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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.
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