Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company focused on neuromuscular diseases, announced that Health Canada has approved with conditions SNT-MC17/idebenone for the treatment of Friedreich's Ataxia. Health Canada's decision is the first marketing authorization worldwide for any Friedreich's Ataxia therapy. The new drug will be marketed in Canada under the brand name Catena.
Santhera has established a wholly owned Canadian subsidiary, Santhera Pharmaceuticals (Canada), Inc. recently incorporated in Montréal, Quebec, to address the needs of Canada's several hundred patients with this rare and severely progressive muscle disease. Launch of Catena is anticipated for the end of October 2008.
In clinical studies submitted to Health Canada as part of the approval process, Catena showed statistically and clinically relevant improvements in Friedreich's Ataxia patients, as measured by Activities of Daily Living scores as well as cardiac and neurological functions. The approved product labelling allows for the treatment of symptoms of Friedreich's Ataxia. Two doses are approved: a starting dose of 450 mg/day for patients below 45 kg body weight and 900 mg/day for patients above 45 kg body weight whereby treating physicians have an option to dose up to 1,350 mg/day for patients below 45 kg body weight and up to 2,250 mg/day for patients of more than 45 kg body weight if needed. Under the conditions of the Notice of Compliance with Conditions, Santhera has agreed to submit additional data from its ongoing phase III clinical trial in the United States to confirm the efficacy of the therapy.
Klaus Schollmeier, chief executive officer of Santhera said: "We are very pleased about this market authorization by the Canadian authority. Health Canada concluded that the data presented were promising enough to allow Catena's approval for the benefit of patients now while requiring confirmatory efficacy data when they become available. Today's approval is a major milestone for the Friedreich's Ataxia community in Canada and elsewhere. For the first time, physicians will be able to offer patients an approved, safe and efficacious therapy to treat their devastating disease." He continued: "This first marketing authorization marks a significant event for our Company, one that has been our goal since the inception of Santhera in 2004. Today, Santhera's vision of offering therapies for orphan indications is becoming reality. The entire team at Santhera is energized by this success and is even further encouraged to work towards approvals in other regions."
MJ Roach, VP marketing & sales and Santhera's general manager for North America, commented: "Canada's marketing authorization provides an excellent foundation to establish a medical and marketing platform in North America for the treatment of rare neuromuscular diseases in general and for Friedreich's Ataxia in particular. The Canadian market will also provide valuable insights for launching the product in the United States, once the ongoing clinical trial is completed and the product is approved. We look forward to working with physicians in Canada who prescribe Catena to Friedreich's Ataxia patients."
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.
Catena may be useful in the symptomatic management of patients with Friedreich's Ataxia. The drug is believed to increase the supply of energy to cells in the body. Additionally it has antioxidant properties and may protect the cells in the body which are damaged by the disease.