RegulatoryNews:
Santhera Pharmaceuticals (SIX:SANN) and Ipsen (Paris:IPN)
(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 Parkinsons Disease.
Initiation of a first PhaseIII study by Biovail is scheduled for 2011.
Todays 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 Parkinsons
Disease. Dyskinesia is a condition that is functionally disabling to
patients and limits effective treatment of the underlying Parkinsons
Disease. Ipsen complements perfectly our North American partnership with
Biovail. Todays 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.
Stphane Thiroloix, Ipsens 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 Ipsens 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 EUR13 million
and additional payments contingent to future development, regulatory and
sales milestones of up to EUR128 million. In addition, Santhera is
entitled to royalty payments on Ipsens future net sales.
In a similar transaction in August 2009, Santhera granted Biovail
(Canadas largest specialty pharmaceutical company) the development and
commercial rights to fipamezole in the United States and Canada. The
first PhaseIII 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. Todays 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 Parkinsons
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 Parkinsons 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. Ipsens 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. Ipsens
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. Ipsens shares are traded on segment A of Euronext Paris
(stock code: IPN, ISIN code: FR0010259150) and eligible to the Service
de Rglement Diffr (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. Santheras first product, Catena
to treat Friedreichs Ataxia, is marketed in Canada. Following positive
clinical results in Lebers Hereditary Optic Neuropathy, the drug is
prepared for regulatory filings for marketing approval. Catena is also
being investigated in a PhaseIII study in Duchenne Muscular Dystrophy.
Commercial rights in Europe for Friedreichs Ataxia and Duchenne
Muscular Dystrophy are licensed to Takeda Pharmaceutical. Santheras
second compound fipamezole has demonstrated efficacy in reducing
levodopa-induced Dyskinesia in Parkinsons 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 Companys 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 Groups 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 Groups 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 Groups business is subject to
the risk factors outlined in its registration documents filed with the
French Autorit des Marchs 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 statem
Source: Business Wire
