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Details:
Syfovre (pegcetacoplan) is the first and only approved therapy for geographic atrophy (GA). It targets C3 to provide comprehensive control of the complement cascade, part of the body’s immune system.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: Syfovre
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2024
Details:
Syfovre (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). It targets C3 to provide comprehensive control of the complement cascade, part of the body’s immune system.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: Syfovre
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2023
Details:
Empaveli (pegcetacoplan) is the first treatment for PNH that binds to the complement protein C3, which is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Rare Diseases and Disorders Product Name: Empaveli
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: OrphanDC
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2023
Details:
Empaveli (pegcetacoplan) Injector is a compact, single-use, on-body device designed to enhance self-administration, which is indicated for treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
Lead Product(s): Pegcetacoplan
Therapeutic Area: Rare Diseases and Disorders Product Name: Empaveli
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2023
Details:
Syfovre™ (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). It targets C3 to provide comprehensive control of the complement cascade, part of the body’s immune system.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Neurology Product Name: Syfovre
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2023
Details:
Syfovre™ (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). It targets C3 to provide comprehensive control of the complement cascade, part of the body’s immune system.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: Syfovre
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2023
Details:
The net proceeds will be used to support the commercialization of Empaveli (pegcetacoplan) and Syfovre, to fund clinical development of our current and future product candidates, to conduct research activities and for working capital and other general corporate purposes.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Rare Diseases and Disorders Product Name: Empaveli
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: J.P. Morgan Securities
Deal Size: $402.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 27, 2023
Details:
The company intend to use the net proceeds, to support the commercialization of Empaveli (pegcetacoplan) and SYFOVRE, to fund clinical development of their current and future product candidates and to conduct research activities.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Rare Diseases and Disorders Product Name: Empaveli
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: J.P. Morgan Securities LLC
Deal Size: $350.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 22, 2023
Details:
Syfovre™ (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). It targets C3 to provide comprehensive control of the complement cascade, part of the body’s immune system.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: Syfovre
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 17, 2023
Details:
Empaveli™ having pegcetacoplan, is a targeted C3 therapy designed to regulate the activity of the complement cascade, which can lead to the onset and progression of many serious diseases.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Rare Diseases and Disorders Product Name: Empaveli
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2022
Details:
APL-2 (Pegcetacoplan) is an investigational, 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.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
Two post hoc analyses of microperimetry data showed positive trends with increasing effects over time, demonstrating both monthly and every-other-month (EOM) APL-2 (pegcetacoplan) treatment preserved visual function of retinal cells near the GA lesion border compared to sham.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2022
Details:
In a pre-specified analysis of GA lesion growth over 24 months, both monthly and every-other-month (EOM) APL-2 (pegcetacoplan) showed clinically meaningful reduction in GA lesion growth from baseline compared to sham.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2022
Details:
In the studies, treatment with both monthly and every-other-month Empaveli (pegcetacoplan) resulted in a clinically meaningful reduction of GA lesion growth across a broad, heterogeneous population of more than 1,500 patients.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: Empaveli
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
Data from Phase 3 DERBY and OAKS studies, which showed mean rate of GA lesion growth at 18 months with both monthly and every-other-month intravitreal pegcetacoplan, an investigational, targeted C3 therapy for geographic atrophy secondary to age-related macular degeneration.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: Empaveli
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
New analyses demonstrated that treatment with EMPAVELI (pegcetacoplan) resulted in meaningful improvements in quality of life for treatment-naïve patients and suggested the incidence of thrombosis was comparable to eculizumab, a C5 inhibitor.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: Empaveli
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
Empaveli (pegcetacoplan), is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, a part of the body's immune system, which can lead to the onset and progression of many serious diseases.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Nephrology Product Name: Empaveli
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2022
Details:
In the studies, treatment with both monthly and every-other-month Empaveli (pegcetacoplan) resulted in a clinically meaningful reduction of GA lesion growth across a broad, heterogenous population of more than 1,500 patients.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: Empaveli
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
Empaveli/Aspaveli (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.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: Empaveli
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
Monthly and every-other-month treatment with APL-2 (pegcetacoplan) showed a continuous and clinically meaningful reduction in the growth of both extrafoveal and foveal lesions at month 18 (all p-values nominal).
