SOURCE: Santhera Pharmaceuticals Holding AG

August 24, 2009 01:08 ET

Santhera and Biovail Enter into License Agreement to Develop and Commercialize JP-1730/Fipamezole in North America

LIESTAL, SWITZERLAND--(Marketwire - August 24, 2009) -

Santhera Pharmaceuticals (SWISS: SANN), and Biovail Corporation (NYSE/TSX:BVF) announced today that the two specialty pharmaceutical companies have signed a license agreement for Santhera's JP-1730/fipamezole. Biovail acquires the US and Canadian rights to develop and commercialize the drug for the treatment of Dyskinesia in Parkinson's Disease. JP-1730/ fipamezole is a first-in-class compound that, in a recent Phase IIb study, displayed the potential to reduce levodopa-induced dyskinesia.

"Biovail is an emerging key player in the area of neurodegenerative disorders. With its commitment to this therapeutic area and the strong track record it has developed in a short period of time, I am confident that JP-1730/fipamezole will become a key product for the improved management of Parkinson's disease," said Klaus Schollmeier, Chief Executive Officer of Santhera. "Importantly, today's agreement is consistent with our strategy of partnering larger indications whilst retaining co-promotional rights for our commercial operations in the United States."

Bill Wells, Biovail's Chief Executive Officer said, "This agreement with Santhera is directly on strategy and another important step in our efforts to build a sustainable product-development pipeline in specialty central nervous system disorders."

Under the terms of the agreement between Biovail Laboratories International SRL and Santhera Pharmaceuticals (Switzerland) Ltd and subject to customary closing conditions, Santhera will receive an upfront payment of USD 8 million and a further payment of USD 4 million upon the successful closing of its acquisition of Oy Juvantia Pharma Ltd. Biovail will pay up to USD 35 million in potential development and regulatory milestones associated with the initiation of a Phase III study, regulatory submissions and approvals of JP-1730/fipamezole in Dyskinesia Parkinson's Disease. The agreement also stipulates that Biovail make additional milestone payments of up to USD 145 million as certain sales thresholds are met. Santhera will also receive royalty payments of 8% to 15% on net commercial sales of JP-1730/fipamezole. Should Biovail pursue a second indication, up to USD 20 million in additional success milestones would be payable to Santhera upon approval.

Biovail will be responsible for the remaining clinical development programs and costs in the United States and Canada. The companies have agreed to collaborate on the development program. Santhera will have the right to use and sublicense data generated for development and commercialization purposes outside of North America. Initiation of the first Phase III study in the United States is scheduled for 2011. Santhera will retain co-promotion rights in the United States.

In connection with the partnering of JP-1730/fipamezole, Santhera recently exercised its option to acquire Oy Juvantia Pharma Ltd, the owner of the compound. In consideration and subject to certain conditions, Santhera will issue 105,973 previously reserved shares from its authorized capital to the shareholders of Juvantia.

Santhera was advised by JSB Partners in this transaction.

About Dyskinesia in Parkinson's Disease

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. It is estimated that approximately 400,000 patients in Europe and North America are affected by troublesome dyskinesia associated with their levodopa therapy.

About Fipamezole

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 has the potential to reduce Dyskinesia in Parkinson's Disease with the study results also suggesting that the drug potentially reduces "off time" and improves 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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About Santhera

Santhera Pharmaceuticals Holding AG (SWISS: 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 showed 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

Catena® is a trademark of Santhera Pharmaceuticals.

About Biovail Corporation

Biovail Corporation, Canada's largest publicly traded pharmaceutical company, is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products. The Company is focused on the development and commercialization of medicines that address unmet medical needs in niche specialty central nervous system (CNS) markets. For more information about Biovail, visit the Company's Web site at

Webcast / Teleconference
At 15.00 CET / 14.00 UKT / 09.00 EST on August 24, 2009, Santhera's
management will discuss today's announcement. Anyone interested in
participating may join either the webcast on
or the teleconference (ID: 26492918) using one of the following
         Switzerland                    0565 800 007 (local call)
         United States                             1866 966 9439
         Canada                                    1866 966 0399
         Germany                  0692 222 3479 or 0692 222 4918
         United Kingdom / International     +44 (0) 1452 555 566
The webcast will be available for playback one hour after the
presentation ends.

For further information, contact
Klaus Schollmeier, Chief Executive Officer
Phone: +41 (0)61 906 89 52

Barbara Heller, Chief Financial Officer
Phone: +41 (0)61 906 89 54

Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47

Nelson F. Isabel
Vice-President, Investor Relations & Corporate Communications
Phone +1 905 286 3000

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 statements.

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