April 22, 2009: Santhera Enrolls Last Patient in Phase IIb FJORD study with JP-1730/Fipamezole in Dyskinesia in Parkinson's Disease

 

The Phase IIb study named FJORD (Fipamezole from Juvantia fOR treatment of Dyskinesia) follows a double-blind, randomized, placebo-controlled dose escalation design and evaluates the safety and efficacy of three doses of JP-1730/fipamezole compared to placebo over a treatment period of 28 days. The primary endpoint is the reduction of dyskinetic movements in patients with Parkinson's Disease as assessed by the levodopa-induced dyskinesia scale (LIDS). The FJORD study evaluates additional benefits of JP-1730/fipamazole in motor functions of Parkinson's Disease as well as its impact on cognitive function measured by a neuropsychological testing battery. The trial is being conducted at 33 centers in the United States and India. A total of 180 patients have now been recruited and, with the current lower-than-expected drop-out rate, the target of 120 evaluable patients in the database will be exceeded.

 

"The completion of the enrollment into the FJORD study is an important milestone in the development of JP-1730/fipamezole for Dyskinesia in Parkinson's Disease, Santhera's second core program next to our Catena® franchise," said Klaus Schollmeier, Chief Executive Officer of Santhera. "Our clinical investigators were tremendously supportive in the recruitment for this trial. Their strong commitment reflects the significant unmet medical need in the management of this severe condition which overshadows chronic levodopa therapy used for treatment of the underlying Parkinson's disease. We believe that the FJORD study will demonstrate the drug's efficacy and provide critical information for the late-stage development of JP-1730/fipamezole in order to make it available as quickly as possible to the benefit of Parkinson's sufferers."

 

Keijo Väkiparta, Chairman of Juvantia, said: "Together, Santhera and Juvantia have efficiently moved forward the confirmatory Phase IIb trial with JP-1730/fipamezole in Dyskinesia in Parkinson's Disease. The current clinical program represents an excellent opportunity to drive the further development of this important product."

 

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 is responsible for conducting and funding further development work to generate data required for commencement of the Phase III program. Santhera has a call option to secure all rights to JP-1730/fipamezole via the acquisition of Juvantia at predetermined conditions any time before December 31, 2009. The Company's partnering activities for Phase III clinical development and commercialization have met considerable interest from mid- to large-sized pharmaceutical companies.

 

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 diminish and additional movement disorders appear, which become gradually very severe. In advanced stages, 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. It is estimated that approximately 400,000 patients in Europe and North America are affected by troublesome dyskinesia associated with their levodopa therapy.

 

Fipamezole is an antagonist of the adrenergic alpha-2 receptor and offers a novel and unique mode of action to treat 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 a rebalancing of the distorted brain network and alleviating symptoms of advanced Parkinson's Disease such as dyskinesia, motor fluctuations, orthostatic hypotension and cognitive impairment. In addition, fipamezole is believed to extend the beneficial effects of commonly used levodopa (prolonged on-time) and other dopamine agonists without the negative side effects associated with these treatments. Such therapy is expected to improve the quality of life of Parkinson's patients.

 

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Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the discovery, 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® has received marketing approval from Health Canada to treat Friedreich's Ataxia. The drug is investigated in two fully recruited pivotal trials in the United States and in Europe. The same compound has also shown efficacy in a clinical trial as a potential treatment for Duchenne Muscular Dystrophy. 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

 

 

Keijo Väkiparta, Chairman

Phone: +358 400 455 571

 

 

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.