ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has received FDA's Breakthrough Device Designation for its Elecsys® GDF-15 assay, a companion diagnostic for identifying cachectic patients with solid tumors eligible for treatment with Pfizer’s investigational drug PF-06946860. Cachexia affects over 30 million globally, significantly impairing the quality of life and increasing mortality risks among cancer patients. This partnership aims to enable precision medicine approaches, ensuring effective treatment for patients suffering from cachexia, thus enhancing cancer therapy outcomes.

Roche reported a 1% increase in group sales at constant exchange rates for 2020, despite a 5% decline in Swiss francs due to currency appreciation. The Pharmaceuticals Division experienced a 2% decline in sales, hindered by competition from biosimilars and missed COVID-19 medical appointments. Conversely, the Diagnostics Division surged by 14%, driven by COVID-19 diagnostics. Roche's IFRS net income rose by 17% to CHF 15.1 billion.

An increase in dividends to CHF 9.10 is proposed, pending shareholder approval.

Roche has received CE marking for its new SARS-CoV-2 Rapid Antigen Test Nasal, which provides a less invasive method for COVID-19 testing. Unlike previous versions that require nasopharyngeal swabs, this test uses nasal samples for quicker, easier collection. The test is suitable for self-collection under professional supervision and is expected to launch in mid-February 2021. Clinical studies show a relative sensitivity of 90.6% for professionally collected samples and 84.4% for self-collected samples, ensuring effective detection of the virus.

Genentech announced positive topline results from two Phase III studies, TENAYA and LUCERNE, for its bispecific antibody faricimab in treating neovascular age-related macular degeneration (nAMD). Both studies met their primary endpoint, demonstrating that faricimab injections at intervals up to 16 weeks achieved comparable visual acuity to aflibercept given every 8 weeks. Approximately 45% of participants receiving faricimab were treated every 16 weeks, marking a significant milestone in treatment durability. Faricimab was generally well tolerated with no new safety concerns.

Genentech, part of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the FDA has accepted its supplemental New Drug Application (sNDA) for Esbriet^® (pirfenidone) to treat unclassifiable interstitial lung disease (UILD) and granted Priority Review. A decision is expected by May 2021. This sNDA is based on a Phase II trial, the first randomized controlled study for UILD, indicating Esbriet may benefit patients. The treatment has previously received Orphan Drug and Breakthrough Therapy Designations from the FDA.

Genentech has received Breakthrough Therapy Designation (BTD) from the FDA for tiragolumab, an innovative cancer immunotherapy targeting TIGIT, in combination with Tecentriq for treating metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. This marks the first anti-TIGIT molecule to receive BTD, based on promising results from the Phase II CITYSCAPE trial, which demonstrated improved overall response rates and progression-free survival. Genentech plans to further develop tiragolumab across multiple cancer types, aiming for significant advancements in treatment.

Genentech has received FDA approval for a shorter two-hour infusion time for Ocrevus (ocrelizumab) for patients with relapsing or primary progressive multiple sclerosis (MS) without prior serious infusion reactions. This decision follows data from the ENSEMBLE PLUS study, showing comparable infusion reaction rates between the two-hour and previous 3.5-hour infusions. Ocrevus is already the most prescribed MS medication in the U.S., with dosing every six months and approved in 94 countries.

Roche has announced the full FDA approval of Venclexta (venetoclax) in combination with azacitidine or decitabine for treating newly diagnosed acute myeloid leukemia (AML) in adults 75 and older or those unable to undergo intensive chemotherapy. This approval is based on phase III trials, VIALE-A and VIALE-C, with VIALE-A showing a 34% reduction in death risk compared to azacitidine alone. Venclexta’s approval was expedited under the FDA’s Real-Time Oncology Review and Project Orbis initiatives, enhancing its global availability.

Roche reported a 1% sales increase in the first nine months of 2020, reaching CHF 44.0 billion, despite a 5% decline in Swiss francs due to currency appreciation. The Pharmaceuticals Division saw a slight decrease of 1% in sales, while the Diagnostics Division grew by 9%, primarily driven by COVID-19 testing. Key FDA approvals included Enspryng and Evrysdi for rare diseases, with ongoing strong demand for newly launched medicines. Roche maintains its 2020 outlook with expected growth in sales and core earnings. Challenges include competition from biosimilars and ongoing impacts from the COVID-19 pandemic.