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SEP-363856 (ulotaront) is a TAAR1 agonist with 5-HT1A agonist activity, is currently under investigation for the treatment of schizophrenia, generalized anxiety disorder and the adjunctive treatment of MDD with additional indications under consideration.
Lead Product(s): Ulotaront
Therapeutic Area: Psychiatry/Psychology Product Name: SEP-363856
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka America Pharmaceutical, Inc.
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2023
Details:
Ulotaront (SEP-363856), a TAAR1 agonist with 5-HT1A agonist activity, is currently under investigation for the treatment of schizophrenia as well as the adjunctive treatment of MDD, with additional indications under consideration.
Lead Product(s): Ulotaront
Therapeutic Area: Psychiatry/Psychology Product Name: SEP-363856
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Recipient: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2022
Details:
The acquisition of Brovana® (arformoterol tartrate) Inhalation Solution and Xopenex HFA® (levalbuterol tartrate) Inhalation Aerosol brands expands Lupin’s portfolio of inhalation products in the U.S. and strengthens the company’s presence in the respiratory therapy area.
Lead Product(s): Arformoterol Tartrate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Brovana
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lupin Ltd
Deal Size: $75.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 20, 2022
Details:
Sep-4199, enhance 5-HT7 receptor antagonist activity and reduce dopamine D2 receptor antagonist activity is in SEP380-301, Phase 3 clinical development for treatment of major depressive episodes associated with bipolar I disorder also showed positive Phase 2 clinical result.
Lead Product(s): Amisulpride
Therapeutic Area: Psychiatry/Psychology Product Name: Sep-4199
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2022
Details:
The collaboration will focus on solutions to address areas of unmet medical need by advancing four promising compounds―ulotaront (SEP-363856), SEP-4199, SEP-378614 and SEP-380135―that address serious neuropsychiatric disorders.
Lead Product(s): Ulotaront
Therapeutic Area: Psychiatry/Psychology Product Name: SEP-363856
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: $890.0 million Upfront Cash: $270.0 million
Deal Type: Collaboration September 30, 2021
Details:
Under the terms of the agreement, BIAL will be responsible for regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA) for APL-130277, which is currently in Phase 3 clinical development in Europe.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Kynmobi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bial
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 02, 2021
Details:
Latuda becomes the first 2nd generation antipsychotic to be approved for patients suffering from schizophrenia as young as 13 years of age. In addition to the new indication, Latuda was also granted an additional year of marketing protection.
Lead Product(s): Lurasidone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Latuda
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Angelini Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2020
Details:
Under the terms of the agreement, Sunovion will deploy its multi-specialty sales force to bring vibegron to primary care physicians (PCP). In support of this effort, Sunovion will provide sales and marketing activities targeting the PCP segment through March 31, 2026.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: RVT-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Urovant Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 07, 2020
Details:
Sunovion Pharmaceuticalsannounced today that Health Canada has approved KYNMOBI™ (apomorphine HCI) soluble film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD).
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Kynmobi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
In a Phase 3 study, patients with Parkinson’s disease treated with KYNMOBI experienced significant improvements in motor symptoms at 30 minutes, compared to placebo.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Kynmobi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
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