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
Both monthly and every-other-month pegcetacoplan, an investigational, targeted C3 therapy continued to reduce GA lesion growth compared to pooled sham at 18 months with all p-values below 0.05. Treatment effects in DERBY were comparable to OAKS during months 6-18.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
Empaveli™/Aspaveli® (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.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: Empaveli
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2021
Details:
The company’s plans to submit a NDA for intravitreal pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration. The NDA will be supported by efficacy and safety data from the Phase 3 DERBY and OAKS studies and the Phase 2 FILLY study.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2021
Details:
The positive opinion is based on the results from the head-to-head Phase 3 PEGASUS study, which evaluated the efficacy and safety of Aspaveli compared to eculizumab at 16 weeks in adults with PNH who had persistent anemia despite treatment with eculizumab.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: Aspaveli
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2021
Details:
The primary objective of this study was to establish the efficacy and safety of EMPAVELI™ (pegcetacoplan) in patients who have not received treatment with any complement inhibitor within three months prior to screening.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: EMPAVELI
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2021
Details:
In the study, EMPAVELI met the primary endpoint, demonstrating superiority to Soliris for the change from baseline in hemoglobin level at Week 16 with an adjusted mean increase of 3.84 g/dL of hemoglobin.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: Empaveli
Highest Development Status: Phase IVProduct Type: Peptide
Partner/Sponsor/Collaborator: SFJ Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2021
Details:
Pegcetacoplan is an investigational, 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.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL2
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2021
Details:
The results published in NEJM highlight that pegcetacoplan met the study’s primary endpoint for efficacy, demonstrating superiority to eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2021
Details:
Treatment with pegcetacoplan resulted in a sustained improvement in haemoglobin with a mean increase from baseline of 2.7 g/dL at week 48, which is equal to the 2.7 g/dL increase seen at week 16 with pegcetacoplan-treated patients.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Apellis Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2020
Details:
The MERIDIAN study will assess whether pegcetacoplan may offer a new treatment approach for people living with ALS by controlling complement activation at the level of C3. There are currently no treatments to slow the advance of ALS.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Neurology Product Name: APL-2
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
These results highlight the significant unmet need in GA, and we are working urgently to advance pegcetacoplan, a targeted C3 therapy, in two ongoing Phase 3 GA studies.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Highlights include new analyses from the Phase 3 head-to-head PEGASUS study, which demonstrate a markedly greater proportion of patients achieved better hematological responses as well as quality-of-life improvements with pegcetacoplan versus eculizumab, a C5 inhibitor.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
Under the collaboration, Sobi gets global co-development and exclusive ex-US commercialisation rights for systemic pegcetacoplan. Apellis retains US commercialisation rights for systemic pegcetacoplan and worldwide commercialisation rights for ophthalmological pegcetacoplan.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: $1,245.0 million Upfront Cash: $250.0 million
Deal Type: Collaboration October 27, 2020
Details:
Results demonstrate a greater than 65% mean reduction in proteinuria at week 48 in C3G patients treated with pegcetacoplan .
Lead Product(s): Pegcetacoplan
Therapeutic Area: Nephrology Product Name: APL-2
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2020
Details:
Apellis is advancing a registrational program in C3G / IC-MPGN beginning with the Phase 2 NOBLE study, a randomized, controlled trial in 12 patients with post-transplant disease recurrence that will focus on the histopathology of the kidneys.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Nephrology Product Name: APL-2
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2020
Details:
This new analysis of the FILLY study demonstrates that pegcetacoplan impacts the progression of nascent GA,1,2 the earlier stage of disease that precedes atrophy, in areas of the retina outside of GA lesions.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
The NDA and MAA submissions are based on results from the Phase 3 PEGASUS study, which met its primary endpoint, demonstrating the superiority of pegcetacoplan to eculizumab with a statistically significant improvement in hemoglobin levels at 16 weeks.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Details:
A total of 1,259 patients are enrolled in DERBY and OAKS, which are pivotal randomized Phase 3 studies designed to compare the efficacy and safety of intravitreal pegcetacoplan with sham treatment in patients with GA secondary to AMD.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Details:
The study was designed to evaluate the efficacy of pegcetacoplan in 48 adult patients who are treatment-naïve, showed evidence of hemolysis (elevated LDH ≥ 1.5x ULN) and had hemoglobin levels that were less than the lower limit of normal at the time of their screening.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: APL-2
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2020
Details:
71% of pegcetacoplan-treated patients achieved LDH normalization vs. 15% of eculizumab-treated patients. Detailed results from positive head-to-head Phase 3 PEGASUS study in patients with paroxysmal nocturnal hemoglobinuria presented at the European Hematology Association.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2020
Details:
The NDA submission is backed by results from Apellis Phase 3 PEGASUS study. Based on feedback from the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting to discuss the registration strategy for pegcetacoplan.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
Details:
The analysis of APL2-103 has shown that the Phase 3 formulation was well tolerated over 12 months of treatment.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2020
Details:
In a head-to-head phase 3 trial after 16 weeks, hemoglobin levels in the pegcetacoplan arm had increased by 3.8 g/dL over the Soliris group, resulting in the trial hitting its primary endpoint.
Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 07, 2020
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