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            Lead Product(s): ASP8062

            Therapeutic Area: Psychiatry/Psychology Product Name: ASP8062

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: National Institutes of Health

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Funding July 22, 2020

            Details:

            This NIH grant will help fund Astellas's two phase 1 clinical studies to evaluate the safety and efficacy of ASP8062, an oral small molecule GABAB receptor Positive Allosteric Modulator (PAM), as an add-on maintenance therapy for Opioid Use Disorder (OUD).

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            Lead Product(s): Gilteritinib

            Therapeutic Area: Oncology Product Name: Xospata

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 16, 2020

            Details:

            With the submission of supplementary clinical data showing that gilteritinib demonstrated superior overall survival benefit compared to chemotherapy, increasing median OS from 5.6 months to 9.3 months.

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            Lead Product(s): Roxadustat

            Therapeutic Area: Hematology 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 June 08, 2020

            Details:

            The data showed non-inferiority of roxadustat to darbepoetin alfa in the correction of hemoglobin levels during the first 24 weeks of treatment, meeting the study's primary endpoint.

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            Lead Product(s): Enzalutamide

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 29, 2020

            Details:

            With this approval, XTANDI is now indicated for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.

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            Lead Product(s): Enzalutamide,Androgen deprivation therapy

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Recipient: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 29, 2020

            Details:

            Phase 3 PROSPER trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) vs placebo plus ADT in men with non-metastatic castration-resistant prostate cancer, revealed that XTANDI plus ADT reduced the risk of death by 27% compared to placebo plus ADT.

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            Lead Product(s): Solifenacin Succinate

            Therapeutic Area: Urology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 27, 2020

            Details:

            VESIcare LS is an oral suspension dosage form that was specifically developed to facilitate dosing and administration in the pediatric population.

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            Lead Product(s): Roxadustat

            Therapeutic Area: Hematology 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 MAA is supported by positive results from a pivotal Phase 3 program, which involved more than 9,000 patients worldwide.

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            Lead Product(s): Gilteritinib

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 10, 2020

            Details:

            New drug application for XOSPATA, for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation, has been accepted by the NMPA for regulatory review in China.

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            Lead Product(s): Enzalutamide,Androgen deprivation therapy

            Therapeutic Area: Oncology 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 February 11, 2020

            Details:

            The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with XTANDI plus ADT.

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            Lead Product(s): Evolocumab

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Amgen Inc

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition January 23, 2020

            Details:

            Under the acquisition, Amgen Astellas BioPharma will change its name to Amgen K.K., and simultaneously relocate its Headquarters to Tokyo Midtown.

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