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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): 20-valent pneumococcal conjugate vaccine

            Therapeutic Area: Infections and Infectious Diseases Product Name: PF-06482077

            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 June 22, 2020

            Details:

            Two studies of the 20-valent pneumococcal polysaccharide conjugate vaccine candidate, 20vPnC, evaluating a four-dose series in infants starting at 2 months of age.

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            Lead Product(s): 20-valent pneumococcal conjugate vaccine

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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 May 14, 2020

            Details:

            In this study the 20vPnC safety profile was similar to the Prevnar 13® (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) control group.

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            Lead Product(s): 20vPnC

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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): Cantharidin

            Therapeutic Area: Infections and Infectious Diseases Product Name: VP-102

            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 June 29, 2020

            Details:

            Company received a letter from the U.S.FDA as part of the FDA’s ongoing review of the its NDA for VP-102. The letter states that there are deficiencies that preclude discussion of labeling and post-marketing requirements/commitments.

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            Lead Product(s): Terbinafine

            Therapeutic Area: Infections and Infectious Diseases Product Name: MOB-015

            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 June 25, 2020

            Details:

            MOB-015 (topical terbinafine) met the primary endpoint in the European Phase 3 study including 452 onychomycosis patients, showing non-inferiority versus topical ciclopirox. Mycological cure was achieved in 84 percent of patients.

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            Lead Product(s): Berdazimer sodium

            Therapeutic Area: Infections and Infectious Diseases Product Name: SB206

            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 June 25, 2020

            Details:

            The Company is targeting enrolling the first patient for B-SIMPLE4 in September 2020 and, if the trial is initiated on this timetable and not further impacted by the COVID-19 pandemic, top-line efficacy results would be targeted for late in the second quarter of 2021.

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            Lead Product(s): Islatravir,Doravirine

            Therapeutic Area: Infections and Infectious Diseases Product Name: MK-8591A

            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 June 24, 2020

            Details:

            The data presentations also include a post-hoc analysis of weight change from the Phase 3 DRIVE-SHIFT trial evaluating the effect of switching to DELSTRIGO™ as well as an examination from the OPERA cohort of weight changes in people living with HIV.

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            Lead Product(s): Losmapimod

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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 June 23, 2020

            Details:

            The LOSVID trial is a Phase 3, international, multicenter trial designed to assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod compared to placebo for 14 days on top of standard of care in hospitalized with COVID-19.

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            Lead Product(s): Hydroxychloroquine Sulphate

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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 June 22, 2020

            Details:

            A data and safety monitoring board determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19. After its fourth interim analysis the DSMB recommended to the NHLBI, part of NIH, to stop the study.

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            Lead Product(s): 15-valent pneumococcal conjugate vaccine

            Therapeutic Area: Infections and Infectious Diseases Product Name: V114

            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 June 22, 2020

            Details:

            Company announced results from two initial Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine.

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