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Sobi Restructures Royalty Agreement with Apellis for Aspaveli®

On July 1, 2025, Sobi® (STO: SOBI) announced a strategic adjustment to its existing royalty agreement with Apellis Pharmaceuticals, Inc., which governs the ex-U.S. royalties for Aspaveli® (systemic pegcetacoplan). This new arrangement will see a remarkable 90% reduction in royalty obligations owed to Apellis while ensuring continued collaboration and shared success in bringing innovative treatments to rare disease patients.

Details of the New Agreement

Sobi's secured a capped royalty purchase agreement from Apellis that involved an upfront cash payment of $275 million. Additionally, it includes potential milestone payments of up to $25 million, contingent upon regulatory approvals for Aspaveli in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) within the European Union.

CEO Guido Oelkers of Sobi expressed his optimism regarding the partnership, stating that this collaboration reflects a mutual belief in the potential of Aspaveli/EMPAVELI to enhance patient outcomes significantly. Furthermore, he emphasized their preparedness to navigate the regulatory landscape in Europe to ensure the treatment reaches those in need promptly.

Aspaveli is already approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, across various global markets, including the U.S. It is currently undergoing review to expand its indications to encompass C3G and IC-MPGN, two serious kidney diseases. The European Medicines Agency (EMA) is expected to provide its opinion by the end of the year, while the U.S. Prescription Drug User Fee Act (PDUFA) action date is set for July 28, 2025.

Significance of Aspaveli's Indications

C3 glomerulopathy and IC-MPGN represent rare but challenging kidney conditions that can lead to significant health complications, including kidney failure. The severity of these diseases is underscored by the alarming statistic that approximately 50% of individuals diagnosed will progress to kidney failure within five to ten years, and many will require either dialysis or a kidney transplant. With a patient population significantly affected both in the U.S. and Europe, the successful development and market availability of Aspaveli for these indications can be transformational.

Timothy Sullivan, CFO at Apellis, highlighted how this agreement encapsulates the shared commitment between the two companies in harnessing Aspaveli's potential to meet unaddressed medical needs in the realm of rare diseases. He noted that their collaboration has yielded a robust understanding of the drug's capabilities to elevate patient care.

Financial and Operational Implications

Under this agreement, Sobi's ex-U.S. royalty obligations to Apellis will be significantly minimized until certain predefined caps are hit. After reaching these limits, royalties will revert to the provisions set out in the original license agreement, ensuring a balanced risk-reward structure for both parties involved.

The collaboration between Sobi and Apellis continues to illustrate the potential for strategic financial agreements to advance medical innovation while supporting the commercial viability of essential treatments. As Sobi seeks to expand its reach in the rare disease arena, developments such as these highlight the importance of agile partnerships in the biopharmaceutical sector.

Conclusion

Sobi's recent amendment to its agreement with Apellis represents a significant step forward in the ongoing development of innovative treatments for rare diseases. This collaboration not only aims to enhance the commercial landscape but also underscores the commitment to improving patient outcomes through accessible therapeutic options. As the regulatory processes unfold, stakeholders from both companies remain focused on bringing forward solutions that may transform current treatment paradigms for conditions that have long challenged the medical community.