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 DesignationFDA 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 NeuroViveNeuroVive 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
(http://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
(http://hugin.info/139945/R/1469105/406443.pdf)