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Find Drugs for Infections and Infectious Diseases in Phase III Clinical Development in JAPAN

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            Lead Product(s): Maribavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: TAK-620

            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 December 04, 2020

            Details:

            Phase 3 clinical trial evaluating the efficacy and safety of the investigational drug TAK-620 (maribavir), in the treatment of transplant recipients with refractory/resistant cytomegalovirus (CMV) infection met its primary endpoint.

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            Lead Product(s): Camostat

            Therapeutic Area: Infections and Infectious Diseases Product Name: Foipan

            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 November 09, 2020

            Details:

            Foipan® Tablets is an oral protease enzyme inhibitor created internally at ONO, and obtained a manufacturing and marketing approval in 1985 for the alleviation of acute symptoms associated with chronic pancreatitis.

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            Lead Product(s): mRNA-1273

            Therapeutic Area: Infections and Infectious Diseases Product Name: mRNA-1273

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Government of Japan

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership October 29, 2020

            Details:

            Under the terms of the new agreement with the MHLW and Moderna, Takeda will be responsible for securing the necessary regulatory approvals prior to distributing 50 million doses of Moderna’s COVID-19 vaccine candidate in Japan.

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            Lead Product(s): Favipiravir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Avigan

            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 16, 2020

            Details:

            FUJIFILM conducted a phase III trial in Japan for COVID-19 patients with non-severe pneumonia. Based on the results, it seeks to add, indication as well as dosage and administration concerning COVID-19 to the current manufacturing and marketing approval items of Avigan.

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            Lead Product(s): Favipiravir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Avigan

            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 23, 2020

            Details:

            The efficacy primary endpoint is time to negative conversion of detectable SARS-CoV 2 viral RNA in the RT-PCR assays, and to alleviation of symptoms (body temperature, oxygen saturation and chest images).

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            Lead Product(s): Favipiravir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Avigan

            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 July 10, 2020

            Details:

            Although patients given the drug early in the trial showed more improvement than those who got delayed doses, the results did not reach statistical significance.

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            Lead Product(s): Favipiravir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Avigan

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Dr. Reddy's Laboratories

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement July 01, 2020

            Details:

            The agreement provides for Fujifilm Toyama Chemical to grant Dr. Reddy's and Dubai-based Global Response Aid the right to develop, make and sell Avigan overseas and get a lump-sum license fee and royalties on sales.

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            Lead Product(s): Favipiravir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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 May 20, 2020

            Details:

            The data reported to Japan’s health ministry by hospitals treating people showing mild or no symptoms raises doubts about whether the drug can be approved by the end of this month as sought by Japan’s government.

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            Lead Product(s): Favipiravir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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 May 12, 2020

            Details:

            Government of Japan intends to approve Fujifilm’s anti-flu drug Avigan by the end of this May 2020 for the treatment of patients suffering from Covid-19 infection.

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            Lead Product(s): Favipiravir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: FUJIFILM Toyama Chemical

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement April 23, 2020

            Details:

            CMIC is providing monitoring services as a CRO for Avigan® for phase III clinical trial in Japan led by FUJIFILM Toyama Chemical and will support for manufacturing the product as a CDMO.

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