GSK acquires Canadian biotech 35Pharma for USD950M to expand its pulmonary hypertension treatment pipeline

CANADA—GSK plc has announced its acquisition of 35Pharma Inc., a Canada-based, private, clinical-stage biopharmaceutical company that specializes in developing novel protein-based therapeutics.

The pharmaceutical giant will pay USD 950 million in cash to acquire 100% of the equity in the Canadian company, subject to regulatory clearances.

The acquisition centers on HS235, an investigational medicine that GSK describes as potentially best-in-class for treating pulmonary hypertension.

The drug candidate has completed phase I clinical trials in healthy volunteers, and studies in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) are set to begin imminently.

Addressing a critical gap in treatment options

Pulmonary hypertension represents a progressive, life-shortening disease characterized by dangerously high blood pressure in the lungs.

Patients initially experience breathlessness, fatigue, and chest pain, which eventually progresses to heart failure.

The condition affects approximately 82 million people worldwide across multiple disease forms, yet treatment options remain severely limited.

The stark reality facing patients becomes clear when examining survival rates: only around 50% of those diagnosed survive beyond five years.

The market for pulmonary hypertension therapies reflects this urgent medical need.

Industry forecasts project the global market will reach USD18 billion by 2032, with activin signaling inhibitors expected to capture 50% of this substantial market.

Innovative approach to reduce bleeding risks

HS235 targets the activin receptor signaling pathway, which researchers have clinically validated as an effective therapeutic target in pulmonary hypertension.

However, 35Pharma designed HS235 with enhanced selectivity that sets it apart from existing treatments.

The drug reduces binding to BMP9 and BMP10, ligands that scientists have associated with adverse events such as bleeding and telangiectasia, a condition marked by broken blood vessels.

This design feature addresses a critical limitation in current pulmonary hypertension treatment.

Many patients require concomitant anticoagulant or antiplatelet therapy, which increases their bleeding risk.

By potentially lowering this risk, HS235 could offer a safer treatment option for a significant proportion of the patient population.

Additional metabolic benefits show promise

The underlying mechanism of HS235 offers potential benefits that extend beyond direct treatment of pulmonary hypertension.

Early clinical studies have revealed promising metabolic effects, including fat-selective weight loss, preservation of lean muscle mass, and improved insulin sensitivity.

Researchers observed beneficial changes in inflammation markers and adipokines, hormones produced by fat tissue, during these studies.

These metabolic attributes carry particular significance given the high prevalence of obesity and insulin resistance among pulmonary hypertension patients.

The additional clinical benefits may enhance both the therapeutic value and commercial potential of the drug.

Industry leaders express confidence in acquisition

Tony Wood, Chief Scientific Officer at GSK, emphasized the significant unmet need in this therapeutic area.

He stated that pulmonary hypertension affects millions of people worldwide, yet patients remain underserved.

Wood expressed enthusiasm about adding HS235 to GSK’s pipeline, highlighting the medicine’s differentiated profile that reduces bleeding risk while providing metabolic benefits clinically relevant to patients.

Wood further noted that HS235’s potential protective effects on vascular function, combined with benefits on fat-derived markers of metabolism and inflammation, create new development opportunities within GSK’s Research, Innovation, and Immunology portfolio.

These opportunities could enable broader coverage across the metabolic, inflammatory, vascular, and fibrotic drivers of multiple chronic diseases affecting the lung, liver, and kidney.

Ilia Tikhomirov, CEO of 35Pharma, acknowledged the recent revolution in understanding pulmonary hypertension and the potential to reverse this life-threatening disease.

He expressed satisfaction about joining forces with GSK, recognizing the pharmaceutical giant as a leader in addressing respiratory and inflammatory drivers of disease.

Tikhomirov emphasized that GSK shares 35Pharma’s vision of HS235’s potential to transform treatment for this debilitating condition.

Regulatory pathway and market context

The transaction requires customary regulatory approvals, including clearances from applicable agencies under the Hart-Scott-Rodino Act in the United States and the Competition Act in Canada.

GSK must also complete a filing under the Investment Canada Act before finalizing the acquisition.

Pulmonary hypertension encompasses different types, including pulmonary arterial hypertension and PH due to heart failure with preserved ejection fraction.

Specialized academic centers treat the condition, where pulmonologists and cardiologists manage PH programs within larger lung, respiratory, and critical care centers.

In the United States alone, the addressable patient population for PAH and PH-HFpEF reaches approximately 100,000 people, representing a significant portion of the 82 million people affected globally.