Copenhagen, 2 June 2009 - NeuroSearch announces that the World Health Organisation (WHO) has proposed ‘pridopidine' as the INN (International Nonproprietary Name/generic name) for ACR16, the company's leading novel compound in late-stage development for the treatment of Huntington's disease. NeuroSearch successfully launched its pivotal development programme for pridopidine (ACR16) in Huntington's disease in April 2008. The programme comprises two clinical studies; MermaiHD, a European Phase III study, which in late March completed the recruitment of more than 420 patients, and HART, a North American Phase IIb confirmatory study. Results from MermaiHD are expected around the turn of the year 2009/2010, whilst HART results are anticipated in 2010. Dieter H. Meier, Executive Vice President and Chief Medical Officer of NeuroSearch commented: “This latest milestone supports our commitment to developing new and effective therapies for specialist CNS disease areas of significantly unmet medical need. Pridopidine (ACR 16) is being developed for Huntington's disease, a disease with very limited treatment options yet with potentially devastating consequences for patients and their families.” NeuroSearch expects the final INN as well as a new brand name for ACR16 to be granted in the near future and until then the company will refer to the drug by its proposed generic name as pridopidine (ACR16). Contact persons: Flemming Pedersen, CEO, telephone + 45 2148 0118 Hanne Leth Hillman, Vice President, Director of Investor & Capital Market Relations, telephone: +45 4017 5103 Pridopidine (ACR16) - A dopaminergic stabiliser Pridopidine (ACR16) belongs to a novel class of active agents called dopaminergic stabilisers, which have the unique ability to both strengthen and inhibit dopamine-regulated functions in the brain, depending on the base level of dopamine activity. Dopamine is an important neurotransmitter in the brain, and the dopaminergic system plays a central role in the control of motor and mental functions. In preclinical studies dopaminergic stabilisers have demonstrated the ability to stabilise motor, cognitive and psychiatric dysfunction, and they do this without compromising normal brain functions. NeuroSearch is evaluating pridopidine in a pivotal programme for the treatment of Huntington's disease, comprising of a European Phase III study, MermaiHD, and a North American Phase IIb confirmatory study, HART. Pridopidine has previously been evaluated in a Phase II Proof of Concept study in Huntington's disease with positive results showing a statistically significant improvement in patients' motor function (gait and Parkinsonism) as well as improvements in their attention and psychiatric symptoms. Further, the agent has been studied also in clinical Phase I studies in Huntington's disease, Parkinson's disease and schizophrenia with favourable and consistent results. Pridopidine was discovered by NeuroSearch, which holds the global rights to the compound. Both the European (EMEA) and the US (FDA) Health Authorities have granted pridopidine orphan drug designation for the treatment of Huntington's disease. Huntington's disease Huntington's disease is a fatal, hereditary neurodegenerative genetic disorder, which leads to damage of the nerve cells in certain areas of the brain including the basal ganglia and the cerebral cortex. Patients with Huntington's disease experience a wide variety of symptoms, including severe motor disturbances (both lack of voluntary movements and involuntary movements), cognitive impairment and psychiatric disorders. Symptoms onset is typically around 35 and 45 years of age and patients hereafter have a life expectancy of 10 to 15 years. The disease occurs at a rate of about one in every 10,000 in most western countries with an estimated 70,000 affected patients in North America and Europe. In other parts of the world the prevalence of Huntington's disease is lower, and the total number of patients affected with the disease outside North America and Europe is estimated at 30,000 to 35,000. The rate of diagnose also varies among geographic regions. After symptoms onset the disease progresses without remission, and eventually every person afflicted by Huntington's disease will require full-time care. There is currently no cure or effective treatment for Huntington's disease and only a limited number of novel drugs in development. About NeuroSearch NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on Nasdaq OMX Copenhagen. The core business of the company covers the development of novel pharmaceutical agents, based on a broad and well-established drug discovery platform focusing on ion channels and central nervous system (CNS) disorders. A substantial share of the activities is partner financed through strategic alliances with Eli Lilly and Company and GlaxoSmithKline (GSK), and license collaboration with Abbott. The drug pipeline comprises seven clinical (Phase I-III) development programmes: Pridopidine (ACR16) for Huntington's disease (Phase III), tesofensine for obesity (Phase III ready), ABT-894 for ADHD (Phase II) in partnership with Abbott, ACR325 to treat dyskinesias in Parkinson's disease (Phase II ready), ACR343 for schizophrenia (Phase I), ABT-560 for the treatment of various CNS disorders (Phase I) in collaboration with Abbott, and NSD-788 for anxiety/depression (Phase I). In addition, NeuroSearch has a broad portfolio of preclinical drug candidates and holds equity interests in several biotech companies.
NeuroSearch announces pridopidine as the generic name for ACR16, the company's novel drug in pivotal stage development for Huntington's disease
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