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            Radboud University

            • Development Update

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            Lead Product(s): BCG vaccine

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase IV Product Type: Vaccine

            Partner/Sponsor/Collaborator: Hellenic Institute

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 01, 2020

            Details:

            BCG-vaccinated participants had their first infection on average 16 weeks after vaccination, compared to 11 weeks for the placebo group. There was no difference in side effects.

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            Lead Product(s): Rabies Immune Globulin [Human]

            Therapeutic Area: Infections and Infectious Diseases Product Name: Kedrab

            Highest Development Status: Phase IV Product Type: Vaccine

            Partner/Sponsor/Collaborator: Kedrion

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 19, 2020

            Details:

            The study of KEDRAB® (Rabies Immune Globulin [Human]) conducted in children was the first and only pediatric study for any HRIG available in U.S. The study met its primary objective, which was to confirm the safety of KEDRAB in the pediatric population.

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            Lead Product(s): Eicosapentaenoic Acid

            Therapeutic Area: Infections and Infectious Diseases Product Name: Vascepa

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 07, 2020

            Details:

            MITIGATE COVID-19 will randomly assign 1500 U.S. patients aged 50 years or older with established ASCVD and no prior history of confirmed COVID-19 to receive 4 grams per day of icosapent ethyl (VASCEPA) and follow these patients for a minimum of 6 months.

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            Lead Product(s): Zingivir-H

            Therapeutic Area: Infections and Infectious Diseases Product Name: Zingivir-H

            Highest Development Status: Phase IV Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 07, 2020

            Details:

            The studies found that 58 patients treated with the herbo-mineral drug, ZingiVir-H recovered and reported a negative Reverse Transcription Polymerase Chain Reaction (RT-PCR) recovery in an average of five days while others took an average of eight days to recover.

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            Lead Product(s): Amrta Karuna

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 03, 2020

            Details:

            Notable results for the Amrta Karuna treatment group compared to the control showed Significant reduction in hospital quarantine (28% decrease) , Significantly reduced CRP inflammatory levels, RT-PCR negative on day 7 at 71.42% vs 42.85% , TLC within normal range.

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            Lead Product(s): Human Immune Globulin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Octagam

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 15, 2020

            Details:

            The data shows that IVIG treatment reduces inflammation, which is associated with poor clinical outcomes and death, and points to an increase in survival, in critically ill COVID-19 patients, when compared to a control group.

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            Lead Product(s): Favipiravir

            Therapeutic Area: Infections and Infectious Diseases Product Name: FabiFlu

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 13, 2020

            Details:

            Glenmark has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team within the country, ensuring self-reliance with regard to longterm production and manufacturing.

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            Lead Product(s): Zingivir-H

            Therapeutic Area: Infections and Infectious Diseases Product Name: Zingivir-H

            Highest Development Status: Phase IV Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 10, 2020

            Details:

            Clinical trials of ZingiVir-H, Pankajakasthuri’s new drug, are underway among 112 patients as an adjunct therapy for the pandemic as well as among 135 additional patients as a stand-alone treatment in a double-blind study.

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            Lead Product(s): Eritoran

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: The Global Coalition for Adaptive Research

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership July 01, 2020

            Details:

            The trial will be conducted in the multi-hospital UPMC health system along with other medical centers in the United States. Additional global sites across the trial network, including Japan, will follow.

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            Lead Product(s): DMX-200

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase IV Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 04, 2020

            Details:

            DMX-200 has been selected for inclusion in the protocol as a new treatment arm in the global the REMAP-CAP program aimed at treating patients with Acute Respiratory Distress Syndrome (ARDS) as a result of COVID-19.

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