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Find Clinical Drug Pipeline Developments & Deals by RedHill Biopharma

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 22, 2020

            Details:

            The ongoing global Phase 2/3 study with orally-administered opaganib in patients with severe COVID-19 is approved in Italy, the UK, Russia, Israel, Mexico and Brazil; 16 clinical sites initiated globally to date.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            Opaganib completely inhibited SARS-CoV-2 viral replication as measured after three days incubation in an in vitro model of human bronchial tissue, comparing favorably with remdesivir, the positive control in the study.

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            Lead Product(s): Opaganib

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: State of Pennsylvania

            Deal Size: $0.3 million Upfront Cash: Undisclosed

            Deal Type: Funding September 03, 2020

            Details:

            A global Phase 2/3 study in up to 270 patients hospitalized with severe COVID-19 pneumonia, and a U.S. Phase 2 study in up to 40 patients, are ongoing with opaganib, a novel sphingosine kinase-2 selective inhibitor with dual anti-inflammatory and anti-viral properties.

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            Lead Product(s): Omeprazole Magnesium,Amoxicillin,Rifabutin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Cosmo Pharmaceuticals

            Deal Size: $21.0 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement August 13, 2020

            Details:

            Pursuant to the agreement, the companies will co-develop a novel next-generation therapy for the eradication of H. pylori infection. Cosmo is to receive the exclusive European rights to the new drug.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 06, 2020

            Details:

            The Phase 2/3 study is set to enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy.

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            Lead Product(s): Naloxegol

            Therapeutic Area: Gastroenterology Product Name: Movantik

            Highest Development Status: Approved Product Type: Small molecule

            Recipient: Daiichi Sankyo Co Ltd

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement August 03, 2020

            Details:

            RedHill and Daiichi Sankyo replaced their co-commercialization agreement for Movantik® with a new royalty-bearing agreement, under which RedHill will maintain sole and exclusive responsibility for the commercialization of Movantik® in the U.S.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 30, 2020

            Details:

            RedHill Biopharma has initiated a global Phase 2/3 clinical study evaluating opaganib (Yeliva®) in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia requiring treatment with supplemental oxygen.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III 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:

            The Ministry of Health of the Russian Federation has approved RedHill's Clinical Trial Authorization (CTA) application for a Phase 2/3 study evaluating opaganib (Yeliva®) in patients hospitalized with severe SARS-CoV-2 infection and pneumonia.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2020

            Details:

            The Phase 2/3 multi-center, randomized, double-blind, parallel-arm, placebo-controlled study with opaganib aims to enroll 270 severe COVID-19 patients in up to 40 clinical sites across the UK, Italy, Russia and additional countries.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 10, 2020

            Details:

            The multi-center, open-label Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors with the goal of identifying a recommended dose and schedule. Curis expects to initiate this study in the second half of 2020.

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