just 2% since the start of the year and it has gained around 20% from its March lows. Despite the recent run, Roche could offer an upside in the near term, as the company's revenues and earnings are expected to see steady gains going forward.

Covid Tests And New Drugs To Drive Roche's Stock Growth

Basel, 07 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the pivotal phase Ib/II GO29365 study, including data from a single-arm extension cohort of 106 additional patients, which show the benefit of Polivy® (polatuzumab vedotin) plus bendamustine and MabThera®/Rituxan® (rituximab) (BR) in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not eligible for stem cell transplant. Updated data from the randomised cohort (n=80) show that with longer follow-up (48.9 months) a complete response (CR) rate of 42.5% (n=17/40) was maintained in patients following completion of treatment with Polivy plus BR, compared to 17.5% (n=7/40) with BR alone, indicating responses to the Polivy regimen were durable. No new or delayed safety signals were reported. Furthermore, new data from an extension cohort showed a CR rate of 38.7% (n=41/106) with Polivy plus BR. These results, which were presented as a poster (Abstract #3020) at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on 5-8 December 2020, further support the clinical benefit this Polivy-based combination brings to patients with this aggressive disease. “Despite recent advances, treatment options are needed that can improve survival outcomes, enhance convenience, and support a good quality of life for patients with relapsed or refractory diffuse large B-cell lymphoma,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are encouraged by the continued survival benefit seen with this Polivy combination across a broad range of patients, which reinforces the positive impact that this off-the-shelf treatment option could have for people with this aggressive disease.” Additional data from the randomised cohort also show that the survival benefit with Polivy plus BR persisted with longer follow-up. After 48.9 months, median progression-free survival (PFS) was 9.2 months with Polivy plus BR, versus 3.7 months for BR alone, as assessed by an independent review committee. Median overall survival (OS) was also sustained at 12.4 months for Polivy plus BR compared to 4.7 months for BR alone. New data from the extension cohort, which included 37 patients with second-line DLBCL were consistent with previously reported results from the GO29365 study, and show Polivy plus BR is effective in a broad range of patients. The median PFS was 6.6 months and median OS was 12.5 months with the Polivy combination. Sub-group analyses of this cohort also show that Polivy plus BR was effective in different patient populations, including high-risk patients, regardless of prior lines of therapy, with results from the pooled Polivy plus BR arms achieving a median OS of 7.6 months in primary refractory patients (n=55), and 32.0 months in non-primary refractory patients (n=97). Based on initial results from the GO29365 study, in January 2020 Polivy was granted conditional marketing authorisation by the European Commission in combination with bendamustine and MabThera for the treatment of adult patients with R/R DLBCL, who are not candidates for a haematopoietic stem cell transplant. Prior to this, the U.S. Food and Drug Administration granted accelerated approval of Polivy in combination with BR for the treatment of adult patients with R/R DLBCL, who have received at least two prior therapies. Beyond R/R disease, Polivy is also being investigated in first-line DLBCL, with results from the phase III POLARIX trial anticipated in 2021. Other ongoing studies include combinations of Polivy with Gazyva®/Gazyvaro® (obinutuzumab), Venclexta®/Venclyxto® (venetoclax) and CD20xCD3 bispecific antibodies mosunetuzumab and glofitamab to identify areas where Polivy has the potential to deliver benefit in areas of unmet need. About the GO29365 study GO29365 [ NCT02257567 ] is a global, phase Ib/II study evaluating the safety, tolerability and activity of Polivy® (polatuzumab vedotin) in combination with bendamustine and MabThera®/Rituxan® (rituximab) (BR) or Gazyva®/Gazyvaro® (obinutuzumab) in relapsed or refractory (R/R) follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). Eligible patients were not candidates for a haematopoietic stem cell transplant at study entry. The phase II part of the study randomised 80 patients with heavily pre-treated R/R DLBCL to receive either BR, or BR in combination with Polivy for a fixed duration of six 21-day cycles. Of the patients enrolled, 80% had refractory disease. The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography and assessed by an independent review committee (IRC). Secondary endpoints included overall response rate (ORR; CR and partial response) by investigator assessment and best ORR at the end of treatment by investigator and IRC assessment. Exploratory endpoints included duration of response, progression-free survival, event-free survival and overall survival. In addition to the randomised cohort of the study, an additional 106 patients were treated with Polivy plus BR in a single-arm extension cohort, also with CR as the primary endpoint. About Polivy® (polatuzumab vedotin) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells (an immune cell impacted in some types of non-Hodgkin lymphoma (NHL)), making it a promising target for the development of new therapies.[1,2] Polivy binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells.[3,4] Polivy is being developed by Roche using Seattle Genetics ADC technology and is currently being investigated for the treatment of NHL. Polivy is marketed in the US by Genentech as Polivy (polatuzumab vedotin-piiq), with piiq 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 diffuse large B-cell lymphoma (DLBCL) DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.[5] DLBCL is an aggressive (fast-growing) type of NHL, which is generally responsive to treatment in the frontline.[6] However, as many as 40% of patients will relapse, at which time salvage therapy options are limited and survival is short.[6] Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.[7] 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 haematologic 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 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. More than 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. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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 . All trademarks used or mentioned in this release are protected by law. References [1] Dornan D, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood 2009;114:2721-29. [2] Pfeifer M, et al. Anti-CD22 and anti-CD79B antibody drug conjugates are active in different molecular diffuse large B-cell lymphoma subtypes. Leukemia 2015;29:1578-86. [3] Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug Chem. 2010;21:5-13. [4] ADC Review. What are antibody-drug conjugates? [Internet; cited December 2020]. Available from: https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/ . [5] Lyon, France. World Health Organization Classification of Tumors of Haematopoietic and Lymphoid Tissues. IARC Press; 2008. [6] Maurer JM, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol 2014;32:1066-73. [7] Numbers derived from GLOBOCAN 2018: Estimated cancer incidence, mortality and prevalence worldwide in 2018. [Internet; cited December 2020]. Available from: http://globocan.iarc.fr. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma

