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Roche Holdings Ltd. S/ADR (RHHBY) is a leading biotechnology company with a global presence in the field of in-vitro diagnostics. Roche focuses on scientific excellence to develop medicines and diagnostics for improving and saving lives. The company's pivotal role in personalized healthcare is reflected in its commitment to transforming healthcare delivery. Roche's innovative approach encompasses the discovery and development of cutting-edge treatments, including the first CD20xCD3 bispecific antibody, Columvi® (glofitamab), for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The company's recently FDA-cleared whole-slide imaging system, VENTANA DP 200, signifies Roche's dedication to revolutionizing pathology workflows through digitalization and artificial intelligence-based tools, ensuring pathologists can provide accurate and timely diagnoses. Roche's extensive portfolio and pipeline of haematology medicines demonstrate its unwavering commitment to advancing treatment options for patients worldwide.
Roche's phase III SKYSCRAPER-02 study of tiragolumab in extensive-stage small cell lung cancer (ES-SCLC) has reported disappointing results, failing to meet its co-primary endpoint of progression-free survival. Although the combination treatment was well-tolerated, the interim analysis revealed that overall survival is unlikely to achieve significance in future evaluations. Roche remains committed to developing tiragolumab in other cancer types, continuing its exploration of innovative therapies to enhance treatment options for patients with hard-to-treat cancers.
Roche has received a positive recommendation from the European Medicines Agency's CHMP for Polivy® (polatuzumab vedotin) combined with R-CHP therapy for previously untreated diffuse large B-cell lymphoma (DLBCL). This regimen marked the first significant improvement in patient outcomes in over 20 years, highlighting a need for better treatment options for the 40% of patients unresponsive to current therapies. Based on the POLARIX study, Polivy plus R-CHP demonstrated a 27% improvement in progression-free survival compared to traditional R-CHOP treatment, with comparable safety profiles.
On March 25, 2022, Roche announced new data concerning its neuroscience portfolio to be presented at the 74th AAN Annual Meeting from April 2-7, 2022. Key highlights include:
- OCREVUS: First data on disability progression in non-active secondary progressive multiple sclerosis.
- EVRYSDI: Long-term safety and efficacy in spinal muscular atrophy.
- ENSPRING: Reinforced long-term efficacy in neuromyelitis optica spectrum disorder.
- New findings in Alzheimer’s disease to enhance understanding of early treatment impact.
Roche has collaborated with Bristol Myers Squibb to enhance personalised healthcare through digital pathology. The partnership focuses on the development of two AI-driven assays aimed at improving clinical trial processes for solid tumor treatment. One algorithm will assist in interpreting the VENTANA PD-L1 Assay, while the second will integrate CD8 biomarker analysis into Roche's NAVIFY Digital Pathology software. This initiative aims to boost cancer diagnosis accuracy and patient treatment options.
Roche (OTCQX: RHHBY) has announced a significant donation of medical supplies to Ukraine, delivering an additional 4,600 packs of specialized medicines alongside 150,000 packs of antibiotics. These new provisions include treatments for influenza, rheumatoid arthritis, spinal muscular atrophy, and various cancers, plus reagents for 120,000 blood tests and diabetes management support. Roche emphasizes its commitment to addressing healthcare needs in Ukraine while condemning the invasion and striving to maintain global supply chains for its products.
Roche, through its subsidiary TIB Molbiol, announced the availability of research tests identifying SARS-CoV-2 variants, including Omicron subvariants BA.1, BA.1.1, BA.2, BA.2.2, BA.3, and Delta. The WHO has noted an increase in the prevalence of the BA.2 subvariant, particularly in Denmark. Roche's tests are designed to monitor the spread of variants and inform public health responses, aiding the ongoing development of vaccines and therapeutics. These research tests complement Roche's existing SARS-CoV-2 diagnostic solutions, underscoring Roche's commitment to addressing the COVID-19 pandemic.
Roche announced new three-year efficacy data for Evrysdi (risdiplam) in spinal muscular atrophy (SMA), confirming sustained motor function improvements in patients aged 2-25 years from the SUNFISH study.
Additionally, interim results from RAINBOWFISH showed that most babies treated with Evrysdi for at least a year were able to stand and walk within typical developmental timelines. Over 5,000 patients have received Evrysdi in various settings, demonstrating its broad application and safety profile, with adverse events decreasing over time.
Roche's Annual General Meeting (AGM) held on March 15, 2022, approved all Board of Directors' proposals, including the re-election of Christoph Franz as Chairman with 98.91% support. Notably, the dividend was raised for the 35th consecutive time to CHF 9.30 per share. Shareholders also confirmed the remuneration packages for the Corporate Executive Committee and the Board. New Board member Jemilah Mahmood was elected, and the independent proxy Testaris AG represented 77.25% of total shares. Roche continues to make significant advancements in diagnostics and therapeutics amid the ongoing pandemic.
Roche has announced new data on Evrysdi® (risdiplam) for spinal muscular atrophy (SMA) and gene therapy for Duchenne muscular dystrophy (DMD) ahead of the MDA Conference from March 13-16, 2022. Interim results from the RAINBOWFISH study indicate that most infants treated with Evrysdi for at least 12 months achieved milestones such as sitting, standing, and walking. Roche, alongside Sarepta, is also reporting promising early-stage gene therapy results for DMD, supporting progression into the pivotal Phase III EMBARK study.
On March 2, 2022, Roche announced a donation of 150,000 packages of Rocephin, an essential antibiotic, to Ukraine amidst the ongoing conflict. Roche condemns the invasion and emphasizes its commitment to support the Ukrainian people through medical products. The medicines will be delivered promptly, with the company coordinating efforts with external partners despite logistical challenges. Roche aims to ensure consistent supply of critical medicines, diagnostics, and ongoing clinical trial access for displaced Ukrainian patients.