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, 9 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the initiation of an innovative Phase III clinical trial programme for its investigational medicine fenebrutinib in multiple sclerosis (MS), along with a higher-dose Phase III clinical trial programme for OCREVUS® (ocrelizumab) and a distinct OCREVUS trial specifically to support African-American and Hispanic- and Latinx-American patients with MS. Overviews of clinical trials and scientific rationale will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 11-13 September 2020.  “We remain committed to advancing the science in MS by investigating potential new medicines such as fenebrutinib, with the ultimate goal of halting progression of this disease,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “In addition, over 170,000 people have been treated with OCREVUS, our first-in-class B-cell therapy, and we are incorporating years of clinical trial data and real-world evidence to optimise its potential to improve outcomes for patients with MS.”   Fenebrutinib Phase III clinical trial programme  Roche is initiating a Phase III clinical trial programme for fenebrutinib, an investigational oral Bruton’s tyrosine kinase (BTK) inhibitor in relapsing MS (RMS) and primary progressive MS (PPMS). Increasing evidence suggests that B cells and myeloid lineage cells contribute to disease progression in MS. Fenebrutinib is a dual inhibitor of both B-cell and myeloid lineage-cell activation, which may conceivably offer a novel approach to suppress disease activity and slow disease progression by targeting both acute and chronic inflammatory aspects of MS, which will be studied in the Phase III clinical trial programme.  Pre-clinical data have shown fenebrutinib is highly selective and acts as a non-covalent agent with a slow release rate from its target.  The Phase III clinical trial programme includes two identical Phase III trials in RMS (named FENhance 1 and FENhance 2) and one Phase III trial in PPMS (named FENtrepid). All three trials are targeting clinical disability progression and have a primary endpoint of 12-week composite confirmed disability progression (cCDP-12), with the addition of a co-primary endpoint of annualised relapse rate in the RMS trials. The PPMS study is the first study in this patient population to have an active comparator – OCREVUS – rather than placebo.  OCREVUS higher dose Phase IIIb clinical trial programme  Halting disease progression is the ultimate aim for patients and physicians, and we are acting on the needs of the MS community, informed by recent data, to optimise the potential of OCREVUS to slow progression for a broad range of patients. Roche is therefore initiating two new Phase IIIb trials, one in RMS (named MUSETTE) and one in PPMS (named GAVOTTE), which will evaluate a higher OCREVUS dose compared with the currently approved 600 mg dose, with both evaluated at the twice-yearly (six-monthly) dosing schedule. This decision was based on analyses from the pivotal RMS and PPMS studies presented at the American Academy of Neurology Annual Meeting 2019, which showed higher OCREVUS exposure was associated with lower B-cell levels and with greater control of disability progression, without impacting safety.   At the currently approved 600 mg dose, OCREVUS is the only MS treatment that has demonstrated a consistent and significant impact on slowing disability progression in both RMS and PPMS Phase III studies. The clinical trial programme will evaluate the potential benefit of higher dose OCREVUS in further reducing disability progression for people living with both RMS and PPMS.   OCREVUS CHIMES trial in minority patients  Roche recently initiated the Phase IV CHIMES (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) trial in African-Americans and Hispanic- and Latinx-Americans with RMS. These patient populations are more likely to experience more relapses and greater disability than Caucasians, yet are vastly underrepresented in most clinical trials.   CHIMES is the first prospective trial developed in collaboration with MS patients, patient advocacy groups and investigators to exclusively focus on meeting the needs of minority patients with MS. The findings are expected to improve current understanding of MS disease biology and treatment response, among African-American and Hispanic- and Latinx-American patients with MS, with the ultimate goal of increasing high-quality standard of care to traditionally underserved communities and enhancing equality through clinical research.   All of the newly announced clinical trials are underway and anticipated to begin recruiting in the coming months.   About multiple sclerosis  Multiple sclerosis (MS) is a chronic disease that affects nearly 1 million people in the U.S. and more than 2.3 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults.  People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system and gradual worsening of disability – at the beginning of their disease even if their clinical symptoms aren’t apparent or don’t appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, both in terms of their physical, mental and financial health. An important goal of treating MS is to slow the progression of disability as early as possible.   Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there had been no FDA approved treatments for PPMS.  About fenebrutinib  Fenebrutinib is designed to be a highly selective small molecule and is the only reversible (non-covalent) BTK inhibitor currently in Phase III development in MS. Increasing evidence suggests that B cells and myeloid lineage cells contribute to disease progression in MS. Fenebrutinib is a dual inhibitor of both B-cell and myeloid lineage-cell activation, which may offer a novel approach to suppress disease activity and slow disease progression by targeting both acute and chronic inflammatory aspects of MS, which will be studied in our Phase III clinical trial programme. The safety profile of fenebrutinib has been studied in more than 1,200 people to date across several inflammatory diseases, and the data indicate that the high selectivity of fenebrutinib may limit off-target effects.  About OCREVUS® (ocrelizumab)  OCREVUS is the first and only therapy approved for both RMS (including clinically isolated syndrome, RRMS and active, or relapsing, SPMS, in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS. OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved. OCREVUS is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.  About Roche in multiple sclerosis  Roche is following the science in an effort to ultimately stop disease progression and preserve function in people living with multiple sclerosis (MS). As a company, we continue to advance the clinical understanding of MS and progression with the aim of bringing the most benefit to people living with MS.  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’s 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

