Date: 2013-09-03
Type of information: Licensing agreement
Compound: Catena® (idebenone)
Company: Santhera Pharmaceuticals (Switzerland) Takeda Pharmaceutical (Japan)
Therapeutic area: Rare diseases - Neuromuscular diseases
Type agreement: licensing
commercialisation
Action mechanism: Idebenone is a synthetic short-chain benzoquinone and a cofactor for the enzyme NAD(P)H:quinone oxidoreductase (NQO1) capable of transferring electrons directly onto complex III of the mitochondrial electron transport chain, thereby capable of restoring cellular energy levels.
Disease: Duchenne muscular dystrophy
Details: * On September 3, 2013, Santhera Pharmaceuticals has announced that it reached an agreement with Takeda to license back previously granted European rights to Catena® (idebenone) in Duchenne muscular dystrophy. In a back-loaded deal, Santhera regains European commercialization rights for Catena®. In 2007, Takeda Pharmaceutical has acquired the exclusive marketing rights in Europe and Switzerland for Catena® for the treatment of Duchenne muscular dystrophy. Under this latest agreement reached, Santhera licenses back all such previously granted rights to increase its strategic flexibility. In return, Takeda is eligible to obtain a percentage from future licensing and/or sales income generated by Santhera in Duchenne muscular dystrophy. In addition, Santhera has obtained the right to cross-reference Takeda's idebenone data for regulatory use in any indication in any territory. If Santhera makes use of such cross-reference right, Takeda is eligible to obtain a percentage from future licensing and/or sales income generated by Santhera in such indications. Lastly, both companies agreed to terminate a similar agreement for Friedreich's Ataxia signed in 2005 and Santhera\'s previously disclosed contingent liability of € 1 million payable to Takeda has been waived. Takeda is eligible to receive € 1 million as a percentage from future income generated by Santhera to offset this waiver.
The drug is currently being investigated in a Phase III study in Duchenne muscular dystrophy conducted in Europe and in the USA (NCT01027884). DELOS (DuchEnne Muscular Dystrophy Long-term IdebenOne Study) is a Phase III randomized, placebo-controlled double-blind study in patients aged 10-18 years with DMD of any mutational etiolology, ambulatory or non-ambulatory, recruited in Europe and in North America. The study is designed to assess the efficacy of orally administered Catena® (900 mg/day) in improving or delaying the loss of respiratory function in Duchenne patients compared to placebo. The study plans to sequentially enroll two cohorts of patients, 60 corticosteroid non-using and 200 corticosteroid using patients, to allow these sub-groups to be independently powered for efficacy and analyzed separately in the final primary endpoint analysis. As was agreed with both the US and European regulatory agencies, DELOS is intended to provide pivotal efficacy data for regulatory filings for Catena® in the treatment of patients with DMD in these territories. Santhera expects to report data from the first cohort of patients in the DELOS study in the second quarter of 2014. Recently, the independent Data Safety Monitoring Board for DELOS informed Santhera that the study has a reasonable chance of achieving its primary endpoint for improving or delaying the loss of respiratory function in Duchenne patients not using corticosteroids and since no safety issues were detected, recommended that the study should continue as planned.
Santhera also develops idebenone as treatment for patients with Leber\'s Hereditary Optic Neuropathy, and primary progressive multiple sclerosis.
Financial terms:
Latest news:
