Breakthrough Clinical Results
Roche has entered into a definitive merger agreement to acquire 89bio, Inc., a clinical-stage biopharmaceutical company, for up to $3.5 billion. The acquisition aims to enhance Roche’s portfolio in cardiovascular, renal, and metabolic diseases (CVRM), particularly in the treatment of moderate to severe Metabolic Dysfunction-Associated Steatohepatitis (MASH). 89bio’s lead candidate, pegozafermin, a FGF21 analog, is in late-stage development for MASH and offers potential for combination development with incretins. The transaction is expected to close in the fourth quarter of 2025.
Key Highlights
- Roche to acquire 89bio for up to US$3.5 billion.
- Acquisition strengthens Roche's CVRM portfolio with 89bio's pegozafermin.
- Pegozafermin is a Phase 3 FGF21 analog for moderate to severe MASH.
- The deal includes a contingent value right (CVR) for 89bio stockholders based on commercial milestones.
Incidence and Prevalence
Latest Estimates of MASH Incidence and Prevalence Globally
Metabolic dysfunction-associated steatohepatitis (MASH) has emerged as a significant global health concern, affecting approximately 5.27% of the global population. This condition, previously termed non-alcoholic steatohepatitis (NASH), represents a more severe form of liver disease that can progress from the broader condition of Metabolic dysfunction-associated steatotic liver disease (MASLD).
MASLD has rapidly become the most common cause of liver disease worldwide, currently affecting an estimated 38% of the global population. Other estimates suggest a global prevalence range of 25-35%, representing a growing socioeconomic burden. The progression from MASLD to MASH occurs in approximately 20-30% of people with MASLD.
Recent studies provide more detailed insights into these conditions:
- In a UK Biobank study of 40,189 patients who underwent liver MRI, 27.0% had steatotic liver disease (SLD).
- Among those with SLD, the vast majority (89.0%) had MASLD, while 2.2% had at-risk MASH.
- The at-risk MASH group represented approximately 0.6% of the general population and demonstrated the highest mean liver fat on MRI and the highest BMI.
In populations with severe obesity, the prevalence is significantly higher. A study of 2091 participants with severe obesity found an overall MAFLD prevalence of 79.5%, with 44.5% having MASH and 24.4% having severe fibrosis (Stage 2 or higher).
The prevalence of MASH is increasing globally, particularly in the United States, where it has become the dominant cause of liver disease. This increase is closely linked to rising rates of obesity and type 2 diabetes. In Mexico, where obesity affects 36.9% of adults, MASLD prevalence has risen significantly, especially with metabolic syndrome affecting 56.31% by 2018.
Gender and BMI significantly influence prevalence rates: - MASLD was significantly higher among men with a BMI ≥30 kg/m² - Non-obese women showed only a 12% risk of MASLD - MetALD (combined metabolic alcoholic liver disease) had similar prevalence in obese men and women but was absent in non-obese women
MASH is characterized by progressive tissue fibrosis and sterile liver inflammation that can lead to serious complications including liver cirrhosis, hepatocellular carcinoma, and death. Patients with at-risk MASH (MASH with moderate or significant fibrosis) face higher risks of comorbidity/mortality, particularly cardiovascular diseases and major adverse liver outcomes.
Despite the high prevalence and serious health implications, there is currently only one drug approved for MASH, highlighting a significant unmet medical need in this area.
Company drugs in pipeline
Roche's Drug Pipeline Indications
I don't have specific information about which indications Roche has drugs in pipeline for. The data needed to provide details about Roche's drug development pipeline, therapeutic areas, or clinical trials for pipeline medications is not available.
To provide accurate information about Roche's pipeline, we would need details about:
- Current development programs
- Clinical trial phases for various compounds
- Therapeutic areas of focus
- Innovative treatments under investigation
- Regulatory status of pipeline candidates
Roche is known as one of the world's largest pharmaceutical companies with a history of developing medications across multiple therapeutic areas, but without specific current pipeline information, I cannot detail which disease indications they are currently targeting.
For the most up-to-date and comprehensive information about Roche's drug pipeline, I would recommend visiting Roche's official website, reviewing their investor relations materials, or consulting pharmaceutical industry databases that track development pipelines.