Ionis Pharmaceuticals Inc (Nasdaq: IONS), a provider of RNA-targeted medicines, announced on Wednesday that it has expanded its partnership with biopharmaceutical company Sobi (STO: SOBI), granting the company exclusive rights to commercialise olezarsen outside the US, Canada and China.
The drug, approved by the U.S. FDA in December 2024 under the name TRYNGOLZA, is used to treat familial chylomicronemia syndrome (FCS) and severely elevated triglycerides.
Ionis will continue to manage commercialisation of olezarsen in the US. Sobi, leveraging its expertise in rare and prevalent diseases, will be responsible for regulatory submissions and commercialisation in countries excluding Canada and China. Olezarsen is currently under review by the European Medicines Agency, with approval expected this year.
The agreement includes an upfront payment, milestone-based payments and royalties up to the mid-20% range on net sales. Ionis is also exploring olezarsen's potential in treating severe hypertriglyceridemia (sHTG) in ongoing Phase 3 trials, with data expected in 2025.
FCS, a rare genetic disorder, is estimated to affect 3,000 people in the US and is associated with severe health risks like acute pancreatitis. sHTG, affecting over three million Americans, also increases the risk of acute pancreatitis and cardiovascular disease. Olezarsen has not yet been approved for sHTG treatment.
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