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recAP (Ilofotase Alfa) is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase. It is under phase 2 clinical development for the treatment of cardiac surgery-associated renal damage.
Lead Product(s): Ilofotase Alfa
Therapeutic Area: Nephrology Product Name: recAP
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2024
Details:
Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, which is investigated for enzyme replacement therapy in adult hypophosphatasia (HPP) patients.
Lead Product(s): Ilofotase Alfa
Therapeutic Area: Genetic Disease Product Name: recAP
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2023
Details:
Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, which is investigated for cardiac surgery-associated renal damage.
Lead Product(s): Ilofotase Alfa
Therapeutic Area: Genetic Disease Product Name: recAP
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 26, 2023
Details:
Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, that in multiple clinical trials was shown to be stable and highly active.
Lead Product(s): Ilofotase Alfa
Therapeutic Area: Nephrology Product Name: Undisclosed
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 October 20, 2022
Details:
Study shows ilofotase alfa protects against ischemia-reperfusion induced acute kidney injury in rodents through the activation of adenosine receptors and the metabolism of extracellular adenosine triphosphate (ATP), a pro-inflammatory molecule.
Lead Product(s): Ilofotase Alfa
Therapeutic Area: Nephrology Product Name: Undisclosed
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 July 05, 2022
Details:
Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, that in multiple clinical trials was shown to be stable and highly active.
Lead Product(s): Ilofotase Alfa
Therapeutic Area: Nephrology Product Name: recAP
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 April 25, 2022
Details:
Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, that was shown in multiple clinical trials to be stable and highly active.
Lead Product(s): Ilofotase Alfa
Therapeutic Area: Nephrology Product Name: recAP
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 March 07, 2022
Details:
Under the terms of the agreement, AM-Pharma is entitled to tiered double-digit royalties on sales and a drug supply fee. Kyowa Kirin will gain the exclusive right to develop and commercialize ilofotase alfa in Japan.
Lead Product(s): Ilofotase Alfa
Therapeutic Area: Nephrology Product Name: recAP
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: $290.0 million Upfront Cash: $23.6 million
Deal Type: Licensing Agreement September 08, 2021
Details:
The REVIVAL trial is a Phase III pivotal study evaluating AM-Pharma’s proprietary recombinant alkaline phosphatase, ilofotase alfa, for the treatment of patients with SA-AKI.
Lead Product(s): Recombinant Human Alkaline Phosphatase
Therapeutic Area: Infections and Infectious Diseases Product Name: Ilofotase Alfa
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 July 01, 2021
Details:
KBI will conduct manufacturing and validation in its existing facilities. AM-Pharma and KBI Biopharma began collaborating on the recAP program in 2011 when KBI performed initial process development and cGMP manufacturing for early clinical use.
Lead Product(s): Ilofotase Alfa
Therapeutic Area: Nephrology Product Name: recAP
Highest Development Status: Phase IIIProduct Type: Large molecule
Recipient: KBI Biopharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 17, 2021
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