Ionis Pharmaceuticals has entered a licence agreement with Sobi in which the latter obtains exclusive rights to commercialise olezarsen intended for familial chylomicronaemia syndrome (FCS) and severely elevated triglycerides.
Sobi’s rights cover nations outside Canada, China and the US.
Go deeper with GlobalData
Ionis will continue handling the therapy’s commercialisation in the US, while Theratechnologies has the licence for commercialisation in Canada.
Sobi will handle upcoming regulatory filings and commercialisation in the agreed territories, excluding the US geographies.
Sobi will make upfront, milestone-based payments to Ionis and up to mid-20% tiered royalties on yearly net sales.
Olezarsen, known by the tradename Tryngolza, gained approval from the Food and Drug Administration in December 2024 as an adjunct to diet for decreasing triglycerides in the adult population with FCS.
The European Medicines Agency is reviewing the therapy, with approval expected in 2025 to treat FCS.
Olezarsen is also being evaluated for severe hypertriglyceridemia in the Phase III CORE, CORE2 and ESSENCE clinical trials, with ESSENCE data anticipated in the middle of 2025 and CORE and CORE2 later in the year.
As the European commercialisation partner of Ionis for Waylivra (volanesorsen), Sobi is set to utilise its current market expertise, allowing the launch of olezarsen for FCS.
FCS results from impaired enzyme lipoprotein lipase function.
Ionis Pharmaceuticals CEO Brett Monia stated: “This agreement enables us to advance our goal of making olezarsen available to patients globally while focusing our independent commercialisation efforts in the US.
“With anticipated data from our robust sHTG Phase III programme in 2025, we are enthusiastic about the potential for olezarsen to also address the significant medical need in this more prevalent patient population in addition to FCS.”
