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, 17 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved ENSPRYNG™ (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system, often misdiagnosed as multiple sclerosis, that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis.  “Today’s FDA approval of ENSPRYNG, the first subcutaneous NMOSD treatment using novel recycling antibody technology, builds upon the work we’ve done in multiple sclerosis with OCREVUS to develop first-in-class medicines and further the scientific understanding of neuroimmunological diseases,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “We thank the NMOSD community, including patients and investigators who participated in ENSPRYNG clinical trials.”  ENSPRYNG is a humanised monoclonal antibody and the only approved therapy designed to target and inhibit interleukin-6 (IL-6) receptor activity, believed to play a key role in the inflammation associated with NMOSD. The treatment was designed by Chugai, a member of the Roche group, using novel recycling antibody technology, which compared to conventional technology, allows for longer duration of antibody circulation and subcutaneous dosing every four weeks.  “For people with NMOSD, relapses can cause devastating, irreversible and disabling neurological effects,” said Professor Jeffrey Bennett, University of Colorado Neurology & Ophthalmology, and investigator for the ENSPRYNG pivotal clinical trials. “Having an approved therapy that can be administered subcutaneously in the home, and has demonstrated an impact on the frequency of relapses, is an important advancement for patients.”  “We are very optimistic the addition of this new approved treatment option will make a meaningful difference for those living with NMOSD, those who love and support them and the doctors who treat them,” said Victoria Jackson, founder, The Guthy-Jackson Charitable Foundation. “When my daughter was diagnosed with NMOSD in 2008, there were no approved treatment options, and a critical lack of resources and understanding for people living with this disabling disorder. After years of dedicated effort and collaboration, the FDA approval of ENSPRYNG exemplifies how patients, industry, and academia can find solutions together.”  ENSPRYNG can be administered in the home by a person living with NMOSD or a caregiver following training from a healthcare provider. ENSPRYNG treatment is administered every four weeks after an initial loading dose.  ENSPRYNG will be available in the United States in two weeks.  FDA approval is based on results from one of the largest pivotal clinical trial programmes undertaken for this rare neurological disorder  This approval is supported by results from two randomised controlled Phase III clinical trials, the  SAkuraStar  and  SAkuraSky  studies, in which ENSPRYNG demonstrated robust and sustained efficacy and a favourable safety profile in adults with AQP4 antibody positive NMOSD. Results were sustained for 96 weeks, significantly reducing the risk of relapse compared with placebo as a monotherapy and when used concurrently with baseline immunosuppressant therapy (IST), which has commonly been used to manage NMOSD symptoms associated with relapses.  In the SAkuraStar monotherapy study’s AQP4 antibody positive subgroup, 76.5% of ENSPRYNG-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated ENSPRYNG when used concurrently with baseline IST, 91.1% of ENSPRYNG-treated AQP4 antibody positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo. The primary endpoint of both SAkuraStar and SAkuraSky was time to first protocol-defined relapse (PDR) adjudicated by an independent review committee in the double-blind period.  The most common adverse reactions with ENSPRYNG (incidence ≥ 15%) were nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue and nausea.  About SAkuraStar and SAkuraSky in NMOSD  SAkuraStar is a Phase III multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of ENSPRYNG monotherapy administered to patients with NMOSD. The primary endpoint is the time to first protocol-defined relapse (PDR), adjudicated by an independent review committee in the double-blind period. Results from the SAkuraStar study were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 11-13, 2019, and were published in  The Lancet Neurology  in April 2020.  