API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
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 primary endpoint of the NEPTUNE study was not achieved. Patients given OV101 showed a 0.7 point improvement in CGI-I-AS over baseline while placebo also showed a 0.8 point improvement in CGI-I-AS.
Lead Product(s): Gaboxadol
Therapeutic Area: Genetic Disease Product Name: OV101
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 December 01, 2020
Details:
Ovid to collaborate with renowned molecular geneticist and Angelman syndrome expert Stormy J. Chamberlain, Ph.D., to advance a short hairpin RNA (shRNA)-based therapeutic with the goal of addressing the underlying genetic cause of Angelman syndrome.
Lead Product(s): Short hairpin RNA,Gaboxadol
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: University of Connecticut
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 23, 2020
Details:
Angelini Pharma obtains exclusive development, manufacturing and commercialization rights to OV101 for the treatment of Angelman syndrome in the European Union and other countries in the European Economic Area, and also Switzerland, Turkey, the United Kingdom and Russia.
Lead Product(s): Gaboxadol
Therapeutic Area: Genetic Disease Product Name: OV101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Angelini Pharma
Deal Size: $232.0 million Upfront Cash: $20.0 million
Deal Type: Licensing Agreement July 13, 2020
Details:
OV101 is believed to be the only delta (δ)-selective GABAA receptor agonist in development and is currently being evaluated in the Company’s pivotal Phase 3 NEPTUNE trial in Angelman syndrome, with topline results expected in the fourth quarter of 2020.
Lead Product(s): Gaboxadol
Therapeutic Area: Genetic Disease Product Name: OV101
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 June 19, 2020
Details:
The presentation will highlight data from the pivotal Phase 3 NEPTUNE trial investigating OV101 (gaboxadol) in Angelman syndrome.
Lead Product(s): Gaboxadol
Therapeutic Area: Genetic Disease 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 June 08, 2020
Details:
OV101 produced statistically significant reductions in behavioral and functional symptoms in individuals with Fragile X syndrome and met the study’s primary objective of safety and tolerability.
Lead Product(s): Gaboxadol
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 07, 2020