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Santhera and Ipsen Enter into Licensing Agreement for Fipame-zole for the Treatment of Dyskinesia in Parkinson's Disease |
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Santhera Pharmaceuticals Holding AG / Santhera and Ipsen Enter into Licensing Agreement for Fipame-zole for the Treatment of Dyskinesia in Parkinson's Disease processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Liestal (Switzerland) and Paris (France) - September 3, 2010 - Santhera
Pharmaceuticals (SIX: SANN) and Ipsen (Euronext: IPN; ADR: IPSEY) today
announced a license agreement for the development and commercialization of
fipamezole (antagonist of the adrenergic alpha-2 receptor) for territories
outside of North America and Japan. This first-in-class compound is currently
under investigation for the treatment of levodopa-induced dyskinesia in
Parkinson's Disease. Initiation of a first Phase III study by Biovail is
scheduled for 2011. Today's agreement stipulates a data sharing, under which
Ipsen has the right to use these data for its own purposes.
Klaus Schollmeier, Chief Executive Officer of Santhera, said: "We are pleased to
be partnering with Ipsen to advance the potential of fipamezole as a possible
first treatment for Dyskinesia in Parkinson's Disease. Dyskinesia is a condition
that is functionally disabling to patients and limits effective treatment of the
underlying Parkinson's Disease. Ipsen complements perfectly our North American
partnership with Biovail. Today's agreement is another strong endorsement for
fipamezole and proves that our out-licensing strategy for this innovative drug
candidate is working well for the benefit of all parties."
Stéphane Thiroloix, Ipsen's Executive Vice-President, Corporate Development
said: "L-dopa induced dyskinesia is a serious unmet medical need, and we look
forward to providing patients with a positive transformation in the management
of their condition. This agreement with Santhera will further enrich Ipsen's
pipeline with a new promising first-in-class compound thus complementing our
fast-growing neurology franchise, in clear medical and operational synergy with
our existing portfolio. We have been impressed with the scientific and
development capabilities of both Santhera and Biovail. Ipsen will benefit from
the Biovail development and collaborate fully to achieve regulatory filings
excluding North America planned for 2015."
About the agreement
Under the agreement, Ipsen acquires the rights to fipamezole outside the United
States, Canada and Japan for an upfront payment of EUR 13 million and additional
payments contingent to future development, regulatory and sales milestones of up
to EUR 128 million. In addition, Santhera is entitled to royalty payments on
Ipsen's future net sales.
In a similar transaction in August 2009, Santhera granted Biovail (Canada's
largest specialty pharmaceutical company) the development and commercial rights
to fipamezole in the United States and Canada. The first Phase III study is
scheduled for 2011 in the treatment of levodopa induced dyskinesia. Santhera has
the right to use and sublicense data generated by Biovail for development and
commercialization purposes outside of the United States and Canada. Today's
agreement stipulates that Ipsen has acquired the right to use these data for its
own development and commercialization purposes outside the United States, Canada
and Japan, whereas the Japanese rights for fipamezole remain with Santhera.
About Fipamezole
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
phase 2b data exist in support of 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 clear unmet medical need.
About Ipsen
Ipsen is a global biopharmaceutical group, with sales exceeding 1 billion euros
in 2009. The Group has total worldwide staff of more than 4,400 employees, of
which nearly 900 contribute to the discovery and development of innovative drugs
for patient care. Ipsen's development strategy is based on fast growing
specialty care drugs in oncology, endocrinology, neurology and hematology, and
on primary care drugs. This strategy is supported by an active policy of
partnerships. Ipsen's research & development (R&D) centers and its peptide &
protein engineering platform give the Group a strong competitive edge. In 2009,
R&D expenditure totaled close to ?200 million, representing nearly 20% of Group
sales. Ipsen's shares are traded on segment A of Euronext Paris (stock code:
IPN, ISIN code: FR0010259150) and eligible to the "Service de Règlement Différé"
("SRD"). The Group is part of the SBF 120 index. Ipsen has implemented a
Sponsored Level I American Depositary Receipt (ADR) program, which trade on the
over-the-counter market in the United States under the symbol IPSEY. For more
information on Ipsen, visit our website at www.ipsen.com.
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. Following positive clinical results in Leber's Hereditary
Optic Neuropathy, the drug is prepared for regulatory filings for marketing
approval. Catena® is also being investigated in a Phase III study in Duchenne
Muscular Dystrophy. Commercial rights in Europe for Friedreich's Ataxia and
Duchenne Muscular Dystrophy are licensed to Takeda Pharmaceutical. Santhera's
second compound fipamezole has demonstrated efficacy in reducing
levodopa-induced Dyskinesia in Parkinson's Disease. Phase III development and
commercialization rights in the United States and Canada are partnered with
Biovail, and outside North America and Japan with Ipsen. For further
information, please visit the Company's web site at www.santhera.com. Catena® is
a trademark of Santhera Pharmaceuticals.
Ipsen forward-looking statements
The forward-looking statements, objectives and targets contained herein are
based on the Group's management strategy, current views and assumptions. Such
statements involve known and unknown risks and uncertainties that may cause
actual results, performance or events to differ materially from those
anticipated herein. Moreover, the targets described in this document were
prepared without taking into account external growth assumptions and potential
future acquisitions, which may alter these parameters. These objectives are
based on data and assumptions regarded as reasonable by the Group. These targets
depend on conditions or facts likely to happen in the future, and not
exclusively on historical data. Notably, future currency fluctuations may
negatively impact the profitability of the Group and its ability to reach its
objectives. Actual results may depart significantly from these targets given the
occurrence of certain risks and uncertainties. The Group does not commit nor
gives any guarantee that it will meet the targets mentioned above. Furthermore,
the Research and Development process involves several stages each of which
involve the substantial risk that the Group may fail to achieve its objectives
and be forced to abandon its efforts with regards to a product in which it has
invested significant sums. Therefore, the Group cannot be certain that favorable
results obtained during pre-clinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will be
sufficient to demonstrate the safe and effective nature of the product
concerned. The Group also depends on third parties to develop and market some of
its products which could potentially generate substantial royalties; these
partners could behave in such ways which could cause damage to the Group's
activities and financial results. The Group expressly disclaims any obligation
or undertaking to update or revise any forward looking statements, targets or
estimates contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such statements are based,
unless so required by applicable law. The Group's business is subject to the
risk factors outlined in its registration documents filed with the French
Autorité des Marchés Financiers.
Santhera 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.
For further information:
Santhera
Klaus Schollmeier, Chief Executive Officer
Phone: +41 (61) 906 89 52
klaus.schollmeier@santhera.com
Barbara Heller, Chief Financial Officer
Phone: +41 (61) 906 89 54
barbara.heller@santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (61) 906 89 47
thomas.staffelbach@santhera.com
Ipsen
Media
Didier Véron
Director, Public Affairs and Corporate Communications
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
E-mail:didier.veron@ipsen.com
Financial Community
David Schilansky Pierre Kemula
Vice President Finance Investor Relations Officer
Tel.: +33 (0)1 58 33 51 30 Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63 Fax: +33 (0)1 58 33 50 63
E-mail: david.schilansky@ipsen.com E-mail: pierre.kemula@ipsen.com
[HUG#1442466]
--- End of Message ---
Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
ISIN: CH0027148649;
News release Ipsen partnering:
http://hugin.info/137261/R/1442466/386678.pdf
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other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
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