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news.Theratechnologies has entered into a licensing agreement with Ionis Pharmaceuticals to acquire exclusive Canadian rights for two investigational RNA-targeted medicines, olezarsen and donidalorsen.
The agreement involves Ionis’ investigational RNA-targeted medicines, olezarsen and donidalorsen. Credit: digitale.de on Unsplash.
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This move grants Theratechnologies the ‘rights’ to potentially introduce treatments for familial chylomicronaemia syndrome (FCS), hereditary angioedema (HAE), and severe hypertriglyceridemia (sHTG) within the Canadian market.
Under the terms of the agreement, Ionis will obtain a $10m upfront payment, with additional milestone payments of up to $12.75m contingent upon regulatory achievements, public reimbursement, and sales targets.
Additionally, Ionis is set to receive tiered double-digit royalties on annual net sales for each medication.
Theratechnologies is set to handle the regulatory approval processes, including filing and maintaining approvals for olezarsen and donidalorsen in the country.
Ionis will supply both products, while also granting Theratechnologies the right to manufacture them under certain conditions.
The licensing agreement will remain in effect until Theratechnologies ceases the commercialisation of the licensed products in Canada or if terminated earlier by standard provisions.
Theratechnologies CEO and president Paul Lévesque said: “Theratechnologies is proud to be the partner of choice for Ionis to bring two innovative treatments for three potential indications to patients with unmet medical needs across Canada, thus expanding upon our foundational HIV portfolio and primary business in the US.
“The agreement with Ionis is a testament to our team’s capabilities to advance innovation across North America and reaffirms our commitment to be a commercially focused company that delivers sustained top- and bottom-line growth and value for shareholders.”
Theratechnologies is aiming to submit olezarsen for Health Canada’s review next year, aiming to introduce it in the country.
Ionis has concluded subject enrolment for the Phase III olezarsen clinical programme targeting sHTG, with results from the CORE, CORE2, and ESSENCE trials expected in the second half of 2025.
