Regulatory News:
Santhera Pharmaceuticals (SIX: SANN) and Ipsen (Paris:IPN) (Euronext:
IPN, ADR: IPSEY) announced today that they had renegotiated their
fipamezole licensing agreement. Santhera regains the worldwide rights to
the development and commercialization of fipamezole, its first-in-class
selective adrenergic alpha-2 receptor antagonist for the management of
levodopa-induced Dyskinesia in Parkinson’s Disease. Under the
renegotiated terms, Ipsen returns its rights for territories outside of
North America and Japan in exchange for milestone payments and royalties
based on future partnering and commercial success of fipamezole. Ipsen
retains a call option for worldwide license to the program under certain
conditions.
Thomas Meier, Chief Executive Officer of Santhera, commented: "Under
the agreement reached with Ipsen, Santhera has regained global marketing
rights for fipamezole, which we can further develop in line with the
Company’s strategy. In the short term, the focus of our investments
remains on our lead product Catena® and its
multiple product opportunities in neuromuscular and mitochondrial orphan
indications. However, fipamezole continues to be a valuable asset in
Santhera’s late-stage clinical pipeline.”
Pierre Boulud, Ipsen’s Executive Vice-President, Corporate Strategy
stated: "We are pleased that Santhera regains the worldwide rights to
a compound like fipamezole. This new agreement will help to leverage the
drug’s value on a global basis while allowing Ipsen to focus on its rich
late stage development pipeline. With its important commercial overlap
with movement disorders, Parkinson Disease remains an important area of
commercial focus for Ipsen. Santhera’s commitment to this first-in-class
drug has the potential to benefit levodopa-induced dyskinesia in
Parkinson’s Disease patients in crucial need of better therapies.”
About the agreement
According to a licensing agreement signed in September 2010, Ipsen had
acquired the rights to fipamezole outside the United States, Canada and
Japan for an upfront payment of 13 million euros. Under the new
agreement, Santhera regains full control over the development and
commercialization of fipamezole, whilst Ipsen is entitled to receive
milestone and royalty payments contingent upon the occurrence of certain
events. Santhera is free to license the program to a third party whereby
Ipsen is entitled to receive a percentage of any license income. In
addition, the agreement includes a call option allowing Ipsen
under certain circumstances to obtain an exclusive worldwide license.
Should Ipsen exercise this call option, Santhera will receive milestone
and royalty payments from Ipsen.
About Fipamezole
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. As a highly selective adrenergic alpha-2 receptor antagonist,
fipamezole is an innovative, first-in-class drug in clinical development
for the treatment of levodopa-induced dyskinesia in Parkinson’s Disease.
Santhera successfully completed two Phase II clinical studies which
demonstrated efficacy and safety of fipamezole in the treatment of
dyskinesia in Parkinson’s Disease. Fipamezole also showed attractive
potential for the reduction of levodopa "wearing-off”, and demonstrated
improvement in cognition and activities of daily living.
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 neuromuscular and
mitochondrial diseases, areas of high unmet medical with no current
therapies. Santhera’s first product Catena® is currently
marketed in Canada to treat Friedreich’s Ataxia. Catena® is
also under review for marketing authorization by the European Medicine
Agency as the first therapy for patients suffering from Leber’s
Hereditary Optic Neuropathy. For further information, please visit
www.santhera.com.
Catena® is a trademark of Santhera
Pharmaceuticals.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.1 billion in 2010. Ipsen’s ambition is to become a
leader in specialty healthcare solutions for targeted debilitating
diseases. Its development strategy is supported by four franchises:
neurology / Dysport®, endocrinology / Somatuline®,
uro-oncology / Decapeptyl® and hemophilia. Moreover, the
Group has an active policy of partnerships. R&D is focused on innovative
and differentiated technological patient driven platforms, peptides and
toxins. In 2010, R&D expenditure totaled more than €220 million, above
20% of Group sales. The Group has total worldwide staff of close to
4,500 employees. 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 www.ipsen.com.
Santhera’s 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, un
certainties 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.
Ipsen’s forward Looking Statement
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. All of the above risks
could affect the Group’s future ability to achieve its financial
targets, which were set assuming reasonable macroeconomic conditions
based on the information available today.
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. Actual results may depart
significantly from these targets given the occurrence of certain risks
and uncertainties, notably the fact that a promising product in early
development phase or clinical trial may end up never being launched on
the market or reaching its commercial targets, notably for regulatory or
competition reasons. The Group must face or might face competition from
Generics that might translate into loose of market shares.
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 favourable 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.
