January 24, 2012: Santhera and Ipsen Renegotiate Fipamezole Licensing Agreement
· Santhera regains worldwide rights for fipamezole
· Ipsen retains a call option for worldwide license to the program under certain conditions
Liestal (Switzerland) and Paris (France), January 24, 2012 - Santhera Pharmaceuticals (SIX: SANN) and Ipsen (Euronext: IPN, ADR: IPSEY) announced today that they have 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 an agent 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.
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.
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.
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.
For further information:
Thomas Meier, Chief Executive Officer
Phone: +41 (0)61 906 89 64
Thomas Staffelbach, VP Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
| Director, Public Affairs and Corporate Communications|
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
| Financial Community|
|Stéphane Durant des Aulnois|
| Investor Relations Officer|
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
| Investor Relations Manager|
Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58 33 50 63
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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.
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