API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
Copaxone Depot, a long-acting glatiramer acetate designed to be administered as an intramuscular injection, is being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS).
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Neurology Product Name: WhisperJECT
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mapi Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2023
Details:
Copaxone (glatiramer acetate) its ability to induce the peripheral Th2 cells and their subsequent crossing of the blood barrier allows for the reduction of further inflammation within the CNS.
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Oncology Product Name: Copaxone
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2023
Details:
The study evaluating a long-acting glatiramer acetate (copaxone) injection, GA Depot 40 mg once every four weeks, met the primary endpoint, significantly reducing the annualized relapse rate (ARR) by 30.1 percent compared to placebo.
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Neurology Product Name: Copaxone
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 21, 2022
Details:
At AAN, company will be presenting 5 year data from Phase IIa study in RRMS. Also, the results seeN in the ongoing Phase II study for GA Depot in primary progressive MS (PPMS) patients, to be presented at the meeting as plan to initiate a Phase-3 for PPMS at the end of 2022.
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Neurology Product Name: GA Depot
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
GA Depot is a long-acting injection version of the approved Copaxone® (Glatiramer Acetate) designed to be administered as an intramuscular injection once every four weeks, is being evaluated for treatment of relapsing forms of multiple sclerosis.
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Neurology Product Name: Copaxone
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Details:
The label update of COPAXONE® (Glatiramer Acetate) follows the review of clinical and non-clinical evidence, including latest data from the COBRA study that investigated safety outcomes in infants breastfed by mothers with MS undergoing GA treatment during the first 18 months.
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Immunology Product Name: Copaxone
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 10, 2022
Details:
Patients were eligible for the study if they were diagnosed with relapsing MS (RMS), gave a live birth, were breastfeeding under GA treatment (COPAXONE® 20 or 40 mg/mL) or breastfeeding under no DMT treatment.
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Neurology Product Name: Copaxone
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 13, 2021
Details:
A non-interventional analysis of the study found no evidence of safety concerns in infants born to mothers with multiple sclerosis (MS) who were breastfeeding and receiving glatiramer acetate (GA) treatment.
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Neurology Product Name: Copaxone
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 22, 2021
Details:
GA Depot is a long-acting version of Teva Pharmaceutical’s Copaxone (glatiramer acetate). Mapi Pharma is working with the CRO PRA Health Sciences for its Phase III trial investigating glatiramer acetate depot (GA Depot) for relapsing forms of multiple sclerosis (RMS).
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Neurology Product Name: Copaxone
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: PRA Health Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2021
Details:
GA Depot is a long acting injection version of the approved Glatiramer Acetate products (Copaxone® and its generic versions) for treating multiple sclerosis (RMS), designed to be administered as an intramuscular injection once every four weeks.
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Immunology Product Name: GA Depot
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 December 21, 2020
Details:
Pharma announced an additional investment from Mylan in support of continued Phase 3 clinical study progress to bring to market in the U.S. Glatiramer Acetate Depot for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Viatris
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Funding June 15, 2020