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Details:
Upacicalcet is a novel calcimimetic with the potential to improve the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients. It is already approved in Japan for the treatment of SHPT in patients on dialysis.
Lead Product(s): Upacicalcet Sodium
Therapeutic Area: Endocrinology Product Name: Upasita
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Launch Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2023
Details:
Launch Tx will have the lead role in the operational execution and management of the planned clinical trials of Upasita (upacicalcet sodium hydrate) and Pathalys will retain primary responsibility for manufacturing, FDA regulatory interactions and commercialization.
Lead Product(s): Upacicalcet Sodium
Therapeutic Area: Endocrinology Product Name: Upasita
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Launch Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 18, 2023
Details:
The co-development agreement creates a collaboration that combines the exceptional clinical development resources available through Launch Tx and the extensive dialysis expertise of Pathalys to advance the Upasita (upacicalcet) clinical development program.
Lead Product(s): Upacicalcet Sodium
Therapeutic Area: Endocrinology Product Name: Upasita
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Abingworth
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Financing January 18, 2023
Details:
The primary endpoint was proportion of patients with mean iPTH between 60 and 240 pg/mL over weeks 22 to 24 and was achieved in 69 of 103 patients (67.0 percent) in upacicalcet group and 4 of 50 patients (8.0 percent) in the placebo group (difference of 59.0 percent, p<0.001).
Lead Product(s): Upacicalcet Sodium
Therapeutic Area: Endocrinology Product Name: Upasita
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
Pathalys launches with a novel clinical-stage asset, upacicalcet, that was acquired through a license granted by EA Pharma for exclusive rights to the development and commercialization of the product, worldwide outside of Japan and Asia.
Lead Product(s): Upacicalcet Sodium
Therapeutic Area: Endocrinology Product Name: Upasita
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: DaVita Venture Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 01, 2022
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