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.

Roche Holdings AG (OCTMKTS: RHHBY) posted Q1 sales of CHF 14.9 billion, up 3% Y/Y on a constant currency basis and down 1% on a reported basis.  Sales in the Pharmaceuticals Division decreased 9% to CHF 10.6 billion, hit by biosimilars competition, which cut CHF 1.6 billion from revenue.

Roche Backs 2021 Outlook Despite Lackluster Q1 Performance In Pharmaceuticals Division

Roche reports solid results in the first quarter of 2021

Novartis

Novartis (NVS) enters into an agreement with Roche for the manufacturing of the active pharmaceutical ingredient (API) for Actemra/RoActemra.

Novartis (NVS) Collaborates with Roche for API of RA Drug Actemra

Earlier this week, Swiss pharma-giant Roche announced that Regeneron's investigational antibody cocktail - casirivimab and imdevimab - reduced risk of symptomatic Covid-19 infections by 81%. As per the agreement with Regeneron, Roche will manufacture and market the antibody cocktail outside of the.

What's Next For Roche's Stock?

Basel, 16 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new OCREVUS® (ocrelizumab) analyses supporting its significant benefit on disease progression in early-stage relapsing-remitting multiple sclerosis (RRMS) and primary progressive MS (PPMS) as well as demonstrating high persistence and strong adherence to twice-yearly (six-monthly) dosing. These data are being presented virtually at the 73rd American Academy of Neurology (AAN) Annual Meeting from 17–22 April 2021. OCREVUS is the number one prescribed MS medication in the U.S. for patients starting a new treatment, and more than 200,000 people have now been treated with OCREVUS globally. “All patients regardless of their form of MS experience disease progression from the start. Therefore, we are encouraged by these new analyses showing that early treatment with OCREVUS may significantly control disease progression in both relapsing-remitting MS and in primary progressive MS. Controlling progression can enable people with MS to maintain mobility and limit their disability,” said Levi Garraway, M.D., Ph.D. Roche's Chief Medical Officer and Head of Global Product Development. “In addition, our data show that more people with MS are staying on OCREVUS, the only twice-yearly treatment for MS, compared with other therapies, which may translate to improved outcomes.” Interim analysis Phase IIIb ENSEMBLE: No evidence of disease progression in early-stage RRMS OCREVUS treatment provided consistent benefit over one year in patients who were recently diagnosed with RRMS and had not received prior disease modifying treatment (DMT) in an interim analysis of open-label Phase IIIb study ENSEMBLE. After 48 weeks, 85% of OCREVUS-treated patients achieved no evidence of disease activity (NEDA; no relapses, worsening of disability or new or enlarging brain lesions with pre-specified MRI re-baselining at 8 weeks). The average annualised relapse rate across all patients was very low (0.005) and their mean change in Expanded Disability Status Scale score (EDSS) from baseline significantly improved from 1.71 to 1.55 (p=0.002). Additionally, neurofilament light chain (NfL), a marker of nerve cell damage, was reduced to nearly healthy control levels with OCREVUS treatment (10.5 pg/mL at baseline to 4.55 pg/mL at 48 weeks with OCREVUS vs. 4.12 pg/mL in healthy controls). The safety profile of OCREVUS in this trial was consistent with its overall favourable safety profile. Post-hoc analysis Phase III ORATORIO: Slowed atrophied T2-lesion accumulation in PPMS OCREVUS treatment significantly slowed accumulation of atrophied T2-lesion volume (aT2-LV) compared with placebo at 120 weeks in a post-hoc analysis of the ORATORIO study in PPMS (319 mm3 vs. 366 mm3 with placebo, p

New data for Roche's OCREVUS (ocrelizumab) reinforce significant benefit on slowing disease progression in relapsing and primary progressive multiple sclerosis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new Ocrevus® (ocrelizumab) analyses supporting its significant benefit on disease progression in early-stage relapsing-remitting multiple sclerosis (RRMS) and primary progressive MS (PPMS) as well as demonstrating high persistence and strong adherence to twice-yearly (six-monthly) dosing. These data are being presented virtually at the 73rd American Academy of Neuro

New Data for Genentech's Ocrevus (ocrelizumab) Reinforce Significant Benefit on Slowing Disease Progression in Relapsing and Primary Progressive Multiple Sclerosis

