Hematology | Phase III Developments

Apellis Pharmaceuticals

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Apellis Completes Enrollment in Phase 3 Study of Pegcetacoplan in Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Lead Product(s): Pegcetacoplan

Therapeutic Area: Hematology Product Name: APL-2

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 02, 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.

Apellis Pharmaceuticals

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New Pivotal Data Demonstrate Superiority of Apellis’ Pegcetacoplan to Eculizumab in Improving Hemoglobin Levels

Lead Product(s): Pegcetacoplan

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 12, 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.

Rigel Pharmaceuticals

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Rigel to Present Poster Highlighting TAVALISSE at the Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress

Lead Product(s): Fostamatinib Disodium

Therapeutic Area: Hematology Product Name: Tavalisse

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

Details:

In this previously presented post-hoc analysis, 32 patients received TAVALISSE as a second-line therapy, and 78% achieved ≥1 platelet count of ≥50,000/µL. Adverse events were manageable and consistent with those previously reported with fostamatinib.

Omeros

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Omeros’ Narsoplimab Pivotal Trial Data to be Shared as an Oral Presentation at Annual European Hematology Association Congress

Lead Product(s): Narsoplimab

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

Details:

The results of Omeros’ pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy will be shared as an oral presentation at the virtual edition of the 25th annual European Hematology Association Congress.

Astellas Pharma

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JAPAN Japan

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Roxadustat Reports Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Patients with CDK

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 08, 2020

Details:

The data showed non-inferiority of roxadustat to darbepoetin alfa in the correction of hemoglobin levels during the first 24 weeks of treatment, meeting the study's primary endpoint.

FibroGen, Inc

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FibroGen Announces New Roxadustat Data Presented at 2020 ERA-EDTA Virtual Congress

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 08, 2020

Details:

Roxadustat demonstrates non-inferiority to darbepoetin alfa in achievement of Hb correction in DOLOMITES Phase 3 study of anemia in non-dialysis dependent patients with chronic kidney disease.

Fresenius Kabi AG

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GERMANY Germany

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FDA Accepts for Review Fresenius Kabi’s BLA Submission for Pegfilgrastim Biosimilar

Lead Product(s): Pegfilgrastim

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 27, 2020

Details:

U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta®* (pegfilgrastim).

GlaxoSmithKline

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United Kingdom

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FDA Grants Priority Review of Nucala for Patients with Hypereosinophilic Syndrome

Lead Product(s): Mepolizumab

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 27, 2020

Details:

If approval is obtained, it would make Nucala the first targeted biologic treatment for patients with this rare and life-threatening disease caused by eosinophilic inflammation.

Fresenius Kabi AG

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GERMANY Germany

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Fresenius Kabi’s Regulatory Submission for Pegfilgrastim Biosimilar Accepted for Review By EMA

Lead Product(s): Pegfilgrastim

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 22, 2020

Details:

Fresenius Kabi’s MAA submission for pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data.

Apellis Pharmaceuticals

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Apellis Announces Plans to Submit NDA for Pegcetacoplan in Paroxysmal Nocturnal Hemoglobinuria (PNH)

Lead Product(s): Pegcetacoplan

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 21, 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.

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Apellis Pharmaceuticals

Apellis Completes Enrollment in Phase 3 Study of Pegcetacoplan in Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Apellis Pharmaceuticals

New Pivotal Data Demonstrate Superiority of Apellis’ Pegcetacoplan to Eculizumab in Improving Hemoglobin Levels

Rigel Pharmaceuticals

Rigel to Present Poster Highlighting TAVALISSE at the Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress

Omeros

Omeros’ Narsoplimab Pivotal Trial Data to be Shared as an Oral Presentation at Annual European Hematology Association Congress

Astellas Pharma

Roxadustat Reports Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Patients with CDK

FibroGen, Inc

FibroGen Announces New Roxadustat Data Presented at 2020 ERA-EDTA Virtual Congress

Fresenius Kabi AG

FDA Accepts for Review Fresenius Kabi’s BLA Submission for Pegfilgrastim Biosimilar

GlaxoSmithKline

FDA Grants Priority Review of Nucala for Patients with Hypereosinophilic Syndrome

Fresenius Kabi AG

Fresenius Kabi’s Regulatory Submission for Pegfilgrastim Biosimilar Accepted for Review By EMA

Apellis Pharmaceuticals

Apellis Announces Plans to Submit NDA for Pegcetacoplan in Paroxysmal Nocturnal Hemoglobinuria (PNH)