Basel, 7 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a new analysis of pooled, three-year follow-up data of 401 people with haemophilia A from the pivotal HAVEN 1-4 studies, which reinforce the long-term efficacy and safety profile of Hemlibra® (emicizumab).[1] These data, from adults, adolescents and children with haemophilia A with and without factor VIII inhibitors, were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 5-8 December 2020. “The long-term benefit of Hemlibra, with a consistent safety profile and durably effective control of bleeding, underscores its potential to redefine the standard of care for people living with haemophilia A,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “As the first new class of medicine in nearly 20 years, Hemlibra continues to show a positive impact on disease burden and quality of life for people with haemophilia A, regardless of their inhibitor status or age.” The analysis included pooled data from 401 people with haemophilia A with and without factor VIII inhibitors, from across the four pivotal HAVEN studies (HAVEN 1, n=113; HAVEN 2, n=88; HAVEN 3, n=152; HAVEN 4, n=48) with a median duration efficacy period of 120.4 weeks.[1] Hemlibra maintained low treated bleed rates across the study period, with model based annualised bleed rates (ABR) remaining low throughout the evaluation period at 1.4 (95% CI: 1.1-1.7). Further, the proportion of participants who experienced zero treated bleeds (70.8-83.7%) increased with each consecutive 24-week period.[1] In addition, with Hemlibra prophylaxis, 95.1% of target joints were resolved.[1] Results showed that Hemlibra's safety profile was consistent with previous observations and no new safety signals were observed after the longer follow-up. Furthermore, the first interim analysis of the European Haemophilia Safety Surveillance (EUHASS) Database, also presented at the ASH Virtual Congress, suggests the safety profile of Hemlibra in the real-world setting is consistent with that seen in clinical trials, with no new or emerging safety signals. EUHASS is a large pharmacovigilance programme that monitors the safety of treatments for inherited bleeding disorders.[2] Data from the HAVEN studies supported Hemlibra approvals to treat people with haemophilia A with factor VIII inhibitors in more than 90 countries worldwide and for people without factor VIII inhibitors in more than 80 countries worldwide, including the US, EU and Japan. Since its initial approval more than three years ago, 8,200 people have received Hemlibra globally, and in the US, Hemlibra is now the most prescribed preventative (prophylactic) treatment for haemophilia A. About the Hemlibra clinical development programme Hemlibra has been studied in one of the largest pivotal clinical trial programmes in haemophilia A with and without factor VIII inhibitors, including eight phase III studies. The programme assesses the efficacy and safety of Hemlibra and its potential to help overcome current clinical challenges in the management of haemophilia A, including the short-lasting effects of existing treatments, the development of factor VIII inhibitors and the need for frequent venous access. Results from the HAVEN 1 and HAVEN 2 studies supported approvals of Hemlibra for people with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. These data, as well as results from the HAVEN 3 and HAVEN 4 studies supported approvals of Hemlibra for people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors. Additional studies, HAVEN 5, HAVEN 6, HAVEN 7 and STASEY, reflect Roche's ongoing commitment to continuing to characterise the safety and efficacy of Hemlibra and to addressing unmet needs for people living with haemophilia A. 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 US 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 320,000 people worldwide,[3,4] approximately 50-60% of whom have a severe form of the disorder.[5] 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.[3] 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.[6] A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies.[7] Inhibitors are antibodies developed by the body's immune system that bind to and block the efficacy of replacement factor VIII,[8] 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 haematologic 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. All trademarks used or mentioned in this release are protected by law. 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. More than 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. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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 . All trademarks used or mentioned in this release are protected by law. References [1] Michael C, et al. Safety and Efficacy of Emicizumab in Persons with Hemophilia A With or Without FVIII Inhibitors: Pooled Data from Four Phase III Studies (HAVEN 1-4) [Abstract #1800] Poster presented at: American Society Of Hematology (ASH) Annual Meeting; 5 – 8 December, 2020. [2] Shang A, et al. Real-World Safety of Emicizumab: The First Interim Analysis of the European Haemophilia Safety Surveillance (EUHASS) Database [Abstract #2685] Poster presented at: American Society Of Hematology (ASH) Annual Meeting; 5 – 8 December, 2020. [3]WFH. Guidelines for the management of haemophilia. 2012 [Internet; cited December 2020]. Available from: http://www1.wfh.org/publications/files/pdf-1472.pdf . [4] Berntorp E, et al. Modern haemophilia care. The Lancet. 2012; 370:1447-1456. [5] Marder VJ, et al. Hemostasis And Thrombosis. 6th ed. Wisconsin. Lippincott Williams & Wilkins; 2013. [6]Franchini M, et al. Haemophilia A in the third millennium. Blood Rev. 2013; 179-84. [7] Gomez K, et al. Key issues in inhibitor management in patients with haemophilia. Blood Transfus. 2014; 12:s319-s329. [8]Whelan SF, et al. Distinct characteristics of antibody responses against factor VIII in healthy individuals and in different cohorts of haemophilia A patients. Blood. 2013; 121:1039-48. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

