X
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)
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:
Deerfield has agreed to terminate its rights for development and commercial milestone payments associated with AEROSURF®, an acute pulmonary drug/device combination intended to treat premature infants with respiratory distress syndrome.
Lead Product(s): Lucinactant
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Aerosurf
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Windtree Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination January 25, 2024
Details:
Under terms of the global license agreement, Lee’s and Zhaoke will receive a global license to develop and commercialize Surfaxin®, lyophilized lucinactant and AEROSURF (lucinactant) for any potential indications and applications.
Lead Product(s): Lucinactant
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Aerosurf
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Lee Pharmaceutical
Deal Size: $78.9 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 23, 2022
Details:
The trial demonstrated that intratracheal administration of reconstituted lyophilized Surfaxin (lucinactant), was generally safe and well tolerated and could be safely administered to critically ill, mechanically ventilated patients with severe COVID-19 associated ARDS.
Lead Product(s): Lucinactant
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Surfaxin
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
Phase 2 trial will evaluate safety and tolerability of KL4 Surfactant (lucinactant) synthetic surfactant designed to imitate the essential attributes of the human surfactant protein B for patients with COVID-19 associated lung injury and acute respiratory distress syndrome.
Lead Product(s): Lucinactant
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Surfaxin
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
FDA has accepted Windtree's Investigational New Drug (IND) application for a Phase 2 clinical trial studying lyo lucinactant, its KL4 surfactant drug, in COVID-19 associated lung injury and acute respiratory distress syndrome (ARDS) patients.
Lead Product(s): Lucinactant
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2020
Details:
The AEROSURF Phase 2b bridging study is a multicenter, randomized, controlled study with masked treatment assignment in up to 90 premature infants 26 to 32 weeks gestational age (GA) receiving nasal continuous positive airway pressure (nCPAP) for RDS.
Lead Product(s): Lucinactant
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Aerosurf
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020
Details:
Study is intended to complete the phase 2 clinical program for AEROSURF and transition clinical development to phase 3 by validating the performance of the new aerosol delivery system (ADS).
Lead Product(s): Lucinactant
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2020
Details:
The financing will fund the AEROSURF phase 2b bridge study which, if successful, is intended to transition the product into a phase 3 ready clinical product development.
Lead Product(s): Lucinactant
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Lee's Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 31, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
