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Details:
ODM-208 (or MK-5684) is an investigational oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as metastatic castration-resistant prostate cancer.
Lead Product(s): MK-5684,Dexamethasone,Hydrocortisone
Therapeutic Area: Oncology Product Name: ODM-208
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2023
Chinaplas 2024
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Efmody® is a modified-release preparation of hydrocortisone that has been specifically designed for the treatment of patients with CAH, a rare condition caused by a genetic deficiency of adrenal enzymes.
Lead Product(s): Hydrocortisone
Therapeutic Area: Genetic Disease Product Name: Efmody
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Diurnal Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 26, 2022
Details:
The results of the Phase I study met its primary objective showing ATRS-1902 delivered a comparable pharmacokinetic profile and also demonstrated that ATRS-1902 was safe and well-tolerated for the treatment of acute adrenal insufficiency.
Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: ATRS-1902
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2022
Details:
Under terms of the agreement, Tolmar’s sales force will promote ALKINDI SPRINKLE® to their pediatric endocrinology targets alongside FENSOLVI®. ALKINDI SPRINKLE® (hydrocortisone) oral granules is FDA-approved as replacement therapy for Adrenocortical Insufficiency (AI).
Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: Alkindi Sprinkle
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eton Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 15, 2021
Details:
Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, a rare condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase.
Lead Product(s): Hydrocortisone
Therapeutic Area: Genetic Disease Product Name: Efmody
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2021
Details:
The active IND enables Antares to initiate a Phase 1 clinical study for ATRS-1902 for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.
Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: ATRS-1902
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2021
Details:
The ready to use ZENEO® Hydrocortisone will provide a 2-step rescue kit developed for a simple and intuitive autoinjection even by non healthcare professionals.
Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: ZENEO Hydrocortisone
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Crossject
Deal Size: $11.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 15, 2021
Details:
The $1.25 million milestone payment has been triggered as a result of the recent European Commission’s approval for Efmody® (hydrocortisone modified-release hard capsules) and the attainment by Citrine of certain development milestones in China for Alkindi.
Lead Product(s): Hydrocortisone
Therapeutic Area: Genetic Disease Product Name: Efmody
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Citrine Medicine
Deal Size: $2.2 million Upfront Cash: $1.0 million
Deal Type: Partnership June 01, 2021
Details:
Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase.
Lead Product(s): Hydrocortisone
Therapeutic Area: Genetic Disease Product Name: Efmody
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2021
Details:
The Phase 3 study results published by the JCEM found that although the standard-deviation-score-focused primary endpoint of the study was missed, Chronocort® improved morning and early afternoon biochemical control for adults with CAH over standard glucocorticoid therapy.
Lead Product(s): Hydrocortisone
Therapeutic Area: Genetic Disease Product Name: Chronocort
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2021
Details:
Citrine will be responsible for obtaining registration for Alkindi® as a treatment for paediatric patients in China and for all commercialisation activities, including pricing and reimbursement.
Lead Product(s): Hydrocortisone
Therapeutic Area: Genetic Disease Product Name: Alkindi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Citrine
Deal Size: $13.2 million Upfront Cash: $0.5 million
Deal Type: Licensing Agreement January 27, 2021
Details:
Eton Pharmaceuticals Canadian rights to ALKINDI® SPRINKLE from Diurnal Group plc. Eton Pharmaceuticals currently commercializes ALKINDI® SPRINKLE in the United States as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.
Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: Alkindi Sprinkle
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eton Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 14, 2021
Details:
The submission for the MHRA is based on the data from the Company’s Phase 3 study, an open-label safety extension study of Chronocort® and written formal Scientific Advice received in April 2019 confirming the clinical and regulatory pathway for Chronocort® for CAH treatment.
Lead Product(s): Hydrocortisone
Therapeutic Area: Genetic Disease Product Name: Chronocort
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2021
Details:
Amgen & Eisai to participate in the immune modulation domain of REMAP-COVID, an adaptive clinical trial to test interventions for patients hospitalized with COVID-19. Amgen’s Apremilast & Eisai’s Eritoran to be evaluated across multiple international trial sites.
Lead Product(s): Apremilast,Eritoran,Hydrocortisone
Therapeutic Area: Infections and Infectious Diseases Product Name: Otezla
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
Under the terms of the agreement EffRx has received the exclusive rights to register and commercialize Alkindi® in Switzerland.
Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: Alkindi Sprinkle
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: EffRx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 21, 2020
Details:
ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children.
Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: Alkindi Sprinkle
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2020
Details:
AVM Biotechnology has been awarded a National Cancer Institute Small Business Innovation Research Grant from the NIH to study the use of AVM0703 as a preconditioning agent to allow safe and efficient delivery of therapeutic immune cells for cancer treatment.
Lead Product(s): Dexamethasone Sodium Phosphate,Hydrocortisone,Undisclosed
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
The acquisition advanced Eton’s leadership in pediatric rare diseases products providing a $100 million market opportunity.
Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eton Pharmaceuticals
Deal Size: $7.5 million Upfront Cash: $3.5 million
Deal Type: Licensing Agreement March 27, 2020
Details:
The agreement gives SYB the right to register, manufacture and market the product in China.
Lead Product(s): Aciclovir,Hydrocortisone
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Shijiazhuang Yuanmai Biotechnology
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement February 24, 2020
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