July 24, 2008

Santhera Wins Marketing Approval for Ataxia Therapy

Santhera Pharmaceuticals has announced that Health Canada has approved SNT-MC17/idebenone, subject to certain conditions, for the treatment of Friedreich's Ataxia.

Health Canada's decision is said to be the first marketing authorization worldwide for any Friedreich's Ataxia therapy. The new drug will be marketed in Canada under the brand name Catena. Launch of Catena is anticipated by 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 labeling allows for the treatment of symptoms of Friedreich's Ataxia. Two doses are approved: a starting dose of 450mg/day for patients below 45kg body weight and 900mg/day for patients above 45kg body weight whereby treating physicians have an option to dose up to 1,350mg/day for patients below 45kg body weight and up to 2,250mg/day for patients of more than 45 kg body weight if needed.

Under the conditions of the notice of compliance, Santhera has agreed to submit additional data from its ongoing Phase III clinical trial in the US to confirm the efficacy of the therapy.

MJ Roach, Santhera's general manager for North America, said: "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 US, once the ongoing clinical trial is completed and the product is approved."