Pfizer and Ionis subsidiary Akcea have signed a global exclusive licensing agreement for antisense therapy AKCEA-ANGPTL3-LRx.

According to the terms of the agreement, Akcea and Ionis will receive $250m upfront from Pfizer, which will be split equally between them; Akcea will settle its $125m obligation to Ionis in common stock.

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Akcea and Ionis will also be eligible for up to $1.3bn in regulatory, development and sales milestone payments, as well as tired, double-digit royalties in annual global net sales following AKCEA-ANGPTL3-LRx’s approval. Any additional fees will be split equally between the two.

AKCEA-ANGPTL3-LRx is being developed for cardiovascular and metabolic diseases, as it controls the production of angiopoietin-like-3 (ANGPTL3) protein in the liver, which is known to regulate triglycerides, cholesterol, glucose and energy metabolism.

Akcea interim CEO Damien McDevitt said: “AKCEA-ANGPTL3-LRx has the potential to treat people suffering from certain cardiovascular and metabolic diseases.

“Given the unmet medical need for this patient population and the broad market potential, we believe Pfizer’s expertise and breadth of experience in cardiovascular and metabolic diseases makes it well suited to accelerate clinical development of AKCEA-ANGPTL3-LRx, and to deliver it to patients in need of additional therapies for these life threatening diseases.”

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The drug is currently being trialled in a Phase II study for Type 2 diabetes, hypertriglyceridemia and non-alcoholic fatty liver disease.

According to the terms of the licensing agreement, Pfizer will now be responsible for the further development of AKCEA-ANGPTL3-LRx in this trial and future studies, as well as regulatory activities and all of the costs associated with the drug. Akcea will retain the option to participate in certain commercialisation activities in the US and additional markets.

Pfizer chief scientific officer and worldwide research and development and medical president Mikael Dolsten said: “Pfizer is committed to delivering breakthrough medicines to patients with unmet medical needs.

“AKCEA-ANGPTL3-LRx is a novel therapy that will complement our clinical mid-stage internal medicine pipeline, and we believe that our deep expertise in cardiovascular and metabolic diseases will help allow this program to reach its maximum potential for patients.”

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