Basel, 15 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 2 of FIREFISH, a Phase 2/3 global study evaluating Evrysdi™ (risdiplam) in infants aged 1-7 months at enrollment with symptomatic Type 1 spinal muscular atrophy (SMA). The data showed Evrysdi continued to improve motor function between months 12 and 24, including the ability to sit without support. The study also showed Evrysdi continued to improve survival, improve ability to feed orally and reduce the need for permanent ventilation*. Exploratory data suggested Evrysdi continued to improve the ability to swallow and reduce hospitalisations compared to the natural course of Type 1 SMA. Safety for Evrysdi was consistent with its established safety profile. These longer-term data build upon one-year pivotal findings from FIREFISH Part 2 and will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021.

Roche's Evrysdi continues to improve motor function and survival in babies with Type 1 Spinal Muscular Atrophy (SMA)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 2 of FIREFISH, a Phase 2/3 global study evaluating Evrysdi™ (risdiplam) in infants aged 1-7 months at enrollment with symptomatic Type 1 spinal muscular atrophy (SMA). The data showed Evrysdi continued to improve motor function between months 12 and 24, including the ability to sit without support. The study also showed Evrysdi continued to

Genentech's Evrysdi Continues to Improve Motor Function and Survival in Babies With Type 1 Spinal Muscular Atrophy (SMA)

Adaptive Biotechnologies

Barnwell Industries

GenMark Diagnostics

Meridian Bioscience

Meridian Bioscience Inc. (NASDAQ:VIVO) edged out GenMark Diagnostics Inc. (NASDAQ:GNMK) as the top gainer in the March GenomeWeb Index with a 25% boost in its share price compared to GenMark's 22.5% increase. At the other end of the spectrum were Adaptive Biotechnologies Corp. (NASDAQ:ADPT), whose shares plummeted 28%, Burning Rock Biotech (BRN) with a 25% decline and Quanterix Corp. (QNTX), which fell 22.8%.

GenomeWeb Index Drops 3% for 2nd Consecutive Month

●  Xolair for self-injection offers healthcare providers and appr opriate patients another administration option for more flexibility in managing their treatment Basel, 13 April 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 for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. indications.1 Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps. “Today's approval reflects our commitment to continued innovation with Xolair to address the critical needs of people living with allergic and inflammatory conditions,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the COVID-19 pandemic.” Before starting self-injection with Xolair prefilled syringe, the patient must have no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity (allergic reactions). After Xolair therapy has been initiated and safely established in a healthcare setting, a healthcare provider may determine whether self-injection with Xolair prefilled syringe by the patient or a caregiver is appropriate. The healthcare provider must train the patient or caregiver on the correct subcutaneous injection technique, how to recognize the signs and symptoms of anaphylaxis and how to treat anaphylaxis appropriately, before the first self-injection outside a healthcare setting. “Expanding treatment options for personalised care and self-management is always welcome news for the patient community,” said Kenneth Mendez, CEO and President, Asthma and Allergy Foundation of America. “The possibility of administering FDA-approved treatment outside of the healthcare provider's office, but still guided by that healthcare provider, may reduce barriers to care for patients and their caregivers.” Approximately 460,000 patients have been treated in the U.S. with Xolair since its initial approval in 2003.2 The use of Xolair across allergic asthma, CIU and nasal polyps is based on its well-established efficacy and safety profile and supported by a robust clinical development program, including 10 Phase III studies.1 In the U.S., Genentech, a member of the Roche group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair. 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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