Ninety-five adult patients were randomised to either of the following two treatment groups in a 2:1 ratio: ENSPRYNG (120 mg) or placebo. Both treatments were administered subcutaneously at week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals. The double-blind treatment period ended at 1.5 years after the enrolment of the last patient. After experiencing a PDR or upon completion of the study, patients in both groups were offered treatment with ENSPRYNG in an open label extension (OLE) period. Patients with aquaporin-4 (AQP4) antibody positive or negative neuromyelitis optica (NMO, as defined by the diagnostic criteria in 2006) and those with AQP4 antibody positive NMOSD were enrolled. The number of AQP4 antibody negative patients was limited to approximately 33% of the total population of the study. Data have shown that AQP4 antibody positive patients may experience a greater likelihood of relapse and poorer long-term outcomes than AQP4 antibody negative patients.  SAkuraSky is a Phase III multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of ENSPRYNG added to baseline immunosuppressant therapy in patients with NMOSD. The primary endpoint was the time to first relapse as adjudicated by an independent review committee in the double-blind period. Results from the SAkuraSky study were published in the November 28, 2019 edition of the  New England Journal of Medicine  (NEJM).  Seventy-six adult patients were randomised to either of the following two treatment groups in a 1:1 ratio: ENSPRYNG (120 mg) or placebo added to baseline therapy (azathioprine, mycophenolate mofetil and/or corticosteroids). Both treatments were administered subcutaneously at week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals. The double-blind treatment ended when patients experienced a PDR; the study ended when the total number of PDRs reached 26. After experiencing a PDR or upon completion of the study, patients in both groups were offered treatment with ENSPRYNG in an OLE period. Patients with AQP4 antibody positive or negative neuromyelitis optica (NMO, as defined by diagnostic criteria in 2006) and those with AQP4 antibody positive NMOSD were enrolled. AQP4 antibody negative patients represented approximately 30% of the SAkuraSky study population.  About neuromyelitis optica spectrum disorder (NMOSD)  NMOSD is a rare, lifelong and debilitating autoimmune condition of the central nervous system that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis. People with NMOSD experience unpredictable, severe relapses directly causing cumulative, permanent, neurological damage and disability. In some cases, relapse can result in death. NMOSD affects over 10,000 people in Europe, up to 15,000 people in the US and approximately 200,000 people worldwide. NMOSD can affect individuals of any age, race and gender, but is most common among women in their 30s and 40s, and appears to occur at higher rates in people of African or Asian background. There is some evidence that people of African or Asian descent may also experience a more severe disease course.  NMOSD is commonly associated with pathogenic antibodies (AQP4) that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain. AQP4 antibodies are detectable in the blood serum of around 70-80% of NMOSD patients.  Although most cases of NMOSD can be confirmed through a diagnostic test, people living with the condition are still frequently misdiagnosed with multiple sclerosis. This is due to overlapping characteristics of the two disorders, including a higher prevalence in women, similar symptoms and the fact that both are relapse-based conditions.   About ENSPRYNG™ (satralizumab-mwge)  ENSPRYNG, which was designed by Chugai, a member of the Roche group, is a humanised monoclonal antibody that targets IL-6 receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD, triggering the inflammation cascade and leading to damage and disability. ENSPRYNG was designed using novel antibody recycling technology, which compared to conventional technology, allows for longer duration of the antibody and subcutaneous dosing every four weeks.  Positive Phase III results for ENSPRYNG, as both monotherapy and used concurrently with baseline immunosuppressant therapy, suggest that IL-6 inhibition is an effective therapeutic approach for NMOSD. The Phase III clinical development programme for ENSPRYNG includes two studies: SAkuraStar and SAkuraSky.  ENSPRYNG is also approved in Canada, Japan and Switzerland. Applications are under review with numerous regulators, including in the EU and China.  ENSPRYNG has been designated as an orphan drug in the US, Europe and Japan. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018.  About Roche in neuroscience  Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.  Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.  About Roche 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 eleventh 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

