Liestal, Switzerland, February 27, 2013 - Santhera Pharmaceuticals (SIX: SANN) announced today the voluntary withdrawal of Catena® from the Canadian market. This decision follows review of additional data from clinical trials in patients with Friedreich`s Ataxia, and subsequent consultation with Health Canada.
Santhera Pharmaceuticals (Canada), Inc, the holder of conditional market authorization (Notice of Compliance with conditions, NOC/c) in Canada for Catena® in the treatment of Friedreich`s Ataxia, will discontinue sales effective April 30, 2013. Catena® had been conditionally authorized in Canada in July 2008 on the basis that it demonstrated promising evidence of clinical effectiveness for the treatment of patients with Friedreich`s Ataxia. One of the conditions of authorization was to provide confirmatory evidence of this effectiveness in further clinical studies. However, the data from the program of studies conducted were not considered by Health Canada to provide such confirmation, and following consultation between Santhera and Health Canada, Santhera has agreed to voluntarily withdraw Catena® from the Canadian market.
No specific safety issues were identified that have prompted this action, and the withdrawal does not preclude the submission of a new application for market authorization in the future. A communication strategy for treating physicians and patients has been agreed with Health Canada.
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Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan neuromuscular and mitochondrial diseases, areas of high unmet medical need with no current therapies. For further information, please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals.
For further information, contact
Thomas Meier, Chief Executive Officer
Phone: +41 61 906 89 64
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE