Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Idebenone
Therapeutic Area : Ophthalmology
Study Phase : Approved FDF
Sponsor : Chiesi Group
Deal Size : $104.0 million
Deal Type : Divestment
Santhera Completes Divestment of Raxone®/Idebenone Business to Chiesi Group
Details : Under the terms of the agreement, Chiesi Group acquired all assets and certain liabilities related to Raxone (idebenone) in all indications worldwide, including Raxone in leber hereditary optic neuropathy (LHON).
Product Name : Raxone
Product Type : Other Small Molecule
Upfront Cash : $49.2 million
July 31, 2023
Lead Product(s) : Idebenone
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Sponsor : Chiesi Group
Deal Size : $104.0 million
Deal Type : Divestment
Lead Product(s) : Idebenone
Therapeutic Area : Ophthalmology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Santhera's Raxone® Meets Phase 4 Endpoint in Optic Neuropathy
Details : Raxone (idebenone) is an antioxidant benzoquinone, small molecule drug candidate which is indicated for the treatment of Leber’s Hereditary Optic Neuropathy.
Product Name : Raxone
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 23, 2021
Lead Product(s) : Idebenone
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
UK’s MHRA renews EAMS Scientific Opinion for Santhera’s Idebenone in Duchenne Muscular Dystrophy
Details : Uk's Medicines and Healthcare products Regulatory Agency has renewed for a further year the Early Access to Medicines Scheme scientific opinion for idebenone for patients with Duchenne muscular dystrophy in respiratory function decline who are not taking...
Product Name : Puldysa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 23, 2020
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Data from an interim analysis conducted by the (DSMB) concluded that the study was unlikely to meet its primary endpoint. Santhera will discontinue the study, withdraw the European marketing authorization application and end the global development progra...
Product Name : Puldysa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 10, 2020
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Data from an interim analysis conducted by the independent Data and Safety Monitoring Board concluded that the Phase 3 SIDEROS study with Puldysa® (idebenone) was unlikely to meet its primary endpoint.
Product Name : Puldysa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 10, 2020
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The large Phase 3 SIDEROS study was designed to confirm the efficacy of idebenone in patients with respiratory function decline who are concurrently taking glucocorticoids.
Product Name : Puldysa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 20, 2020
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Highbridge Capital Management
Deal Size : $21.1 million
Deal Type : Financing
Details : In combination with Santhera's existing cash and cash equivalents, this financing will provide the Company with sufficient funding to complete regulatory work for Puldysa®, including the CHMP review, and with the achievement of Company milestones.
Product Name : Puldysa
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
April 06, 2020
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Highbridge Capital Management
Deal Size : $21.1 million
Deal Type : Financing