Basel, 12 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The trial, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), met its primary and key secondary endpoints. It showed that the subcutaneous administration of casirivimab and imdevimab reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. In addition, individuals treated with casirivimab and imdevimab who still experienced a symptomatic infection resolved their symptoms on average within one week, compared to three weeks with placebo. No new or serious safety signals were observed. “Today's data confirm the potential dual value of casirivimab and imdevimab to reduce household COVID-19 infections and to decrease the disease burden in those who do become infected, when given as a subcutaneous option,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Although vaccinations are increasing globally, there remains a critical unmet need worldwide to prevent infections and provide immediate protection from COVID-19 between close contacts. This is why we are excited to bring this data to health authorities with the goal of making the combination available to more people as soon as possible.” The phase III, double-blind, placebo-controlled trial assessed the effect of casirivimab and imdevimab on individuals without SARS-CoV-2 antibodies or any COVID-19 symptoms, who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days. It included 1,505 people who were not infected with SARS-CoV-2 at baseline and received either one dose of casirivimab with imdevimab (1,200 mg) or placebo, administered as subcutaneous injections. In addition, the multi-part study evaluated the antibody cocktail in a cohort of 204 recently infected asymptomatic patients randomised to receive either one dose of casirivimab and imdevimab (1,200 mg subcutaneous administration) or placebo. In this cohort, casirivimab and imdevimab reduced the overall risk of progressing to symptomatic COVID-19 by 31%. Detailed results from the trial will be shared with regulatory authorities as soon as possible. Regeneron will share new data with the United States (U.S.) Food and Drug Administration (FDA) and Roche and Regeneron will continue to work with the European Medicines Agency (EMA) and other health authorities across the globe. The antibody cocktail continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalised and certain hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the UK. As of April 2021, more than 25,000 people have participated in clinical trials involving casirivimab and imdevimab. In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic. Table 1: Key results from phase III prevention cohort in uninfected individuals*

Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%

Basel, 8 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. These new data include 23 abstracts highlighting the expanding Roche neuroscience portfolio across six therapeutic areas, including EVRYSDI™ (risdiplam) for spinal muscular atrophy (SMA), OCREVUS® (ocrelizumab) in relapsing and primary progressive multiple sclerosis (RMS and PPMS), investigational Bruton's tyrosine kinase inhibitor (BTKi) fenebrutinib in Phase III trials for RMS and PPMS, ENSPRYNG® (satralizumab) in neuromyelitis optica spectrum disorder (NMOSD), and data from investigational programmes in Alzheimer's disease (AD) and Huntington's disease (HD). “Following U.S. FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche's data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are proud to collaborate with patient advocates, academia, industry and the broader healthcare community through cutting-edge research and partnerships to advance the scientific understanding of neurological conditions, which have historically been among the hardest disorders to study, diagnose and treat.” Spinal Muscular Atrophy (SMA) Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. The programme includes infants aged 2 months to adults aged 60 years with varying degrees of disability, including people with scoliosis or joint contractures, and those previously treated for SMA with another medication. New 2-year findings from Part 2 of the Phase II/III FIREFISH trial show longer-term efficacy and safety of EVRYSDI in infants with symptomatic Type 1 SMA treated with EVRYSDI. This includes the number of infants able to sit without support for 5 and 30 seconds, a key motor milestone not normally seen in the natural course of the disease, as well as data on event-free survival and reduced hospitalisations. Additional data being presented across EVRYSDI's broad clinical trial programme include updated data from the JEWELFISH trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of EVRYSDI in patients previously treated with SMA targeting therapies, as well as updated pooled safety analyses from the FIREFISH, SUNFISH, RAINBOWFISH and JEWELFISH trials. Multiple Sclerosis (MS) Roche will be presenting data from its MS Franchise, including five presentations covering OCREVUS and results from studies on the investigational BTKi fenebrutinib. Real-world data continue to show the highest persistence and adherence to OCREVUS, the only MS therapy with a twice-yearly dosing schedule, over one year compared to other disease-modifying therapies (DMTs). Additionally, a post-hoc analysis of the ORATORIO Phase III PPMS study will be presented, which suggest OCREVUS significantly slowed atrophied T2-lesion volume accumulation, a subclinical measure of disease progression. Furthermore, interim analysis of the open-label Phase IIIb ENSEMBLE study shows OCREVUS treatment provided consistent benefit over one year in patients who were recently diagnosed with relapsing-remitting multiple sclerosis (RRMS) and had not received prior DMT. Roche is continuing to advance the science in MS and is exploring the investigational medicine fenebrutinib. Data from fenebrutinib, a highly selective, non-covalent, reversible oral BTKi, support its safety profile in several autoimmune diseases and high potency, which is encouraging for the ongoing Phase III studies in RMS and PPMS. Fenebrutinib is a dual inhibitor of both B-cell and myeloid lineage-cell activation, which may offer a novel approach to slowing disease progression by targeting both acute and chronic inflammatory aspects of MS. Neuromyelitis Optica Spectrum Disorder (NMOSD) Roche will present five sets of data on adults living with NMOSD. Data from the Phase III SAkuraStar and SAkuraSky clinical trials reinforce the favourable safety and efficacy of this therapy for those living with NMOSD, including patients with concomitant autoimmune diseases (CAIDs). New longitudinal, observational data from the CIRCLES study, conducted in collaboration with the Guthy-Jackson Charitable Foundation, a patient advocacy organisation dedicated to funding research on NMOSD epidemiology, pathogenesis and treatment, will also be presented. The CIRCLES study explored factors that influence treatment change in people living with NMOSD, including those who have experienced only one relapse. Alzheimer's Disease (AD) Roche will present data on the increased use of home nursing capabilities in the Phase III GRADUATE studies of gantenerumab during the COVID-19 pandemic, which enabled home-bound trial participants to continue dosing to maintain medicine exposure. Gantenerumab is a late-stage investigational anti-beta-amyloid antibody being evaluated in two Phase III studies (GRADUATE I and II), which are the only late-stage AD clinical trials to offer subcutaneous administration. We expect data from the studies in 2022. Huntington's Disease (HD) Roche will also present an analysis of the Enroll-HD study and REGISTRY database, which will highlight the role that genetic factors and medical history may have in predicting the rate of disease progression in HD. These data may help advance the understanding of HD and inform future treatment approaches for this rare, neurological condition. The full range of data from Roche's clinical development programme in neuroscience being presented at 2021 AAN include:

