Liestal, Switzerland, September 3, 2013 - Santhera Pharmaceuticals (SIX: SANN) announced today that it 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 today, 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. "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."
About Duchenne Muscular Dystrophy and the DELOS Phase III trial
Duchenne Muscular Dystrophy is one of the most common and devastating type of muscular degeneration and results in rapidly progressive muscle weakness. It is a genetic, degenerative disease that is inherited in an X-linked recessive mode with an incidence of approximately 1 in 3,500 live born males worldwide. DMD is characterized by a complete loss of the protein dystrophin, leading to cell damage, impaired calcium homeostasis, elevated oxidative stress and reduced energy production in muscle cells. This results in progressive muscle weakness and wasting and early morbidity due to respiratory failure.
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, previously agreed with both the EMA and the FDA, 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.
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.
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. Santhera develops Catena®/Raxone® as treatment for patients with DMD, Leber`s Hereditary Optic Neuropathy (LHON), and primary progressive multiple sclerosis (ppMS).
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Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan mitochondrial and neuromuscular diseases, areas of high unmet medical need with no current therapies. For further information, please visit www.santhera.com.
Catena® and Raxone® are trademarks of Santhera Pharmaceuticals.
For further information, contact
Thomas Meier, Chief Executive Officer
Phone: +41 61 906 89 64
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