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The FDA accepts Roche's (RHHBY) sBLA for a new self-administration option for Xolair across all approved U.S. indications.

Roche's Xolair sBLA for Self Administration Accepted by FDA

              Basel, 10 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Evrysdi™ (risdiplam) for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months of age and older. Evrysdi showed clinically-meaningful improvements in motor function across two clinical trials in people with varying ages and levels of disease severity, including Types 1, 2, and 3 SMA. Infants achieved the ability to sit without support for at least 5 seconds, a key motor milestone not normally seen in the natural course of the disease. Evrysdi also improved survival without permanent ventilation at 12 and 23 months, compared to natural history. A liquid medicine, Evrysdi is administered daily at home by mouth or feeding tube.   “Given the majority of people with SMA in the U.S. remain untreated, we believe Evrysdi, with its favorable clinical profile and oral administration, may offer meaningful benefits for many living with this rare neurological disease,” said Levi Garraway, M.D., Ph. D., Roche’s Chief Medical Officer and Head of Global Product Development. “The strength and resolve of the SMA community has continually inspired us as we developed this first-of-its-kind medicine for SMA, so today we celebrate our collective accomplishment together with them.”  Evrysdi is being studied in more than 450 people as part of a large and robust clinical trial program in SMA. The program includes infants aged 2 months to adults aged 60 with varying symptoms and motor function, such as people with scoliosis or joint contractures, and those previously treated for SMA with another medication. The approval is based on data from two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic infants aged 2 to 7 months; and SUNFISH in children and adults aged 2 to 25 years. SUNFISH is the first and only placebo-controlled trial to include adults with Types 2 and 3 SMA.  In FIREFISH, 41% (7/17) of infants treated with the therapeutic dose achieved the ability to sit without support for at least 5 seconds as measured by the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). Additionally, 90% (19/21) of infants were alive without permanent ventilation at 12 months of treatment and reached 15 months of age or older. As described in the natural history of untreated infantile-onset SMA, infants would not be expected to be able to sit independently, and only 25 percent would be expected to survive without permanent ventilation beyond 14 months of age. In SUNFISH, children and adults treated with Evrysdi experienced a clinically-meaningful and statistically significant improvement in motor function at 12 months (1.55 point mean difference; p=0.0156) compared to placebo (1.36 points [95% CI: 0.61, 2.11]; -0.19 points [95% CI: -1.22, 0.84], respectively), as measured by a change from baseline in the Motor Function Measure-32 (MFM-32) total score.  Evrysdi demonstrated a favorable efficacy and safety profile, with the safety profile established across the FIREFISH and SUNFISH trials. The most common adverse reactions were fever, diarrhea, and rash in later-onset SMA. In infantile-onset SMA, the most common adverse events were similar and also included upper respiratory tract infection, pneumonia, constipation, and vomiting. There were no treatment-related safety findings leading to withdrawal from either study.   “Throughout their lives, many people with SMA may lose their ability to perform critical movements, which can impact the ability to independently participate in aspects of daily life and even be life altering,” said Kenneth Hobby, president of Cure SMA. “The approval of Evrysdi is an eagerly awaited milestone for our community. We appreciate Genentech/Roche’s commitment to reflecting the full scope of the real-world SMA population in their clinical trial program and developing a treatment that can be administered at home.”  Evrysdi is designed to treat SMA by increasing production of the survival of motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.  Evrysdi will be available in the United States within two weeks for direct delivery to patients’ homes through Accredo Health Group Inc., an Express Scripts specialty pharmacy.   About Evrysdi™ (risdiplam) Evrysdi is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.  Risdiplam was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. At this time, risdiplam has been filed in Brazil, Chile, China, Indonesia, Russia, South Korea, and Taiwan. A Marketing Authorization Application (MAA) submission to the EMA for Evrysdi is imminent.  About the  Pivotal Studies  FIREFISH (NCT02913482)  FIREFISH, an open-label, two-part pivotal study, was designed to assess Evrysdi safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) in patients aged 1 to 7 months with Type 1 SMA. Part 1 evaluated several doses of Evrysdi and determined the therapeutic dose of 0.2 mg/kg for Part 2. In Part 1, after 12 months of Evrysdi treatment:

