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[{"orgOrder":0,"company":"Pathalys Pharma","sponsor":"DaVita Venture Group","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Pathalys Pharma, Inc. Launches with Mission to Address High Priority Needs in Chronic Kidney Disease","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase IV"},{"orgOrder":0,"company":"Sanwa Kagaku Kenkyusho","sponsor":"Kissei Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Launch of UPASITA\u00ae IV Injection Syringe for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase IV","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase IV"},{"orgOrder":0,"company":"Pathalys Pharma","sponsor":"Launch Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Pathalys Pharma Raises $150 Million in Secured Product Financing and Equity led by Abingworth; Forms Strategic Collaboration with Launch Therapeutics to Advance Upacicalcet through Pivotal Phase 3 Studies","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Preclinical"},{"orgOrder":0,"company":"Pathalys Pharma","sponsor":"Abingworth","pharmaFlowCategory":"D","amount":"$150.0 million","upfrontCash":"Undisclosed","newsHeadline":"Pathalys Pharma Raises $150 Million in Secured Product Financing and Equity led by Abingworth; Forms Strategic Collaboration with Launch Therapeutics to Advance Upacicalcet through Pivotal Phase 3 Studies","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Preclinical"},{"orgOrder":0,"company":"Pathalys Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pathalys Pharma Announces Phase 3 Program for Upacicalcet","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase IV"},{"orgOrder":0,"company":"Pathalys Pharma","sponsor":"Launch Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pathalys Pharma and Launch Therapeutics Announce First Patient Enrolled Ahead of Schedule in Pivotal Phase 3 Program for Upacicalcet in Patients Receiving Hemodialysis","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase IV"}]

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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: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Launch Therapeutics

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 31, 2023

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            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: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Launch Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration January 18, 2023

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            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: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Abingworth

            Deal Size: $150.0 million Upfront Cash: Undisclosed

            Deal Type: Financing January 18, 2023

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            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: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 07, 2022

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            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: Phase IV Product 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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            Details:

            UPASITA® is administered by intravenous injection to dialysis patients through dialysis circuit and it is possible to adjust the dose and control the medication under the control of physicians or medical staffs.

            Lead Product(s): Upacicalcet Sodium

            Therapeutic Area: Endocrinology Product Name: Upasita

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Kissei Pharmaceutical

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 19, 2021

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