Roche expands its multiple sclerosis portfolio with investigational BTK inhibitor fenebrutinib and initiates novel clinical trials for OCREVUS (ocrelizumab)

Basel, 8 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) 510k clearance for the cobas® BKV Test on the cobas® 6800 and 8800 Systems. The test was previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients. The test provides standardised, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options.   BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications. Infection can occur without symptoms and happen early in life. After primary infection, the virus can remain inactive, only to possibly reactivate in immunocompromised individuals such as transplant recipients.  “Our diagnostic tests can help clinicians greatly improve patient treatment plans and make quick adjustments for personalised healthcare,” said Thomas Schinecker, CEO Roche Diagnostics. “This FDA clearance allows Roche to offer healthcare professionals a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus and BK virus so they can simultaneously monitor and improve care for transplant patients who are at risk for these common infections or viral reactivations which can cause further illness or death.”  The cobas BKV 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. Along with the previously approved cobas® EBV and CMV Tests, the cobas BKV Test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international units, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of BKV DNA.  About the cobas BKV Test  The cobas BKV Test was previously granted Breakthrough Device Designation by the FDA, together with the cobas EBV Test.   The cobas BKV Test is a real-time polymerase chain reaction (PCR) test with dual-target technology that provides quantitative accuracy and guards against the risk of sequence variations that may be present in the BK virus. The cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma.  The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (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 BKV Test and the cobas CMV and cobas EBV Tests can run on the cobas 6800/8800 Systems simultaneously, providing absolute automation with proven performance and flexibility, leading to time savings and increased efficiency.  About BK polyomavirus  BK polyomavirus (BKV) is a member of the polyomavirus family that can cause transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic stem cell transplantation. Infection can occur early in life, often with no symptoms. After primary infection, the virus can remain inactive throughout life, only to possibly reactivate in immunocompromised individuals, such as patients who receive solid-organ transplants. For kidney transplant patients, BKV infection is considered the most common viral complication, causing polyomavirus nephropathy (PVN) in up to 10 percent of kidney transplant recipients, and about 50 percent of PVN-affected patients will experience transplant graft failure.1  BKV is also associated with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.2   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 three hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight 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] Jamboti, J. S. (2016) BK virus nephropathy in renal transplant recipients. Nephrology, 21: 647– 654. doi: 10.1111/nep.12728.     [2] Hirsch HH, Randhawa PS; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13528. doi:10.1111/ctr.13528  Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com

Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients

Roche's (RHHBY) lung cancer arm gets a boost with the FDA approval of Gavreto for NSCLC.