FDA approves Roche’s Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older

Basel, 10 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced topline results from its phase III study programme evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis. Mixed results were seen in studies evaluating etrolizumab as an induction therapy, and both studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints, showing no significant difference in the proportion of people achieving remission with subcutaneous etrolizumab versus placebo.  In the HIBISCUS I induction study, in people without prior anti-tumour necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, did not meet its primary endpoint. In the HICKORY study, in people with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction but not at maintenance. In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint. The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four phase III clinical trials reported to date.  “We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are fully analysing these data to learn more about how we might address the needs of people with this devastating disease. These studies were part of the largest clinical trial programme ever undertaken in inflammatory bowel diseases, and we thank all the patients, investigators and healthcare professionals for their participation.”  Further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings.  Etrolizumab continues to be studied as an investigational induction and maintenance treatment in people with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment in a global phase III study (BERGAMOT) and open-label extension and safety monitoring study (JUNIPER), involving more than 1,100 people with Crohn’s disease. In addition, Roche is studying other investigational medicines in inflammatory bowel diseases and is committed to further understanding this disease.  About inflammatory bowel diseases and ulcerative colitis Inflammatory bowel diseases (IBD) are a group of chronic gastrointestinal disorders affecting almost 7 million people worldwide.1 The two main types of IBD are ulcerative colitis (mainly affecting the colon and rectum) and Crohn’s disease (affecting the entire gastrointestinal tract).2,3 Patients can experience unpredictable symptoms that include abdominal pain and cramping, frequent and urgent bowel movements, diarrhoea, leakage, rectal bleeding, weight loss, energy loss and fatigue.2,3 About 80% of all individuals with IBD do not experience lasting remission, which can have a long-term impact on quality of life and leave many feeling like they have little control over their daily lives.4   Ulcerative colitis is most commonly diagnosed in young people aged 15 to 30 years, affecting them over the course of their entire future lives.5 Up to a quarter of people with ulcerative colitis will require a colectomy within 10 years of diagnosis, in which all or part of the colon is removed.6   About etrolizumab  Etrolizumab is the first investigational dual anti-integrin studied in inflammatory bowel diseases (IBD). It is designed to target IBD on two fronts by selectively inhibiting α4β7 and αEβ7 to control both trafficking of immune cells into the gut and their inflammatory effects on the gut lining.7   About the etrolizumab study programme Etrolizumab is being studied in the largest clinical trial programme in inflammatory bowel diseases to date, comprised of eight randomised-controlled and open-label trials.8-15 The landmark study programme includes more than 3,100 patients across six phase III studies, plus two open-label extension (OLE) and safety monitoring studies for ulcerative colitis and Crohn’s disease, spanning more than 40 countries globally, including head-to-head trials against the most common current treatments.  The etrolizumab study programme consists of:

Roche provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis

AstraZeneca

Gilead Sciences

iShares Nasdaq Biotechnology ETF

Johnson & Johnson

Eli Lilly

Merck

Moderna

Novo Nordisk

Regeneron Pharmaceuticals

Sanofi

Vertex Pharmaceuticals

SPDR S&P Biotech ETF

The biotech sector had a troubled Q2, as doctor visits were curtailed and new Rx'es were in short supply; R&D efforts were also harmed.

Biotech's Q2:  Lots Of Candidates That May Deliver Alpha

Roche Holding AG ROG, -0.27% said Friday that the Food and Drug Administration had approved Evrysdi, a treatment for spinal muscular atrophy in adults and most children.

FDA approves Roche's new spinal muscular atrophy drug

PTC Therapeutics

Roche and PTC Therapeutics will challenge Novartis and Biogen with competitive pricing for Evrysdi.

