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Annual Report 2006 2006 Highlights Safinamide confirms efficacy and safety in a Phase III trial for Parkinson’s disease Safinamide shows very promising effects on cognition, giving the drug potential as a treat- ment for Alzheimer’s disease and Mild Cognitive Impairment Global Development and Commercialisation agreement for safinamide signed with Merck Serono, worth up to $ 200 million – plus royalties – to Newron Start of a pivotal Phase III trial with safinamide in mid to late-stage Parkinson’s disease patients Ralfinamide set up to generate Phase II MTD data in neuropathic pain by mid-2007 and design of trial for use in inflammatory pain IPO completed on the SWX Swiss Exchange raises ¤ 74.3 million – one of the largest biotech IPOs of 2006 Corporate Profile Newron (SWX: NWRN) is a clinical-stage biopharmaceutical company based in Bresso, Milan. Our mission is to discover, develop and commercialise novel drugs to treat diseases of the Central Nervous System (CNS) and pain. The products that we are developing include safinamide, in late-stage trials for the treat- ment of patients with Parkinson’s disease, and ralfinamide to treat neuropathic pain and inflammatory pain. Newron’s clinical pipeline is supported by a portfolio of early-stage proprietary compounds generated by its ion channel drug discovery platform. Table of Contents Dear Shareholder .................................................................................................... 4 Company Information ............................................................................................. 6 A Focus on CNS ....................................................................................................... 8 Diseases and Markets .............................................................................................. 12 Drug Pipeline ......................................................................................................... 17 Strong Partnership .................................................................................................. 24 Newron’s Team ....................................................................................................... 26 Corporate Governance ............................................................................................ 28 Group Structure and Shareholders ............................................................................. 31 Capital Structure ..................................................................................................... 33 Board of Directors ................................................................................................... 36 Senior Management ................................................................................................ 44 Compensation, Shareholdings and Loans .................................................................... 47 Shareholders’ Participation ....................................................................................... 49 Change of Control and Defence Measures .................................................................... 51 Auditors ................................................................................................................ 52 Information Policy .................................................................................................. 53 IFRS Financial Statements ....................................................................................... 54 Income Statement ................................................................................................... 56 Balance Sheet ......................................................................................................... 57 Statement of Changes in Shareholders’ Equity .............................................................. 58 Cash Flow Statement ............................................................................................... 59 Notes to the Financial Statements .............................................................................. 60 Auditors’ Report ..................................................................................................... 74 Italian GAAP Financial Statements ........................................................................... 76 Directors’ Report ..................................................................................................... 78 Financial Statements ............................................................................................... 94 Notes to the Financial Statements .............................................................................. 99 Auditors’ Report ..................................................................................................... 116 Information for Investors ........................................................................................ 118 Glossary ............................................................................................................... 119 Dear Shareholder Rolf Stahel Luca Benatti The importance of finding effective new treatments for diseases of the Central Nervous System is well understood. Conditions such as Parkinson’s disease carry an enormous burden for the patients, their families and carers, and the healthcare systems that provide drug treatments and rehabilitation care. Europe and the US both have approximately 53,000 new cases of Parkinson’s disease each year. According to a recent report, between now and 2030, the number of patients could more than double. Current treatments, some of which have been around since the 1960’s, carry significant long-term side effects. The team at Newron have proven research and development expertise within the CNS field. Many of them have been involved previously in the development and commercialisation of major CNS drugs. We are confident that, as a team, we will build on these successes within Newron. Since 1999 we have had many achievements in the development of our clinical pipe- line. We are a young company, however, and there is more to do, but we are fully committed to successfully achieving our goal of bringing important new treatments to patients whose lives are blighted by disease. 2006 was a landmark year for Newron. Safinamide’s development was highlighted with excellent data from the first Phase III trial. Not only did we confirm the safety and efficacy data seen previously in our Phase II study, but we were also able to show very promising effects on cognition compared to patients on dopamine agonist therapy. This could mean that safinamide is a potential treatment for cognitive decline in Parkinson’s disease as well as the larger indica- tions of Alzheimer’s disease and Mild Cognitive Impairment. With such positive results, we renewed our discussions with potential pharmaceutical part- ners and concluded a deal with Serono, now Merck Serono, in September. Merck Serono is the right partner both for Newron and for safinamide. The collaboration is extremely positive and our teams share a joint dedication to progress safinamide in PD towards regulatory filing in 2009. One of the additional benefits of our agreement with Merck Serono is the option for us to consider co-marketing safinamide in certain European countries. This could potentially accel- erate our objective to build a small, focused, CNS specialty sales force whereby we can retain the value of our future marketed products. In the meantime, we look forward to reporting data from existing trials with both safinamide and ralfinamide and the commencement of new trials. Newron Annual Report 2006 In 2006, our drug discovery programmes were focused on the ion channel target class. The main objective of these programmes was to provide leads and product candidates to fuel the Company’s pipeline. Chemistry optimization work has resulted in the synthesis of lead molecules which showed significant activity in several CNS disease models. The most advanced of these compounds could enter preclinical development in 2007. As a result of our good data, the opportunities that we have with both our lead drugs, and the global agreement with Merck Serono, we felt the time was right for us to seek new funds through an IPO on the SWX Swiss Exchange. We were delighted with the response to our road show and the fact that international investors across Europe and the US have shared our vision for Newron’s future. The IPO raised ¤ 74.3 million and was amongst the largest biotech fund- raising initiatives during 2006. Our intentions are to use these funds by supporting the ongoing and new clinical development programmes, licensing or acquiring new products to expand our Central Nervous System (CNS) pipeline, and begin the development of a specialty sales and marketing force once we have the appropriate products ready for launch. Based on the achievements of 2006, Newron is well positioned to build further on its CNS expertise and focus. This is only possible through the expertise and commitment of our team and we thank them for their ongoing support. As a public company, Newron has entered an exciting new phase and we believe that we are well positioned for continued growth. Rolf Stahel Luca Benatti Chairman Chief Executive Officer Newron Annual Report 2006 6 Newron Annual Report 2006 Company Information Newron Annual Report 2006 A Focus on CNS Newron’s goal is to become a fully integrated biopharmaceutical company focused on the discovery, development and commer- cialisation of drugs for the treatment of CNS-related diseases
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