NeuroSearch successfully completes patient recruitment in MermaiHD, a pivotal Phase III study of ACR16 in Huntington’s disease – and updates on other pipeline news 31 March 2009 - Announcement PDF version   -     ACR16 for Huntington’s disease: Target recruitment of 420 Huntington’s patients completed in the European Phase III study, MermaiHD -     Tesofensine for obesity: FDA has granted an End of Phase II meeting and confirmed a date in Q2 2009 -     ABT-107: Discontinuation of further development in Phase I (Abbott collaboration)     Recruitment completed in Phase III study with ACR16 in Huntington’s disease    NeuroSearch has successfully completed the recruitment of patients in MermaiHD, the European Phase III study of ACR16, a dopaminergic stabiliser and the company’s novel drug candidate for the treatment of Huntington’s disease. The recruitment is completed less than a year after the first Huntington’s patient was screened for the study, which, with 420 patients planned for enrolment, is the biggest Huntington’s disease trial that has ever been performed in Europe.   MermaiHD is a multi-centre, randomised, double-blinded and placebo-controlled study to evaluate the efficacy and safety of ACR16 as a novel treatment for Huntington’s disease.  In the study, Huntington’s patients are randomised to receive either 45 mg ACR16 once daily, 45 mg ACR16 twice daily or placebo over 26 weeks of treatment. The study is performed at centres in eight European countries including Austria, Belgium, France, Germany, Italy, Portugal, Spain and the United Kingdom.   To date, 80 patients who have completed the 26 weeks of randomised treatment in MermaiHD have elected to continue in the six month, open-label extension to the study, and the first patients are approaching one year treatment with ACR16.  So far, the safety profile of ACR16 has been very satisfactory.   MermaiHD is performed in collaboration with the European Huntington’s Disease Network (EHDN), an association of investigators dedicated to improving the care of patients with Huntington’s disease through clinical research. Their efforts to help identify eligible patients and support participating clinics have played a significant role in the timely recruitment for the study.   MermaiHD is a Phase III study and part of NeuroSearch’s pivotal development programme for ACR16, which also comprises HART, a Phase IIb study, being conducted in North America. HART was initiated in October 2008 and patient recruitment is expected to complete later in 2009. Dieter Meier, MD, CMO of NeuroSearch, comments: “We would like to thank the patients and caregivers, who, by their participation, are making this study possible. Thanks should also go to the Huntington’s Disease associations of the participating countries, who have helped in creating awareness of the study among patients. Together we have succeeded in recruiting more than 400 patients with Huntington’s disease in less than a year. This is in absolute accordance with our plans, and the completion of patient recruitment in MermaiHD, the largest study ever conducted with a novel drug in Huntington’s disease in Europe, is a very important milestone for us.” Flemming Pedersen, CEO of NeuroSearch, adds; “We are excited about the prospects of launching ACR16 in 2011 as a novel and better treatment for Huntington’s disease. In this area, the need for better drugs is huge, and bringing ACR16 to the market to help improve lives for both patients and their relatives will mark a tremendous change for our company.”     Tesofensine for obesity – End of Phase II meeting in Q2 2009 NeuroSearch has been granted an End of Phase II meeting with the FDA on tesofensine for the treatment of obesity, and a meeting date in the second quarter of 2009 has been agreed.   In a Phase II Proof-of-Concept study, TIPO-1, including 203 patients with obesity (average BMI of 34.5 and an average weight of 100 kg), 24 week treatment with tesofensine resulted in an out-standing placebo-controlled weight-loss of approximately 10 %. The full results of the study was published in the Lancet in October 2008 with the conclusion that tesofensine elicits more than double the weight-loss of existing anti-obesity drugs and should be evaluated in Phase III studies.   Through 2008, NeuroSearch has performed a number of additional clinical studies, thereby adding to the substantial efficacy and safety data package supporting the strong profile of tesofensine. All available data together with the planned Phase III programme will now be discussed with the FDA, and NeuroSearch also prepares for meetings with EMEA, the European Healthcare authorities later in 2009.   After the regulatory interactions, NeuroSearch will finally decide on the pivotal Phase III programme for tesofensine as well as on the strategy for final development of the drug.       Discontinuation of ABT-107 in Phase I development under collaboration with Abbott   ABT-107 is an alpha7-specific neuronal nicotinic receptor (NNR) modulator, which Abbott has been evaluating in preclinical and clinical Phase I studies under a license agreement with NeuroSearch. Based on results from these studies, Abbott and NeuroSearch have decided not to pursue further development of the compound at this time.     Flemming Pedersen CEO       Contact person: Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148 0118 Hanne Leth Hillman, Vice President, Director of Investor Relations & Corporate Communications, telephone: +45 4460 8212 or +45 4017 5103