Novartis to acquire Regulus for $1.7bn to boost renal pipeline

Novartis is set to enhance its research and development portfolio through the acquisition of Regulus Therapeutics for $1.7 billion. This strategic move significantly strengthens the pharmaceutical giant's focus on treatments for renal diseases. A core component of the acquisition is Regulus's developmental drug, farabursen, which is aimed at treating autosomal dominant polycystic kidney disease (ADPKD), a prevalent genetic condition leading to kidney failure.

ADPKD is characterized by the gradual formation of small, fluid-filled cysts in the kidneys, which can lead to renal failure. Farabursen is an innovative treatment under investigation, designed to inhibit microRNA. Its objective is to reduce cyst growth, decrease kidney enlargement, and slow the progression of disease severity for those suffering from ADPKD. The drug targets miR-17 and has recently shown encouraging results in a phase 1b trial involving multiple ascending doses. The initial trials indicated that farabursen effectively impacts urinary polycystin, a key biomarker, and reduces height-adjusted total kidney volume, an important measure of disease progression.

Shreeram Aradhye, who serves as the president of development and chief medical officer at Novartis, highlighted farabursen as a potential first-in-class medication. He noted its potential to provide enhanced efficacy, tolerability, and safety compared to existing treatment options. Aradhye praised Regulus's foundational work in developing farabursen and expressed eagerness to further explore its potential as a superior treatment for patients in need.

The acquisition agreement is structured to include an upfront payment of $800 million, with an additional $900 million contingent on achieving future regulatory milestones. The transaction is scheduled for completion in the latter half of the year. Jay Hagan, CEO of Regulus, expressed enthusiasm about the merger with Novartis, emphasizing the potential to advance farabursen for ADPKD patients who have few treatment options. Hagan noted that Novartis’s global expertise in drug development and commercialization could help bring this promising treatment to market, pending approval.

This announcement builds on Novartis's recent strategic moves to expand its late-stage research initiatives. Less than three months prior, Novartis declared its intent to acquire Anthos Therapeutics for approximately $3.1 billion, broadening its cardiovascular drug pipeline. This deal, expected to conclude by mid-2025, includes the drug abelacimab, which is undergoing phase 3 trials to prevent stroke and systemic embolism in patients with atrial fibrillation.

The acquisition of Regulus and its promising drug farabursen exemplifies Novartis's commitment to addressing unmet medical needs in renal diseases. With this move, Novartis aims to leverage its robust development capabilities to bring new, effective treatments to market, ultimately delivering improved outcomes for patients worldwide.