Santhera Announces Intent To File Marketing Authorization Application for Leber's Hereditary Optic Neuropathy
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Santhera Pharmaceuticals Holding AG / Santhera Announces Intent To File Marketing Authorization Application for Leber's Hereditary Optic Neuropathy processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Liestal, Switzerland, September 22, 2010 - Santhera Pharmaceuticals (SIX: SANN)
announced today that it has formally notified the European Medicines Agency of
its intent to file for Leber's Hereditary Optic Neuropathy (LHON). In the recent
RHODOS study, Catena® showed consistent superiority over placebo and, in
particular, improved or protected visual acuity as well as color contrast
sensitivity. Santhera expects to file a Marketing Authorization Application in
the first half of 2011 with a potential marketing approval in Europe in the
second half of 2012. Discussions with health authorities aimed at filings for
regulatory approvals in other territories are ongoing.
LHON is a rare genetic eye disease that leads to a rapid loss of central vision
and ultimately to blindness as a result of nerve cell degeneration in the retina
and optic nerve. Catena® is the first drug that has ever been clinically
investigated in a controlled clinical study in this neuro-ophthalmological
disorder. An estimated 20,000 LHON patients live in Europe and in the United
States. The global market potential is currently estimated to exceed USD 700
million annually excluding preventive treatment (Source: Datamonitor 2010).
Santhera holds global rights on the use of Catena® as a treatment of LHON and
has been granted orphan drug designations in the European Union and the United
States.
"We are pleased with the prospect of bringing Catena® to market as the first
treatment for LHON. Our position is that the consistent efficacy data, which are
robust despite the small sample size, in combination with the excellent safety
profile, results in a positive benefit/risk balance for our drug," said Klaus
Schollmeier, Chief Executive Officer of Santhera. "We believe this innovative
product, if approved, could meet a significant and unmet demand."
Data from the RHODOS study support the use of Catena® in LHON. Specifically, the
data show that the drug can protect patients who are at highest risk of vision
loss and enhance the recovery of visual acuity in severely affected eyes. These
data are supported by secondary efficacy variables such as clinical benefit,
color contrast sensitivity and changes in retinal nerve fiber layer thickness.
The study conduct and analyses were in compliance with recommendations received
from regulatory authorities.
* * *
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company
focused on the development and commercialization of innovative 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. For further information, please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals.
For further information, contact
Klaus Schollmeier, Chief Executive Officer
Phone: +41 (0)61 906 89 52
klaus.schollmeier(at)santhera.com
Barbara Heller, Chief Financial Officer
Phone: +41 (0)61 906 89 54
barbara.heller(at)santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach(at)santhera.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.
[HUG#1445839]
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Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
ISIN: CH0027148649;
News release Intent to file LHON:
http://hugin.info/137261/R/1445839/388974.pdf
This announcement is distributed by Thomson Reuters on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 22.09.2010 - 07:00 Uhr
Sprache: Deutsch
News-ID 42894
Anzahl Zeichen: 0
contact information:
Town:
Liestal
Kategorie:
Business News
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