FDA Approves First Oral Treatment for Spinal Muscular Atrophy

Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population.  The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoint of OS and data were immature at time of analysis. OS follow-up is planned to continue until final analysis. Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified.  In the previous IMpassion130 study, Tecentriq (atezolizumab) in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel) demonstrated a statistically significant PFS benefit and, while not formally tested, showed clinically meaningful improvements in OS for people with metastatic TNBC whose tumours express PD-L1 (≥1%). Tecentriq in combination with nab-paclitaxel is approved in over 70 countries for the treatment of adults with unresectable locally advanced or metastatic TNBC whose tumours express PD-L1 (≥1%).  “While we are disappointed by the results from the IMpassion131 study, we are grateful for all the patients, families and physicians who were involved in the study," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "Today’s results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens. We remain committed to finding optimal treatments for all people living with this aggressive disease.”  Full results from IMpassion131 are being discussed with global health authorities and will be presented at a future medical meeting. The insights will also be used to inform existing and future studies in triple-negative breast cancer with Tecentriq in combination with paclitaxel.  Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.   About the IMpassion131 study  The IMpassion131 study is a Phase III, multicentre, randomised, double-blind study evaluating the efficacy and safety of Tecentriq in combination with paclitaxel, in comparison to placebo plus paclitaxel, in people with previously untreated, inoperable, locally advanced or metastatic TNBC. The study enrolled 651 people who were randomised in a 2:1 ratio to receive Tecentriq or placebo plus paclitaxel. The primary endpoint is PFS per investigator assessment (RECIST 1.1) in the PD-L1-positive population followed by intention-to-treat (ITT) populations. Secondary endpoints include OS, objective response rate and duration of response in the PD-L1-positive and ITT populations.  About triple-negative breast cancer  Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.1 TNBC represents ~15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.2-4 It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification.5 Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer.3   About Roche in breast cancer  Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.  Our targeted medicines Herceptin, Perjeta, Kadcyla and Tecentriq are continuing to transform the treatment of early and advanced HER2-positive and triple-negative breast cancers and, through our Tecentriq and ipatasertib clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.  About Tecentriq  Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.  Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer and in PD-L1-positive metastatic triple-negative breast cancer. In the US, Tecentriq in combination with Avastin is approved for people with unresectable or metastatic hepatocellular carcinoma.  About Roche in cancer immunotherapy  Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.  In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:  http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm    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 eleventh 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]World Health Organization: Globocan 2018 – Breast Cancer Factsheet. [Internet; cited 24 July] Available from:  http://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf . [2] Yao H et al. Triple-negative breast cancer: is there a treatment on the horizon? Oncotarget. 2017;8(1):1913–1924. [3] BreastCancer.org. What is Triple-Negative Breast Cancer? [Internet; cited 24 July] Available from:  https://www.breastcancer.org/symptoms/diagnosis/trip_neg?what . [4] Cancer Treatment Centers of America. Triple negative breast cancer risk factors. [Internet; cited 24 July] Available from:  https://www.cancercenter.com/breast-cancer/risk-factors/tab/triple-negative-breast-cancer-risk-factors/ . Accessed May 2019. [5] Pal SK et al. Triple negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627–636.

Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer

Basel, 5 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorisation gives healthcare professionals a key tool in monitoring transplant patients at risk for complications from infections or reactivations of EBV, by providing the ability to run a large number of patient tests for this virus in a short period of time.   “Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threatening diseases, such as cancer in transplant patients,” said Thomas Schinecker, CEO Roche Diagnostics. “The EBV test helps set a new standard of care for patients, as healthcare professionals now can act early in the management of this virus with best-in-class monitoring tools and can make more informed decisions when treating patients.”  The cobas EBV test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas® 6800 and cobas® 8800 Systems. The test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international measures, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of EBV DNA.  The test was previously granted FDA Breakthrough Device designation, which enables an expedited review process for medical devices that provide improved treatment or diagnosis of life-threatening diseases or conditions.  About the cobas EBV test  The cobas EBV test is a real-time PCR (polymerase chain reaction) viral load test with dual target technology, which provides quantitative accuracy and guards against the risk of sequence variations that may be present in the Epstein-Barr virus. The cobas EBV test has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL to 1E+08 IU/mL in EDTA plasma.  The test offers an alternative to lab-developed tests (LDTs) or Assay Specific Reagents (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making.  The fully automated cobas EBV test can be run on the cobas 6800/8800 Systems providing absolute automation with proven performance and flexibility. Simultaneous testing with CMV or other virology tests leads to time savings and increased efficiency.  About Epstein-Barr virus (EBV)  Epstein-Barr virus is a member of the herpes virus family and has been associated with a range of cancers in transplant patients, such as post-transplant lymphoproliferative disorder (PTLD). Once infection with EBV occurs, the virus establishes as a latent form and can remain in the body. Most people harbor EBV with no long-term clinical ramifications.  EBV spreads most commonly through bodily fluids, primarily saliva. This does not always cause symptoms, but people with weakened immune systems, including transplant patients, are more likely to develop symptoms if EBV reactivates.1   About the cobas 6800/8800 Systems  When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about 3 hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift.*  Both systems make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.*  These real-time PCR systems serve the areas of infectious disease, donor screening, sexual health, transplant, respiratory and antimicrobial stewardship.   Through an ever-increasing worldwide install base of cobas 6800/8800 Systems, labs are quickly and easily processing millions of tests per month to meet the changing demands of their communities, their customers and the patients relying on the results of each assay. Globally, labs know and trust that a Roche assay guarantees high precision, accuracy and traceability to World Health Organization standards.  Today, rapid advancements in healthcare technology, a shortage of skilled workers, industry-wide consolidation, and the proven need to be ready for the next outbreak have health systems looking to lay a reliable foundation for the future. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7—cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.  Learn more now: www.cobas68008800.com or http://diagnostics.roche.com.  *May vary based on workflow demands  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 eleventh 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] Kanakry JA, et al. The clinical significance of EBV DNA in the plasma and peripheral blood mononuclear cells of patients with or without EBV diseases. Blood. 2016; Apr 21;127(16):2007-17  Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com

Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients

              Basel, 03 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has granted conditional marketing authorisation for Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options. The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.1   “We are excited to announce the approval of Rozlytrek in Europe for two indications, bringing patients with NTRK and ROS1 gene fusions a new effective treatment even when their cancer has spread to the brain,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This advance represents another important step forward in cancer care by allowing us to treat certain genetic drivers of cancer irrespective of the location of the tumour within the body. Roche is deeply committed to driving personalised healthcare and addressing the high unmet need in patients around the world with rare cancers.”  The approval is based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials, and data from the phase I/II STARTRK-NG study. These studies demonstrate that Rozlytrek has durable responses across several NTRK gene fusion-positive solid tumours, including sarcoma, non-small cell lung, salivary MASC, secretory and non-secretory breast, thyroid, colorectal, neuroendocrine, pancreatic, ovarian, endometrial carcinoma, cholangiocarcinoma, gastrointestinal cancers and neuroblastoma, as well as ROS1-positive NSCLC.1 Results showed:

Rozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer

Basel, 31 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.  The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines.  The supplemental Biologics License Application (sBLA) for Tecentriq was granted under priority review.  The review was also conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners.   "When receiving a cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. "Today’s FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma."  The approval is based on results from the Phase III IMspire150 study, in which the addition of Tecentriq to Cotellic and Zelboraf helped people live longer without disease worsening or death compared to placebo plus Cotellic and Zelboraf (median PFS 15.1 months versus 10.6 months respectively; hazard ratio, HR=0.78; confidence interval: 0.63-0.97; P=0.025).  The most common adverse reactions (rate ≥20%) in patients who received Tecentriq plus Cotellic and Zelboraf were rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%), nausea (30%), pruritus (26%), edema (26%), stomatitis (23%), hypothyroidism (22%), and photosensitivity reaction (21%).  Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.  About the IMspire150 study IMspire150 is a Phase III, multi-center, double-blind, placebo-controlled randomised study in people with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. The study compared the efficacy and safety of Tecentriq plus Cotellic and Zelboraf to the combination of placebo plus Cotellic and Zelboraf. The primary endpoint of the study was investigator-assessed PFS. Key secondary endpoints include PFS by an independent review committee, overall survival, objective response rate, duration of response and other safety and pharmacokinetic measures.  Five hundred and fourteen adult patients took part in the study. Randomisation was stratified by lactate dehydrogenase (LDH) level and geographic region. Eligible patients were randomised 1:1 to one of two treatment groups, to receive 28-day cycles of either: Tecentriq plus Cotellic and Zelboraf (the Tecentriq group) or Placebo plus Cotellic and Zelboraf (the control group). In cycle 1, all patients received once-daily oral Cotellic 60 mg plus twice-daily oral Zelboraf 960 mg for 21 days followed by twice-daily Zelboraf 720 mg or 960 mg for 7 days in the Tecentriq group or control group, respectively. Patients in the Tecentriq group received Zelboraf 720 mg Days 1–28 of each subsequent cycle. The lower 720 mg dose of Zelboraf in the Tecentriq group was a safety measure to mitigate the risk of overlapping toxicities, while ensuring an efficacious dose of Zelboraf. Treatment was continued until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, whichever occurred first.  About advanced melanoma Melanoma is a less common, but more aggressive and potentially deadly form of skin cancer.1,2 When melanoma is diagnosed early, it is generally a curable disease,3,4 but most people with advanced melanoma have a poor prognosis.2 More than 287,000 people worldwide are currently diagnosed with melanoma each year.5 BRAF is mutated in approximately half of melanomas.6 In recent years, there have been significant advances in treatment for advanced melanoma and people with the disease have more options. However, it continues to be a serious health issue with a high medical need and a steadily increasing incidence over the past 30 years.7   About Tecentriq (atezolizumab) Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.  About Cotellic (cobimetinib) Cotellic is designed to inhibit MEK1/2, proteins in a cell signaling pathway that helps control cell growth and survival. Cotellic, when used in combination with Zelboraf, is approved in the United States and Europe, as well as many countries around the world, for the treatment of people with melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation. Cotellic was discovered by Exelixis and is being developed by Genentech, a member of the Roche Group, in collaboration with Exelixis.   About Zelboraf (vemurafenib) Zelboraf is a prescription medicine for the treatment of people with melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation. Zelboraf is designed to inhibit some mutated forms of BRAF, which cause abnormal signaling inside cancer cells leading to tumor growth. BRAF is a protein in a cell signaling pathway that helps control cell growth and survival. Zelboraf was the first approved product in its class. Zelboraf was co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon Inc., the small molecule structure-guided R&D center of the Daiichi Sankyo Group.   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 eleventh 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] Algazi AP, et al. Treatment of cutaneous melanoma: current approaches and future prospects. Cancer Manag Res. 2010;2:197-211[2] Finn L, et al. Therapy for metastatic melanoma: the past, present, and future. BMC Med. 2012;10:23.[3] Leong SP. Future perspectives on malignant melanoma. Surg Clin North Am. 2003;83:453-6.[4] Creagan ET. Malignant melanoma: an emerging and preventable medical catastrophe. Mayo Clin Proc. 1997;72:570-4.[5] Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2018). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from:  https://gco.iarc.fr/today/home  Last accessed: July 2020.[6] Ascierto PA, Kirkwood JM, Grob JJ, et al. The role of BRAF V600 mutation in melanoma. J Transl Med. 2012;10:85.[7] Bataille V. Risk factors for melanoma development. Expert Rev Dermatol. 2009;4:533-9

FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma

Genentech, a subsidiary of Roche Holding AG ROG, -2.00% , confirmed that it eliminated 474 positions in July in the U.S.

Roche eliminates 474 positions

PLEASANTON, Calif., July 30, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas® prime Pre-analytical System to improve efficiency in molecular diagnostics laboratories.

Roche launches cobas prime Pre-analytical System, a first-of-its-kind solution designed to automate all common manual steps in molecular diagnostics laboratories

Hanover Insurance Group

The Hanover Insurance Group, Inc. (THG) CEO John Roche on Q2 2020 Results - Earnings Call Transcript

Actemra fails another clinical trial, but there are still two ongoing late-stage studies.

Roche's Rheumatoid Arthritis Drug Fails to Help COVID-19 Patients (Again)

Basel, 29 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. HER2 - human epidermal growth factor receptor 2 - is an important biomarker sometimes found in breast cancers.2 Its detection and inhibition can help healthcare professionals more effectively manage this aggressive cancer.  The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within the same day, enabling clinicians to get results back faster than with other common methods of confirmatory testing for HER2. Results can be read using light microscopy, eliminating the need for a specialised fluorescence microscope.  “With this new VENTANA HER2 Dual ISH assay, Roche continues to deliver on its commitment to advance personalised healthcare,” said Thomas Schinecker, CEO Roche Diagnostics. “Quick test results are crucial in the fight against cancer and by delivering critical information on treatment options for breast cancer patients faster, this assay will aid clinicians in their therapeutic decisions.”   This assay was launched as a CE IVD in April 2019.   The new VENTANA HER2 Dual ISH DNA Probe Cocktail assay is one component of Roche’s comprehensive breast cancer solutions portfolio designed to help inform decision making in cancer care and contribute to improved patient outcomes. For more information about the assay and the portfolio, please visit the Roche Tissue Diagnostics  breast cancer IHC/ISH portfolio page  or the  Anatomic Pathology  site.  About the VENTANA HER2 Dual ISH DNA Probe Cocktail assay Roche is the only provider of an FDA approved ready-to-use brightfield Dual ISH solution for the detection of HER2 amplification. The new VENTANA HER2 Dual ISH DNA Probe Cocktail assay is optimised for use with the VENTANA Silver ISH DNP Detection Kit and the VENTANA Red ISH DIG Detection Kit on the fully-automated BenchMark ULTRA. The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is an enhanced version of the previous-generation test. New oligonucleotide probes and highly sensitive detection kits provide clear results to pathology labs more quickly, allowing clinicians to make treatment decisions earlier.  As a global leader in breast cancer diagnostics, Roche provides a comprehensive menu of both diagnostic and predictive assays, including the PATHWAY HER2/neu (4B5) Rabbit Monoclonal Primary Antibody that is indicated as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered.  About Herceptin (trastuzumab) Herceptin® is a humanised monoclonal antibody designed to target and block the function of the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Herceptin binds to a specific section of the HER2 protein, inhibiting the signals it sends that encourage tumour cell growth, while also calling on the body’s immune system to attack the cancer cells.  