Basel, 22 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue. "While modern lifestyles are a major driver, as much as 30 ...

The FDA granted this designation to inavolisib in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) to treat adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. HR-positive breast cancer is the most prevalent type of breast cancer and roughly accounts for approximately 70% of cases. The d ...

Basel, 21 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completin ...

cagkansayin/iStock via Getty Images And from Carmot's 4-week data release last year, we know that 4-week efficacy was in the ballpark of Viking's VK2735 – absolute weight loss of 8.4% for CT-388 at its highest dose versus 7.8% for the highest VK2735 dose in its 4-week trial. Roche Holding (OTCQX:RHHBY) announced positive topline results from the phase 1b trial of its obesity candidate CT-388 this week and its share price received a 4% boost on the day of the announcement. The results look strong with 18.8% ...

Roche forayed into the obesity market when it acquired privately owned Carmot Therapeutics for $2.7 billion. CT-388 is one of the assets added by the company to its pipeline post this buyout. Roche also added other incretin-based obesity drug candidates, namely CT-996 and CT-868. While CT-996 is an oral formulation to treat obesity patients with and without T2D, CT-868 is intended to treat obese patients with type I diabetes (T1D). Per Roche, this recently acquired incretin-based portfolio could also be exp ...

A logo at the Roche Holding AG headquarters in Basel, Switzerland, on Thursday, Feb. 1, 2024. Roche on Thursday said its experimental weight loss drug showed promising results in an early-stage trial, boosting the company's bid to compete in the booming market for those treatments. The Swiss company joined a slate of drugmakers racing to develop obesity drugs through its almost $3 billion acquisition of Carmot Therapeutics in December. But its weekly weight loss injection, called CT-388, is still years away ...

Basel, 16 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase I clinical trial of CT-388, a dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes. The study found that a once-weekly subcutaneous injection of CT-388 over 24 weeks resulted in significant weight loss in healthy adults with obesity compared to placebo. The weight loss achieved with CT-388 was clinically meaningful, with a mean placebo-adjusted weight loss of 18 ...

Sean Anthony Eddy/E+ via Getty Images Roche (OTCQX:RHHBY)(OTCQX:RHHBF)(OTCPK:RHHVF) still has good long-term prospects since the last time I wrote an article about it. This was with respect to an article entitled "Roche, With Ocrevus And Fenebrutinib Advancement, Should Be Top MS Contender". In this article, I noted that this company had good long-term value with Ocrevus, which has been approved to treat patients with multiple sclerosis [MS]. Plus, that it was working on another drug for its pipeline, k ...

Financial Data and Key Metrics Changes - The company reported a strong base business growth of 7% across both divisions, with overall group sales including COVID at plus 2% at constant exchange rates [98][106] - COVID-19 sales decreased by CHF 0.7 billion, indicating that the impact of COVID sales is largely behind the company [98][116] - The company confirmed guidance for mid-single-digit growth and intends to further increase dividends in Swiss francs [106][125] Business Line Data and Key Metrics Changes - Pharma sales reached CHF 10.9 billion, growing by 2% at constant exchange rates or 7% excluding Ronapreve [125] - Diagnostics division grew at 2% or CHF 0.1 billion at constant exchange rates, impacted by the washout of COVID-19 sales [62][106] - The diagnostics segment saw strong growth in pathology lab sales at plus 19%, driven by advanced staining and companion diagnostics [63] Market Data and Key Metrics Changes - U.S. sales were slightly down by about 1%, primarily due to buying patterns and softer demand, but the hematology franchise showed strong growth [29] - The company experienced a decline in Japan due to mandatory price cuts and the absence of Ronapreve sales, with a 6% decline in constant exchange rates [125] - The company noted that the washout of COVID-19 is complete, with only a minor impact of around 0.6% to 0.7% on overall growth rates expected for the remainder of the year [116] Company Strategy and Development Direction - The company is focusing on pipeline prioritization, having removed 20% of total NMEs while bringing in high-value assets in areas such as hypertension and obesity [114] - The integration of point of care and diabetes care into one organization aims to leverage complementary patient segments and technologies [115] - The company is optimizing its manufacturing network, having divested its Vacaville biologics manufacturing facility for CHF 1.2 billion to enhance efficiency [117] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the base business, with expectations for single-digit growth in the U.S. for Hemlibra despite recent competitive pressures [87] - The company anticipates strong uptake for Ocrevus subcutaneous, viewing it as a blockbuster opportunity with significant market potential [90] - Management highlighted the importance of upcoming regulatory approvals and clinical data readouts, particularly in neurology and oncology [99][127] Other Important Information - The company achieved U.S. approval for XOLAIR in food allergies, marking it as the first and only medicine for this indication [17] - The diagnostics division is set for a significant launch year, with multiple key launches planned [18] - The company has received breakthrough device designation for the pTau217 ruling assay for Alzheimer's disease, indicating a strong focus on neurology [99] Q&A Session Summary Question: Impact of KEYTRUDA on Tecentriq sales and competition in small cell lung cancer - Management indicated that Tecentriq sales globally will stabilize as peak sales are reached in key indications, with competition impacting U.S. sales [42] Question: Changes in pipeline criteria for NMEs - Management clarified that while there was a 20% reduction in NMEs, new criteria for inclusion in the pipeline have been established to focus on high-value opportunities [76] Question: Updates on Columvi and its sales potential - Management confirmed that Columvi's recent positive data from the STARGLO study will be submitted to health authorities, indicating potential for future sales growth [81][127] Question: Expectations for Ocrevus subcutaneous uptake - Management expects strong uptake for Ocrevus subcutaneous, viewing it as a significant opportunity for new patient growth [90] Question: Competitive landscape for inavolisib - Management noted that inavolisib's selective profile may lead to a strong switch opportunity from Piqray, despite previous challenges with the latter [91]

Growth rates – from 31.12.2022 to 31.12.2023 (Total installed modules as of 31.12.2023) SWA=Serum Work Area 49 Accu-Chek SmartGuide CGM solution Enabling better decision-making for people with diabetes Accu-Chek SmartGuide CGM solution Improving diabetes management and care continuum • Data released at ATTD shows strong performance of first Roche CGM • 14 days of reliable and accurate real-time glucose sensor data • Predictive algorithms for 2 hours and night-time hypo • Addressing the needs of T1D and T2D ...