NeuroVive receives Orphan Drug Designation in Europe for moderate and severe traumatic brain injury

October 11, 2010 - Lund, Sweden. The European Commission has granted Orphan
Medicinal Product Designation status to NeuroVive Pharmaceutical AB's product
NeuroSTAT® for the treatment of patients with moderate and severe traumatic
brain injury. This follows the positive opinion of the European Medicines Agency
EMA in July. Orphan drug designation gives NeuroVive access to regulatory
assistance from the European Medicines Agency (EMA) during the development
phase, reduced regulatory fees, and market exclusivity in the EU for ten years
after the product attains marketing authorization.
 
CEO Mikael Brönnegård comments:
"The Commission's decision is an affirmation of our development strategy. From a
market point of view, the possibility of ten years exclusivity from registration
in the EU is extremely important to NeuroSTAT's continued development in
neuroprotection and it creates the conditions for more rapid commercialization.
Orphan Drug Designation gives us access to important regulatory assistance which
will greatly facilitate the development of neuroprotective therapy for acute
treatment of patients with moderate and severe traumatic brain injury."
 
Traumatic brain injury (TBI) is the leading cause of death in men between the
ages of 15 and 45 and it disables almost 100,000 men and women in Europe each
year. Victims of TBI often cannot return to work or independent living. There is
no approved drug that can reduce brain damage that results from TBI.
Cyclosporine, the active ingredient in NeuroVive's product NeuroSTAT®, has been
shown to dramatically reduce brain damage from TBI in numerous animal studies.
 
CSO Eskil Elmér states: "An effective treatment for traumatic brain injury has
long been sought by neurosurgeons. NeuroSTAT® cyclosporine has been shown to
protect energy-producing mitochondria and counteract brain damage in TBI models.
Our clinical development program will begin to test its efficacy in patients."
 
Orphan Designation
Orphan Medicinal Product legislation in the European Union provides incentives
to encourage the development and marketing of medicines for rare diseases.
Designation as an Orphan Medicinal Product does not indicate that the product
has yet fulfilled the efficacy, safety and quality criteria required for drug
marketing in the EU. These criteria remain to be fulfilled in the pharmaceutical
and clinical development of the drug and assessed by EMA at the marketing
authorization stage.
 
NeuroSTAT®
The active ingredient in NeuroVive's lead product NeuroSTAT®, cyclosporin-A, has
for years been used for immunosuppression, such as in organ transplantation. The
established intravenous cyclosporin-A based products on the market for
immunosuppression contain Cremophor® EL which has been reported to cause severe
hypersensitivity reactions (anaphylaxis) in a small number of treated patients.
NeuroSTAT® is a novel Cremophor® EL-free formulation of cyclosporin-A which is
bioequivalent to Sandimmune® Injection and designed for safe intravenous use,
especially for neuroprotection indications in head injury, and cardioprotection
in myocardial infarction where patients will not, in contrast to transplant
patients, receive corticosteroid pre-treatment which would reduce the risk of
Cremophor® EL-induced sensitivity reactions.
 
For further information contact:
Mikael Brönnegård, MD PhD
CEO, NeuroVive
 
Telephone: Direct. +46 (0) 46-288 01 10, Mobile. +46 (0) 70-299 62 64
E-mail:mikael.bronnegard@neurovive.se
Homepage:www.neurovive.com, www.neurovive.se
Mailing address: Biomedical Center, BMC D10, SE-221 84 Lund, Sweden
 
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Press Release (PDF): 
http://hugin.info/139945/R/1450780/392062.pdf
 
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Source: NeuroVive Pharmaceutical AB via Thomson Reuters ONE