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Neuromuscular Disease Treatment Catena(R) Available in Europe on a Named Patient Basis
Liestal, Switzerland and Weybridge, England (ots/PRNewswire) --
- Santhera and Idis Partner to Facilitate Patient Access to Friedreich's Ataxia Drug
Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company focused on orphan neuromuscular diseases and Idis announced today that Catena(R) will be made available on a named patient basis in Europe. Santhera's Named Patient Programme (NPP) managed by Idis, allows healthcare professionals to prescribe the drug to individual patients. Santhera has established this programme to bridge the time until the drug is registered in the European Union and in Switzerland. The Catena(R) NPP has been developed by Idis, the global leader in the development and implementation of such programmes.
Catena(R) is approved in Canada to treat the symptoms of Friedreich's Ataxia, an inherited disease that causes progressive damage to the nervous system resulting in symptoms ranging from gait disturbance and speech problems to heart disease. Santhera has already established an NPP for countries outside of the European Union, Switzerland and North America to meet individual requests for Catena(R). The extension of this programme into Europe is of particular importance for patients and physicians waiting for the marketing authorisation of the drug. The NPP is in accordance with Takeda, who will market the drug under the brand name Sovrima(R) once it is finally approved by the health authorities in the European Union and in Switzerland. Idis will manage the Catena(R) NPP in all countries (except the United States) where the drug is not yet approved. Eligible patients need a prescription from a physician and individual reimbursement secured.
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(R) 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.
"Named Patient Programmes 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," commented Klaus Schollmeier, Chief Executive Officer of Santhera. "Responding to inquiries from physicians and patients, we are now making Catena(R) available in Europe at the prescriber's request, while we continue to work towards the approval of Sovrima(R). We expect to report results from our MICONOS Phase III study in the first half of 2010."
"The Idis Named Patient Programme we have developed for Santhera will help to ensure that Friedreich's Ataxia patients with an urgent unmet medical need have access to Catena(R). Whilst NPPs allow physicians to become more knowledgeable and experienced with the medicine before it is available on the market, they also mean that we can manage requests for the product in a way that is reliable, responsible and compliant with national regulatory obligations," commented Simon Estcourt, Director Business Development, Idis.
Contact information for the Catena(R) Named Patient Programme
Licensed healthcare professionals in Europe interested in Catena(R) should contact Idis, telephone +44-1932-824-100, fax +44-1932-824-300, email firstname.lastname@example.org.
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization 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. Santhera's first product, Catena(R) to treat Friedreich's Ataxia, is marketed in Canada and in a well-advanced Phase III development programme. Recently published study results show that the Company's second compound JP-1730/fipamezole is efficacious in reducing levodopa-induced Dyskinesia in Parkinson's Disease. For further information, please visit the Company's web site http://www.santhera.com.
Catena(R) is a trademark of Santhera Pharmaceuticals.
Idis is the global long-term partner to pharmaceutical and biotech companies, pharmacies and physicians. Making sure that the patient is at the heart of everything we do, by developing long-term strategic solutions to creating an understanding of and access to medicines around the globe, enhancing life from different perspectives. Idis Named Patient Programmes (NPPs) create access for the benefit of the patient. Corporate headquarter based near central London, Idis has been a strategic partner to the world's top 10 pharmaceutical and biotech companies. For more information on Idis, please visit the website http://www.idispharma.com.
For further information on Catena(R), contact:
Thomas Staffelbach, Head Public & Investor Relations
For further information on Idis, contact:
Madeleine Weinert, Ogilvy Healthworld Communications
ots Originaltext: Santhera Pharmaceuticals and Idis
Im Internet recherchierbar: http://www.presseportal.ch
For further information on Catena(R), contact: Thomas Staffelbach,
Head Public & Investor Relations, Phone: +41-61-906-89-47,
email@example.com. For further information on Idis,
contact: Madeleine Weinert, Ogilvy Healthworld Communications, Phone: