Santhera Pharmaceuticals has announced that it has reached an agreement with Takeda to license back previously granted European rights to Catena® (INN: idebenone) in Duchenne Muscular Dystrophy (DMD).
In a back-loaded deal, Santhera regains European commercialization rights for Catena®. The drug is currently being investigated in a Phase III study in DMD conducted in Europe and in the USA.
In 2007, Takeda Pharmaceutical Company Limited (TSE: 4502, "Takeda") acquired the exclusive marketing rights in Europe and Switzerland for Catena® for the treatment of DMD.
Under the 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 DMD.
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 EUR 1 million payable to Takeda has been waived.
Takeda is eligible to receive Euro 1 million as a percentage from future income generated by Santhera to offset this waiver.
"The agreement we reached today with Takeda clearly increases our strategic flexibility. Potential licensees interested in Catena® in DMD can now be offered global rights to this program", commented Thomas Meier, CEO of Santhera.
Meier continued, "The ongoing DELOS study has recently passed a futility analysis and we expect to report top-line data from the first cohort of patients in this study in the second quarter of 2014. Today's agreement with Takeda also grants us right of cross-reference to certain data which may be needed for any regulatory filings for indications currently being developed or which may be developed in the future."