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Find Gastroenterology Drugs in Phase III Clinical Development in UNITED STATES

A collaboration with SCORR Marketing

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            Lead Product(s): Antolimab

            Therapeutic Area: Gastroenterology

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 24, 2020

            Details:

            Six-month treatment with antolimab resulted in a 64 percent mean reduction in TSS-8 compared to baseline.

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            Lead Product(s): Colesevelam Hydrochloride

            Therapeutic Area: Gastroenterology

            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 26, 2020

            Details:

            Data showed improvement in both heartburn and regurgitation symptoms and further demonstrated the role of bile acid in refractory gastroesophageal reflux disease (GERD

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            Lead Product(s): Avasopasem manganese

            Therapeutic Area: Gastroenterology

            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 24, 2020

            Details:

            Galera will present data from the two-year tumor outcomes follow up of patients with head and neck cancer treated with lead product GC4419, for severe oral mucositis in a Phase 2b clinical trial.

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            Lead Product(s): Ustekinumab

            Therapeutic Area: Gastroenterology

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 14, 2020

            Details:

            First study to explore a treat-to-target strategy in crohn’s disease using endoscopy to guide dose adjustment. First study to evaluate intestinal ultrasound monitoring in an interventional setting.

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            Lead Product(s): Reloxaliase

            Therapeutic Area: Gastroenterology

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 12, 2020

            Details:

            Allena now plans to reducing target enrollment to 200 subjects. Conducting earlier interim analysis, expected in Q3 2021.

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            Lead Product(s): Dusquetide

            Therapeutic Area: Gastroenterology

            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 03, 2020

            Details:

            The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs.

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            Lead Product(s): Metoclopramide

            Therapeutic Area: Gastroenterology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Eversana

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement January 23, 2020

            Details:

            Under the terms of the agreement, Evoke retains Gimoti NDA rights as well as all legal, regulatory and production obligations, while EVERSANA will sell and supply Gimoti in the United States.

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            Lead Product(s): Metoclopramide

            Therapeutic Area: Gastroenterology

            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 January 21, 2020

            Details:

            A six-month period of review from the FDA’s date of receipt has been assigned for the resubmitted NDA and the PDUFA target goal date is June 19, 2020.

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            Lead Product(s): Etrasimod

            Therapeutic Area: Gastroenterology

            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 January 06, 2020

            Details:

            Arena Pharmaceuticals expanded multi-program collaboration with Beacon Discovery for immune and inflammatory targets (Project Cabrillo).