New Roche data at 2021 AAN highlight impact and breadth of expanding neuroscience portfolio

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. These new data include 23 abstracts highlighting the expanding Genentech neuroscience portfolio across six therapeutic areas, including Evrysd

New Genentech Data at 2021 AAN Highlight Impact and Breadth of Expanding Neuroscience Portfolio

Johnson & Johnson

Merck

A common saying among investors is that you have to spend money to make money. If that's the case, the top R&D spenders in the pharmaceutical industry should have a high potential to be among the leading cash generators in the industry going forward, which would be good news for investors in the companies.

Roche, Merck and J&J: Kings of R&D Spenders in 2020

Basel, 07 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. This test is used to aid physicians to diagnose throat cancer, bowel cancer and breast cancer in patients, in conjunction with other diagnostic tests. The assay is now available for all markets accepting the CE Mark. “The addition of our Elecsys Anti-p53 immunoassay will help clinicians to quickly and reliably diagnose several prevalent cancers and might assist in leading to a better prognosis for many patients.”, said Thomas Schinecker, CEO Roche Diagnostics. “Beyond breakthrough cancer medicines, Roche also offers a growing number of testing solutions to help physicians diagnose and treat people with cancer. p53 is protein which, when active, helps to regulate processes which stop tumors from developing. A mutation of p53 is present in half of solid tumor cancers and is the most common genetic change identified so far in human cancers.1 Certain mutations of p53 can lead to a build up of p53 which results in the formation of anti-p53 autoantibodies. Autoantibodies are antibodies that mistakenly target and react with a person's own tissues. Between 20-50% of patients with mutated p53 will produce anti-p53 autoantibodies.2 This mutation causes the tumor suppressive function of p53 to switch to a tumor-promoting function and thus cancer development. Early appearance of anti-p53 antibodies during tumour development may have potential to detect malignant changes.3 The Elecsys Anti-p53 immunoassay detects these anti-p53 antibodies and, when used with other diagnostic tests, can help to diagnose certain cancers, at an earlier stage, which may help to improve patient outcomes. Determining the presence of anti-p53 antibodies may also be useful for monitoring cancerous cells that are still in the body following treatment.4 In addition, the Elecsys Anti-p53 test could aid in determining which patients may require less invasive treatment procedures, as part of their cancer treatment. About Elecsys Anti-p53 Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 autoantibodies in human serum and plasma. Elecsys Anti-p53  is a high precision immunoassay, with a low turn-around time for testing, complementing our overall tumor marker portfolio.  The new Elecsys Anti-p53 immunoassay uses the well-established electrochemiluminescence immunoassay “ECLIA” technology and is intended for use on cobas e immunoassay analyzers.

Roche launches Elecsys Anti-p53 immunoassay to aid diagnosis of various cancer types

Oncimmune Holdings PLC (LON:ONC) said it landed two substantial new contracts for an infectious disease panel that helps predict the severity of Coronavirus (COVID-19) along with the potential effectiveness of vaccines and other drugs used to treat it. The agreements are with drug giant Roche Pharmaceuticals and the world-famous Cedars-Sinai Medical Center.

