Santhera Closes License-Back Deal with Takeda
News Sep 27, 2013
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."
PPD and Quotient Sciences Form Innovative Partnership to Accelerate Pediatric Drug DevelopmentNews
Will shorten timelines, reduce costs and simplify contracting process in pediatric programs.READ MORE
Safety and Efficacy of MERS Treatment Confirmed in Phase I TrialNews
An experimental treatment developed from cattle plasma for Middle East respiratory syndrome (MERS) coronavirus infection shows broad potential, according to a small clinical trial. The treatment, SAB-301, was safe and well tolerated by healthy volunteers, with only minor reactions documented.READ MORE
Alzheimer’s Drug Discovery Foundation Announces $1.8M in New FundingNews
The Alzheimer’s Drug Discovery Foundation (ADDF) announces nearly $1.8 million in new funding, which reflects a commitment to advancing drugs in or near human clinical trials. All five funded programs are potential treatments for Alzheimer’s disease and other forms of dementia.READ MORE