ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech, a Roche Group member, announced four-year data from the RHONE-X extension study for Vabysmo (faricimab-svoa) in treating diabetic macular edema (DME). The study met all primary endpoints, demonstrating Vabysmo's consistent safety profile. Key findings include:

- Over 90% of patients showed absence of DME after four years
- Nearly 80% of patients received treatment at 3-4 month intervals
- Sustained vision gains and anatomical improvements were observed
- Vabysmo maintained efficacy in preserving vision and drying retinal fluid

This represents the largest long-term extension dataset in DME, reinforcing Vabysmo's potential as a standard treatment for the 29 million people affected worldwide. Vabysmo is currently approved in nearly 100 countries for DME and wet AMD.

Roche announced four-year data from the RHONE-X extension study for Vabysmo (faricimab) in treating diabetic macular edema (DME). The study met all primary endpoints, demonstrating Vabysmo's consistent safety profile. Key findings include:

- Over 90% of patients showed absence of DME after four years
- Nearly 80% of patients received treatment at 3-4 month intervals
- Sustained vision gains and anatomical improvements were observed
- Vabysmo continued to preserve vision and dry retinal fluid

This is the largest long-term extension dataset in DME to date, reinforcing Vabysmo's potential as a standard of care treatment for the 29 million people affected by DME worldwide.

Genentech, a Roche Group member, announced positive Phase I results for CT-996, an oral GLP-1 receptor agonist for obesity treatment. After four weeks, CT-996 demonstrated a clinically meaningful weight loss of -7.3% compared to -1.2% with placebo. The safety profile was consistent with other oral GLP-1 agonists, with no unexpected safety signals.

Key findings include:

• Placebo-adjusted mean weight loss of -6.1% within four weeks
• Once-daily oral dosing regimen supported by pharmacokinetic data
• Potential for dosing without regard to meal timing
• Well-tolerated with mostly mild to moderate gastrointestinal-related adverse events

This marks the second positive readout from Genentech's metabolic pipeline in less than three months, following data for CT-388.

Roche announced positive Phase I results for CT-996, an oral GLP-1 receptor agonist for obesity treatment. Key findings include:

- 7.3% weight loss after 4 weeks (vs 1.2% with placebo)
- Supports once-daily oral dosing
- Safety profile consistent with other oral GLP-1 agonists
- Potential for use in type 2 diabetes and obesity

CT-996 showed a placebo-adjusted mean weight loss of 6.1% in participants with obesity without type 2 diabetes. The drug was well-tolerated with mostly mild to moderate gastrointestinal side effects. Roche sees potential for CT-996 as a therapy for glycemic control, weight loss, and weight maintenance following injectable treatments.

Remix Therapeutics has achieved a near-term milestone in its collaboration with Roche, announced today. This collaboration, initiated in January 2024, focuses on discovering and developing small molecule therapeutics that modulate RNA processing using Remix's REMaster platform. Remix received an upfront payment of $30 million and is now eligible for up to $1 billion in preclinical, clinical, commercial, and sales milestones, as well as tiered royalties. Roche gains exclusive rights to specific targets, while Remix handles discovery and preclinical activities. Roche will manage the development and commercialization of any resulting products.

Roche has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This AI-enabled device offers accurate real-time glucose monitoring for adults with type 1 and type 2 diabetes on flexible insulin therapy.

It provides glucose values for 14 days and predicts hypoglycemia risk within the next 30 minutes and glucose levels for the next two hours using AI algorithms. Clinical evaluations show a mean absolute relative difference (MARD) of 9.2%, with 99.8% of glucose values falling within acceptable ranges.

The Accu-Chek SmartGuide aims to alleviate concerns about nighttime hypoglycemia and enable proactive diabetes management, enhancing the quality of life for users.

Roche has reintroduced Susvimo, an ocular implant for neovascular age-related macular degeneration (nAMD), in the US. The FDA approved updates to Susvimo's implant and refill needle, which address previous performance issues that led to a voluntary recall in 2022. Susvimo offers a twice-yearly refill alternative to regular eye injections, continuously delivering medicine to the eye. This innovative approach, highlighted in Phase III studies, aims to maintain vision for patients with nAMD, a condition affecting 20 million people globally. The product will be available to US retina specialists and patients in the coming weeks.

Genentech, a member of the Roche Group, has announced the reintroduction of Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant to treat wet age-related macular degeneration (AMD) in the U.S. This comes after a voluntary recall in 2022.

The FDA has approved updates to Susvimo's ocular implant and refill needle, ensuring they meet performance standards. Susvimo offers a unique alternative to regular eye injections by providing continuous medication delivery through a refillable implant, requiring only two refills a year. This innovative approach could benefit 1.5 million people in the U.S. and 20 million globally who are affected by wet AMD.

The implant is surgically inserted and refilled every six months, providing sustained vision maintenance. Genentech is committed to easing access barriers and offers comprehensive support services for patients prescribed Susvimo.

On July 5, 2024, Roche announced that the FDA has approved its Vabysmo (faricimab) 6.0 mg prefilled syringe (PFS) for the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). These conditions affect nearly 80 million people globally. The Vabysmo PFS is designed to simplify administration, offering a ready-to-use solution for retina specialists. This approval follows Vabysmo's initial US approval in 2022 and its availability in over 95 countries. More than four million doses have been distributed globally.