Fipamezole Transition from Biovail completed - Program Well Advanced Towards Phase III
(Thomson Reuters ONE) -
Santhera Pharmaceuticals Holding AG /
Fipamezole Transition from Biovail completed - Program Well Advanced Towards
Phase III
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Liestal, Switzerland, February 18, 2011 - Santhera Pharmaceuticals (SIX: SANN)
announced today that the transition of the fipamezole program back from Biovail
was successfully completed. Fipamezole is being developed as a potential first
treatment of Dyskinesia in Parkinson's Disease. During its partnership with
Santhera and in preparation for Phase III development, Biovail generated
additional data in numerous clinical and nonclinical studies. The additional
data confirm and build upon the excellent profile of fipamezole established in
two previous Phase II studies. The agreement was terminated following the merger
between Valeant and Biovail. Santhera has the right to use all data generated by
Biovail for further development and commercialization worldwide. Whilst it
continues with the preparation for Phase III development, Santhera intends to
license the US and Canadian rights to a new partner. Rights to fipamezole
outside North America and Japan are licensed to Ipsen (Euronext: IPN;
ADR: IPSEY).
Fipamezole is widely perceived by clinicians as one of the most promising drug
candidates to treat Dyskinesia in Parkinson's Disease, the second most common
and a severely debilitating neurodegenerative disorder. The majority of
Parkinson's patients will develop dyskinesia over time. Two Phase II studies
with fipamezole showed that dyskinesia symptoms could be significantly reduced
while suggesting a reduction in "off time", i.e. the hours spent with diminished
mobility. Furthermore, the reduction in dyskinesia was found to be well
correlated with the clinical global impression of improvement.
In August 2009, Biovail acquired the rights to develop and commercialize
fipamezole in the US and Canada. The work conducted includes numerous
nonclinical and clinical studies required prior to the start of Phase III
development. These studies confirm the favorable profile of fipamezole.
Furthermore, the development of a synthesis route for the drug substance which
is suitable for commercial supply and technical process optimization for supply
of proprietary drug product have been completed. Following termination of the
agreement by Valeant after its merger with Biovail, Santhera recently regained
all US and Canadian rights to the program. In September 2010, Santhera and Ipsen
closed a separate collaboration for the development and commercialization of
fipamezole outside North America and Japan. This agreement stipulates a data
sharing arrangement, under which Santhera and its licensees share all clinical
and nonclinical data generated in their respective development programs.
"An analysis of all data including those generated by Biovail confirms the
excellent efficacy and safety profile of fipamezole. Importantly, the program
has advanced very well since we entered the partnership in fall 2009. We
continue to work towards initiation of the Phase III development", said Klaus
Schollmeier, Chief Executive Officer of Santhera. "The high level of interest we
are receiving for the North American rights confirms the medical and commercial
attractiveness of this innovative drug. Fipamezole holds the potential to be the
first approved therapy to treat Dyskinesia in Parkinson's Disease."
Since August 2009, Santhera received a total of USD 31 million licensing fees.
In parallel to the preparation of Phase III development, Santhera has initiated
a process to partner the rights to develop and commercialize fipamezole in North
America. The closing of such an agreement is anticipated during 2011.
About Fipamezole and Dyskinesia in Parkinson's Disease
Parkinson's disease is the second most common neurodegenerative disease. Doctors
prescribe levodopa and other dopaminergic compounds as standard therapy. Over
time, as the disease progresses, the beneficial effects of this medication often
diminish and additional movement disorders can appear (sometimes quite
severely). These movement disorders include dyskinesia which can be described as
sudden uncontrollable, often chaotic movements of limbs, face, tongue and body.
These complications derive principally from long-term levodopa use, but there is
currently no alternative to using levodopa or dopamine agonists.
Fipamezole is an antagonist of the adrenergic alpha-2 receptor with a novel mode
of action in the treatment of Dyskinesia in Parkinson's disease. The rationale
behind the development is to increase noradrenergic release in certain areas of
the brain resulting in the rebalance of the distorted brain network and
potentially alleviating symptoms of advanced Parkinson's disease such as
dyskinesia, motor fluctuations and other disturbing symptoms without
exacerbating the underlying parkinsonian features of the disease. Encouraging
clinical data from Santhera's FJORD Phase IIb study support this rationale. Loss
of motor control and dyskinesia is feature of the majority of Parkinson patients
after 5 years of levodopa therapy, and remains a high unmet medical need.
* * *
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 severe neuromuscular diseases, an area 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.
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.
--- End of Message ---
Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
ISIN: CH0027148649;
Fipamezole Update:
http://hugin.info/137261/R/1490302/425878.pdf
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1490302]
Unternehmensinformation / Kurzprofil:
Datum: 18.02.2011 - 07:00 Uhr
Sprache: Deutsch
News-ID 51660
Anzahl Zeichen: 8865
contact information:
Town:
Liestal
Kategorie:
Business News
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