Oncimmune Holdings wins COVID-19 contracts with Roche and Cedars-Sinai Medical Center

Oncimmune Holdings PLC (LON:ONC) has landed two substantial new contracts for an infectious disease panel that can help predict the severity of COVID-19 along with the potential effectiveness of vaccines and other drugs used to treat it. The agreements are with drug giant Roche Pharmaceuticals and the world-famous Cedars-Sinai Medical Center.

Oncimmune Holdings lands contracts with Roche Pharmaceuticals and the world-famous Cedars-Sinai Medical Center

BeiGene

Global X China Biotech Innovation ETF

Global X MSCI China Health Care ETF

KraneShares MSCI All China Health Care Index ETF

Healthcare was the second-best performing sector in China in 2020.

China Healthcare: A Rediscovered Sector Keeps Its Momentum

Basel, 31 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Elecsys® EBV panel has launched in countries accepting the CE Mark. Roche will file for approval with the FDA in the future. The Elecsys® EBV panel consists of three immunoassays: Elecsys EBV IgM, Elecsys EBV VCA IgG, and Elecsys EBV EBNA IgG, that detect antibodies specific to the Epstein-Barr virus (EBV), at different stages of infection. When used in combination, the three tests can help to define how far the infection has progressed in a patient.

Roche launches Elecsys Epstein-Barr Virus (EBV) immunoassay panel to improve EBV infection staging

Roche (RHHBY) gains a regulatory nod for its SMA treatment Evrysdi in Europe for patients aged two months and above.

Roche's (RHHBY) SMA Treatment Evrysdi Secures EC Approval

Johnson & Johnson's (NYSE:JNJ) 2020 revenue topped all pharmaceutical companies, according to rankings published by Fierce Pharma.

Johnson & Johnson, Roche and Novartis Top in Pharma Sales

Basel, 30 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Evrysdi™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. SMA is a leading genetic cause of death in infants and 5q SMA is the most common form of the disease. The condition causes muscle weakness and progressive loss of movement and significant unmet need remains, particularly in adults living with this condition.

Roche's Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy

Basel, 26 March 2021 – 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 Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. Based on this recommendation, a final decision regarding the approval of Tecentriq in this disease setting, along with the full details of the approved indication, is expected from the European Commission in the near future. “Today's CHMP recommendation is a significant step forward in bringing a new chemotherapy-free treatment with flexible treatment schedules to people in Europe with certain types of lung cancer,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We remain committed to providing effective and tailored lung cancer treatment options, and this announcement is an important step toward this goal.” If approved, Tecentriq would provide a new treatment option, free from chemotherapy-related adverse effects. It will also be the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks, giving physicians and patients flexibility to manage their treatment. The recommendation from the CHMP is based on data from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; p=0.0106) in people with high PD-L1 expression (TC3 or IC3-wild-type [WT]).1 Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified. Grade 3–4 treatment-related adverse events were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.2 Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets around the world. It was the first approved cancer immunotherapy for first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Furthermore, Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types. *High PD-L1 expression in the indication statement is defined as PD-L1 stained ≥50% of tumour cells [TC] [TC ≥50%] or PD-L1 stained tumour-infiltrating cells [IC] covering ≥10% of the tumour area [IC ≥10%]. PD-L1 staining is the process by which the PD-L1 protein is visualised during testing. About the IMpower110 study IMpower110 is a Phase III, randomised, open-label study evaluating the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in PD-L1-selected, chemotherapy-naïve participants with Stage IV non-squamous or squamous NSCLC. The study enrolled 572 people, of whom 554 were in the intention-to-treat WT population, which excluded people with EGFR or ALK genomic tumour aberrations, and were randomised 1:1 to receive:

Roche receives positive CHMP opinion for Tecentriq as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer

Basel, 25 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of $24.05 per share. The tender offer is being made pursuant to the previously announced merger agreement dated as of March 12, 2021 among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Geronimo Acquisition Corp., a wholly owned subsidiary of Roche Holdings, Inc., and GenMark.

Roche commences tender offer for all shares of GenMark Diagnostics, Inc. for $24.05 per share in cash

Roche (RHHBY) halts dosing in the phase III GENERATION HD1 study evaluating tominersen in manifest Huntington's disease following recommendation from an iDMC.

News for Roche Holding AG Stock (RHHBY)