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Details:
With the acquisition of Prometic, Kedrion has finalized a series of transactions with the announcement that it was acquiring the plasma purification plant at Laval in Québec, and the license to distribute the new product called Ryplazim in the United States.
Lead Product(s): Plasminogen
Therapeutic Area: Rare Diseases and Disorders Product Name: Ryplazim
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Kedrion
Deal Size: $17.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 18, 2021
Details:
This acquisition would include the Ryplazim® (plasminogen, human-tvmh) (“Ryplazim®”) business operated through its subsidiaries, Prometic Bioproduction Inc., the Company’s plasma-derived therapeutics manufacturing facility (“PBP”), and Prometic Biotherapeutics Inc.
Lead Product(s): Plasminogen
Therapeutic Area: Genetic Disease Product Name: Ryplazim
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Kedrion
Deal Size: $17.0 million Upfront Cash: Undisclosed
Deal Type: Agreement June 23, 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:
According to terms and conditions, the Option would grant Kedrion the right to acquire all of the shares of PBP and PBT and would entitle Liminal BioSciences to receive up to seventy percent of the net proceeds, if granted, associated with a potential FDA approval of Ryplazim.
Lead Product(s): Plasminogen
Therapeutic Area: Rare Diseases and Disorders Product Name: Ryplazim
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Kedrion
Deal Size: $17.0 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
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