New follow-up phase III data reinforce the long-term benefit of Roche's Hemlibra for people with haemophilia A

              Basel, 5 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from the pivotal phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta®/Venclyxto® (venetoclax)-based combinations in certain people with chronic lymphocytic leukaemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD). Data were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday 5 December 2020. “These results reinforce the long-term value of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based combinations in CLL, potentially offering patients a significant period of time without treatment following initial therapy,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “These data also reflect our ongoing commitment to accelerating clinical advancements for patients by exploring the novel endpoint minimal residual disease as a potential predictor of patient outcomes.” Five-year data from the pivotal phase III MURANO trial continue to show sustained investigator-assessed progression-free survival (PFS) with Venclexta/Venclyxto plus MabThera®/Rituxan® (rituximab). Data, presented in an oral session, showed:

Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data from the pivotal Phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta® (venetoclax)-based combinations in certain people with chronic lymphocytic leukemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD). Data were presented at the all-virtual 62nd American Societ

Genentech Announces New Data Reinforcing the Long-Term Benefit of Venclexta-Based Combination for People With Relapsed or Refractory Chronic Lymphocytic Leukemia

Roche (RHHBY) wins FDA approval of the label expansion of Xolair along with EUA for a serology test.

Roche's (RHHBY) Xolair Gets FDA Nod for Label Expansion

Roche has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for a new test that measures levels of Covid-19 antibodies.

Roche's coronavirus antibody test gets emergency use authorization from the U.S.

Basel, 2 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These indications were approved under the FDA's accelerated approval programme based on data from the phase I/II ARROW study. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Roche announces FDA approval of Gavreto (pralsetinib) for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers

Basel, 2 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The EUA in the United States follows the launch of the Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark announced on 18 September.

Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies

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 approved Gavreto™ (pralsetinib) for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who requ

Genentech Announces FDA Approval of Gavreto (pralsetinib) for People With Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

              Basel, 01 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.1 Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation. “With Xolair, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal polyps in two pivotal Phase III studies,” said Joseph Han, M.D., Chief of the Division of Rhinology and the Division of Allergy at Eastern Virginia Medical School and study investigator of the POLYP 1 and POLYP 2 trials. “Xolair provides a new option for treating these patients, who often have other respiratory and allergic conditions that may further worsen symptoms.” The FDA's approval is based on results from the Phase III POLYP 1 and POLYP 2 trials. Both trials showed that adult patients with nasal polyps who had an inadequate response to nasal corticosteroids and received Xolair had statistically significant greater improvement from baseline at Week 24 in Nasal Polyp Score (NPS) and weekly average Nasal Congestion Score (NCS) than patients who received placebo.1 The greater improvements in NPS and NCS in the Xolair group compared to the placebo group were observed as early as the first assessment at Week 4 in both studies. All patients received background nasal mometasone therapy during both the treatment period and a five-week run-in period. The safety profile in POLYP 1 and POLYP 2 was consistent with the established safety profile for Xolair. “With today's approval, people living with nasal polyps now have a treatment option that targets IgE, an underlying driver of various allergic conditions,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are committed to understanding the full potential of Xolair across the spectrum of allergic diseases and are