GlobeNewswire by notified

New data for Roche’s OCREVUS (ocrelizumab) show benefit in disability progression and cognitive decline in both secondary progressive and primary progressive multiple sclerosis

Share
  • 75% of patients with secondary progressive multiple sclerosis (SPMS) and primary progressive MS (PPMS) achieved no evidence of progression (NEP) in a one-year interim analysis of CONSONANCE study
  • 70% of patients with SPMS and PPMS demonstrated stable or improved cognition after one year of OCREVUS treatment in CONSONANCE
  • Separate analysis on treatment disparities showed fewer Black and Hispanic patients with MS initiate high-efficacy treatments within two years of diagnosis
  • Data at AAN support the body of evidence for OCREVUS more than 450,000 patient years and more than 225,000 patients treated globally

Basel, 04 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new OCREVUS® (ocrelizumab) data that show its benefit on disease progression and cognitive outcomes in primary progressive multiple sclerosis (PPMS) and secondary progressive MS (SPMS). Separate analyses on treatment disparities among newly diagnosed patients with MS by race and ethnicity will be a platform presentation at the 74th American Academy of Neurology (AAN) Annual Meeting 02–07 April 2022 in Seattle. CONSONANCE data will be presented virtually at AAN 24-26 April 2022.

“We continue to work on closing treatment gaps for all people impacted by MS, as everyone living with this neurodegenerative condition experiences disease progression from the start. For people with progressive forms of MS and in some Black and Hispanic subpopulations, the disease may progress faster,” said Levi Garraway, M.D., Ph.D. Roche's Chief Medical Officer and Head of Global Product Development. “We are encouraged by the low levels of disability progression and cognitive decline in OCREVUS-treated patients seen across the complete spectrum of progressive MS for the first time, since SPMS and PPMS often bring a substantial quality of life burden.”

CONSONANCE interim analysis: low levels of disease progression in SPMS and PPMS patients
Treatment with OCREVUS resulted in a majority of patients experiencing no disease progression in a one-year analysis of CONSONANCE, a first-of-its-kind open-label Phase IIIb trial to evaluate the effect of OCREVUS in SPMS and PPMS patients. After one year, 75% of OCREVUS-treated patients with SPMS and PPMS achieved No Evidence of Progression (NEP; no evidence of confirmed disability progression as measured by an increase in Expanded Disability Status Score sustained for at least 24 weeks, and less than 20% worsening of performance on the timed 25-foot walk [T25-FW] and Nine-Hole Peg Test [9-HPT]). NEP is a novel composite endpoint and reflects no evidence of worsening of a person’s physical disability.

Additionally, 59% of OCREVUS-treated patients in the trial achieved No Evidence of Progression or Active Disease (NEPAD; NEP plus no protocol-defined relapses, new and/or enlarging T2 lesions or T1 gadolinium-enhancing lesions) over one year. NEPAD is another novel composite endpoint and reflects no evidence of clinical or MRI disease activity or worsening of a person’s physical disability. Progression was primarily driven by T25-FW (16% of patients) and activity of new and/or enlarging T2 lesions (19% of patients), detected almost exclusively within the first 6 months of the trial.

The analysis also demonstrated the positive effects of OCREVUS on cognition, with 70% of patients having stable or improved cognition over one year, as measured with the Symbol Digit Modalities Test (SDMT). Clinically meaningful improvement (increase of ≥4 points on the SDMT) was observed in 34% of patients treated with OCREVUS and worsening (decrease of ≥4 points) in 30% of patients treated with OCREVUS. At enrolment, patients had moderate-to-severe dysfunction in information processing speed and visuospatial memory, which was stable or improved in a majority of patients after OCREVUS treatment.

After one year of participating in the trial, 75% of patients had one or more adverse events (AEs) and 7% experienced at least one serious AE. The interim analysis included 629 patients, and longer-term evaluation of OCREVUS will continue for four years with a target of 900 patients with PPMS or SPMS (in a 1:1 ratio) across 26 countries.

Continued research on the treatment patterns of minority populations living with MS
Current treatment guidelines recommend the initiation of high-efficacy disease modifying therapies (DMTs) for patients with highly active disease, as frequently seen with Black and Hispanic populations. However, a recent analysis of a U.S. commercial claims database found that only 30% of non-Hispanic Black, and 20% of Hispanic patients initiated any high-efficacy DMTs, in comparison to 39% of non-Hispanic white patients in the first two years after diagnosis.

These insights further support Roche’s Phase IV ‘Characterization of ocrelizumab in Minorities with Multiple Sclerosis’ (CHIMES) trial in Black/African-American and Hispanic/Latino patients with relapsing MS (RMS). The results are expected to improve the current understanding of MS disease biology and treatment response to OCREVUS among these populations with MS, to improve standard of care in traditionally underserved communities and improve inclusivity in clinical research.

With rapidly growing real-world experience and more than 225,000 people treated globally, OCREVUS is the first and only therapy approved for relapsing MS (RMS; including relapsing-remitting MS [RRMS] and active SPMS, in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS. At Roche, we are constantly striving to optimise the care for people with MS and a shorter two-hour OCREVUS infusion time, dosed twice yearly (six-monthly), is approved for eligible people with RMS or PPMS in the U.S. and European Union (EU).

OCREVUS is approved in 100 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland, the United Kingdom and the EU.

