Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
AM-Pharma Initiates Phase 2 Trial Of Ilofotase Alfa for Kidney Damage
Details : recAP (Ilofotase Alfa), a recombinant alkaline phosphatase, is in Phase 2 trials for cardiac surgery-associated renal damage.
Brand Name : recAP
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 16, 2024
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : recAP
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 11, 2023
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
AM-Pharma Announces Updated Clinical Development Strategy
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.
Brand Name : recAP
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 26, 2023
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 20, 2022
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 05, 2022
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : recAP
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 25, 2022
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : recAP
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 07, 2022
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Kyowa Kirin
Deal Size : $290.0 million
Deal Type : Licensing Agreement
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.
Brand Name : recAP
Molecule Type : Large molecule
Upfront Cash : $23.6 million
September 08, 2021
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Kyowa Kirin
Deal Size : $290.0 million
Deal Type : Licensing Agreement
Lead Product(s) : Recombinant Human Alkaline Phosphatase
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
AM-Pharma Enrolls First Patient in Japan for Ongoing Phase III SA-AKI Pivotal REVIVAL Trial
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.
Brand Name : Ilofotase Alfa
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 01, 2021
Lead Product(s) : Recombinant Human Alkaline Phosphatase
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Study Phase : Phase III
Recipient : KBI Biopharma
Deal Size : Undisclosed
Deal Type : Agreement
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.
Brand Name : recAP
Molecule Type : Large molecule
Upfront Cash : Undisclosed
June 17, 2021
Lead Product(s) : Ilofotase Alfa
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Recipient : KBI Biopharma
Deal Size : Undisclosed
Deal Type : Agreement
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