Roche Gets FDA Nod for Gavreto for RET Fusion-Positive NSCLC

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33 Dividend Stocks Fit For COVID-19 Times: A September Update

              Basel, 7 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations. It is jointly commercialised by Genentech, a wholly owned member of the Roche Group, and Blueprint Medicines in the US and will be commercialised by Roche outside of the US, excluding Greater China*.  “The FDA approval of Gavreto for RET fusion-positive non-small cell lung cancer is an important step towards our goal of providing an effective treatment option for every person diagnosed with lung cancer, no matter how rare or hard-to-treat their type of disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We remain committed to finding personalised treatment options for people with cancer based on specific genomic or molecular alterations, and we look forward to partnering with Blueprint Medicines to further explore the potential of Gavreto across multiple RET-altered tumour types.”  RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and medullary thyroid cancer (MTC), and treatment options that selectively target these genetic alterations are limited. In NSCLC, RET fusions represent approximately 1-2% of patients.1 Biomarker testing for these fusions is the most effective way to identify people who are eligible for treatment with Gavreto.  The approval is based on the results from the phase I/II ARROW study, in which Gavreto produced durable clinical responses in people with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement.2 Gavreto demonstrated an overall response rate (ORR) of 57% (95% CI: 46%, 68%) and complete response (CR) rate of 5.7% in the 87 people with NSCLC previously treated with platinum-based chemotherapy, and the median duration of response (DoR) was not reached (95% CI: 15.2 months, not reached).2 In the 27 people with treatment-naïve NSCLC, the ORR was 70% (95% CI: 50%, 86%), with an 11% CR rate.2 The most common adverse reactions (≥25%) were fatigue, constipation, musculoskeletal pain and increased blood pressure (hypertension).2   Gavreto is now the sixth FDA-approved medicine in Roche’s portfolio of treatments for lung cancer. The FDA granted Breakthrough Therapy Designation to Gavreto for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy and for RET mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.  The FDA has also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer, and is expected to make a decision on approval by 28 February 2021. This New Drug Application (NDA) was accepted for review under the FDA's Real-Time Oncology Review (RTOR) pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.   About the ARROW study3   ARROW (NCT03037385) is a phase I/II, open-label, first-in-human study designed to evaluate the safety, tolerability and efficacy of Gavreto, administered orally in people with rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC), RET fusion-positive thyroid cancer and other RET-altered solid tumours. The trial consists of two parts: a dose escalation portion, which is complete, and an expansion portion in people treated with 400 mg of Gavreto, once-daily. ARROW is being conducted at multiple sites across the United States, European Union and Asia.

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer

Drugmaker Roche on Friday said it had received Emergency Use Authorization from the U.S. Food and Drug Administration for a test to quickly detect whether a patient has SARS-CoV-2 or one of two forms of influenza

Roche receives U.S. emergency approval for coronavirus vs.

Basel, 04 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800/8800 Systems has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19. Additionally, it is available in markets accepting the CE mark.  “With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” said Thomas Schinecker, CEO of Roche Diagnostics. “As a leader in diagnostics testing solutions, this launch demonstrates our ongoing commitment to stop the spread of serious infectious diseases by increasing access to accurate, reliable and efficient testing options.”  Roche’s widely-available, fully-automated cobas 6800/8800 Systems, which are used to perform the SARS-CoV-2 & Influenza A/B Test, 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. Roche is committed to delivering as many tests as possible within the limits of supply.  The test is another key addition to the comprehensive Roche diagnostic portfolio to help healthcare providers combat COVID-19 and make informed decisions for optimised patient care. Currently, this portfolio includes molecular, serology and digital solutions, which help during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.   About cobas SARS-CoV-2 & Influenza A/B Test  The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, and Influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory infection, and is not intended for the detection of Influenza C virus. Under FDA EUA, the test can be taken by individuals suspected of a respiratory viral infection like COVID-19 by their healthcare provider. The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control and internal control. Multiplexing will increase lab efficiency and save resources in the labs.  Negative results do not preclude infection from SARS-CoV-2 or Influenza virus and should not be used as the sole basis of treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.  The cobas SARS-CoV-2 & Influenza A/B Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. In the United States, the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800 and  cobas® 8800 Systems is only for use under the FDA’s Emergency Use Authorization.  About Emergency Use Authorization status  The cobas SARS-CoV-2 & Influenza A/B Test has not been FDA cleared or approved. It has been authorised by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform moderate and high complexity tests. The test has been authorised only for the detection of RNA from SARS-CoV-2 virus, Influenza A virus, and Influenza B virus and not any other viruses or pathogens. It is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use of in vitro diagnostics for detection and differentiation of SARS-CoV-2 virus, Influenza A, and Influenza B under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorisation is terminated or revoked sooner.  About SARS-CoV-2 (coronavirus) Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.1   Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.  To control the spread of the infection, the World Health Organisation (WHO) recommends regular hand washing, covering mouth and nose when coughing and sneezing, and avoiding close contact with anyone showing symptoms of respiratory illness.  About Roche’s response to the COVID-19 pandemic The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:

Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems

Basel, 3 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) data will be presented at MSVirtual2020, the 8th Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) - European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Meeting from 11-13 September 2020.   “While conditions of the nervous system are some of the most complex to understand and treat, we are committed to following the science to reduce relapses in NMOSD and slow and eventually stop disease progression in MS,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “From the success of our first-in-class B-cell MS therapy OCREVUS, we are poised to continue advancing the science in MS with our new investigational BTK inhibitor fenebrutinib, and in NMOSD with the recent FDA approval of ENSPRYNG.”   Multiple Sclerosis (MS)  New analyses from the two-year open-label Phase IIIb CASTING study will show patients with relapsing-remitting MS (RRMS) who experienced a prior suboptimal response to one or more disease-modifying therapies (DMTs) achieved a high rate of no evidence of disease activity (NEDA) after switching to OCREVUS. Other data to be presented will show high treatment persistence and strong adherence for patients treated with OCREVUS compared to other DMTs in real-world settings. Additionally, new longer-term safety data will reinforce the consistently favourable benefit:risk profile of OCREVUS.  We are exploring potential optimisation of OCREVUS, our first-in-class B-cell therapy, in a large Phase IIIb clinical trial programme to evaluate the impact of higher dose OCREVUS on reducing disability progression in relapsing MS (RMS) and primary progressive MS (PPMS). This decision was based on analyses from the pivotal RMS and PPMS studies presented at the American Academy of Neurology Annual Meeting 2019, which showed higher OCREVUS exposure was associated with lower B-cell levels and with greater control of disability progression, without impacting safety.   Roche is also deeply committed to addressing barriers to clinical trial participation and advancing inclusive research. The study design of the recently initiated CHIMES (CHaracterisation of ocrelizumab In Minorities with multiplE Sclerosis) trial, an open-label, multi-centre Phase IV study evaluating disease activity and neurological biomarkers in African-American and Hispanic- and Latinx-American people with RMS treated with OCREVUS, will be presented.  Roche's commitment to potentially slow or stop disease progression continues with the Phase III clinical trial programme initiation of fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor in RMS and PPMS. Fenebrutinib is designed to be a highly selective small molecule and is the only reversible (non-covalent) BTK inhibitor currently in Phase III development in MS.  Neuromyelitis Optica Spectrum Disorder (NMOSD)  New data show ENSPRYNG lowered relapse severity in people with NMOSD in double-blind periods of SAkura Phase III studies. Pooled data from SAkura open-label extension (OLE) studies also showed ENSPRYNG significantly reduced risk of relapse, further reinforcing the findings from the double-blind period. Preventing relapses, the most severe of which cause cumulative, irreversible neurological damage and disability, is the primary goal for NMOSD disease management.   On 14 August, ENSPRYNG was approved by the US Food and Drug Administration (FDA) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive NMOSD, a rare disabling neurological disorder often mistaken for MS. ENSPRYNG can be self-administered every four weeks by a person living with NMOSD or a caregiver, after an initial loading dose and following training by a healthcare provider.  Until recently, people living with NMOSD did not have medicines specifically tested and designed to treat the condition. Many people with NMOSD remain misdiagnosed and untreated.   New data from the double-blind and OLE trials continue to build on one of the largest pivotal clinical trial programmes undertaken for this rare neurological disease, further demonstrating ENSPRYNG’s sustained efficacy and favourable safety profile in adults with NMOSD.  Follow Roche on Twitter via @Roche and keep up to date with MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting news and updates by using the hashtag #MSVIRTUAL2020.  A full list of Roche presentations can be found at: https://cslide.ctimeetingtech.com/msdc2020/attendee/confcal/session   Presentations at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting include:

