Tous Actualités
Suivre
Abonner Santhera Pharmaceuticals and Idis

Santhera Pharmaceuticals and Idis

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  customerservices@idispharma.com.
About Santhera
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.
About Idis
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
    Phone: +41-61-906-89-47
     thomas.staffelbach@santhera.com
    For further information on Idis, contact:
    Madeleine Weinert, Ogilvy Healthworld Communications
    Phone: +44-207-108-6522
     madeleine.weinert@ogilvyhealthworld.com

Contact:

For further information on Catena(R), contact: Thomas Staffelbach,
Head Public & Investor Relations, Phone: +41-61-906-89-47,
thomas.staffelbach@santhera.com. For further information on Idis,
contact: Madeleine Weinert, Ogilvy Healthworld Communications, Phone:
+44-207-108-6522, madeleine.weinert@ogilvyhealthworld.com