Quotient Sciences Quotient Sciences

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[{"orgOrder":0,"company":"Zosano Pharma","sponsor":"Eversana","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Zosano Pharma Announces Partnership Agreement with EVERSANA to Support the Launch and Commercialization of Qtrypta\u2122","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Zosano Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zosano Pharma Receives Preliminary FDA Communication on Qtrypta\u2122 NDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Zosano Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta\u2122","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Zosano Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zosano Pharma Confirms NDA Resubmission Strategy Following Type A Meeting Minutes from FDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Zosano Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zosano Pharma Confirms Plan to Move Forward with Pharmacokinetic Study Following Protocol Review by FDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Zosano Pharma","sponsor":"Emergex Vaccines Holding","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Emergex Acquires Intradermal and Patch Drug Delivery Technology with Its Manufacturing Equipment from Zosano Pharma","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Zosano Pharma","sponsor":"Emergex Vaccines Holding","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Successful Transfer of New Drug Application (NDA), Acknowledged by U.S. FDA, from Former Zosano Pharma to Emergex for Investigational Microneedle-Based Drug Delivery Patch","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]

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            Details:

            The assets acquired include Zosano’s proprietary microneedle array patch (MAP) intradermal drug delivery system, intended for the epidermal delivery of M207 (zolmitriptan) for the treatment of migraine attacks in adults.

            Lead Product(s): Zolmitriptan

            Therapeutic Area: Neurology Product Name: M207

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Emergex Vaccines Holding

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition December 18, 2023

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            Details:

            The MAP technology developed by Zosano is an exceptional strategic fit that complements our CD8+ T cell Adaptive Vaccine platform and intend to develop the MAP technology acquired from Zosano for delivery of vaccines.

            Lead Product(s): CD8+ T-cell Adaptive Vaccine

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Vaccine

            Partner/Sponsor/Collaborator: Emergex Vaccines Holding

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition October 12, 2022

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            Details:

            Company has received feedback from the U.S. Food and Drug Administration Division of Neurology II (the “Division”) on the protocol for the pharmacokinetic study required to support the resubmission of the Qtrypta™ NDA.

            Lead Product(s): Zolmitriptan

            Therapeutic Area: Neurology Product Name: Qtrypta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 26, 2021

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            Details:

            Company has received the official Type A meeting minutes from the U.S. FDA Division of Neurology II regarding the requirements for resubmission of the Qtrypta™ New Drug Application following the Complete Response Letter received on October 20, 2020.

            Lead Product(s): Zolmitriptan

            Therapeutic Area: Neurology Product Name: Qtrypta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 2021

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            Details:

            The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies and recommended the company to conduct a repeat bioequivalence study between three of the lots used during development.

            Lead Product(s): Zolmitriptan

            Therapeutic Area: Neurology Product Name: Qtrypta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 21, 2020

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            Details:

            The DRL described two concerns regarding clinical pharmacology section of the NDA; (i) regarding unexpected high plasma concentrations of zolmitriptan observed from two pharmacokinetic studies; (ii) the FDA raised questions regarding differences in zolmitriptan exposures.

            Lead Product(s): Zolmitriptan

            Therapeutic Area: Neurology Product Name: Qtrypta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 30, 2020

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            Details:

            Zosano and EVERSANA will utilize EVERSANA’s commercial execution expertise for marketing, market access, distribution, sales force deployment, reimbursement, and patient adherence support services. EVERSANA to commercialize and distribute Qtrypta™ in the United States.

            Lead Product(s): Zolmitriptan

            Therapeutic Area: Neurology Product Name: Qtrypta

            Highest Development Status: Phase III Product Type: Small molecule

            Recipient: Eversana

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership August 06, 2020

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