ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced positive results from the global phase III COMMODORE 2 study, evaluating crovalimab for treating paroxysmal nocturnal haemoglobinuria (PNH). The study met its co-primary efficacy endpoints, showing crovalimab achieved disease control and transfusion avoidance in patients not previously treated with complement inhibitors. The phase III COMMODORE 1 study corroborated the favorable benefit-risk profile of crovalimab for patients switching from current C5 inhibitors. Roche plans to submit the findings to regulatory authorities globally and present results at an upcoming medical meeting.

Roche has appointed Teresa Graham as the new CEO of Roche Pharmaceuticals, effective March 2023. Previously Head of Global Product Strategy, Graham will join the Corporate Executive Committee. Levi Garraway, the Chief Medical Officer, will also become a member of this committee. Both executives will report to the new Roche Group CEO, Thomas Schinecker. Graham brings extensive experience from her tenure at Genentech and has a solid track record in strategic roles. Garraway is renowned for his expertise in cancer genomics and has contributed significantly to the field. These changes reflect Roche's commitment to strong leadership as it continues to focus on innovation.

Roche's group sales grew by 2% at constant exchange rates, totaling CHF 63.3 billion in 2022, despite a decline in COVID-19-related sales. The Pharmaceuticals Division saw a 2% increase in sales, bolstered by strong performance from newer medicines, while the Diagnostics Division grew by 3%.

Core earnings per share rose by 5%, but IFRS net income dropped by 6% to CHF 13.5 billion. Looking ahead, Roche anticipates low single-digit sales decline due to a projected CHF 5 billion drop in COVID-19 product sales, while new product launches suggest potential for solid growth.

Roche has announced that the European Commission approved the expansion of the marketing authorization for Hemlibra (emicizumab), allowing it to be used as a prophylactic treatment for moderate haemophilia A. This approval, based on results from the HAVEN 6 trial, demonstrates Hemlibra's effective bleed control and favorable safety profile for patients without factor VIII inhibitors. Currently, around 900,000 people are affected by haemophilia A globally, with approximately 14% having a moderate form. The goal of this approval is to help improve quality of life for those with moderate disease, many of whom currently lack effective prophylactic treatment options.

Jana Care has partnered with Roche Diagnostics to develop a point-of-care blood testing platform aimed at enhancing remote healthcare access for patients with chronic kidney disease and heart failure. This collaboration focuses on at-home testing capabilities, allowing patients to perform essential blood tests and enabling clinicians to remotely review results. The initiative addresses significant healthcare challenges, considering that over 43 million Americans live with these chronic conditions. The platform is expected to improve disease management and monitoring, providing a much-needed solution to the limitations of current testing methods.

Roche has launched a new COVID-19 PCR test targeting the XBB.1.5 Omicron sub-variant, which is rapidly spreading in the U.S. and beyond. This test, named VirSNiP SARS-CoV-2 Spike F486P, is designed for research use and operates on the LightCycler® 480 II and cobas® z480 platforms. It aims to differentiate emerging variants and provide insights into their epidemiological impacts, aiding public health response strategies. The World Health Organization has expressed concerns over XBB.1.5's high transmissibility. Roche emphasizes its commitment to developing timely diagnostics to support healthcare communities globally, continuing its innovation in pandemic response.

Roche's Phase III IMbrave050 study has successfully met its primary endpoint of recurrence-free survival (RFS) for Tecentriq (atezolizumab) combined with Avastin (bevacizumab) in patients with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence post-surgery. This study underscores an urgent need for new treatments, as 70-80% of early-stage HCC patients face recurrence. Although overall survival data remains immature, safety profiles for both drugs align with established data. Roche plans to discuss findings with global health authorities and present results at future medical meetings.

Genentech, part of the Roche Group (OTCQX: RHHBY), announced that its Phase III IMbrave050 study successfully met the primary endpoint of recurrence-free survival (RFS) in patients with early-stage hepatocellular carcinoma (HCC) at high risk of disease recurrence after surgery. The combination of Tecentriq and Avastin showed statistically significant improvements compared to active surveillance. Currently, 70-80% of early-stage HCC patients face recurrence post-surgery, making this finding crucial. Further data discussions with health authorities, including the FDA and EMA, are anticipated as part of regulatory steps.

Roche's Xofluza (baloxavir marboxil) has received approval from the European Commission for treating uncomplicated influenza in children aged one and above, as well as for post-exposure prophylaxis. This marks the first single-dose oral antiviral for children in Europe and the first new mechanism of action for influenza treatment in nearly 20 years. The approval was based on positive Phase III miniSTONE-2 and BLOCKSTONE studies, demonstrating Xofluza's ability to reduce viral replication significantly faster than oseltamivir and effectively prevent influenza after exposure.