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

Roche Holding AG (OTC: RHHBY) said Tuesday it will launch a COVID-19 rapid antigen test in late September in Europe and intends to file for emergency use authorization (EUA) in the United States.

Roche To Launch Rapid COVID-19 Test In Europe This Month, Seek FDA Emergency Use Approval

"Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment," Roche's CEO Thomas Schinecker said in a statement.

Roche to launch new rapid coronavirus test in Europe later this month following regulatory clearance

Basel, 1 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA).   The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes.1 In addition, it serves as a valuable initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high risk environment.The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers.* At launch, there will be 40 million SARS-CoV-2 Rapid Tests available, per month. This capacity will increase more than two-fold at the end of this year to help with testing demands of healthcare systems globally.  The launch is a partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July.   The test is the tenth addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions which help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.   The SARS-CoV-2 Rapid Antigen Test is performed by healthcare professionals in a number of different settings close to the patient. This is highly beneficial where timely decisions are needed or laboratory testing is inaccessible. The test will help to quickly identify people who are infected and allows better patient management as well as more effective use of healthcare resources.  Thomas Schinecker, CEO of Roche Diagnostics, stated, “As the COVID-19 pandemic persists, healthcare systems remain challenged. Testing continues to be an important focus for many countries. Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment. COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus. We are working relentlessly to deliver solutions that help alleviate some of the healthcare burden with reliable SARS-CoV-2 testing solutions as we learn more about the disease and how it affects people around the world.”  About the SARS-CoV-2 Rapid Antigen Test  Roche’s SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. This test is performed by healthcare professionals using a nasopharyngeal swab collected from a patient.1 The results are intended to aid in the early diagnosis of SARS-CoV-2 infection in patients showing clinical symptoms of SARS-CoV-2 and assist in the initial screening of patients. The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers. Results are ready in only 15 minutes.1 This test is another important addition to the testing options for SARS-CoV-2 at the point of care, following the launch of the SARS-CoV-2 Rapid Antibody Test, in July 2020, that is helping healthcare professionals identify patients that have developed antibodies against SARS-CoV-2, indicating prior infection.   About antigen testing  An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen.2 In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes.1,3   In general, antigen tests have a high specificity, though are not as sensitive as molecular tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal to indicate the presence of the virus in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be analysed together with additional patient factors, such as COVID-19 exposure history, clinical symptoms, additional test results to help guide the diagnosis and subsequent treatment of the patient.   About Roche’s response to the COVID-19 pandemic  The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:

Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

Basel, 1 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options.  “Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS,” said Thomas Schinecker, CEO Roche Diagnostics. “Being able to reliably determine a person’s HIV status and accurately diagnose which HIV type they may have is crucial for patients and healthcare providers in preventing further community transmission and selecting an individual’s best treatment options.”    Studies show that 50% of new HIV infections may be transmitted during the acute period, between three days and three weeks from the time of infection1. Current serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate. The higher sensitivity of PCR technology, which is used with the cobas HIV-1/HIV-2 Qualitative Test, can reduce this time-to-detection period by one week or more. This significant reduction in time to detection is critical to improve personalised healthcare while curbing further disease transmission.   About the cobas HIV-1/HIV-2 Qualitative Test      cobas HIV-1/HIV-2 Qualitative for use on the cobas 6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.        The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection. cobas HIV-1/HIV-2 Qualitative may also be used as an additional test to confirm the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects and pregnant women.  About HIV-1 and HIV-2 in the U.S.  The U.S. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2 million people were living with HIV in the United States. Among them, more than 160,000 people did not know their HIV status, and only 53 percent were virally suppressed having low amounts of virus circulating in their blood. During this same year, 37,968 people became newly infected with HIV2.   Human immunodeficiency virus (HIV) is categorized into two types, HIV-1 and HIV-2. Worldwide, most HIV infections are HIV-1, whereas HIV-2 largely has been confined to persons in or from West Africa. However, HIV-2 has been steadily increasing in the U.S. due to immigration3. HIV-1 and HIV-2 have the same routes of transmission, and both can cause acquired immunodeficiency syndrome (AIDS); however, it is important to differentiate HIV-2 infections from HIV-1 infections because they require different clinical management4.  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. 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   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] Branson BM, Mermin J. Establishing the diagnosis of HIV infection: new tests and a new algorithm for the United States. J Clin Virol. 2011;52 Suppl 1:S3-S4. doi:10.1016/j.jcv.2011.09.024 [2] Statistics Overview. Centers for Disease Control and Prevention website. Reviewed June 8, 2020. Accessed July, 24 2020. https://www.cdc.gov/hiv/statistics/overview/index.html.  [3] Campbell-Yesufu OT, Gandhi RT. Update on human immunodeficiency virus (HIV)-2 infection. Clin Infect Dis. 2011;52(6):780-787. doi:10.1093/cid/ciq248 [4] Ekouevi DK, Tchounga BK, Coffie PA, et al. Antiretroviral therapy response among HIV-2 infected patients: a systematic review. BMC Infect Dis. 2014;14:461. Published 2014 Aug 26. doi:10.1186/1471-2334-14-461  Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com

Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS

Basel, 28 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours. FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyses more than 300 cancer-related genes and multiple genomic signatures to optimise patient care. Cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA. CGP is used to identify these unique mutations to determine how a tumour behaves and grows, and these insights can help physicians to determine a personalised treatment plan for each individual patient based on the specific mutations identified.  As well as approving FoundationOne Liquid CDx as a CGP test for patients with any solid tumour, the FDA approved the test for use as a companion diagnostic to identify patients who may benefit from treatment with certain prostate and lung cancer therapies, including Rubraca® (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase (TKI) inhibitors for the treatment of patients with non-small cell lung cancer. By incorporating multiple genes, including several companion diagnostic biomarkers, the test can help save time versus sequential biomarker testing.  “Many cancer patients are unable to have a tissue biopsy. FoundationOne Liquid CDx may provide a minimally-invasive option for patients who otherwise might not have benefitted from comprehensive genomic profiling,” said Levi Garraway, M.D., Ph.D., Roche’s Executive Vice President, Chief Medical Officer, Head of Global Product Development and Co-Founder of Foundation Medicine Inc. “The convenience of testing a blood sample may also enable more rapid treatment decisions, so that patients can feel reassured they are not losing time to fight their disease.”   FoundationOne Liquid CDx analyses circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. The report also delivers information about genomic signatures, including microsatellite instability and blood tumour mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies, and provides relevant clinical trial information.  “With the acceleration towards precision therapy approaches, it is important that physicians have the highest quality tools that can provide an accurate picture of their patients’ cancers in a timely manner,” said Fortunato Ciardiello, M.D., Ph.D, Professor of Medical Oncology, Director of the Division of Medical Oncology at the Università della Campania Luigi Vanvitelli, Italy. “With the approval of FoundationOne Liquid CDx physicians have the choice of two high-quality, FDA-approved comprehensive genomic profiling tests, enabling them to select the most optimal option for their patients.”  The FDA approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies including more than 7,500 samples and 30,000 unique variants across more than 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumour types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples 1,2.   FoundationOne Liquid CDx is the latest addition to Foundation Medicine’s portfolio of high-quality CGP tests and the second of the company’s CGP tests to receive FDA approval. FoundationOne®CDx, Foundation Medicine’s tissue-based genomic test for patients with solid tumours received FDA approval in 2017. Together, these high-quality genomic profiling tests offer physicians important options for detecting specific genomic alterations that help guide efficient, personalised treatment decisions, while reducing the time and sample needed when testing for multiple biomarkers one at a time. FoundationOne Liquid CDx can also provide complementary insights to tissue-based testing regarding tumour heterogeneity (the differences between cancer cells), and clonal evolution (how tumours evolve over time).  About FoundationOne®Liquid CDx FoundationOne Liquid CDx is a qualitative next-generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridisation-based capture technology to analyse 324 genes utilising circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumour tissue testing and mutation status confirmed using an FDA-approved tumour tissue test, if available. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.   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] Foundation Medicine Inc. Internal data on file. 95% limit of detection (median) of 0.40% variant allele fraction (VAF) for select substitutions and indels, 0.37% VAF for select rearrangements, 21.7% tumor fraction (TF) for copy number amplifications, and 30.4% TF for copy number losses. [2] Foundation Medicine Inc. Internal data on file. 0% false positive rate for rearrangements and copy number alterations, 0.013% false positive rate for substitutions and indels   Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com

Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test

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Regeneron's REGN-COV2 is a leading candidate to treat the illness.

Regeneron and Roche Team Up to Triple Production of COVID-19 Treatment

Regeneron and Roche said Wednesday they are teaming up on Regeneron's coronavirus treatment, an antiviral antibody cocktail in late-stage testing, a deal that could ease supply constraints. 
The post Regeneron Teaming With Roche On Coronavirus Treatment; Adds Capacity appeared first on Investor's Business Daily.

Regeneron Teaming With Roche On Coronavirus Treatment; Adds Capacity

Regeneron (REGN) teams up with Roche to develop and distribute REGN-COV2, its experimental dual antibody cocktail for the prevention and treatment of COVID-19.

Regeneron, Roche to Distribute Antibody Cocktail for Coronavirus

Regeneron and Roche are teaming up on an investigational antibody cocktail against Covid-19, with the U.S. company to sell it in the United States and the Swiss drugmaker to sell it elsewhere, should the drug win approval.

Roche and Regeneron link up on a coronavirus antibody cocktail

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Roche Holding AG (OTC: RHHBY) on Monday disclosed that they are collaborating to develop, manufacture, and distribute the former's COVID-19 antibody cocktail.

Regeneron To Collaborate With Roche For Global Supply Of Its Coronavirus Treatment

Basel, 19 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Regeneron (NASDAQ: REGN) announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion.  REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.  “We are excited about the potential for one medicine to serve both as a treatment for those infected as well as protection for people exposed to the virus. REGN-COV2 could be a critical line of defense against the COVID-19 pandemic,” said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. “We’re committing our manufacturing expertise and capacity, and our global distribution network to bring Regeneron’s potential antibody combination to as many people around the world as we possibly can.”  “Regeneron has progressed the REGN-COV2 research and development program at record speed and worked tirelessly to maximize our in-house manufacturing capacity,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “This major collaboration with Roche provides important scale and global expertise to bring REGN-COV2 to many more patients in the United States and around the globe.”   Under the terms of the agreement, each company has committed to dedicate a certain manufacturing capacity to REGN-COV2 each year, and the collaborators have already begun the technology transfer process. Each company will bear its own distribution expenses in their designated territories. The collaborators will jointly fund and execute the ongoing Phase 3 prevention and Phase 1 healthy volunteers safety studies as well as additional global studies to evaluate further the potential for REGN-COV2 in treating or preventing COVID-19. Roche will be primarily responsible for securing regulatory approvals outside the U.S., following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the U.S.  About REGN-COV2  REGN-COV2 was designed specifically by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications.  REGN-COV2's development, manufacturing and clinical trials have been funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.  About Roche’s response to the COVID-19 pandemic  The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This partnership is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:

Roche and Regeneron collaborate to significantly increase global supply of REGN-COV2 investigational antibody combination for COVID-19

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that Genentech and Roche are joining forces with Regeneron in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe.

Genentech and Regeneron Collaborate to Significantly Increase Global Supply of REGN-COV2 Investigational Antibody Combination for COVID-19

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