ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced positive phase III results for Xofluza (baloxavir marboxil) in the CENTERSTONE study, demonstrating its ability to significantly reduce influenza transmission from infected individuals to household members. This marks the first time an antiviral for respiratory illnesses has shown such a benefit in a global phase III study. Xofluza, currently approved for treating symptoms and preventing infection post-exposure, may now offer additional benefits in limiting community spread. The study met its primary endpoint with a single, oral dose, and no new safety concerns were identified. These findings could have significant implications for both seasonal and pandemic influenza management, potentially easing the burden on healthcare systems worldwide.

Genentech, a Roche Group member, announced FDA approval of Ocrevus Zunovo™ for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This is the first twice-yearly, 10-minute subcutaneous injection approved for both MS forms, expanding treatment options.

Key points:

• Builds on a decade of Ocrevus® IV safety and efficacy data
• Offers flexibility for healthcare providers and patients
• After the first dose, treatment time could be as little as 55 minutes
• Phase III OCARINA II trial showed consistent efficacy with IV formulation
• 92% of trial participants reported satisfaction with subcutaneous administration

Roche has received FDA approval for Tecentriq Hybreza, the first subcutaneous anti-PD-(L)1 cancer immunotherapy. This new formulation offers greater flexibility in treatment options, reducing administration time from 30-60 minutes to approximately seven minutes. It's approved for all adult indications of IV Tecentriq in the U.S., including certain types of lung, liver, skin, and soft tissue cancers.

The approval is based on the IMscin001 study, which showed comparable efficacy and safety to the IV formulation. The IMscin002 study revealed that 71% of patients preferred Tecentriq Hybreza over IV administration, with 79% choosing to continue treatment with the subcutaneous option. This development aligns with Roche's commitment to improving patient experience and offering diverse treatment options.

Genentech, a Roche Group member, announced FDA approval of Tecentriq Hybreza, the first subcutaneous PD-(L)1 inhibitor for cancer immunotherapy in the US. This new formulation reduces treatment time from 30-60 minutes to about 7 minutes, offering greater flexibility for patients and physicians. It's approved for all adult indications of IV Tecentriq, including certain lung, liver, skin, and soft tissue cancers.

The approval is based on the IMscin001 study, showing comparable efficacy and safety to IV Tecentriq. The IMscin002 study revealed 71% of patients preferred Tecentriq Hybreza, with 79% choosing to continue treatment with it. This development aligns with Genentech's commitment to improving patient experience and offering diverse administration options across various diseases.

Roche has opened its new Pharma Research and Early Development (pRED) Center at its global headquarters in Basel, Switzerland. The center, representing a CHF 1.2 billion investment, is designed to accelerate scientific innovation and meet patient needs. It features cutting-edge technologies and houses around 1,000 state-of-the-art laboratory and office workplaces.

The facility consists of two high-rise laboratory buildings (114m and 72m) with advanced lab technologies and digital solutions, an office building, and a convention center. In total, it offers 33 combined laboratory and office floors with 150 labs and workplaces for around 1,800 researchers. This investment is part of Roche's larger commitment to the Basel/Kaiseraugst site, totaling CHF 5.8 billion from 2009 to 2030.

Roche (SIX: RO, ROG; OTCQX: RHHBY) has expanded its digital pathology open environment by integrating over 20 advanced AI algorithms from eight new collaborators. This expansion aims to enhance cancer research and diagnosis through Roche's navify® Digital Pathology enterprise software. The AI tools are designed to provide valuable insights in pathology, supporting precision medicine and targeted treatments for cancer patients.

The new collaborators include Deep Bio, DiaDeep, Lunit, Mindpeak, Owkin, Qritive, Sonrai Analytics, and Stratipath. Their algorithms cover various aspects of cancer detection and analysis, including prostate cancer grading, breast cancer biomarker quantification, and microsatellite stability screening in colorectal cancer. This integration demonstrates Roche's commitment to advancing personalized healthcare and improving patient outcomes in cancer diagnostics and treatment.

Roche has announced new 48-week data for its investigational Bruton's tyrosine kinase (BTK) inhibitor fenebrutinib from the Phase II FENopta open-label extension study in relapsing multiple sclerosis (RMS). The results, to be presented at ECTRIMS 2024, show that:

- 96% of patients were relapse-free at one year
- Annualized relapse rate (ARR) was 0.04
- No change in disability over 48 weeks (EDSS)
- 99% of patients were free of T1 gadolinium-enhancing lesions
- Three times more reduction in T2 lesion volume compared to the double-blind period

The safety profile was consistent with previous data. Three Phase III trials (FENhance 1 and 2 for RMS, FENtrepid for PPMS) are ongoing, with results expected by the end of 2025.

Roche's PiaSky (crovalimab) has received EU approval as the first monthly subcutaneous treatment for paroxysmal nocturnal haemoglobinuria (PNH) in adults and adolescents. PiaSky is a novel recycling monoclonal antibody that inhibits the complement protein C5, offering a more flexible treatment option compared to current intravenous infusions.

Key points:

• PiaSky can be self-administered, potentially reducing treatment burden
• Approval based on COMMODORE 2 study, showing equivalence to intravenous eculizumab
• Innovative recycling technology enables monthly subcutaneous administration
• Demonstrated non-inferiority and comparable safety to eculizumab
• Already approved in the US and Japan

Roche has announced its support for the global response to the mpox outbreak, declared a Public Health Emergency of International Concern by the WHO on August 14, 2024. The company is providing high-quality PCR testing and working to enhance laboratory capacity worldwide. Roche has developed three LightMix® Modular Virus kits and the cobas® MPXV test to detect the mpox virus, confirming that these tests can identify the latest variants.

Matt Sause, CEO of Roche Diagnostics, emphasized the importance of diagnostics in addressing public health challenges like mpox. Roche is partnering with governments, healthcare providers, and organizations to combat the outbreak, and is providing training for laboratories across Africa at the Roche Scientific Campus in South Africa and locally.