Santhera Closes License-Back Deal with Takeda For European Rights to Catena® in Duchenne Muscular Dystrophy
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Santhera Pharmaceuticals Holding AG /
Santhera Closes License-Back Deal with Takeda For European Rights to Catena® in
Duchenne Muscular Dystrophy
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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).
* * *
About Santhera
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
thomas.meier(at)santhera.com
Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for
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.
News release Takeda:
http://hugin.info/137261/R/1726670/576221.pdf
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1726670]
Unternehmensinformation / Kurzprofil:
Datum: 03.09.2013 - 07:15 Uhr
Sprache: Deutsch
News-ID 292749
Anzahl Zeichen: 7551
contact information:
Town:
Liestal
Kategorie:
Business News
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