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.
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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@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
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.
