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Details:

Amphastar intends to use the proceeds for the payment of milestone payments in connection with the acquisition of Baqsimi (glucagon) nasal powder, used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Baqsimi

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $300.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement September 11, 2023

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Through the divestment, Amphastar will continue Lilly's mission to help more people benefit from Baqsimi (glucagon), the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Baqsimi

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Amphastar Pharmaceuticals

Deal Size: $1,075.0 million Upfront Cash: $625.0 million

Deal Type: Divestment June 30, 2023

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Through the divestment, Amphastar will continue Lilly's mission to help more people benefit from Baqsimi (glucagon), the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Baqsimi

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Amphastar Pharmaceuticals

Deal Size: $1,075.0 million Upfront Cash: $625.0 million

Deal Type: Divestment April 24, 2023

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Gvoke (glucagon) increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Gvoke

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 18, 2023

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Ogluo® is a ready-to-use, ambiently stored, preparation of glucagon that has been specifically designed for patients living with diabetes with severe hypoglycaemia.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Ogluo

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Arecor

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 12, 2022

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This two-year grant will allow AmideBio to select a long-acting soluble stable glucagon candidate and do the necessary work to support the filing of an Investigational New Drug (IND) application with the FDA at the end of the grant period.


Lead Product(s): Glucagon

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Peptide

Partner/Sponsor/Collaborator: NIDDK

Deal Size: $2.7 million Upfront Cash: Undisclosed

Deal Type: Funding October 04, 2022

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Under the terms of the proposed acquisition, Arecor Therapeutics has agreed to acquire Tetris Pharma and will continue to commercialize Ogluo in the UK and EEA. Gvoke® (US) /Ogluo® (EU), the first prescription, ready-to-use, pre-mixed, pre-measured glucagon injection.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Ogluo

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Arecor

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition August 01, 2022

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Under the terms of the applicable agreements, Xeris will be responsible for Gvoke® PFS and Gvoke HypoPen® (glucagon injection) supply and Tetris will be responsible for the commercialization of Ogluo in the Territory.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Ogluo

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Tetris Pharma

Deal Size: $71.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 19, 2021

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The United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo® (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Ogluo

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 29, 2021

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European Commission (EC) has approved Ogluo™ (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Ogluo

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 12, 2021

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Megapharm will be responsible for registration and marketing of Gvoke in Israel and the Palestinian Authority, and named patient services supply. Xeris will manufacture, supply, and will take care of the quality assurance and control, regulatory support, and maintenance of IP.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Gvoke

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Megapharm

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 22, 2020

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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®.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Ogluo

Highest Development Status: Phase IIIProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 11, 2020

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Xeris Pharmaceuticals announced positive topline results of a Phase 2 study of its developmental Gvoke RTU Micro™ for the prevention of hypoglycemia during and after moderate-to-high intensity aerobic exercise in adults with Type 1 diabetes mellitus who use insulin pumps.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Gvoke RTU Micro

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 15, 2020

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Rebound hypoglycemia observed in the placebo arm with oral glucose tablet use; No rebound hypoglycemia observed in the RTU glucagon treatment arm.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 22, 2020

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Results show a mini dose (150 µg) of RTU glucagon prevents Exercise-Induced Hypoglycemia (EIH) during prolonged, moderate-to-high intensity aerobic exercise in a clinical research setting.


Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 06, 2020

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