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Details:
Under the agreement, Pint-Pharma will be obtaining and maintaining all marketing authorizations and commercializing BESREMi (ropeginterferon alfa-2b-njft), the first approved mono-pegylated proline interferon for polycythemia vera, a rare blood cancer, in Latin America.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: Besremi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pint Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 02, 2023
Details:
BESREMi (ropeginterferon alfa-2b-njft) binds to IFNAR initiates a downstream signaling cascade through the activation of kinases, in particular JAK1 and TYK2 and activator of transcription (STAT) proteins. It is indicated for the polycythemia vera.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: BESREMi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2023
Details:
BESREMi (ropeginterferon alfa-2b-njft) binds to IFNAR initiates a downstream signaling cascade through the activation of kinases, in particular JAK1 and TYK2 and activator of transcription (STAT) proteins. It is being investigated for polycythemia vera.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: BESREMi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2023
Details:
The net proceeds from the offering will be used to to support growth plans and pipeline development, including Besremi (ropeginterferon alfa-2b-njft), an innovative monopegylated, long-acting interferon for the treatment of polycythemia vera (PV) in adults.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: Besremi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $462.7 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 21, 2023
Details:
BESREMi (ropeginterferon alfa-2b-njft) binds to IFNAR initiates a downstream signaling cascade through the activation of kinases, in particular JAK1 and TYK2 and activator of transcription (STAT) proteins.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: BESREMi
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 February 23, 2023
Details:
BESREMi (ropeginterferon alfa-2b-njft) binds to IFNAR initiates a downstream signaling cascade through the activation of kinases, in particular JAK1 and TYK2 and activator of transcription (STAT) proteins.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: BESREMi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2023
Details:
BESREMi (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon. It is administered once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi is designed to be self-administered subcutaneously with a pre-filled pen.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: Besremi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Details:
BESREMi (ropeginterferon alfa-2b-njft), is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: Besremi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2022
Details:
P1101 (ropeginterferon alfa-2b-njft) is unique monopegylated, long-acting interferon to treat adults with polycythemia vera. Given well-established safety and efficacy profile demonstrated in prior studies, treatment may represent useful alternative to approved options for ET.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: P1101
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 August 08, 2022
Details:
BESREMi (Ropeginterferon alfa-2b) is long-acting, mono-pegylated proline interferon, unique pharmacokinetic properties new level of tolerability, designed to be conveniently self-administered subcutaneously with pen once every two weeks, or up to monthly after stabilization.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: Besremi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Details:
Reflecting its strong clinical profile and broad label, NCCN Guidelines include BESREMi® (ropeginterferon alfa-2b-njft) as an option for PV regardless of treatment history, and for use in both low- and high-risk settings.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: Besremi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Details:
Besremi is the first FDA-approved medication for polycythemia vera that patients can take regardless of their treatment history, and the first interferon therapy specifically approved for polycythemia vera.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: Besremi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2021
Details:
The study aims to determine if ropeginterferon alfa-2b may represent a potential solution that can help physicians significantly improve the therapy outcomes for patients in need.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Hematology Product Name: P1101
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 January 07, 2021
Details:
Five-year data from the PROUD-PV/CONTINUATION-PV studies demonstrates the shortand long-term effects of ropeginterferon alfa-2b among PV patients.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: P1101
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2020
Details:
Findings from “Long-Term Use of Ropeginterferon Alpha-2b in Polycythemia Vera: 5-Year Results from a Randomized Controlled Study and Its Extension” will be featured as an oral presentation at the Virtual ASH Annual Meeting.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: Besremi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
The filing is supported by robust, durable 24-36-month data from the Phase 3 PROUD/CONTI-PV clinical trial showing high & durable hematologic responses and symptom control with good tolerability and low rates of depression, with effects on relevant MPN mutations.
Lead Product(s): Ropeginterferon-Alfa-2b
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2020
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