Novartis Invests $1.7B in Regulus to Enhance Oligo Pipeline

Novartis has announced its decision to acquire Regulus Therapeutics for an initial payment of $800 million, as stated in a recent press release. This acquisition is set to enhance Novartis' portfolio of oligonucleotide-based therapies with Regulus' promising miRNA-targeting technology. The agreement stipulates that Novartis will purchase all of Regulus’ shares at a rate of $7 each, a figure that reflects a 108% premium over Regulus’ last closing stock price. Additionally, shareholders of Regulus stand to receive a $7-per-share contingent value right upon reaching specified developmental milestones. The total value of the acquisition could escalate to $1.7 billion. Both companies have had their boards of directors unanimously approve the transaction, which is anticipated to finalize in the latter half of the year, subject to standard closing conditions.

Central to this merger is Regulus’ innovative oligonucleotide, farabursen, which is currently in the early development stage for the treatment of autosomal dominant polycystic kidney disease (ADPKD). This rare genetic disorder affects approximately 160,000 individuals in the United States. ADPKD is caused by mutations in the Pkd1 or Pkd2 genes, resulting in the formation of fluid-filled cysts in the kidneys that impair kidney function progressively. If not properly managed, ADPKD can ultimately lead to kidney failure and potentially death.

Regulus has identified that mutations in Pkd1 or Pkd2 are associated with increased levels of miR-17, a microRNA molecule that suppresses certain genes, leading to decreased production of polycystin 1 (PC1) and polycystin 2 (PC2) proteins. Farabursen functions by binding to miR-17, disrupting this pathway and addressing the fundamental pathology of ADPKD. Through this mechanism, farabursen can restore normal levels of PC1 and PC2, thereby reducing cyst growth. Currently, farabursen is undergoing a Phase Ib clinical trial, which is projected to conclude later this year.

In addition to farabursen, Regulus is exploring another therapeutic agent for kidney-related diseases and is developing a treatment for an unspecified central nervous system condition. This acquisition aligns with Novartis' strategic approach towards business growth this year. During a year-end report for 2024, CEO Vas Narasimhan emphasized the company's commitment to pursuing strategic acquisitions that are expected to support growth into 2030 and beyond. In line with this strategy, shortly after announcing the Regulus acquisition, Novartis invested $3.1 billion to acquire Anthos Therapeutics, focusing on their anticoagulant antibody, abelacimab.

This acquisition marks a significant step for Novartis as it seeks to strengthen its position in the pharmaceutical industry by adding innovative treatments to its portfolio. The focus on oligonucleotide and miRNA-targeting therapies highlights Novartis' commitment to addressing rare genetic disorders and expanding its research and development capabilities. By integrating Regulus’ cutting-edge technologies, Novartis aims to advance its pipeline and offer new solutions for patients suffering from challenging and often life-threatening conditions.