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.
Langhua Pharmaceutical passes US FDA's on-site inspection
PTC Therapeutics announces opinion regarding Translarna's (ataluren) European renewal authorisation
Soleno Therapeutics selects PANTHERx Rare as specialty pharmacy for VYKAT XR distribution
Neurim Pharmaceuticals' Slenyto approved for insomnia in children with ADHD
Intelligent Bio Solutions strengthens IP with sixth US patent ahead of 2025 market entry
Merck's CAPVAXIVE approved by EC for pneumococcal disease prevention
Sanofi secures FDA fast track designation for chlamydia vaccine candidate
Ionis announces partnership expansion with Sobi for global olezarsen commercialisation
Nyxoah receives FDA Approvable Letter for Genio system
Palatin Technologies' PL7737 granted US FDA orphan drug designation
Benuvia Operations receives five-year contract from NIDA
Vast Therapeutics' ALX1 drug candidate granted QIDP designation by US FDA