Navigation Links
European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreich's Ataxia by Santhera
Date:8/19/2007

LIESTAL, Switzerland and OSAKA, Japan, August 16 /PRNewswire-FirstCall/ -- Santhera Pharmaceuticals (SWX: SANN, "Santhera"), a Swiss specialty pharmaceutical company with a focus on neuromuscular diseases, and Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda"), jointly announced today that the European Medicines Agency (EMEA) has accepted the filing of the Marketing Authorization Application (MAA) for Santhera's lead compound SNT-MC17 (INN: idebenone, originally developed by Takeda) for the treatment of Friedreich's Ataxia (FRDA). SNT-MC17, which has been granted orphan drug designation in the EU, could become the first approved product for the treatment of FRDA and will be marketed in Europe by Santhera's partner Takeda. SNT-MC17 has shown clinical efficacy in FRDA patients on neurological as well as cardiac endpoints in several clinical studies and proved to be well tolerated in all studies so far.

In a recently completed clinical trial conducted in collaboration with the US National Institutes of Health (NIH), Santhera tested the efficacy of three doses of SNT-MC17 in patients with FRDA. Study results were announced in fall 2006. The MAA file includes data generated in this collaborative study with the NIH analyzing a variety of neurological and cardiac outcome measures, supported by data from earlier clinical trials in FRDA conducted by academic institutions that demonstrated efficacy primarily in the treatment of the cardiac symptoms of this devastating disease. The MAA recommends a starting dose of 450 mg/day for patients below 45 kg body weight and 900 mg/day for patients of 45 kg or above body weight, with the option for the treating physician to use higher doses if needed.

The MAA file includes safety data generated by Santhera with SNT-MC17 as well as safety data from Takeda generated in its earlier preclinical and clinical development program with idebenone for the treatment of Alzheimer's disease. Santhera believes that the com
'/>"/>

SOURCE Santhera Pharmaceuticals AG

Copyright©2007 PR Newswire.

Page: 1 2 3 4 5 6

Related biology technology :

1. Mirus granted European patent for gene therapy
2. Info security group announces first Eastern European chapter
3. EMD Biosciences partners with European biotech company
4. Third Wave lands European distribution deal, reports high earnings
5. Biologist who cloned Dolly the sheep believes therapeutic cloning will gain acceptance
6. Biotech crops gaining acceptance, but their full promise has yet to be fulfilled
7. Risks and returns: Building a search engine marketing portfolio
8. The write stuff: marketing with articles
9. StrandVision signs joint marketing agreement with Pacific Signage
10. CPM contributes marketing program to Michigan hospital
11. MyWeather names new president, marketing officer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/22/2014)... LANSING, Mich., July 22, 2014  Neogen Corporation (NASDAQ: ... its 2014 fiscal year, which ended May 31, increased ... net income was $28,158,000, compared to the prior year,s ... 30, 2013, earnings per share in the current year ... revenues and net income for the 2014 fiscal year ...
(Date:7/22/2014)... , July 22, 2014 Hussey Copper ... MD-Cu 29 antimicrobial copper announces Pullman Regional Hospital,s ... first EPA-registered antimicrobial solid touch surface, at a nominal ... of MRSA, E-coli and other bacteria within 2 hours of ... protecting against bacteria and infectious diseases in its facilities. ...
(Date:7/22/2014)... July 22, 2014  United Therapeutics Corporation (NASDAQ: ... will release its second quarter 2014 financial results ... United Therapeutics will host a half-hour ... a.m. Eastern Time.  The teleconference is accessible by ... rebroadcast of the teleconference will be available for ...
(Date:7/22/2014)... (PRWEB) July 22, 2014 Dr. Williams ... those who have recognized that the greatest health care ... far too often needlessly deadly while trying to serve ... of quasi-experts seeking to transform an enormous system that ... Dr. Williams, in his continuing series of Open Letters ...
Breaking Biology Technology:Neogen reports 19% increase in annual revenues 2Neogen reports 19% increase in annual revenues 3Neogen reports 19% increase in annual revenues 4Neogen reports 19% increase in annual revenues 5Neogen reports 19% increase in annual revenues 6Neogen reports 19% increase in annual revenues 7Neogen reports 19% increase in annual revenues 8Pullman Regional Hospital changes more than 1,100 touch points to Hussey Copper's MD-Cu29 antimicrobial copper to help protect against bacteria 2Pullman Regional Hospital changes more than 1,100 touch points to Hussey Copper's MD-Cu29 antimicrobial copper to help protect against bacteria 3Dr. Ira Williams Asks What’s Wrong With Jonathan Bush’s Book, Where Does It Hurt? 2
... in Key Markets, Differentiated Product Offerings and ... Performance, CARY, N.C., Jan. 10 ... significant milestone with the signing of its ... additional customers during the,second half of 2007. ...
... LONDON, January 10 Amarin Corporation plc,(NASDAQ: AMRN ... and ethical approvals to commence a Phase IIa trial ... The Phase IIa trial will be a randomized, ... AAMI who,will be randomized to receive 1, 2 or ...
... Essilor International,s US subsidiary, has strengthened its,prescription laboratory ... Interstate Optical Co., one of the country,s five ... and,Indianapolis, Indiana serve eye care professionals in 32 ... and 210 employees., Present for more than ...
Cached Biology Technology:SciQuest Continues to Surpass Milestones for Customer Wins, Growth and Market Share; Remains Clear Eprocurement Leader for Academic and Research-Centric Organizations 2SciQuest Continues to Surpass Milestones for Customer Wins, Growth and Market Share; Remains Clear Eprocurement Leader for Academic and Research-Centric Organizations 3SciQuest Continues to Surpass Milestones for Customer Wins, Growth and Market Share; Remains Clear Eprocurement Leader for Academic and Research-Centric Organizations 4Amarin to Commence Phase II Trial With AMR101 in Age Associated Memory Impairment 2Amarin to Commence Phase II Trial With AMR101 in Age Associated Memory Impairment 3Amarin to Commence Phase II Trial With AMR101 in Age Associated Memory Impairment 4
(Date:7/22/2014)... the National Institute of Standards and Technology (NIST), ... dramatically improved technique for analyzing biological cells and ... new NIST technique is an advanced form of ... that delivers signals that are 10,000 times stronger ... times stronger than obtained from comparable "coherent Raman" ...
(Date:7/22/2014)... N.C. In a cost-effectiveness analysis of commercial diet ... drug Qsymia showed the best value for the money. ... but was also the most expensive option tested, according ... Medical School. , The findings, published in the June ... information on the health and weight-loss benefits per dollar ...
(Date:7/22/2014)... Buccola, MSN, APRN, PMHCNS-BC, CNE, Assistant Professor of ... Orleans School of Nursing, contributed samples used in ... associated with schizophrenia and also suggesting a possible ... study, Biological insights from 108 schizophrenia-associated genetic loci, ... Nature , available at http://www.nature.com/nature/journal/vaop/ncurrent/full/nature13595.html., ...
Breaking Biology News(10 mins):Enhanced NIST instrument enables high-speed chemical imaging of tissues 2Enhanced NIST instrument enables high-speed chemical imaging of tissues 3Study compares cost-effectiveness of weight-loss programs and drugs 2Study compares cost-effectiveness of weight-loss programs and drugs 3LSUHSC contributes to work identifying new DNA regions associated with schizophrenia 2
... Bio-Technology Group Co., Inc. (OTC Bulletin Board: ... leading developer, manufacturer and marketer of Traditional Chinese ... other health and nutritional products in the People,s ... its private placement offering for aggregate gross proceeds ...
... In order for medical students to ultimately provide quality patient ... teach physiology, one of the core disciplines of medicine, according ... Journal of the American College of Radiology ( www.jacr.org ... systems. "It is vital that medical schools provide ...
... Avantra Biosciences (Avantra) today announced the selection ... test site for Avantra,s new biomarker quantitation platform. ... has created an automated multiplex immunoassay system to ... patient characteristics, and drug responses. The new Q400 ...
Cached Biology News:Weikang Bio-Technology Announces Completion of $5.0 Million Private Placement 2Weikang Bio-Technology Announces Completion of $5.0 Million Private Placement 3Avantra Biosciences teams with TGen Drug Development to assist pharma 2
Rabbit polyclonal to Bag5 ( Abpromise for all tested applications). entrezGeneID: 9529 SwissProtID: Q9UL15...
Rabbit polyclonal to VEZT ( Abpromise for all tested applications). Antigen: Full length human VEZT conjugated to GST Entrez Gene ID: 55591 Swiss Protein ID: Q9HBM0...
Phospho-4E-BP1 (Thr37/46) (236B4) Rabbit mAb Shipping Temperature: Cold Storage Temperature: -20C...
Goat polyclonal to FBXO2 ( Abpromise for all tested applications). entrezGeneID: 26232 SwissProtID: Q9UK22...
Biology Products: