Apellis and Sobi Report Empaveli™ (pegcetacoplan) Demonstrated Sustained Normalization of Clinical Measures in a Broad PNH Patient Population

• Improvements demonstrated in treatment-naïve patients and patients with baseline hemoglobin levels greater than or equal to 10.0 g/dL
• Data were presented at the American Society of Hematology (ASH) Annual Meeting

WALTHAM, Mass. and STOCKHOLM, Sweden, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) announced today new data demonstrating that Empaveli™/Aspaveli® (pegcetacoplan) provides consistent, sustained normalization of clinical measures across patients with paroxysmal nocturnal hemoglobinuria (PNH) who are treatment-naïve and patients with baseline hemoglobin levels greater than or equal to 10.0 g/dL. The data were presented at the American Society of Hematology Annual Meeting (ASH) taking place December 11 - 14, 2021.

Sustained Normalization and Superior Improvements of Clinical Measures in Treatment-Naïve Patients New data from the Phase 3 PRINCE study in treatment-naïve patients with PNH showed that treatment with EMPAVELI resulted in sustained and superior improvements in the co-primary endpoints of hemoglobin stabilization through Week 26 and reduction in lactate dehydrogenase (LDH) compared to standard of care, which did not include complement inhibitors, at Week 26.

Improvements were seen as early as two weeks after starting treatment with EMPAVELI and patients showed sustained normalization across key markers of disease through Week 26:

• 46% of EMPAVELI patients achieved hemoglobin normalization in the absence of transfusions vs. 0% for standard of care (p