Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Approved
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).
Brand Name : Raxone
Molecule Type : Small molecule
Upfront Cash : $49.2 million
July 31, 2023
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Chiesi Group
Deal Size : $104.0 million
Deal Type : Divestment
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Raxone
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 23, 2021
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Puldysa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 06, 2020
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Puldysa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 06, 2020
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Puldysa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 23, 2020
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 04, 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
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 20, 2020
Lead Product(s) : Idebenone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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