Since it was first approved in 1998, Herceptin has been used to treat over two million patients worldwide, diagnosed with HER2-positive breast and gastric cancers. It has also become the backbone of other innovative treatments for HER2-positive breast cancer, which have continued to improve the outcomes of patients with this otherwise aggressive disease. In addition to the standard intravenous formulation, Herceptin is available in a subcutaneous (SC) formulation which was first approved in 2013. Herceptin SC represents a significant step forward in the treatment of HER2-positive breast cancer as it offers patients a faster, more convenient and less painful way to receive treatment with Herceptin.  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 eleventh 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 .  VENTANA, BENCHMARK and PATHWAY are trademarks of Roche. Other product names and trademarks are the property of their respective owners  References [1] World Health Organization. GLOBOCAN 2018; All cancers fact sheet. [Interned; cited July 2020]. Available from:  http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.%20   [2] Wolff AC, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997-4013. [3] This product is intended for in vitro diagnostic (IVD) use.  Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com

FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy

Shares of Roche Holding AG ROG, +0.71% were up 0.4% in premarket trading on Wednesday after the drugmaker said its rheumatoid arthritis drug Actemra failed in a late-stage clinical trial as a treatment for hospitalized COVID-19 patients.

Roche's  rheumatoid arthritis drug fails in COVID-19 trial

Basel, 29 July - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra. Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal.   “People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.”  The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.  COVACTA evaluated the safety and efficacy of intravenous Actemra/RoActemra added to standard-of-care treatment compared to treatment with placebo plus standard of care. The primary endpoint of clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia was measured by a 7-category ordinal scale, which tracked patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. The COVACTA trial is the first global, randomised, double-blind, placebo-controlled phase III study to investigate Actemra/RoActemra in adult patients hospitalised with severe COVID-19 associated pneumonia, with study locations in the US, Canada and Europe.  Summary of Key COVACTA Clinical and Safety Findings

Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia

Among the largest publicly traded pharmaceutical companies, Novo Nordisk (NYSE:NVO) and Roche (RHHBY) had the highest returns on invested capital during the period from 2011 to 2019, according to a report from the Westhealth Policy Center.

Novo, Roche Scored Highest Returns on Invested Capital

Roche’s ADR (OTCMKTS: RHHBY) lost more than 15% – dropping from $41 at the beginning of the year to below $35 in late March – then spiked over 20% to around $43 now. That means it has fully recovered to the levels where it started the year.

Should You Buy Roche At $43?

Covid-19 Takes Its Toll, But Roche Still Attractive For Longer-Term Investors

The performance of the very timely product category cushioned declines in the company's other businesses.

Roche COVID-19 Testing Products Revenue Shoots 61% Higher in the First Half of 2020

Roche Holding AG (RHHBY) CEO Severin Schwan on Q2 2020 Results - Earnings Call Transcript

Roche's (RHHBY) performance in first-half 2020 was unimpressive as it bears the brunt of the COVID-19 outbreak.

Roche's (RHHBY) 1H20 Sales Hit by the Coronavirus Pandemic

Danaher

Revenue from coronavirus tests helped bolster Roche and Danaher's second quarters, but the health care stocks diverged Thursday. Roche also reported a big decline in pharmaceutical sales.

News for Roche Holding AG Stock (RHHBY)