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Details:
Acquisition brings leading sickle cell disease portfolio and pipeline including Oxbryta® (voxelotor), a first-in-class medicine that directly targets the root cause of SCD, to Pfizer with potential to address critical needs in an underserved patient community.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $5,400.0 million Upfront Cash: $5,400.0 million
Deal Type: Acquisition October 05, 2022
Details:
Proposed acquisition drives growth by bringing leading sickle cell disease expertise and rare hematology portfolio and pipeline of GBT including Oxbryta (voxelotor) tablets for treatment of sickle cell disease (SCD) and GBT601.
Lead Product(s): Voxelotor
Therapeutic Area: Hematology Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $5,400.0 million Upfront Cash: $5,400.0 million
Deal Type: Acquisition August 08, 2022
Details:
Oxbryta (Voxelotor) works by increasing hemoglobin’s affinity for oxygen, inhibits sickle hemoglobin polymerization and resultant sickling and destruction of red blood cells leading to hemolysis and anemia, are primary pathologies faced by every single person living with SCD.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
Oxbryta (voxelotor) is an oral, once-daily therapy for patients with sickle cell disease (SCD). Oxbryta works by increasing hemoglobin’s affinity for oxygen.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
The first sickle hemoglobin polymerization inhibitor approved in Europe, Oxbryta increases hemoglobin levels and reduces sickling and hemolysis – the cause of long-term complications of sickle cell disease.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2022
Details:
This positive opinion means that those patients living with SCD and meeting the eligibility criteria can gain early, pre-license access to voxelotor, while the MHRA completes its review of the Marketing Authorisation Application (MAA).
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2022
Details:
The FDA’s approval of the sNDA is based on data from the open-label Phase 2a HOPE-KIDS 1 Study, which showed that weight-based treatment with the dispersible tablet formulation of Oxbryta (Voxelotor) resulted in rapid and sustained improvements in hemoglobin.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2021
Details:
CHMP opinion is based on Phase 3 HOPE study which demonstrated clinically meaningful and statistically significant improvements in Hb levels and reductions in hemolysis, for patients treated with Oxbryta (Voxelotor) as monotherapy or in combination with hydroxycarbamide.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2021
Details:
GBT intends to use the remainder of the net proceeds from the offering for the continued commercialization of Oxbryta® (voxelotor) and the clinical development of Oxbryta® and GBT’s product candidates.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $300.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 15, 2021
Details:
An oral, once-daily therapy, Oxbryta directly inhibits hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD. The sickling process causes hemolytic anemia, which impairs oxygen delivery to the tissues and organs in the body.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
Oxbryta, a first-in-class therapy that directly targets hemoglobin polymerization, the root cause of red blood cell sickling in SCD, is currently approved by the FDA in a tablet dosage form to treat SCD in patients age 12 years and older.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2021
Details:
A new analysis of data from 45 children with SCD ages 4 to 11 years enrolled in the open-label Phase 2a HOPE-KIDS 1 Study (GBT440-007) showed that treatment with Oxbryta resulted in rapid and sustained improvements in hemoglobin
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
Oxbryta, a first-in-class oral, once-daily therapy, directly inhibits hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2021
Details:
The EAP is designed to provide access to Oxbryta prior to approval for children ages 4 to 11 years with SCD in the U.S who have no alternative treatment options. GBT plans to submit an NDA for a pediatric formulation of Oxbryta for SCD in children aged 4 to 11 by mid-2021.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 04, 2021
Details:
A first-in-class oral, once-daily therapy, Oxbryta directly inhibits hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2021
Details:
Through the voxelotor early access program, physicians in countries with an early access regulatory and legal pathway may be able to request voxelotor for eligible SCD patients who do not have access to the medicine as part of a clinical trial.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2020
Details:
Discovered and developed by GBT, Oxbryta is the first and only therapy that directly inhibits hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in sickle cell disease (SCD).
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
Oxbryta is a once-daily, oral therapy that directly inhibits hemoglobin polymerization for the treatment of SCD. Biopharma-MEA will distribute Oxbryta® (voxelotor) tablets in Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Global Blood Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 08, 2020
Details:
An oral, once daily therapy, Oxbryta directly inhibits hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD. Based on recent discussions with the EMA, GBT intends to seek full marketing authorization of Oxbryta.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020
Details:
GBT intends to submit a New Drug Application for Oxbryta, which will include a new age-appropriate formulation, for the treatment of SCD in children ages 4 to 11 years. The NDA will include clinical data from the ongoing Phase 2a HOPE-KIDS 1 study.
Lead Product(s): Voxelotor
Therapeutic Area: Genetic Disease Product Name: Oxbryta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
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