Swedish Orphan Biovitrum (Sobi) and Enable Injections have entered a global agreement to develop and distribute Aspaveli (pegcetacoplan) in combination with enFuse.
Sobi will distribute the asset in its territories.
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To be produced by Enable Injections, the enFuse injector is designed for the subcutaneous administration of Aspaveli.
EnFuse was created to enhance the patient’s self-administration experience and reduce disruption to daily life.
The technology offers a wearable, hidden needle solution for drug delivery to administer the treatment under the skin.
Aspaveli, also known as EMPAVELI, is a targeted C3 therapy that regulates the complement cascade, an immune system component.
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By GlobalDataDysregulation of the complement cascade leads to the development and progression of several serious diseases.
Aspaveli is currently approved for treating paroxysmal nocturnal haemoglobinuria (PNH) in the US, European Union and other global markets.
The therapy is also being investigated for potential use in treating rare diseases within haematology and nephrology.
Sobi and Apellis Pharmaceuticals share worldwide joint development rights for systemic pegcetacoplan.
Sobi holds sole rights for the asset’s commercialisation outside the US while Apellis retains the sole commercial rights for systemic pegcetacoplan in the US and global rights for its ophthalmological applications, including geographic atrophy indication.
Sobi medical affairs research and development head and chief medical officer Lydia Abad-Franch stated: “We are dedicated to advancing innovative solutions for the treatment of rare diseases, and this agreement with Enable Injections marks an important step in fulfilling that commitment.
“We believe the agreement with Enable will potentially expand patient choice, enhance comfort and support adherence, with the ultimate aim of better health outcomes. By continually improving the patient experience, we are working to make a meaningful difference in the lives of those we serve.”
In June 2024, Sobi received the European Commission’s marketing authorisation for Altuvoct (efanesoctocog alfa) for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A.
