Roche announces US$ 50 bn investment in US to avoid tariffs; Regeneron signs US$ 3 bn onshoring deal with Fujifilm

By PharmaCompass

2025-04-24

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After Eli Lilly, Johnson & Johnson and Novartis, Roche has announced plans to manufacture in the US to avoid tariffs. The Swiss drugmaker plans to invest US$ 50 billion in the US over the next five years. Similarly, Regeneron Pharmaceuticals is significantly boosting its US manufacturing capacity through a US$ 3 billion, 10-year agreement with Fujifilm Diosynth Biotechnologies. Fujifilm will produce biologic medicines at its North Carolina facility.

Sanofi has signed an exclusive licensing agreement worth up to US$ 1.8 billion with Earendil Labs for two next-generation AI-discovered bispecific antibodies targeting autoimmune conditions.

Sanofi and Regeneron’s Dupixent has received yet another FDA approval — to treat chronic spontaneous urticaria in patients aged 12 and older who remain symptomatic despite antihistamine therapy. This marks the drug’s seventh approved indication.

Bristol Myers Squibb’s schizophrenia drug — Cobenfy — failed to meet primary endpoints in a pivotal trial for adjunctive treatment.

The pharmaceutical industry is on high alert as the US President Donald Trump considers implementing international reference pricing to align US drug prices with lower costs in other developed countries. European pharma CEOs, on the other hand, have urged the EU to raise drug prices to US levels.

Eli Lilly’s experimental weight-loss pill orforglipron has demonstrated impressive results in a late-stage trial, positioning it as a convenient alternative to injectable treatments like Ozempic. Meanwhile, Novo Nordisk has submitted its 25-mg semaglutide weight loss pill for FDA approval.

Roche announces massive US$ 50 bn investment in US to counter tariff threats

Swiss pharmaceutical leader Roche has unveiled plans to invest US$ 50 billion in the US over the next five years — a move designed to bolster domestic manufacturing and mitigate potential impacts from the proposed US tariffs on pharmaceutical imports. The investment is expected to generate over 12,000 jobs, including approximately 6,500 construction positions and 1,000 roles at new and expanded facilities.

The investment includes establishment of a gene therapy manufacturing facility in Pennsylvania, a plant in Indiana for continuous glucose monitoring devices, and a 900,000-square-foot facility dedicated to next-generation weight-loss drugs at an undisclosed location. Additionally, Roche plans to open a research and development center in Massachusetts focused on artificial intelligence applications in cardiovascular, renal, and metabolic disease research.

Regeneron signs US$ 3 bn manufacturing deal with Fujifilm, to double US capacity

Regeneron Pharmaceuticals has announced an investment exceeding US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to enhance its US manufacturing capabilities. This partnership aims to nearly double Regeneron’s domestic production capacity for biologic medicines. Under the terms of the agreement, Fujifilm will manufacture and supply drug products for Regeneron’s biologic therapies at its new large-scale biopharmaceutical facility in Holly Springs, North Carolina.

Sanofi inks US$ 1.8 bn deal with Earendil for antibodies discovered by AI

Sanofi has signed an exclusive licensing agreement with US biotech Earendil Labs, valued at up to US$ 1.8 billion, to acquire two next-generation bispecific antibodies targeting autoimmune and immunology indications. The upfront and near-term fees total US$ 175 million. Sanofi will shell out up to US$ 1.72 billion in development and commercial milestones.

The candidates, HXN-1002 and HXN-1003, were discovered via Earendil’s AI-driven high-throughput protein modeling platform. HXN-1002 is being developed to treat moderate-to-severe ulcerative colitis and Crohn’s disease, while HXN-1003 focuses on treating colitis and skin inflammation.

Dupixent wins FDA approval for chronic hives: Sanofi and Regeneron have received FDA approval for Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU) in patients aged 12 and older who remain symptomatic despite antihistamine therapy. This marks the first new targeted therapy for CSU in over a decade. With this new indication, Dupixent now has seven FDA-approved uses, in the treatments of asthma, eczema, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease (COPD).

Trump mulls using international reference pricing to lower drug costs in US

The US President Donald Trump is reportedly considering a significant policy shift to reduce US drug prices by aligning them with the lower costs prevalent in other developed countries, a strategy known as international reference pricing. This initiative, viewed by the pharmaceutical industry as a substantial threat, could impact innovation and healthcare markets.

Pharma CEOs urge EU to abandon price controls: In a related development, CEOs of major European pharmaceutical companies — Novartis and Sanofi — have urged the European Union to raise drug prices to levels comparable with the United States. They argue that the current European price controls diminish the region's appeal to investors, especially amid increasing tariffs and global trade uncertainties.

Lilly’s obesity med matches Ozempic in trial; Novo seeks FDA nod for semaglutide pill

Eli Lilly’s experimental weight-loss pill, orforglipron, has demonstrated efficacy comparable to the injectable Ozempic from rival Novo Nordisk. In a phase 3 trial, patients with type 2 diabetes taking orforglipron lost an average of 16 pounds (7.9 percent of body weight) over 40 weeks, alongside significant improvements in blood sugar control.

The pill’s once-daily oral administration, without food or water restrictions, offers a convenient alternative to injections, potentially enhancing patient adherence. Analysts view orforglipron as a potential game-changer in obesity treatment, expanding access for those hesitant about injections. Eli Lilly plans to seek regulatory approval for weight management in late 2025 and for type 2 diabetes in 2026.

David Ricks, CEO of Eli Lilly, has said the drugmaker would produce orforglipron in the US. The move will help it save on tariffs.

Meanwhile, Novo Nordisk has sought FDA approval for 25-mg pill version of its weight loss med semaglutide. The FDA submission was made earlier this year. The Danish drugmaker certainly took its time, having announced late-stage results in May 2023.

BMS’ schizophrenia drug Cobenfy fails pivotal late-stage trial

Bristol Myers Squibb’s investigational schizophrenia drug, Cobenfy (also known as KarXT), has failed to meet the primary endpoint in a pivotal late-stage trial evaluating its use as an adjunctive treatment for patients who no longer respond to standard antipsychotics. In a six-week study, Cobenfy achieved only a two-point reduction in symptom severity compared to placebo, falling short of the mid-single-digit improvement analysts had anticipated.

BMS had acquired Cobenfy through its US$ 14 billion purchase of Karuna Therapeutics in December 2023. It is a combination of xanomeline and trospium chloride. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy acts on muscarinic receptors (a novel approach in schizophrenia treatment).

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