excited to provide this important treatment for people living with nasal polyps.” Xolair is an injectable biologic medicine that is also FDA-approved for the treatment of moderate to severe persistent allergic asthma in people 6 years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria (CIU) in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines. Approximately 460,000 patients have been treated in the U.S. with Xolair since its initial approval for allergic asthma in 2003.2 In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair. About Nasal Polyps Nasal polyps is a commonly occurring and potentially debilitating condition in adults, impacting 13 million people in the U.S.3,4 Currently, there are limited treatment options available and many patients opt for nasal surgery or systemic steroids. However, polyps may regrow over time. Nasal polyps present as noncancerous lesions on the lining of the nasal sinuses or nasal cavity associated with irritation and inflammation, which can block normal airflow.5 Nasal polyps may co-occur with other respiratory conditions, such as allergies and asthma. About POLYP 1 and POLYP 2 In POLYP 1 and POLYP 2, the mean change from baseline at Week 24 for Xolair compared to placebo were: NPS, -1.1 versus 0.1 (95% CI: -1.6, -0.7) and -0.9 versus -0.3 (95% CI: -1.1, -0.1); NCS, -0.9 versus -0. 4 (95% CI: -0.8, -0.3) and -0.7 versus -0.2 (95% CI: -0.8, -0.2).1 POLYP 1 and POLYP 2 are the ninth and tenth Phase III trials for Xolair, respectively. Results from POLYP 1 and POLYP 2 were recently published in the Journal of Allergy and Clinical Immunology. No new or unexpected safety signals were identified in patients treated with Xolair, with over 95% of patients completing each safety arm of POLYP 1 and POLYP 2.6 The most common adverse reactions (≥3% of patients) included headache, injection site reaction, arthralgia, upper abdominal pain and dizziness. POLYP 1 and POLYP 2 are replicate Phase III pivotal studies designed to determine the efficacy and safety of Xolair compared with placebo in adult patients with nasal polyps who had an inadequate response to nasal corticosteroids. Both trials were randomized, multicenter, double-blind and placebo-controlled. POLYP 1 involved 138 patients, and POLYP 2 involved 127 patients. The co-primary outcomes for both trials were change from baseline to Week 24 in average daily Nasal Congestion Score and Nasal Polyp Score. Patients in the studies were administered either Xolair or placebo by subcutaneous injection every two to four weeks in addition to background nasal mometasone therapy during both the treatment period and a five-week run-in period.1 About Xolair Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade. About Roche in Immunology The Roche Group's immunology medicines include: Actemra®/RoActemra® (tocilizumab) for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and giant cell arteritis (GCA) and for the treatment of severe or life-threatening chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome (CRS); Rituxan®/MabThera® (rituximab) for rheumatoid arthritis granulomatosis with polyangiitis and microscopic polyangiitis and for pemphigus vulgaris (PV); Xolair® (omalizumab) for allergic asthma and chronic idiopathic urticaria (CIU); Pulmozyme® (dornase alfa) for cystic fibrosis; and Esbriet® (pirfenidone) for idiopathic pulmonary fibrosis (IPF). Roche has more than 15 investigational medicines in clinical development for immunological diseases that include asthma, autoimmune diseases, rheumatoid arthritis, ulcerative colitis and Crohn's disease. 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. More than 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. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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 . All trademarks used or mentioned in this release are protected by law. References [1] Xolair® Full Prescribing Information. Genentech, Inc.; November 2020. [2] Data on file. Genentech, Inc. [3] United States Census Bureau. QuickFacts. Census Bureau population estimates (2018). Accessed October 2020. https://www.census.gov/quickfacts/fact/table/US/PST045218 [4] Stevens WW, Schleimer RP, Kern RC. Chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract. 2016;4(4):565572. [5] Mayo Clinic. Nasal polyps. Accessed October 2020. https://www.mayoclinic.org/diseases-conditions/nasal-polyps/symptoms-causes/syc-20351888. [6] Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: two randomized phase III trials. J Allergy and Clin Immunol. 2020; 146(3):595-605. doi: 10.1016/j.jaci.2020.05.032 Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

