October 10, 2008
Santhera Launches CATENA(R) in Canada
LIESTAL, SWITZERLAND--(Marketwire - Oct. 10, 2008) - Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical company with a focus on neuromuscular diseases, announced today the launch of CATENA(R) (idebenone) in Canada. The drug is indicated for the treatment of Friedreich's Ataxia, a rare neuromuscular disease that results in the degeneration of nerve and muscle tissue. Catena is the first and only approved therapy in Canada to treat this devastating genetic disorder. Santhera estimates that there are a few hundred Friedreich's Ataxia patients in Canada, where the prevalence ranks among the highest concentrations in North America. The Company is working with physicians, patient advocacy groups, government agencies and insurance companies in order to quickly provide Catena to the patients. First prescriptions are being processed.
Dr. Bernard Brais, Neurogeneticist at Notre-Dame Hospital and associate Professor of Neurology at University of Montreal in Montreal, Quebec, commented: "For more than 30 years researchers in Canada have contributed to our growing understanding of Friedreich's Ataxia. I am excited to finally be able to prescribe a treatment to my patients for their progressive neurological disorder. It is nice to see that a company like Santhera is putting so much effort in ensuring that Catena be recognized as the first treatment for this orphan disease."Dr. Durhane Wong-Rieger, President of CORD, the Canadian Organization for Rare Disorders (www.raredisorders.ca) said: "We salute the arrival of Catena and Health Canada's approval of this important drug. It is now essential that governments, insurers and treatment centers combine their efforts and assist Friedreich's Ataxia patients in accessing this new therapeutic advancement."
Brenda Dixon, former President of BC Ataxia Society (www.bcataxia.org), currently Vice-President and a Friedreich's Ataxia patient herself, said: "The launch of a first approved therapy is a major event for the whole Friedreich's Ataxia community in Canada. We all have been longing for this moment for many years. It is good to see companies like Santhera develop drugs for patients with rare diseases, an often forgotten patient population."
"The launch of Catena in Canada is a first in many aspects: Catena is our first product and Canada its first market. More importantly, for the first time ever, physicians can prescribe an approved, safe and efficacious therapy to patients suffering from Friedreich's Ataxia", commented Klaus Schollmeier, Chief Executive Officer of Santhera. "Everyone at Santhera is energized to bring this important drug to Friedreich's Ataxia patients, and we managed to be on the Canadian market ahead of our original schedule. We are already experiencing great support from all parties involved and the first signals indicate that our expectations for Canada will be exceeded in all aspects."
Catena is indicated in Canada for the treatment of symptoms of Friedreich's Ataxia in two dose therapies: A lower dose of 450 mg/ day for patients weighing 45 kg or under and 900 mg/day for patients weighing over 45 kg. Based on clinical judgment, treating physicians can use the higher dose therapy, i.e. 1,350 mg/day for patients under 45 kg and 2,250 mg/day for patients above 45 kg body weight. Catena is supplied in polyethylene bottles containing 90 (the initial launch package size), 180, 270 and 450 tablets, containing 150 mg idebenone each.
Catena has received a marketing approval with conditions (NOC/c) from Health Canada and is marketed in Canada by Santhera's wholly- owned subsidiary, Santhera Pharmaceuticals (Canada), Inc. Catena is distributed through a specialty pharmacy model that allows product to be shipped directly to patients' homes.
About Friedreich's Ataxia
Friedreich's Ataxia is a rare but severe genetic neuromuscular disorder that results in the degeneration of an individual's nerve and muscle tissue. This disorder causes loss of muscle control, uncoordinated movements, muscle wasting and thickening of heart walls which frequently leads to a shortened life span. Friedreich's Ataxia affects both Caucasian males and females equally and it is estimated that about 20,000 patients suffer from the disease in both North America and Europe. Average life expectancy for Friedreich's Ataxia patients is limited to approximately 35 to 50 years.
The disorder results from a genetic defect in the gene encoding for frataxin. Reduced levels of this protein ultimately result in impaired energy production in mitochondria, the cells' energy production centers, and elevated oxidative stress. Tissues that have the highest need for energy, in particular nerve and cardiac tissues, are primarily affected by frataxin deficiency resulting in pathological changes in heart muscle anatomy and function and loss of nerve cells.
Santhera Pharmaceuticals (SWX:SANN) is a Swiss specialty pharmaceutical company focused on the discovery, development and marketing of small-molecule 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 currently investigates three compounds in five clinical-stage development programs. The Company's first product, SNT-MC17 (INN: idebenone), has received a marketing approval with conditions from Health Canada to treat Friedreich's Ataxia and will be marketed under its brand name CATENA(R). The product is also under review by health authorities in the EU and in Switzerland, while in the United States, a pivotal Phase III trial is recruiting patients. The compound has also shown efficacy in a Phase II clinical trial as a potential treatment for Duchenne Muscular Dystrophy. For further information, please visit the Company's website www.santhera.com.
CATENA(R) is a trademark of Santhera Pharmaceuticals, registered in Canada and the United States.
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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