Sobi Announces Significant Changes in Partnership with Apellis for Aspaveli Royalties

Sobi and Apellis: A New Chapter in Aspaveli Royalties

In a strategic move to reshape its financial commitments, Sobi (Swedish Orphan Biovitrum AB) has announced a major amendment to its existing agreement with Apellis Pharmaceuticals, Inc. This revised agreement, which centers around the royalties related to the drug Aspaveli® (systemic pegcetacoplan), is expected to bring significant changes to Sobi's obligations and their ongoing partnership with Apellis.

Key Highlights of the Agreement

As part of this new capped royalty purchase agreement, Sobi will dramatically reduce its ex-U.S. royalty obligations to Apellis by 90%. In exchange for this reduction, Sobi will make an upfront payment of $275 million to Apellis, along with the possibility of an additional $25 million dependent upon regulatory milestones in the European Union. These milestones pertain to the approval of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), both rare kidney diseases.

Guido Oelkers, Sobi's CEO, expressed enthusiasm about the continued alliance with Apellis, aligning their shared vision for the potential of Aspaveli/EMPAVELI in driving significant long-term growth. Oelkers highlighted the company's aim to leverage their expertise in rare diseases to navigate the European regulatory landscape effectively.

Aspaveli's Clinical Significance

Aspaveli/EMPAVELI is already approved in the European Union and the United States for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder characterized by severe hemolysis. Presently, the drug is undergoing review in both regions for C3G and IC-MPGN, conditions that can lead to kidney failure and require life-saving interventions like dialysis or transplant. The urgency of advancing this treatment is underscored by the fact that nearly half of those diagnosed with these rare diseases experience kidney failure within five to ten years.

The European Medicines Agency is expected to provide an opinion on these applications before the end of the year, while the U.S. awaits the Prescription Drug User Fee Act (PDUFA) action date on July 28, 2025. Both companies are poised to make a significant impact on the treatment landscape for these diseases.

Transformative Potential of the Collaboration

The partnership between Sobi and Apellis embodies a collaborative spirit that aims to deepen the understanding of Aspaveli/EMPAVELI’s effects on patient outcomes. Timothy Sullivan, CFO of Apellis, emphasized that this transaction reflects their mutual belief in the drug's transformative potential within the rare disease sector.

Moreover, under this collaboration framework, Sobi holds exclusive ex-U.S. commercialization rights for systemic pegcetacoplan, maintaining the option to opt into future development programs, while Apellis retains exclusive commercialization rights in the U.S. and rights for ophthalmological pegcetacoplan.

Understanding C3 Glomerulopathy and IC-MPGN

C3 glomerulopathy and primary IC-MPGN represent rare yet serious kidney conditions driven by excessive deposits of the protein C3, leading to critical inflammation, damage, and eventual kidney failure. The impact on patients cannot be underestimated, with approximately 90% of those who have had a kidney transplant experiencing a recurrence of the disease.

Currently, these conditions affect around 5,000 individuals in the U.S. and up to 8,000 in Europe, reflecting a significant health burden that necessitates urgent and innovative therapeutic solutions. Sobi’s investment and commitment to bringing new options like Aspaveli to the market could revolutionize patient care in this segment.

In conclusion, Sobi and Apellis’s evolving partnership in the face of challenging healthcare dynamics exemplifies proactive business strategies aimed at improving patient outcomes in under-researched areas. The upcoming regulatory decisions and patient responses to Aspaveli could herald a new era not just for the companies involved but also for patients coping with rare diseases worldwide.