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European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreich's Ataxia by Santhera
Date:8/19/2007

pound has the potential to be granted European marketing approval for the treatment of FRDA in the second half of 2008.

A milestone payment of EUR 3 million to Santhera from its European marketing partner Takeda is triggered by the EMEA's acceptance of the SNT-MC17 MAA filing.

Santhera has decided, despite the MAA filing, to continue its ongoing Phase III clinical trial with SNT-MC17 in Europe to collect additional safety and efficacy data in a wider population of FRDA patients, particularly for doses up to 1350 mg/day and 2250 mg/day in the two body weight groups. Santhera amended the study protocol based on the findings of the NIH study to primarily evaluate the benefits of SNT-MC17 on the neurological aspects of FRDA. Santhera also offers all FRDA patients that participate and complete the EU Phase III trial the opportunity to enroll in an open label extension study where patients will receive high dose SNT-MC17.

Klaus Schollmeier, Santhera's CEO commenting on today's announcement said: "We are excited about filing the MAA submission for our first product. This was achieved as a combined effort of our specialists and the support we have received from our business partners, in particular from our marketing partner Takeda. Everyone at Santhera is very positive that we may be able to provide Friedreich' Ataxia patients with the first pharmaceutical product that is approved for the treatment of this devastating disease."

Yasuchika Hasegawa, Takeda's President said: "We are pleased with this important progress in development of SNT-MC17 for FRDA by Santhera, while there is currently no effective pharmacological treatment for this disease. We expect that our joint efforts with Santhera bring notable benefit to the patients with FRDA."

In August 2005, Santhera and Takeda signed an agreement under which Santhera granted exclusive marketing rights for SNT-MC17 in FRDA in the EU and in Switzerland to Takeda. Earlier this month, the two compani
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SOURCE Santhera Pharmaceuticals AG

Copyright©2007 PR Newswire.

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