Today, the Board of Directors adopted the interim report for the period 1 January to 30 June 2007. A loss after tax of DKK 149.1 million (a loss of DKK 98.5 million in the same period of 2006) was posted. The comparative figures for H1 2006 do not include NeuroSearch Sweden AB, which was acquired in Q4 2006. The company's capital resources stood at DKK 354.9 million at 30 June 2007 (DKK 350.1 million at 30 June 2006). Activities in the company's drug discovery and development programmes continue to be at a very high level in 2007, and NeuroSearch has achieved a number of important milestones related to drug products under development during the period since the turn of the year: - For ACR16, full documentation including chronic safety results was obtained for the initiation of Phase III clinical studies in Huntington's disease. - The treatment of all patients in the Phase IIb efficacy study with tesofensine for the treatment of obesity (TIPO-1) has been completed. The processing of data is in progress. - Three new Phase II clinical studies have been initiated. - Two Phase II clinical studies have been completed and reported. - Three new Phase I clinical programmes have been initiated, including the start-up of clinical studies with two new drug candidates. - Under the terms of the option agreement, GlaxoSmithKline (GSK) has accepted NSD-644 as a CEEDD (Center of Excellence for External Drug Discovery) candidate for further development. The research organisation has been very productive, and the development pipeline has been expanded to include four new drug candidates from the drug discovery programmes since the turn of the year. NeuroSearch's pipeline now includes 19 development programmes (or 16 drug candidates) under development in a large number of disease areas. Nine of these are being developed and funded under licence agreements with multinational pharmaceutical groups and with significant earnings potential for NeuroSearch by way of milestone payments totalling DKK 2.3-2.4 billion and royalties on future turnover by the partners. The company's management considers the performance since the turn of the year to be highly satisfactory. Key events in H1 2007 and until the release of this interim report: • ACR16 (Huntington's disease): NeuroSearch has completed six months of toxicology studies with satisfactory results which support data from earlier safety studies. Thus, all preclinical safety studies necessary for the initiation of Phase III studies have now been completed, and applications for the start-up of Phase III are being prepared. • NS2359 (depression): In April NeuroSearch's collaboration partner GSK initiated the second of two clinical Phase II studies evaluating the drug candidate NS2359 as a new treatment for depression (MDD). The combined Phase IIb programme is highly ambitious and will involve approx. 900 patients. • Tesofensine (obesity/type 2 diabetes): In the Phase II efficacy study (TIPO-1), treatment of all patients participating in the study has now been completed, and results from the study are expected in September. Moreover, NeuroSearch has initiated a further clinical study (TIPO-4), in which all patients who have completed TIPO-1 will be offered a further six months of treatment. The enrolment of patients is progressing according to plan. • ABT-894 (ADHD and pain): In March 2007, NeuroSearch's development and license partner, Abbott initiated a Phase IIb clinical study with the drug candidate ABT-894 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults. The ADHD study is progressing according to plan. Abbott is also planning for the initiation of a second Phase II study with this drug candidate in neuropathic pain. • NS1209 (epilepsy/pain): NeuroSearch has completed two minor Phase IIa clinical studies of NS1209 in status epilepticus and neuropathic pain, respectively. Following a thorough evaluation of the combined data package etc., it has been decided to seek a partner focusing on these specialist indications for the future development of NS1209. • ACR16 (schizophrenia): NeuroSearch's development and licence partner, Astellas, has initiated a clinical Phase Ib multiple dosing study with ACR16 in patients suffering from schizophrenia. Astellas holds the global rights to ACR16 in all indications, except for Huntington's disease, for which NeuroSearch holds the rights in North America and Europe. • ABT-107 (CNS disorders): In May, Abbott initiated a clinical Phase I study with ABT-107, a novel neuronal nicotinic receptor (NNR) modulator which has treatment potential within a variety of CNS disorders. The Phase I study is progressing according to plan. • ABT-560 (cognitive dysfunctions): End July, Abbott initiated