X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
The companies entered into a strategic partnership for the development and commercialization of Twymeeg (imeglimin hydrochloride) in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries.
Lead Product(s): Imeglimin Hydrochloride
Therapeutic Area: Endocrinology Product Name: Twymeeg
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitomo Pharma
Deal Size: $299.0 million Upfront Cash: $42.0 million
Deal Type: Partnership June 23, 2021
Details:
Metavant will return all rights to Imeglimin to Poxel, as well as all data, materials, and information, including FDA regulatory filings, related to the program. Metavant is not entitled to any payment from Poxel as part of the return of the program.
Lead Product(s): Imeglimin Hydrochloride
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Metavant Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Terminated January 14, 2021
Details:
Metavant has conducted a strategic review and has decided not to move forward with the development of Imeglimin. Metavant will actively explore options for a potential out-licensing of Imeglimin rights for a period of 60 day.
Lead Product(s): Imeglimin Hydrochloride
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitomo Pharma Oncology
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2020
Details:
Phase 3 TIMES 2 and TIMES 3 trial results demonstrate that Imeglimin met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile.
Lead Product(s): Imeglimin Hydrochloride
Therapeutic Area: Endocrinology Product Name: Undisclosed
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 September 24, 2020
Details:
Sumitomo Dainippon Pharma has submitted a Japanese New Drug Application (J-NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes.
Lead Product(s): Imeglimin Hydrochloride
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitomo Pharma
Deal Size: $21.3 million Upfront Cash: Undisclosed
Deal Type: Agreement July 30, 2020
Details:
Two drug-drug interaction studies assessed the effect of repeated co-administration of commonly prescribed medications, metformin or sitagliptin (Januvia®; Merck & Co.), with Imeglimin.
Lead Product(s): Imeglimin Hydrochloride
Therapeutic Area: Endocrinology Product Name: Undisclosed
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 April 20, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
