LUND, SWEDEN--(Marketwire - October 11, 2010) - 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 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.
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.