Santhera Receives First Product Approval: Health Canada Approves Catena for Treatment of Friedreich's Ataxia

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 labeling 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."

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