Below please find the first part of the NeuroSearch Q3 interim report 2010. The entire report is available in the enclosed PDF document. --------------------------------- Copenhagen, 18 November 2010 - Today, the Board of Directors of NeuroSearch A/S (NEUR) considered and approved the company's interim report for the period 1 January to 30 September 2010. The operating result for the first nine month of 2010 was a loss of DKK 237.3 million (a loss of DKK 260.0 million in the same period of 2009). The company's capital resources totalled DKK 709.4 million at 30 September 2010 (DKK 703.5 million at 30 September 2009), consisting primarily of highly liquid short-term bonds and guaranteed future payments from collaboration partners. Financial net income for the period positively affected net results by DKK 23.4 million. Important business events and pipeline progress in the third quarter of 2010 and the subsequent period: • Huntexil® (pridopidine) - Huntington's disease - Mid October, NeuroSearch reported the results from the HART study, a North American Phase IIb study. The results showed significant effect on Huntington patients' total motor function measured on the Total Motor Score, TMS, after 12 week's treatment with Huntexil®, although the primary endpoint, the modified Motor Score, mMS, was not met. The study also demonstrated a significant dose-response relationship and overall provides firm support to the previous clinical results from the Phase III MermaiHD study. - Based on the results from the MermaiHD and the HART studies, NeuroSearch is convinced that Huntexil® represents a highly promising new treatment for Huntington's disease with unique and beneficial effects on the patients' core motor functions and a favourable safety profile. - NeuroSearch is analysing all available clinical data on Huntexil® and will subsequently initiate discussions with regulatory authorities in the US and in Europe with a view to defining the best way forward to obtaining marketing approvals for the product. It is expected that these regulatory discussions will take place during the first quarter of 2011. - As reported mid September, the results from a 26-week open-label safety extension to the Phase III MermaiHD study showed that Huntexil® was well tolerated and had a good safety profile in patients with Huntington's disease over 12 months' treatment - To meet requests for continued access to treatment with Huntexil® from patients and investigators, who have participated in the HART study, NS has decided to initiate an open-ended open-label study for those patients, who have completed the HART study. The first patients are expected to start treatment in the open study in the first quarter of 2011. • Tesofensine - Obesity - NeuroSearch is preparing a revised Phase III plan for tesofensine, aiming in the first half of 2011 to reach an agreement with the regulatory authorities in the US and in Europe on the way forward for the programme in obesity. In parallel, talks with potential partners on the programme have been intensified. - Supported also by a number of experts in the field, it is the evaluation of NeuroSearch that tesofensine represents a promising and attractive new treatment for obesity. Given the difficult regulatory environment for novel products for medical treatment of obesity and the considerable financial burden associated with Phase III studies, however, it has been decided that NeuroSearch will not invest further in this programme before a partner has been selected. • Other clinical programmes - Seridopidine - Schizophrenia: NeuroSearch is evaluating the potential for seridopidine (previously designated ACR343) within schizophrenia and in parallel, also in the treatment of selected CNS speciality indications. The company plans to initiate the first Phase II study with seridopidine in the course of the first half of 2011. - Ordopidine - Dyskinesias in Parkinson's disease: NeuroSearch expects to complete the ongoing Phase Ib safety study with ordopidine (previously designated ACR325) in Parkinson patients suffering from L-Dopa-induced dyskinesias in the beginning of 2011. Concurrently, a Phase II study is in preparation with the objective of demonstrating Proof of Concept for the treatment effect of ordopidine in this indication. The Phase II-study is expected to be initiated in the first half of 2011. • Discovery and development activities - NeuroSearch is evaluating the development possibilities for NSD-788 and NSD-721, after the two compounds have demonstrated a good tolerability and safety profile in Phase I. - The collaborations with Eli Lilly and Janssen are still progressing satisfactorily and are expected to lead to the identification of new development candidates within the coming 6-12 months. • Organisation - As of 15 September, Patrik Dahlen joined NeuroSearch as new CEO of the company. According to Article 4a of the company's Articles of Association, the Board of Directors has decided to issue up to 650,000 warrants to the Executive Management and other employees, entitling the holders to subscribe NeuroSearch shares at the ratio of 1:1 and corresponding to a total nominal value of up to DKK 13 million. The allocation between the Executive Management and other employees has not yet been decided upon. The Board of Directors has decided that warrants will no longer be issued to Board members. The exercise price of the warrants has been fixed as the average market price of the NeuroSearch shares in the period from 11-24 November 2010. In accordance with Article 4a, the exercise price must not be fixed below the average market price of the shares on 18 November 2010. NeuroSearch maintains the financial guidance for the full year 2010 of a loss before financials and other shares of results of approximately DKK 350 million. Patrik Dahlen Thomas Hofman-Bang CEO Chairman of the Board Contact persons: Patrik Dahlen, CEO, telephone: +45 4460 8214 or +45 2629 7296 Hanne Leth Hillman, Vice President, Director of Investor & Capital Market Relations, telephone: +45 4460 8212 or +45 4017 5103 Telephone conference The interim report for Q3 2010 will be presented at a telephone conference today at 11 am Copenhagen time (10 am London time, 5 am New York time). Participating in the telephone conference will be CEO Patrik Dahlen, Vice President & CFO Anita Milland and Vice President and Director of Investor & Capital Market Relations Hanne Leth Hillman. The telephone conference will be conducted in English and the dial-in numbers are: UK and International +44 207 509 5139, US +1 718 354 1226 and DK +45 3271 4767. About NeuroSearch NeuroSearch A/S is a leading CNS focused and European based biopharmaceutical company listed on NASDAQ OMX Copenhagen A/S (NEUR). The company's core business is development of novel drugs to treat diseases of the central nervous system, and the pipeline comprises eight products in clinical development (Phase I-III). These include Huntexil® (pridopidine), a unique orphan drug in Phase III development for the treatment of Huntington's disease, and tesofensine ready for Phase III development as a novel drug to treat obesity. NeuroSearch is founded on a well-established drug discovery platform in the field of ion channels and monoamine transporters, ensuring the continuous production of novel preclinical development candidates. The company has strategic drug discovery and development alliances with Janssen Pharmaceutica and Eli Lilly as well as a licence collaboration with Abbott. Further, NeuroSearch has equity interests in a number of private companies in the Life Science industry.
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