Novartis to acquire Regulus in deal for kidney disease drug
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Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades ago with plans to make drugs capable of targeting small strips of nucleic acid known as microRNA.
Announced Wednesday, the acquisition will hand the Swiss pharmaceutical firm a drug prospect called farabursen, which recently completed a Phase 1b study in people with autosomal dominant polycystic kidney disease, or ADPKD.
Per deal terms, Regulus shareholders will receive $7 in cash per share, a premium of more than 100% to the stock's closing price Tuesday. Additionally, Novartis has committed to pay an additional $7 per share via a so-called contingent value right that's linked to the achievement of an unspecified regulatory milestone.
Regulus was launched in 2007 as a joint venture between Alnylam Pharmaceuticals and Ionis Pharmaceuticals, building on a paper published in Nature on how a kind of synthetic oligonucleotide could silence microRNA, which plays a role in genetic regulation.
After early successes, such as a 2010 partnership with Sanofi and a 2012 deal with AstraZeneca, the biotech hit setbacks from which it struggled to recover. It also had difficulty finding the right application for its drugmaking technology, trying its hand at a hepatitis C treatment that didn't pan out. Since 2021, Regulus shares have traded below $4 per share.
The drug at the heart of its deal with Novartis, called farabursen, entered the clinic in 2022. Farabursen targets miR-17, which researchers have identified as potentially relevant to kidney disease.
People with ADPKD have few treatment options, relying on the drug tolvaptan to slow the rate of kidney function decline, as well as pain relievers and blood pressure-lowering drugs.
Acquiring Regulus is one of several investments Novartis has made in kidney disease, most notably a $3 billion deal in 2023 for Chinook Therapeutics that netted it Venrafia, which won accelerated approval to treat IgA nephropathy earlier this month. It's also developing Fabhalta, already cleared in IgAN, for several other kidney-related conditions.
'This is a meaningful addition to our renal portfolio as we continue driving innovation in kidney care, following our recent approvals of treatments for IgAN and C3G,' Shreeram Aradhye, Novartis' chief medical officer, wrote in a LinkedIn post.
The pharma hinted earlier this year that it would continue to be active in dealmaking. Its president of biomedical research, Fiona Marshall, told BioPharma Dive that it was looking for early-stage assets. Novartis previously identified ADPKD as a target in its renal portfolio.
'So often, it's having our own program that makes us really like the project, and then if we see somebody else is doing it better than us externally, we'll still bring that in,' she said in January.
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