STOCKHOLM, July 1, 2025 /PRNewswire/ -- Sobi® (STO: SOBI), today announced a capped royalty purchase agreement with Apellis Pharmaceuticals, Inc. under which Sobi will reduce its ex-US royalty obligations to Apellis by 90% for Aspaveli® (systemic pegcetacoplan) in exchange for $275 million upfront and up to $25 million in additional milestone payments dependent on regulatory approvals in the European Union for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).

"We are pleased to continue our ongoing partnership with Apellis and share their strong belief in Aspaveli/EMPAVELI's potential to deliver significant long-term growth," said Guido Oelkers, Chief Executive Officer at Sobi. "We look forward to continuing the regulatory process in Europe and are well positioned to bring this novel treatment to patients with C3G and IC-MPGN leveraging our deep rare disease expertise."

Aspaveli/EMPAVELI is approved in the European Union, other countries globally, and the US for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia, a rare blood disorder. It is currently under review in the European Union and the U.S. for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases. An opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is expected before year-end. In the U.S., the Prescription Drug User Fee Act (PDUFA) action date is July 28, 2025.

"Through our collaboration, Sobi has developed a deep understanding of Aspaveli/EMPAVELI's potential to significantly improve patient outcomes and deliver long-term value as a rare disease franchise," said Timothy Sullivan, Chief Financial Officer, Apellis. "This transaction reflects our shared conviction in the potential of Aspaveli/EMPAVELI to transform the treatment landscape for patients with rare diseases, including C3G and IC-MPGN."

Transaction Highlights

Upfront Payment: $275 million in cash
Milestone Payments: Up to $25 million upon EMA approval of Aspaveli® for C3G and IC-MPGN
Royalty Structure: Sobi will reduce its ex-U.S. royalty obligation to Apellis Pharmaceuticals, Inc. by 90% until defined caps are achieved, after which ex-U.S. royalties revert to the original license agreement.

About the Sobi and Apellis Collaboration

Sobi and Apellis have global co-development rights for systemic pegcetacoplan.

Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan, and its opt-in rights for future development programs are unchanged, exercisable at any time prior to commercialisation. Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.

About C3 Glomerulopathy (C3G) and Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or lifelong dialysis.¹ Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.² The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe.³

About Sobi®

Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO: SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Contacts
For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media, click here.

This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, on 1 July 2025 at 1:00 PM CEST.

Gerard Tobin
Head of Investor Relations

References

1. C3 glomerulopathy. National Institute of Health, Genetics Home Reference. https://ghr.nlm.nih.gov/condition/c3-glomerulopathy#resources. Accessed November 21, 2019.

2. Tarragón, B, et al. C3 Glomerulopathy Recurs Early after Kidney Transplantation in Serial Biopsies Performed within the First 2 Years after Transplantation. Clinical Journal of the American Society of Nephrology. August 2024; 19(8)1005-1015. doi: 10.2215/CJN.0000000000000474.

3. Data on file using literature consensus.

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     https://mb.cision.com/Main/14266/4172822/3540063.pdf Sobi to amend existing agreement with Apellis for ex-U.S. royalties of Aspaveli(R)
                                                              (systemic pegcetacoplan)

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