About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects more than 2.8 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 OCREVUS (ocrelizumab)
OCREVUS is the first and only therapy approved for both RMS (including RRMS, active SPMS and CIS in the U.S.) and PPMS, with six-month dosing. 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 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, 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
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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

Dr. Nicolas Dunant
Phone: +41 61 687 05 17
SileiaUrech
Phone: +41 79 935 81 48

Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67
KarstenKleine
Phone: +41 61 682 28 31

Nina Mählitz
Phone: +41 79 327 54 74
Nathalie Meetz
Phone: +41 61 687 43 05

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Cool Company Ltd. – Q1 2022 Business Update call16.5.2022 23:04:27 CEST | Press release

Cool Company Ltd will hold a Q1 2022 business update call for investors at 10am Oslo time on Tuesday May 31. Prior to the start of the call a presentation will be made available in the Investors section of the Cool Company Ltd. website www.coolcoltd.com We recommend that participants join the conference call via the listen-only live webcast link provided. Sell-side analysts interested in raising a question during the Q&A session that will immediately follow the presentation should access the event via the conference call dial-in information below. Please dial in 10 minutes prior to the start time to allow time for call handling. Information on how to ask questions will be given at the beginning of the Q&A session. There will be a limit of two questions per participant. a. Listen-only live webcastlink Go to the Investors section at www.coolcoltd.com and click on the link to "Webcast". To listen to the conference call from the web, you need to have installed Windows Media Player, and you

Golar releases its 2021 Environmental, Social and Governance report16.5.2022 22:53:05 CEST | Press release

Golar LNG Limited (“Golar”) is pleased to announce that it has issued its 2021 Environmental, Social and Governance (“ESG”) report. This comprehensive report describes Golar’s important role in advancing the global energy transition to a lower carbon future - championing LNG as a transition fuel in partnership with renewables, and as a reliable alternative for those in need of energy security today. As part of our target to further reduce emissions from our operations Golar has invested in a carbon capture technology company that has developed and achieved proof of concept for a CO2 capture and separation membrane technology. Subject to successful completion of a commercial pilot project with another industrial user, the technology could be used in future FLNG projects. Our 2021 ESG report is attached and will also be posted to our website. Forward-Looking Statements This press release contains forward-looking statements (as defined in Section 21E of the Securities Exchange Act of 1934

Inventiva reports 2022 First Quarter Financial Information and provides clinical development update16.5.2022 22:00:00 CEST | Press release

Cash position2 at €80.5m as of March 31, 2022The Group did not generate any revenue in Q1 2022Signature of a €50 million bullet credit facility agreement with the European Investment BankUpdate on lanifibranor recruitment timing for Phase III trial in patients with NASH, as well as for the two Phase II trials in patients with NAFLD and type 2 diabetes, and in combination with empagliflozine Daix (France), Long Island City (New York, United States), May 16, 2022 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis (NASH) and other diseases with significant unmet medical needs, today reported its cash position as of March 31, 2022 and its revenues for the first quarter of 20221, and provided an update on its clinical programs. Cash Position As of March 31, 2022, Inventiva’s cash position stood at €80.5 million com

ASM INTERNATIONAL N.V. ANNOUNCES VOTING RESULTS OF THE ANNUAL GENERAL MEETING OF SHAREHOLDERS16.5.2022 21:00:00 CEST | Press release

Almere, the Netherlands May 16, 2022 ASM International N.V. (Euronext Amsterdam: ASM) today announces the voting results of its Annual General Meeting of Shareholders held on May 16, 2022, at the Van der Valk Hotel in Almere, the Netherlands. The shareholders approved all resolutions as proposed to the Annual General Meeting of Shareholders. The main approved resolutions include the following: Mr. Hichem M’Saad was appointed as a member of the Management Board and as the CTO. The Remuneration Policy for the Management Board and for the Supervisory Board were approved. Also Mr. Marc de Jong was reappointed as member of the Supervisory Board. Furthermore the financial statements for the year 2021 were adopted, the shareholders discharged the members of the Management Board and Supervisory Board from liability in relation to the exercise of their duties in the financial year 2021, and the shareholders also voted in favor of a regular dividend payment of €2.50 per common share. About ASM I

Electra Gruppen AB (publ) (u.ä.t Elon AB (publ)) offentliggör prospekt avseende upptagande till handel av nyemitterade aktier på Nasdaq Stockholm i samband med apportemission16.5.2022 18:00:00 CEST | Pressemelding

ELECTRA GRUPPEN AB (publ) orgnr. 556065-4054 Pressmeddelande 2022-05-16 Electra Gruppen AB (publ) (u.ä.t Elon AB (publ)) offentliggör prospekt avseende upptagande till handel av nyemitterade aktier på Nasdaq Stockholm i samband med apportemission Electra Gruppen AB (publ) (u.ä.t Elon AB (publ)) (”Electra” eller ”Bolaget”), offentliggör idag det prospekt som upprättats inför upptagande till handel av de nyemitterade aktierna på Nasdaq Stockholm med anledning av den apportemission genom vilken Electra förvärvar samtliga aktier i Elon Group AB (”Elon”) (”Transaktionen”). Transaktionen beskrivs närmare i Electras pressmeddelande daterat den 7 december 2021. På Electras årsstämma den 28 mars 2022 bemyndigades styrelsen att besluta om apportemissionen för att genomföra Transaktionen. Den 13 maj 2022 beslutade Electras styrelse om apportemission av 9 659 223 aktier till Elon Group Holding. Prospektet som har upprättats med anledning av upptagande till handel av de nyemitterade aktierna i samb