The average annual ex-factory price achieved in Canada currently amounts to approximately CAD 45,000. The commercial success in Canada suggests a larger global market potential for Catena® in Friedreich's Ataxia than initially expected.
 
In August 2009, Santhera and Takeda signed an agreement under which Catena® can be made available to European patients under a NPP. This program allows healthcare professionals to prescribe Catena® to individual patients in countries where the drug has no approval yet, thereby bridging the time until a full registration is received.
 
Catena®/Sovrima® in Friedreich's Ataxia - MICONOS Phase III study

The last patient recently completed the study, and results are due in the next few months. In meetings with the FDA and EMA, Santhera extensively discussed the insights from the Phase II NICOSIA and Phase III IONIA studies and, derived thereof, the intended analysis plan for the MICONOS data. As a result of these discussions, a responder analysis was introduced as key secondary endpoint, which can be used as primary analysis for ICARS, the study's primary efficacy variable. Another key aspect of the data analysis will be a combination of the mid- and high-dose groups for comparison to the combined placebo and low-dose group. Furthermore, Santhera intends to submit a meta-analysis for all children enrolled in the Company's three clinical Phase II and Phase III studies. The final statistical analysis plan for the MICONOS study incorporates learnings from the previous NICOSIA and IONIA studies and includes a number of pre-specified subgroup analyses. Santhera intends to file a New Drug Application for Catena® in the United States and a Marketing Authorization Application for Sovrima® (Takeda's brand name for the drug) in the European Union in the second half of 2010.  (…)

Webcast/Teleconference
 
At 11:00 CET / 10:00 UKT / 05:00 EST on February 26, 2010, Santhera will host an analyst presentation in Zurich (SIX Swiss Exchange, ConventionPoint, Selnaustrasse 30, Zurich). Anyone interested in participating may join either the webcast on www.santhera.com/webcast or the teleconference using the conference ID 55455911 and one of the following dial-ins.
 
Germany 0692 222 204 55 (local call)
Switzerland 044 580 34 09 (local call)
International +44 (0) 1452 560 068 (standard international)
USA +1 866 966 9439 (free call)
 
The webcast will be available for playback one hour after the analyst presentation ends.

Source/read more: Santhera’s press release

The legacy of Marie Schlau: literature to help cure Friedreich's Ataxia

If you feel like reading an unputdownable novel while collaborating with a just and solidary cause, "The Legacy of Marie Schlau" is your book! 100% of all funds raised will be dedicated to medical research to find a cure for Friedreich's Ataxia, a neurodegenerative disease that affects mostly young people, shortening their life expectancy and confining them to a wheelchair.

The life of Marie Schlau, a German Jewish girl born in 1833 hides great unsolved mysteries: accidents, disappearances, enigmas, unknown diagnoses, disturbing murders, love, tenderness, greed, lies, death ... alternatively a different story unfolds every time and takes us closer to the present. Thus, there are two parallel stories unravelling, each in a different age and place, which surprisingly converge in a revelatory chapter.

Paperback and Kindle versions for "The legacy of Marie Schlau" available for sale at Amazon now!

https://www.amazon.com/Legacy-Marie-Schlau-collective-Friedreichs-ebook/dp/B01N28AFWZ

 

Research projects currently being financed by BabelFAmily

Currently, BabelFAmily is financing two promising research projects aimed at finding a cure for Friedreich's Ataxia. Whenever you make a donation to us or purchase a copy of "The legacy of Marie Schlau", this is where all funds raised will be devoted to:

1) Gene Therapy for Friedreich's Ataxia research project:

https://www.irbbarcelona.org/en/news/international-patient-advocates-partner-to-fund-spanish-gene-therapy-project-to-treat

The project is the result of an initiative of Spanish people affected by this rare disease who are grouped in GENEFA in collaboration with the Spanish Federation of Ataxias and the BabelFAmily. The Friedreich’s Ataxia Research Alliance (FARA), one of the main patients’ associations in the United States now joins the endeavour.

2) Frataxin delivery research project:

https://www.irbbarcelona.org/en/news/new-research-front-to-tackle-friedreichs-ataxia
The associations of patients and families Babel Family and the Asociación Granadina de la Ataxia de Friedreich (ASOGAF) channel 80,000 euros of their donations (50% from each organisation) into a new 18-month project at the Institute for Research in Biomedicine (IRB Barcelona). The project specifically aims to complete a step necessary in order to move towards a future frataxin replacement therapy for the brain, where the reduction of this protein causes the most damage in patients with Friedreich’s Ataxia.

The study is headed by Ernest Giralt, head of the Peptides and Proteins Lab, who has many years of experience and is a recognised expert in peptide chemistry and new systems of through which to delivery drugs to the brain, such as peptide shuttles—molecules that have the capacity to carry the drug across the barrier that surrounds and protects the brain. Since the lab started its relation with these patients’ associations in 2013*, it has been developing another two projects into Friedrich’s Ataxia.

 

 

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