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Analysis of the disproportionate metabolite data from the completed Phase 1 multi-ascending dose ("MAD") clinical trial revealed that PBI-4050 (fezagepras) primary metabolite was a glutamine conjugate.
Lead Product(s): Fezagepras
Therapeutic Area: Genetic Disease Product Name: PBI-4050
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 May 23, 2022
Details:
This site would enable Ocugen to expand its manufacturing and research and development capabilities to support its pipeline. This includes the manufacture of COVAXIN™ (BBV152), the company’s COVID-19 vaccine candidate.
Lead Product(s): BBV152
Therapeutic Area: Infections and Infectious Diseases Product Name: Covaxin
Highest Development Status: ApprovedProduct Type: Vaccine
Partner/Sponsor/Collaborator: Ocugen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 27, 2022
Details:
Based on interim pharmacokinetic results from the ongoing fezagepras multiple ascending dose study, the Company has decided to stop its plans to move fezagepras into a Phase II clinical study in Idiopathic Pulmonary Fibrosis and a phase Ia/IIb study in Hypertriglyceridemia.
Lead Product(s): Fezagepras
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PBI-4050
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 May 28, 2021
Details:
Kedrion will enter into an option agreement with Liminal BioSciences to acquire the remainder of the company’s plasma-derived business, as well as Plasminogen business operated through its subsidiaries including Prometic Biotherapeutics which holds the BLA for Ryplazim.
Lead Product(s): Plasminogen
Therapeutic Area: Genetic Disease Product Name: Ryplazim
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Kedrion
Deal Size: $22.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 17, 2021
Details:
Two posters were presented that highlighted individual case histories of patients with C-PLGD treated with the investigational intravenous Ryplazim® (plasminogen) in compassionate use and expanded access cases.
Lead Product(s): Plasminogen
Therapeutic Area: Genetic Disease Product Name: Ryplazim
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 07, 2020
Details:
The BLA resubmission for Ryplazim® was supported by data from a Phase 2/3 clinical trial, which evaluated 15 patients, both pediatric and adults, with C-PLGD over 48 weeks of therapy with Ryplazim®.
Lead Product(s): Plasminogen
Therapeutic Area: Genetic Disease Product Name: Ryplazim
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 November 08, 2020
Details:
Two abstracts related to the Company’s clinical development activities of Ryplazim® for the treatment of Congenital Plasminogen Deficiency will be presented at the 62nd American Society of Hematology Annual Meeting and Exposition scheduled to take place in a virtual format.
Lead Product(s): Plasminogen
Therapeutic Area: Genetic Disease Product Name: Ryplazim
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 November 05, 2020
Details:
The BLA resubmission for Ryplazim® is supported by data from a Phase 2/3 clinical study which evaluated 15 patients, both pediatric and adults, with congenital plasminogen deficiency over 48 weeks of therapy with Ryplazim®.
Lead Product(s): Plasminogen
Therapeutic Area: Genetic Disease Product Name: Ryplazim
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 September 21, 2020
Details:
In a pivotal phase 2/3 clinical trial for the treatment of C-PLGD, all of the patients treated with Ryplazim® achieved at least the targeted increase from baseline in their individual trough plasminogen activity levels through 12 weeks of therapy.
Lead Product(s): Plasminogen
Therapeutic Area: Genetic Disease Product Name: Ryplazim
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 September 08, 2020
Details:
With this acquisition, Liminal gains a preclinical research program of small molecule antagonists. Investigational therapies developed in this program target a key chemoattractant and activator of eosinophils, which play a key role in Type 2 inflammation-driven diseases.
Lead Product(s): Undisclosed
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Recipient: Fairhaven Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition July 17, 2020
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