Santhera Pharmaceuticals Holding AG : Santhera to Discontinue Sale of Catena®
Santhera Pharmaceuticals Holding AG / Santhera to Discontinue Sale of Catena®
in Canada . Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.
Liestal, Switzerland, February27, 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
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 April30, 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.
* * *
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
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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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
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Santhera Pharmaceuticals Holding AG
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