Santhera Regains Full Rights to Fipamezole in North America
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Santhera Pharmaceuticals Holding AG /
Santhera Regains Full Rights to Fipamezole in North America
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Liestal, Switzerland, October 25, 2010 - Santhera Pharmaceuticals (SIX: SANN)
announced today that as of January 2011 it regains the US and Canadian rights
for fipamezole from Biovail Laboratories International, now a wholly-owned
subsidiary of Valeant Pharmaceuticals International. Fipamezole is being
prepared for Phase III development for the treatment of Dyskinesia in
Parkinson's Disease. Santhera previously established a collaboration and
licensing agreement with Biovail to develop and commercialize fipamezole in
North America, for which Santhera received USD 12 million upfront and milestone
payments. As part of the post-merger review, Biovail has decided to return the
fipamezole project solely due to a shift in strategic focus of the new Valeant
group. Based on the comprehensive clinical development already completed,
Santhera is committed to take on the Phase III development of the product for
the North American markets. In September 2010, Santhera and Ipsen signed a
separate collaboration agreement for the development and commercialization of
fipamezole outside North America and Japan.
"The North American rights to fipamezole enhance Santhera's existing portfolio
of late-stage assets and represent an opportunity to bring to market the
potentially first therapy to treat levodopa-induced Dyskinesia in Parkinson's
Disease," commented Klaus Schollmeier, CEO of Santhera. "While we would have
been pleased to continue with Biovail being part of this partnership, we accept
their strategic decision. We are now preparing ourselves for the transition of
the work and data from Biovail back to us and will discuss our next steps with
Ipsen."
Fipamezole is widely perceived by clinicians as one of the most promising drug
candidates to treat dyskinesia in Parkinson's Disease, a severely debilitating
movement disorder. In two Phase II studies, fipamezole was shown to reduce
levodopa-induced dyskinesia with this beneficial effect not being associated
with a clinically meaningful worsening of parkinsonian features of the disease.
The results also suggest that fipamezole potentially improves cognitive
functions of patients and reduces their "off time", i.e. the hours they spend
with diminished mobility. Furthermore, the reduction in dyskinesia was found to
be well correlated with the clinical global impression of improvement.
In August 2009, Santhera granted Biovail the right to develop and commercialize
fipamezole in North America and received a total of USD 12 million licensing
fees consisting of an upfront and a first milestone payment. Importantly, the
program has advanced significantly over the past year including technical
process optimization for supply of product and the completion of important
nonclinical and clinical studies, which were all performed by Biovail. Following
a strategic review of the combined Biovail/Valeant development portfolio,
Santhera now regains all US and Canadian rights including all data generated by
Biovail.
At the end of September 2010, Santhera's cash and cash equivalents amounted to
approximately CHF 50 million, which gives the Company enough flexibility to
invest in its key programs while keeping a comfortable cash runway. The
financial impact of the in-house development of fipamezole for the North
American markets is currently being analyzed as Santhera looks into the various
options.
* * *
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company
focused on the development and commercialization of specialty niche products for
the treatment of neurodegenerative and neuromuscular diseases, areas of high
unmet medical need which includes many orphan indications with no current
therapy. Santhera's first product, Catena®, to treat Friedreich's Ataxia is
marketed in Canada. For further information, please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals.
Webcast/Teleconference
At 15:00 CET / 14:00 UKT / 09:00 EST on October 25, 2010, Santhera's management
will host a teleconference/webcast. You can either join the webcast on
www.santhera.com/webcast or the teleconference using the conference ID 20231531
and one of the following dial-ins:
Switzerland 056 580 00 07
Germany 0692 222 4918
UK 0844 493 3800
Europe +44 (0) 1452 555 566 (standard international)
USA 1866 966 9439
The webcast will be available for playback one hour after the analyst
presentation ends.
For further information, contact
Klaus Schollmeier, Chief Executive Officer
Phone: +41 (0)61 906 89 52
klaus.schollmeier(at)santhera.com
Barbara Heller, Chief Financial Officer
Phone: +41 (0)61 906 89 54
barbara.heller(at)santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach(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.
[HUG#1454717]
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Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
ISIN: CH0027148649;
News release Fipamezole:
http://hugin.info/137261/R/1454717/394866.pdf
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 25.10.2010 - 07:01 Uhr
Sprache: Deutsch
News-ID 46091
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contact information:
Town:
Liestal
Kategorie:
Business News
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