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

pound has the potential to be granted European marketing approval for the treatment of FRDA in the second half of 2008.

A milestone payment of EUR 3 million to Santhera from its European marketing partner Takeda is triggered by the EMEA's acceptance of the SNT-MC17 MAA filing.

Santhera has decided, despite the MAA filing, to continue its ongoing Phase III clinical trial with SNT-MC17 in Europe to collect additional safety and efficacy data in a wider population of FRDA patients, particularly for doses up to 1350 mg/day and 2250 mg/day in the two body weight groups. Santhera amended the study protocol based on the findings of the NIH study to primarily evaluate the benefits of SNT-MC17 on the neurological aspects of FRDA. Santhera also offers all FRDA patients that participate and complete the EU Phase III trial the opportunity to enroll in an open label extension study where patients will receive high dose SNT-MC17.

Klaus Schollmeier, Santhera's CEO commenting on today's announcement said: "We are excited about filing the MAA submission for our first product. This was achieved as a combined effort of our specialists and the support we have received from our business partners, in particular from our marketing partner Takeda. Everyone at Santhera is very positive that we may be able to provide Friedreich' Ataxia patients with the first pharmaceutical product that is approved for the treatment of this devastating disease."

Yasuchika Hasegawa, Takeda's President said: "We are pleased with this important progress in development of SNT-MC17 for FRDA by Santhera, while there is currently no effective pharmacological treatment for this disease. We expect that our joint efforts with Santhera bring notable benefit to the patients with FRDA."

In August 2005, Santhera and Takeda signed an agreement under which Santhera granted exclusive marketing rights for SNT-MC17 in FRDA in the EU and in Switzerland to Takeda. Earlier this month, the two compani
'/>"/>

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:8/18/2014)... efficiency and data storage may someday run ... polarizations to read and write digital information, ... technology. But ferroelectrics must first overcome a ... habit of "forgetting" stored data. , ... Energy,s Brookhaven National Laboratory have discovered nanoscale ...
(Date:8/18/2014)... According to the new ... (Municipal Wastewater Treatment and Industrial Wastewater Treatment), By ... By Configuration (Internal/Submerged and External/Sidestream), and By Region-Trends ... market for membrane bioreactor systems is projected to ... CAGR of 15.28% between 2014 and 2019. ...
(Date:8/18/2014)... 2014 China is increasingly being ... clinical research industry. Clinicaltrial.gov statistics highlight the popularity ... aging population; a high increase in infectious diseases; ... populated pool of patients and a track record ... points, China also presents challenges for the clinical ...
(Date:8/16/2014)... Arlington has received a $229,214 grant from the Walmart ... testing system that would cut the manufacturing costs of ... United States that were formerly built overseas. , The ... announcement of $4 million in awards to seven research ... in Denver made possible through the collaboration between Walmart, ...
Breaking Biology Technology:Promising ferroelectric materials suffer from unexpected electric polarizations 2Promising ferroelectric materials suffer from unexpected electric polarizations 3Promising ferroelectric materials suffer from unexpected electric polarizations 4Membrane Bioreactor Systems Market Worth $2,927 Million by 2019 2Membrane Bioreactor Systems Market Worth $2,927 Million by 2019 3China – Land of Opportunities & Challenges for the Clinical Research Industry, New Webinar Hosted by Xtalks 2UT Arlington receives Walmart, Walmart Foundation innovation grant 2UT Arlington receives Walmart, Walmart Foundation innovation grant 3
... 16 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: ... company focused on endocrine therapy and oncology, today announced ... its partner and licensee for perifosine in the North ... from the U.S. Food and Drug Administration (FDA) for ...
... , , The ... , , WASHINGTON, Sept. 16 The Foundation ... national animal research education campaign. Since 2004, public support for humane ... points. The ResearchSaves campaign is designed to counter this drop in ...
... , NEW HAVEN, Conn., Sept. 16 Rib-X ... commercialization of novel drugs for the treatment of multi-antibiotic resistant ... the Company,s Board of Directors, succeeding Joseph Amprey, MD, Ph.D. ... of MedImmune, Chief Executive Officer of AstraZeneca North America, and ...
Cached Biology Technology:AEterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine (KRX-0401) for the Treatment of Multiple Myeloma 2AEterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine (KRX-0401) for the Treatment of Multiple Myeloma 3Biomedical Research Organization Launches Groundbreaking National TV Campaign 2Rib-X Pharmaceuticals, Inc. Appoints Tony Zook of MedImmune to Board of Directors 2Rib-X Pharmaceuticals, Inc. Appoints Tony Zook of MedImmune to Board of Directors 3
(Date:8/19/2014)... and tuberculosis live side-by-side. Worldwide there are approximately ... nearly all of them occurring where tuberculosis is ... or BCG, provides only partial protection against both ... is needed to combat both diseases. UCLA-led research ... diseases., In a study published in the September ...
(Date:8/19/2014)... Scientists at the Houston Methodist Research Institute have figured ... using a pipette -- a common laboratory tool that,s ... preliminary test results in a recent issue of the ... "Studying single cells and their unique functions has become ... faculty member Lidong Qin, Ph.D., the project,s principal investigator. ...
(Date:8/19/2014)... awarded a nearly $40,000 grant from the National Center ... the National Park Service (NPS) and U.S. Department of ... of the energy efficiency and cost effectiveness of radiant ... , Radiant barriers are reflective thermal insulations commonly fitted ... reducing the amount of heat emitted in the direction ...
Breaking Biology News(10 mins):New vaccine shows promise as stronger weapon against both tuberculosis and leprosy 2Moving single cells around -- accurately and cheaply 2UTSA researcher awarded $38K+ to evaluate energy efficiency options for historic homes 2UTSA researcher awarded $38K+ to evaluate energy efficiency options for historic homes 3
... the release of GeneLinker(TM) Gold and Platinum ... and Proteomics Analysis,Software products.,"The new releases are ... data, a high priority for many of ... Protein Biomarker Package into the,latest versions of ...
... will be brought to the marketplace, giving laboratories ... Technology Transfer GmbH (EMBLEM), the commercial entity of ... that it has signed a licensing deal with ... technology called SPIM (Selective Plane Illumination Microscopy). , ...
... There's a,paradigm in life science and drug development : ... occasions I've,seen very promising drugs candidates or related research ... it, even if millions would have,been saved worldwide. The ... drug candidate that affect a "profitable" disease in addition ...
Cached Biology News:Improved Outcomes Releases GeneLinker(TM) Gold and Platinum Version 4.6 2Improved Outcomes Releases GeneLinker(TM) Gold and Platinum Version 4.6 3The transparent organism: EMBLEM and Carl Zeiss give labs a unique look at life 2Finding Cures For Tropical Diseases: Is Open Source An Answer? 2
PFK-2 car (P-17)...
... contains 5 ml Dynabeads Epoxy (4.5 m). ... (epoxy) reactive groups. Ideal for coupling of ... hydrophobically on initial coupling with covalent binding ... and sulphydryll groups (SH)) occurring within 16-20 ...
LTBP-2 (7B10)...
... [198C679.2.1] to Presenilin 2 Alzheimer's disease ... the disease carry mutations in the presenilin ... protein (APP). These disease-linked mutations result in ... amyloid-beta (main component of amyloid deposits found ...
Biology Products: