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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Somatrogon

            Therapeutic Area: Endocrinology Product Name: PF-06836922

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 04, 2021

            Details:

            The submission is backed by global Phase 3 trial evaluating the safety and efficacy of somatrogon administered once weekly to pediatric patients with GHD. This study met its primary endpoint of non-inferiority compared to GENOTROPIN® for injection administered once daily.

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            Lead Product(s): Tirzepatide

            Therapeutic Area: Endocrinology Product Name: LY3298176

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 17, 2021

            Details:

            Tirzepatide led to significant A1C and body weight reductions from baseline in adults with type 2 diabetes in Eli Lilly's SURPASS-3 and SURPASS-5 phase 3 clinical trials after 52 weeks and 40 weeks.

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            Lead Product(s): Somatrogon

            Therapeutic Area: Endocrinology Product Name: MOD-4023

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 28, 2021

            Details:

            Submission is based on the results of the Japan Phase 3 and global Phase 3 clinical studies, in which the efficacy and safety of somatrogon administered once weekly were compared with GENOTROPIN, a recombinant human growth hormone for injection, administered once daily.

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            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: SVB Leerink

            Deal Size: $100.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering January 13, 2021

            Details:

            Provention Bio intends to use its net proceeds from the public offering for (i) pre-commercial activities, potential commercial activities, potential milestone or royalty payments, clinical development, and regulatory and manufacturing activities for PRV-031

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            Lead Product(s): Testosterone Undecanoate

            Therapeutic Area: Endocrinology Product Name: Kyzatrex

            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 05, 2021

            Details:

            KYZATREX® has generated strong results in both safety and efficacy studies for KYZATREX® for treatment of primary and secondary hypogonadism in men.

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            Lead Product(s): Glucagon

            Therapeutic Area: Endocrinology Product Name: Ogluo

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 11, 2020

            Details:

            The positive Opinion is based on the results from a Phase 3, multi-center, randomized controlled, non-inferiority study to evaluate the liquid stable glucagon auto-injector as a treatment for severe hypoglycemic events compared with Novo Nordisk’s GlucaGen® HypoKit®.

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            Lead Product(s): Tirzepatide

            Therapeutic Area: Endocrinology Product Name: LY3298176

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 09, 2020

            Details:

            Using the efficacy estimandi, the highest dose of tirzepatide led to an A1C reduction of 2.07 percent and reduced body weight by 9.5 kg (11.0 percent). More than half (51.7 percent) of participants in the treatment arm achieved an A1C less than 5.7 percent.