BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

NeuroVive Pharmaceutical AB Obtains U.S. Orphan Drug Designation for Traumatic Brain Injury


12/6/2010 9:06:57 AM

LUND, SWEDEN--(Marketwire - December 06, 2010) - NeuroVive Pharmaceutical AB (STKM: NVP) announces that the U.S. FDA Office of Orphan Products Development has granted an Orphan Drug Designation to the company's NeuroSTAT® (cyclosporine) product for the treatment of moderate to severe traumatic brain injury. The Orphan Drug Designation covers both open and closed moderate to severe traumatic brain injury and gives NeuroVive market exclusivity for NeuroSTAT® in the United States for seven years from the date of marketing approval.

CEO Michael Bronnegard comments:
"The U.S. Orphan Drug Designation for NeuroSTAT® was granted for patients with both open and closed traumatic brain injury, which exceeded our expectations. It indicates that there is indeed a significant medical need in this group of patients, where no effective pharmaceutical treatment is yet available to treat acute neurodegenerative injuries. Obtaining Orphan status in the U.S. is an important milestone in our company's efforts to develop an effective drug for acute brain injuries and this designation can facilitate more rapid development and commercialization in the United States."

Orphan Designation
FDA Orphan Drug Designation is intended to support the clinical development of drugs for diseases and conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation gives market exclusivity for seven years in the U.S. from the date the product receives marketing approval. Orphan Drug Designation also provides access to regulatory support from the FDA throughout the development process. Designation does not imply that the product has demonstrated the efficacy, safety and quality required for drug approval in the U.S. These criteria must be met in the clinical phase of development and receive approval from the FDA before a market authorization for the product is granted.

About NeuroVive
NeuroVive is a Swedish drug development company focused on cyclosporine-based cyclophilin D inhibitors for mitochondrial neuroprotection. The active ingredient in NeuroVive's lead product NeuroSTAT®, cyclosporine (cyclosporin-A), has been repurposed for neuroprotection after years of use in humans for immunosuppression in organ transplantation. NeuroSTAT®, a cremophor®- and ethanol-free intravenous cyclosporine product, is in clinical trials to evaluate its suitability for patients with traumatic brain injury and other acute neurological injuries. NeuroVive shares are listed on the Swedish trading platform AktieTorget (www.aktietorget.se). The AktieTorget market is focused on emerging, entrepreneurial businesses via an electronic trading system supplied by the OMX Nordic stock exchange in Stockholm, Sweden.

Press Release (PDF) http://hugin.info/139945/R/1469105/406443.pdf


Contact
Michael Bronnegard, MD, PhD
Chief Executive Officer
Tel.: +46 46 288 0110
Mobile: +46 702 99 62 64
E-mail: mikael.bronnegard@neurovive.com
NeuroVive Pharmaceutical AB (publ)
Biomedical Center BMC D10, 221 84
Lund, Sweden
www.neurovive.com



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES