Santhera To Launch Named Patient Program For Catena In Europe

Santhera Pharmaceuticals has announced that Catena will be made available on a named patient basis in Europe. Santhera’s Named Patient Program (NPP) allows healthcare professionals to prescribe the drug to individual patients. Santhera has established this program to bridge the time until the drug is registered in the EU and in Switzerland. The Catena NPP will be managed by Idis.

Catena is approved in Canada to treat the symptoms of Friedreich’s Ataxia. Santhera has already established an NPP for countries outside of the EU, Switzerland and North America to meet individual requests for Catena. The NPP is in accordance with Takeda, who will market the drug under the brand name Sovrima once it is finally approved by the health authorities in the EU and in Switzerland.

Under an NPP physicians can legally prescribe investigational drugs to qualifying patients on an individual basis. Such drugs can be administered to individual patients who are suffering from serious illnesses and have no other treatment options prior to the drug being approved. Among others, beneficiaries of the Catena NPP may be participants in the ongoing MICONOS Phase III study who complete the two-year open-label study extension. Investigators have expressed high interest in keeping their patients on treatment with the drug.

Klaus Schollmeier, chief executive officer of Santhera, said: “Named Patient Programs are developed for patients who are in need of investigational treatments that show promising results in clinical studies, to bridge the time until regulatory approval is received. Responding to inquiries from physicians and patients, we are now making Catena available in Europe at the prescriber’s request, while we continue to work towards the approval of Sovrima. We expect to report results from our MICONOS Phase III study in the first half of 2010.”