Roche Holdings AG (OTC:RHHBY) on Monday outlined its plan to become a leading player in the surging weight-loss drug market, pushing its obesity pipeline farther into late-stage development as it eyes competition with Eli Lilly And Co. (NYSE:LLY) and Novo Nordisk A/S (NYSE:NVO).
The company announced it had advanced CT-388, its experimental obesity treatment, into a Phase 3 trial.
The therapy entered Roche's pipeline through its 2023 acquisition of Carmot Therapeutics.
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In May 2024, Phase 1b data of CT-388 showed 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.
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Teresa Graham, head of Roche's pharmaceutical division, told Reuters the company plans to have six obesity and related-condition therapies on the market by 2030, three of which it expects to generate annual sales of more than $1 billion.
"Our goal is to become a top three player in the obesity drug market, and I want you to know I'm serious about this goal," Graham told Reuters.
In March, Roche agreed to acquire Zealand Pharma's experimental therapy, petrelintide, for up to $5.3 billion.
Last week, it added U.S. biotech 89bio for up to $3.5 billion to expand into liver disease treatments that could complement its obesity portfolio.
On Monday, Roche also released results from the phase 3 evERA study of giredestrant in combination with everolimus for oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer previously treated with cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy.
The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus Novartis AG’s (NYSE:NVS) Afinitor (everolimus).
Overall survival (OS) data were immature, but a positive trend was observed. Follow-up continues to the next OS analysis.
The giredestrant combination was well tolerated, and adverse events were consistent with the known safety profiles of the individual study treatments. No new safety signals were observed.
Roche said it is the first positive head-to-head phase three trial investigating an all-oral selective oestrogen receptor degrader-containing regimen versus a standard of care combination.
RHHBY Price Action: Roche Holdings stock is up 1.98% at $42.62 at publication on Monday.
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