FDA approves Xolair® (omalizumab) for adults with nasal polyps

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 approved the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. Nasal polyps can lead to a loss of smell and nasal congestion, and fr

Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps

INDIANAPOLIS, Dec. 1, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The semi-quantitative serology (blood) test can...

Roche receives FDA Emergency Use Authorization for new semi-quantitative test to measure the level of SARS-CoV-2 antibodies

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Roche is trading at a relative discount compared to other growth companies across Europe. A 1% growth in sales during the first nine months of 2020 at constant exchange rates, despite significant COVID-19 and biosimilar impact.

Roche: Underappreciated Pharma

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Roche (RHHBY) gets FDA approval for Xofluza to prevent influenza in people 12 years of age and older following contact with someone with influenza.

Roche (RHHBY) Gets FDA Nod for Influenza Drug Label Expansion

              Basel, 24 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis. “With today's approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We're hopeful that reducing the burden of influenza may help to mitigate the strain on our healthcare system amid the COVID-19 pandemic.” Post-exposure prophylaxis with single-dose Xofluza was evaluated in the phase III BLOCKSTONE study, which was recently published in The New England Journal of Medicine.1 BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact. The proportion of household members 12 years of age and older who developed influenza was 1% in participants treated with Xofluza and 13% in the placebo-treated group. Xofluza was well tolerated in this study and no new safety signals were identified. “The flu is a serious illness that burdens households and sickens millions across the US every year,” said Serese Marotta, Chief Operating Officer at Families Fighting Flu. “As we are about to enter a flu season within a global COVID-19 pandemic, we welcome Xofluza as a single-dose flu medicine to be used preventively after exposure to flu.” The most frequently reported adverse events (occurring in at least 1% of adult and adolescent influenza patients treated with Xofluza) included diarrhoea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%). Additionally, Roche is determining a path forward with the FDA for a potential indication for Xofluza as a treatment for acute uncomplicated influenza in otherwise healthy children (one to 12 years of age) and for the prevention of influenza in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population. Xofluza is already FDA-approved to treat acute uncomplicated influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.2 Although some of the symptoms of COVID-19 and influenza can look similar, the two illnesses are caused by completely different viruses. Xofluza is specifically designed to treat influenza viruses only and is not effective against SARS-CoV-2, the coronavirus causing COVID-19.3 About BLOCKSTONE 1, 3 BLOCKSTONE is a phase III, double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study that evaluated a single dose of Xofluza® (baloxavir marboxil) compared with placebo in household members (adults and children) who were living with someone with influenza confirmed by a rapid influenza diagnostic test (the ‘index patient'). The study was conducted by Shionogi & Co., Ltd. in Japan during the 2018-2019 influenza season. Those diagnosed with influenza were required to have onset of symptoms for less than 48 hours and participants were required to have lived with those diagnosed for more than 48 hours. The participants were randomised to receive a single dose of Xofluza (dose according to body weight) or placebo as a preventive measure against developing influenza. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact. The proportion of household members 12 years of age and older who developed influenza was 1% in participants treated with Xofluza and 13% in the placebo-treated group. Xofluza was well tolerated in this study and no new safety signals were identified. About Xofluza® (baloxavir marboxil) Xofluza is a first-in-class, single-dose oral medicine with an innovative proposed mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.4 Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.4, 5 Xofluza is available in the US and in several other countries for the treatment of influenza types A and B. In the US, Xofluza is approved for the treatment of acute, uncomplicated influenza in people 12 years of age and older who are otherwise healthy or at high risk of developing serious complications from influenza, and who have been symptomatic for no more than 48 hours. Xofluza is also approved for post-exposure prophylaxis of influenza in people 12 years of age and older following contact with an individual who has influenza. Xofluza was the first new antiviral to be approved by the FDA in 20 years. Robust clinical evidence has demonstrated the benefit of Xofluza in several populations (otherwise-healthy, high-risk and post-exposure prophylaxis). Xofluza is being further studied in a phase III development program, including children under the age of one (NCT03653364) as well as to assess the potential to reduce transmission of influenza from an infected person to healthy people (NCT03969212). 6, 7 Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialised globally in collaboration with the Roche Group (which includes Genentech in the US) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd. About Roche in Influenza Influenza is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. Globally, seasonal epidemics result in three to five million cases of severe disease, millions of hospitalisations and up to 650,000 deaths every year.8, 9, 10, 11 Roche has a long heritage in developing medicines that contribute to public health. We are committed to bringing innovation in the field of infectious diseases, including influenza. Tamiflu® (oseltamivir) has made a significant difference both to the treatment of seasonal influenza as well as in the management of recent pandemics, and we are proud to have brought this innovative medicine to patients. Although vaccines are an important first line of defence in preventing influenza, there is a need for new medical options for prevention (prophylaxis) and treatment. Other antiviral drugs have limitations with respect to efficacy, convenience of dosing, and resistance. Roche is committed to addressing the unmet need in this area through its agreement with Shionogi & Co., Ltd. to develop and commercialise Xofluza. 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. More than 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. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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 . All trademarks used or mentioned in this release are protected by law. References [1] Ikematsu, H., et al. Baloxavir Marboxil for Prophylaxis against Influenza in Household Contacts. New England Journal of Medicine. 2020; 383:309-320.[2] Xofluza PI. [Internet; cited 2020 October]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210854s001lbl.pdf .[3] Roche. Data on file.[4] Noshi, T., et al. S-033447/S-033188, a Novel Small Molecule Inhibitor of Cap-dependent Endonuclease of Influenza A and B Virus: In Vitro Antiviral Activity against Laboratory Strains of Influenza A and B Virus in Madin-Darby Canine Kidney Cells. Poster presentation at OPTIONS IX, August 2016.[5] Hayden F, et al. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med 2018;379:913-923[6] ClinicalTrials.gov. Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms (NCT03653364). [Internet; cited 2020 October]. Available from: https://clinicaltrials.gov/ct2/show/NCT03653364 .[7] ClinicalTrials.gov. Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households (NCT03969212). [Internet; cited 2020 October]. Available from: https://clinicaltrials.gov/ct2/show/NCT03969212 .[8] WHO. Global Influenza Strategy 2019-2030. [Internet; cited 2020 October]. Available from: https://www.who.int/influenza/Global_Influenza_Strategy_2019_2030_Summary_English.pdf?ua=1. [9] CDC. How Well Flu Vaccines Work. [Internet; cited 2020 October]. Available from: https://www.cdc.gov/flu/about/qa/vaccineeffect.htm .[10] WHO. Influenza (Seasonal). [Internet; cited 2020 October]. Available from: https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal) . [11] WHO. Up to 650 000 people die of respiratory diseases linked to seasonal flu each year. [Internet; cited 2020 October]. Available from: https://www.who.int/en/news-room/detail/14-12-2017-up-to-650-000-people-die-of-respiratory-diseases-linked-to-seasonal-flu-each-year Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person

