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Find Drugs for Infections and Infectious Diseases in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): 20vPnC

            Therapeutic Area: Infections and Infectious Diseases

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 18, 2020

            Details:

            The safety objectives were met in adults 18 years of age or older demonstrating that the safety and tolerability of 20vPnC were comparable to licensed pneumococcal vaccines.

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            Lead Product(s): Recombinant quadrivalent influenza vaccine,Matrix-M adjuvant

            Therapeutic Area: Infections and Infectious Diseases

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Novavax

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 31, 2020

            Details:

            Emergent will provide CDMO services to produce Novavax’s NanoFlu™, which has met all primary objectives in its Phase 3 clinical trial evaluating its immunogenicity and safety in people aged 65 years.

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            Lead Product(s): VGX-3100

            Therapeutic Area: Infections and Infectious Diseases

            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 30, 2020

            Details:

            VGX-3100 reduced qualifying high-risk HPV associated precancerous vulvar lesion area in 80% of patients; completely curing vulvar dysplasia with no virus detectable in 20% of patients.

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            Lead Product(s): SER-109

            Therapeutic Area: Infections and Infectious Diseases

            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 30, 2020

            Details:

            Potential for ECOSPOR III to be a single pivotal study supporting product registration with FDA.

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            Lead Product(s): Lenzilumab

            Therapeutic Area: Infections and Infectious Diseases

            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 27, 2020

            Details:

            The study, will be a randomized, clinical trial with lenzilumab for the prevention and treatment of cytokine storm which can lead to ARDS associated with severe acute respiratory syndrome SARS-CoV-2.

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            Lead Product(s): Baloxavir Marboxil

            Therapeutic Area: Infections and Infectious Diseases

            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 March 27, 2020

            Details:

            The filings are based on positive results from two Phase III studies, miniSTONE-2 and BLOCKSTONE, which were both recently presented as late breakers at the 2019 OPTIONS X congress in Singapore.

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            Lead Product(s): Minocycline

            Therapeutic Area: Infections and Infectious Diseases

            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 March 26, 2020

            Details:

            The article highlights the in vitro efficacy of Mino-Lok against various strains of Candida auris from studies conducted at MD Anderson Cancer Center Labs.

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            Lead Product(s): Recombinant hemagglutinin protein nanoparticle influenza vaccine

            Therapeutic Area: Infections and Infectious Diseases

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 24, 2020

            Details:

            NanoFlu achieved the primary endpoints, both GMT and SCR, for all four strains included in the vaccine. NanoFlu was well-tolerated and had a safety profile comparable to Fluzone Quadrivalent.

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            Lead Product(s): Terbinafine

            Therapeutic Area: Infections and Infectious Diseases

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Nice & Green S.A

            Deal Size: $21.2 million Upfront Cash: Undisclosed

            Deal Type: Financing March 23, 2020

            Details:

            The agreement with N&G enables Moberg Pharma to pursue this potential and conduct an additional clinical study, depending on the outcome of the EU study expected at the end of Q2 2020.

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            Lead Product(s): Tocilizumab

            Therapeutic Area: Infections and Infectious Diseases

            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 23, 2020

            Details:

            The Phase III clinical trial will evaluate the safety and efficacy of intravenous Actemra plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.

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