Enable Injections Announces Agreement with Sobi to Develop & Distribute Aspaveli in Combination With enFuse

Enable Injections, Inc. and Swedish Orphan Biovitrum AB (Sobi) recently announced an international development and distribution agreement for the enFuse Injector, for the subcutaneous delivery of Aspaveli (pegcetacoplan).

The enFuse Injector, to be produced by Enable and distributed by Sobi, is designed to streamline and improve patients’ self-administration experience with minimal disruption to their daily lives via the use of wearable enFuse technology. This allows wearable, hidden needle drug delivery through a simple injection under the skin.

“The future availability of Aspaveli with Enable Injection’s enFuse technology, could offer more patients the opportunity to access a simplified treatment experience that allows for greater confidence and mobility,” said Michael D. Hooven, Enable Injections’ Chairman and CEO. “Enable was founded on the goal of redefining drug delivery for the benefit of patients, and our partnership with Sobi is helping us achieve that. Following regulatory approval, enFuse will potentially be the first subcutaneous drug delivery device of its kind available outside of the US and we look forward to improving the treatment experience of even more patients as we establish additional enFuse partnerships.”

“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,” added Lydia Abad-Franch, MD, Head of R&D, Medical Affairs, and Chief Medical Officer at Sobi. “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.”

Enable is currently working with a number of pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies in combination with the enFuse technology. The first enFuse combination product received U.S. FDA approval in 2023.

Aspaveli/EMPAVELI (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is approved for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in the US, European Union, and other countries globally. The therapy is also under investigation for several other rare diseases across haematology and nephrology.

Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of enFuse. enFuse is an innovative wearable drug delivery platform that is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit https://enableinjections.com/our-products.

Sobi and Apellis have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-US commercialization rights for systemic pegcetacoplan, and Apellis has exclusive US commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.

Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of hematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.