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

December 6, 2010 - Lund, Sweden. NeuroVive Pharmaceutical AB (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.
 
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,
Swedenwww.neurovive.com
 
Press Release (PDF): 
http://hugin.info/139945/R/1469105/406443.pdf
 
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Source: NeuroVive Pharmaceutical AB via Thomson Reuters ONE
 
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