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    H. Lundbeck AS
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    Denmark
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    Ottiliavej 9 2500 Valby
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    +45 3630 1311
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    enquiries@pharmacompass.com
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    https://www.lundbeck.com/global
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    • Development Update
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    Otsuka and Lundbeck Submit sNDA for FDA Review of Brexpiprazole and Sertraline Combination as Potential Treatment for PTSD

    Details:

    Rexulti (brexpiprazole) is an partial agonist activity at serotonin 5-HT1A, which is being investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD).


    Lead Product(s): Brexpiprazole,Sertraline Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Product Name: Rexulti

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Recipient: Otsuka Pharmaceutical

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 09, 2024

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    Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Trea...

    Details:

    Rexulti (brexpiprazole) is an partial agonist activity at serotonin 5-HT1A, which is investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD).


    Lead Product(s): Brexpiprazole,Sertraline Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Product Name: Rexulti

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Recipient: Otsuka Pharmaceutical

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 07, 2023

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    Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) ...

    Details:

    Rexulti (brexpiprazole) is an atypical antipsychotic, is the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer’s disease.


    Lead Product(s): Brexpiprazole

    Therapeutic Area: Psychiatry/Psychology Product Name: Rexulti

    Highest Development Status: ApprovedProduct Type: Small molecule

    Recipient: Otsuka Pharmaceutical

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 11, 2023

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    Neuro3 Therapeutics Acquires Exclusive Worldwide Rights to Develop and Commercialize Clinical Stage KCNQ2 Activators from Lundbeck

    Details:

    Under the agreement, Neuro3 will receive a worldwide license for intellectual property covering two clinical stage and one pre-clinical stage KCNQ2 activator programs and will be responsible for their further development through clinical PoC for the treatment of epilepsy.


    Lead Product(s): Undisclosed

    Therapeutic Area: Neurology Product Name: Undisclosed

    Highest Development Status: UndisclosedProduct Type: Undisclosed

    Partner/Sponsor/Collaborator: Neuro3 Therapeutics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement May 08, 2023

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    FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII® (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI) for the Treatment ...

    Details:

    Abilify (aripiprazole) action includes a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. It is approved by USFDA for the treatment of schizophrenia and for bipolar I disorder in adults.


    Lead Product(s): Aripiprazole

    Therapeutic Area: Psychiatry/Psychology Product Name: Abilify Asimtufii

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Otsuka Holdings

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 28, 2023

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    Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on brexpiprazole for the Treatment of Agitatio...

    Details:

    Rexulti (brexpiprazole) has a partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. It is indicated for the treatment if treatment of agitation associated with alzheimer's dementia.


    Lead Product(s): Brexpiprazole

    Therapeutic Area: Psychiatry/Psychology Product Name: Rexulti

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Recipient: Otsuka Pharmaceutical

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 17, 2023

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    Otsuka and Lundbeck Published Study Results Showing Aripiprazole 2-Month, Ready-to-Use, Long-Acting Injectable is as Well-Tolerated, and Provides Simila...

    Details:

    Abilify Maintena (aripiprazole) is a long-acting injectable provided in a single-chamber-type, ready-to-use pre-filled syringe, intended for dosing every two months via IM injection in the gluteal muscle in the same patient as indicated for once-monthly ABILIFY MAINTENA.


    Lead Product(s): Aripiprazole

    Therapeutic Area: Psychiatry/Psychology Product Name: Abilify Maintena

    Highest Development Status: ApprovedProduct Type: Small molecule

    Recipient: Otsuka Pharmaceutical

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 05, 2023

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    Otsuka Pharmaceutical & Lundbeck Present Positive Data From Multiple Phase 3 Studies Showing Brexpiprazole Significantly Improved Symptoms of Agitation ...

    Details:

    Brexpiprazole (Rexulti) is an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults and children ages 13 years and older.


    Lead Product(s): Brexpiprazole

    Therapeutic Area: Psychiatry/Psychology Product Name: Rexulti

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Recipient: Otsuka America Pharmaceutical, Inc.

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 01, 2022

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    Otsuka And Lundbeck Generate Exploratory Data In Major Depressive Disorder Based On Patient Feedback

    Details:

    One of co-primary endpoints of study on adjunctive Rexulti (brexpiprazole) in adults with MDD and inadequate response to ADT was new exploratory outcome focusing on positive health aspects across emotional, physical, social, and cognitive domains.


    Lead Product(s): Brexpiprazole

    Therapeutic Area: Psychiatry/Psychology Product Name: Rexulti

    Highest Development Status: Phase IVProduct Type: Small molecule

    Recipient: Otsuka Pharmaceutical

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 29, 2022

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    Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application for Aripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizop...

    Details:

    If approved, Abilify (aripiprazole) 2-month ready-to-use, long-acting injectable (LAI) would be the first 2-month, LAI antipsychotic indicated for both treatment of schizophrenia and the maintenance treatment of bipolar I disorder in U.S.


    Lead Product(s): Aripiprazole

    Therapeutic Area: Psychiatry/Psychology Product Name: Abilify Asimtufii

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Recipient: Otsuka Pharmaceutical

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 13, 2022

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