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 approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exp

Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person

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Roche's (RHHBY) influenza drug Xofluza and Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) get a positive CHMP opinion.

Roche's (RHHBY) Influenza Drug Gets Positive CHMP Opinion

              Basel, 16 November 2020 - For the eleventh time, Roche (SIX: RO, ROG; OTCQX: RHHBY) has been recognised as the most sustainable company in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). This is based on an in-depth analysis of economic, social and environmental performance. The DJSI family of indices serves as a benchmark for investors who integrate sustainability considerations into their portfolios. Roche has maintained its leadership through its sustainability strategy which is fully embedded in the company's business and culture. “We are proud of being recognised once again for our sustainability efforts,” says Roche CEO Severin Schwan. “At Roche, we know that the key to creating sustainable value and growth lies in partnering with multiple stakeholders. The COVID-19 pandemic has exacerbated the need for public and private sectors across the globe to work together to address this challenge. In these unprecedented times, we are more than ever committed to work in close collaboration with all global health actors to ensure that medicines and diagnostics reach the people who need them.” Roche is at the forefront of the fight against COVID-19 with a growing portfolio of diagnostics solutions, the development of new medicines and a number of partnerships across the industry. In parallel, Roche also continues to deliver medicines and diagnostics for patients across a broad range of other disease areas and is working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. Sustainability at Roche For over 120 years, sustainability has been an integral part of Roche's business. Roche follows a holistic approach when managing sustainability: In addition to improving access to products, the company's strategy also focuses on achieving continuous progress in areas such as social responsibility, environmental protection, supply chain sustainability, people attraction and retention. Roche makes its biggest contribution to society by improving healthcare provision. It does so by developing the best diagnostic tests and medicines capable of meeting some of the world's most pressing medical needs. Roche is aware that this cannot be done alone. The company knows that the key to creating sustainable value and growth lies in partnering with stakeholders and engaging in open, constructive dialogue. By doing so, Roche generates value for society and achieves sustainable economic growth for the company. Examples of our activities in sustainability areas can be found here: www.roche.com/sustainability About the Dow Jones Sustainability Indices (DJSI) This global ranking is published annually by the S&P Dow Jones Indices and SAM and measures the performance of the world's sustainability leaders. SAM invites publicly traded companies to participate. Companies are selected for the indices according to a systematic Corporate Sustainability Assessment (CSA) performed by SAM. Only firms that lead their industries based on this assessment are included in the indices. This is determined by a comprehensive assessment of long-term economic, environmental and social criteria that take account of general as well as industry-specific sustainability trends. 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. More than 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. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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 . 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 ranked the most sustainable healthcare company in the Dow Jones Sustainability Indices for the eleventh time

Basel, 13 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. In addition, Xofluza has been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above. The CHMP recommendation is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.1,2,3 A final decision regarding the approval is expected from the European Commission in the near future.

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