a clinical Phase I study with ABT-560, another novel NNR modulator with potential to treat cognitive dysfunctions in specific patient populations. ABT-560 is the third drug candidate to be brought into clinical development under the license agreement between Abbott and NeuroSearch covering NNR modulators. • Four new development candidates: During H1 2007, three new drug candidates were selected from the drug discovery programmes: NSD-708 for the treatment of anxiety, NSD-788 for the treatment of anxiety and other psychiatric disorders and NSD-726 for the treatment of autoimmune diseases. Most recently, also NSD-721 from the drug discovery programme in GABA modulators was selected for development for the treatment of anxiety, epilepsy and pain. GSK holds options to develop all four compounds under the expanded option agreement from November 2006. TopoTarget and NeuroSearch have decided to stop the further development of NSD-551 due to insufficient efficacy in cancer models. NeuroSearch has decided to change the practice for financial guidance and will no longer include revenues from partnership agreements until they are realised. The reason is that, pursuant to our strategy, we wish to have the greatest flexibility possible when negotiating new partnership agreements and, in addition, the timing of milestone payments in general is subject to significant uncertainty. To this should be added that the international financial reporting rules and the interpretation thereof entail uncertainty with respect to the allocation and recognition of initial payments over the term of licence agreements. The previous financial guidance for 2007 has included probability-adjusted expected revenues from partnership agreements of approx. DKK 150 million. NeuroSearch still expect to generate additional revenue from licence agreement in the second half of the year, but have elected not to include yet un-secured revenues in its full year guidance. Therefore, the financial guidance for 2007 has been adjusted to a loss in the range of DKK 230-250 million (previous guidance of a loss in the range of DKK 80-100 million) before recognition of associates and other equity interests. If earnings from licence agreements are realised, the forecast will be increased continuously as and when such earnings are achieved. The Board of Directors has resolved to issue up to 325,000 warrants pursuant to article 5a of the Articles of Association entitling the holders to subscribe for shares with a nominal value of up to DKK 6,500,000 to the Board of Directors, executive management and employees. The allocation between the Board of Directors, executive management and employees has not yet been made. The exercise price will be fixed as the average trading price during the period 15-28 August 2007 plus 10% p.a. Pursuant to article 5a of the Articles of Association, the exercise price cannot be fixed lower than DKK 361. Asger Aamund Chairman of the Board of Directors Telephone conference: A teleconference will be held today 22 August 2007 at 3 pm Copenhagen time (2 pm London time, 9 am New York time). Flemming Pedersen, CEO, Anita Milland, Vice President & CFO and Hanne Leth Hillman, Vice President & Director of IR & Corporate Communications, will present the H1 report and answer questions. The telephone conference will be conducted in English and the telephone number is +44 (0)20 7162 0025. The corresponding PowerPoint presentation will be available via www.neurosearch.com. Contacts: 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 Please see the entire H1 Report 2007 in the attached pdf file. NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on the OMX Nordic Exchange Copenhagen A/S. Our 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 the company's activities are partner financed through a broad alliance with GlaxoSmithKline (GSK) and collaborations with among others Abbott and Astellas. The drug pipeline comprises 11 clinical (Phase I-III) development programmes: ACR16 in Huntington's disease (Phase III preparation), tesofensine in obesity/type 2 diabetes (Phase II), NS2359 in depression (Phase II) and ADHD (Phase II) in partnership with GSK, NS1209 in epilepsy and pain (Phase II), ABT-894 in ADHD (Phase II) and pain (Phase I) in partnership with Abbott, ACR16 in schizophrenia (Phase I) in partnership with Astellas, ACR325 in Parkinson's disease and bipolar disorder (Phase I) and ABT-107 as well as ABT-560 for the treatment of various CNS diseases - both (Phase I) in collaboration with Abbott. In addition, NeuroSearch has a broad portfolio of preclinical drug candidates and holds equity interests in several biotech companies.
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