Announcement NeuroSearch's TIPO-4 study with tesofensine confirms the efficacy in weight management previously reported in TIPO-1 and provides the first long-term data with an average weight loss of 13 to 14 kg NeuroSearch reports positive key results of an interim analysis after the first 24 weeks of treatment in a 48 weeks clinical Phase II extension study (TIPO-4) with the company's drug candidate, tesofensine, for the treatment of obesity and type II diabetes. The TIPO-4 study is designed as an open-label extension to TIPO-1, a 24 week clinical Phase II Proof-of-Concept study of tesofensine in obesity, from which NeuroSearch reported break-through weight loss results in September 2007 (9 to 10 kg placebo-corrected weight loss). In TIPO-4, a total of 140 subjects having completed treatment in TIPO-1 with either tesofensine (0.25 mg, 0.5 mg or 1.0 mg) or placebo, have been enrolled after a wash-out period of two months to continue treatment with 0.5 mg tesofensine for an additional total of 48 weeks. The summary of the interim analysis at 24 weeks of TIPO-4 shows the following key results: Patients previously treated with placebo in TIPO-1 achieve in TIPO-4 an average weight loss of approximately 9 kg (in addition to the 2 kg they had lost already during TIPO-1) thus confirming the weight management effect of tesofensine seen in TIPO-1 at 0.5 mg under similar treatment conditions and duration. Patients previously treated in TIPO-1 with 0.5 mg tesofensine lost almost 4 kg in the subsequent treatment on 0.5 mg in TIPO-4. Taking into account the weight loss in TIPO-1 inclusive the weight gain during wash-out, the combined effect of TIPO-1 and TIPO-4 results in an average weight loss of 13 to 14 kg. Consistent with earlier clinical results, the 24 weeks safety data from TIPO-4 show that tesofensine is well-tolerated also over extended periods of administration. The most frequently reported adverse events are unchanged with dry mouth, insomnia and gastrointestinal disorders. Further and more detailed analyses to integrate the efficacy and safety data of TIPO- 1 and TIPO-4 are ongoing. In addition, the extension study continues as planned with expected reporting from the full 48 weeks extension treatment period by end 2008. The reported results from the first 24 weeks of TIPO-4 do not change NeuroSearch's financial expectations for 2008 of an operating loss in the region of DKK 450 million. Thomas Hofman-Bang Chairman of the Board Contact person: Flemming Pedersen, CEO, telephone: +45 2148 0118 NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on the OMX Nordic Exchange Copenhagen A/S. The core business covers the development of novel drugs, based on a broad and well-established drug discovery platform focusing on ion channels and CNS disorders. A substantial part of NeuroSearch's activities are partner financed through a broad alliance with GlaxoSmithKline (GSK) and collaborations with among others Abbott and Astellas. The drug pipeline comprises 13 clinical (Phase I-III) development programmes: ACR16 in Huntington's disease (Phase III), tesofensine in obesity and in type II diabetes (Phase III in preparation), NS2359 in depression (Phase II) and ADHD (Phase II) in partnership with GSK, ABT-894 in ADHD (Phase II) and pain (Phase II) in partnership with Abbott, ACR16 in schizophrenia (Phase I) in partnership with Astellas, ACR325 in Parkinson's disease (Phase II in preparation) and bipolar disorder (Phase II in preparation), ABT-107 as well as ABT-560 for the treatment of various CNS disorders - both (Phase I) in collaboration with Abbott, NSD- 644 in pain (Phase I) in partnership with GSK, ACR343 in Parkinson's disease (Phase I) and NSD-788 in anxiety/depression (Phase I). In addition, NeuroSearch has a broad portfolio of preclinical drug candidates and holds equity interests in several biotech companies.
NeuroSearch's TIPO-4 study with tesofensine confirms the efficacy in weight management previously reported in TIPO-1 and provides the first long-term data with an average weight loss of 13 to 14 kg
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