Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company with a focus on neuromuscular diseases, announced the launch of Catena (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 believes that there are a few hundred Friedreich's Ataxia patients in Canada with a higher density in the Quebec Province, 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 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, 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.

Friedreich's Ataxia is a rare but severe genetic neuromuscular disorder that results in the degeneration of an individual's nerve and muscle tissue.

Santhera Pharmaceuticals 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.