KeyNeurotek Pharmaceuticals AG, a biotechnology company focused on the development and marketing of drugs against autoimmune diseases and degenerative disorders of the central nervous system (CNS), announced that the Committee for Orphan Medicinal Products (COMP) of the London-based European Medicines Agency (EMEA) has approved KN38-7271 as an Orphan Medicinal Product for the orphan indication moderate and severe closed traumatic brain injury (TBI).

According to the EMEA, moderate and severe closed TBI was estimated to be affecting less than 4 in 10,000 persons in the European Community at the time of KeyNeurotek's application. Closed TBI is chronically debilitating and life threatening due to the high fatality rate and likelihood of permanent functional neurological impairments in surviving patients. Although satisfactory treatments of TBI have been authorized in the European Community, KN38-7271 may be of significant benefit to the patients.

Orphan Medicinal Products gain from a variety of incentives such as scientific advice and protocol assistance from EMEA during the product development phase, a 10-year marketing exclusivity, fee reductions or exemptions as well as further national incentives. The funds made available by the European Community for fee exemptions for orphan medicinal products amounted to 6 million € in 2007.

KN38-7271 is being tested by KeyNeurotek Pharmaceuticals in an international phase-II study in more than 90 patients with severe TBI since the end of 2006. The cannabinoid receptor agonist activates both CB1 and CB2 receptors in the brain, strengthening important natural protection mechanisms and preventing overacting inflammatory reactions. Four clinical phase-I trials indicated that the product is safe well tolerated in humans.

Dr Frank Striggow, CEO of KeyNeurotek Pharmaceuticals, said, "We are very pleased about this very positive EMEA decision. The Orphan Drug Designation will boost the further clinical development and marketing of our lead product KN38-7271."

KeyNeurotek Pharmaceuticals, a privately held biotechnology company, was founded in 2000 within the Magdeburg, Germany, regions, one of the leading centres of neuroscience in Europe.