August 17, 2009: Santhera Acquires Juvantia and Secures All Rights to JP-1730/Fipamezole

 

Klaus Schollmeier, Chief Executive Officer of Santhera, said: "The positive FJORD Phase IIb results confirmed the efficacy of JP-1730/fipamezole in reducing levodopa-induced dyskinesia in patients suffering from Parkinson's disease. In order to exploit the full potential of the drug for Santhera, including potential out-licensing rights, we now have full access to all rights to the product."

 

Upon the exercise of the option, Santhera Pharmaceuticals Holding AG immediately became the owner of Juvantia. In consideration and subject to certain conditions, Santhera Pharmaceuticals Holding AG will later issue up to 105,973 previously reserved shares from its authorized capital to Juvantia investors. The new shares will be listed on SIX Swiss Exchange. After closing of the transaction, the share capital of Santhera Pharmaceuticals Holding AG will consist of 3,628,688 listed shares with a nominal value of CHF 1 each and the available amount of authorized share capital will be reduced accordingly to CHF 323,945.

 

In July 2006, Santhera and Juvantia signed a collaboration agreement to advance the development of Juvantia's compound JP-1730/fipamezole for the treatment of Dyskinesia in Parkinson's Disease. Under the agreement, Santhera was responsible for conducting and funding further development work. At the same time, a separate option agreement between Santhera and the Juvantia investors effectively granted Santhera the right to acquire Juvantia, thereby securing all rights to the program.

 

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 severe). 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 of fipamezole is to increase noradrenergic release in certain areas of the brain, resulting in rebalancing of the distorted brain network and potentially alleviating symptoms of advanced Parkinson's disease such as dyskinesia, motor fluctuations, orthostatic hypotension and cognitive impairment without exacerbating the underlying Parkinsonian features of the disease. In a recent Phase IIb study, Santhera demonstrated that JP-1730/fipamezole reduces Dyskinesia in Parkinson's Disease with the study results also suggesting that the drug has the potential to reduce "off time" and improve cognitive function. Furthermore, the reduction in dyskinesia was found to be strongly correlated with the investigator's clinical global impression of improvement in overall condition.

 

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Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of small-molecule 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 and in a well-advanced Phase III development program. Recently published study results show that the Company's second compound, JP-1730/fipamezole is efficacious in reducing levodopa-induced Dyskinesia in Parkinson's Disease. For further information, please visit the Company's web site www.santhera.com.

 

 

Klaus Schollmeier, Chief Executive Officer

Phone: +41 (0)61 906 89 52

klaus.schollmeier@santhera.com

 

Barbara Heller, Chief Financial Officer

Phone: +41 (0)61 906 89 54

barbara.heller@santhera.com

 

Thomas Staffelbach, Head Public & Investor Relations

Phone: +41 (0)61 906 89 47

thomas.staffelbach@santhera.com

 

 

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.