Santhera Pharmaceuticals Holding AG : Santhera Closes License-Back Deal with
Takeda For European Rights to Catena® in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals Holding AG / Santhera Closes License-Back Deal with
Takeda For European Rights to Catena® in Duchenne Muscular Dystrophy .
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responsible for the content of this announcement.
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 PhaseIII 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 EUR1million
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
"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 PhaseIII 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 PhaseIII
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^® (900mg/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
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 complexIII 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).
* * *
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
Disclaimer / Forward-looking statements
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or purchase any securities of Santhera Pharmaceuticals Holding AG. This
publication may contain certain forward-looking statements concerning the
Company and its business. Such statements involve certain risks, uncertainties
and other factors which could cause the actual results, financial condition,
performance or achievements of the Company to be materially different from
those expressed or implied by such statements. Readers should therefore not
place undue reliance on these statements, particularly not in connection with
any contract or investment decision. The Company disclaims any obligation to
update these forward-looking statements.
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