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

Santhera Pharmaceuticals (SIX: 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.


* * *

About Santhera
Santhera Pharmaceuticals Holding AG (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 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
www.santhera.com.

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 www.biovail.com.


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 www.santhera.com/webcast
or the teleconference (ID: 26492918) using one of the following
dial-ins
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
Santhera:
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


Biovail:
Nelson F. Isabel
Vice-President, Investor Relations & Corporate Communications
Phone +1 905 286 3000
nelson.isabel@biovail.com


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.


This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
Copyright © Hugin AS 2009. All rights reserved.



 
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