The European Investment Bank (EIB) and Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), signed a financing agreement today, which will allow the Company to borrow up to EUR 40 million over the coming years, subject to achieving a set of agreed performance criteria.
This EIB loan is backed by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment Plan for Europe, the Juncker Plan.
Neurological disorders affect up to one billion people worldwide1. In Europe alone, the annual economic cost of neurological diseases was estimated at about EUR 139 billion in 20042, said Ambroise Fayolle, Vice President of the EIB responsible for operations under EFSI and Innovation. Many patients with CNS diseases are in need of new or more efficacious therapeutics. The EU bank provides long-term and stable capital support to help drive innovation and clinical success in this field. Its this type of support for innovative companies like Newron that is crucial to strengthening Europes competitiveness.
European Commissioner for Health and Food Safety, Vytenis Andriukaitis said: “Sustained investment in research and innovation for treatment of neurological disorders is critical. This new agreement provides further evidence of the EU added value of the Investment Plan, not only for the competitiveness of the EU economy, but above all for the citizens’ wellbeing.”
Stefan Weber, Chief Executive Officer of Newron Pharmaceuticals, added: We are very pleased that the EIB has recognized the potential of Newrons current R&D activities. This loan will provide us with additional financial flexibility over the coming years and significantly enhance our resources. We may use it to further advance our key assets to market and beyond and help in maximizing their market potential.
Newron aims to build a leading Central Nervous System (CNS) company that searches, develops and commercializes innovative drugs, with a special focus on rare diseases. The companys first product developed in-house, Xadago (safinamide), is the first New Chemical Entity in a decade approved in Europe and the U.S. for the treatment of Parkinsons disease (PD). The product is commercialized in a number of European markets as well as in the USA and the Companys partners Zambon and Meiji Seika Pharma are working towards global approval. Newron has two advanced product candidates in late stage clinical development: Sarizotan for the treatment of respiratory disturbances in Rett syndrome, which is evaluated in the ongoing potentially pivotal STARS (Sarizotan Treatment of Apneas in Rett Syndrome) study, and Evenamide as an add-on therapy for the treatment of certain symptoms of schizophrenia, with the additional potential to improve the life of patients who are treatment resistant to Clozapine.
Newron plans to directly market orphan or orphan-like drugs emerging of its innovative clinical pipeline, and to consider partner opportunities directed at larger markets when offering the best return to Newrons shareholders.
EIB financing is intended to boost Newrons R&D activities and will primarily be used to support the Companys pivotal and post approval stage development programs in diseases of the central nervous system.
About Newron Pharmaceuticals Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The company is headquartered in Bresso near Milan, Italy. Xadago/safinamide has received marketing authorization for the treatment of Parkinsons disease in the European Union, Switzerland and the USA, and is commercialized by Newrons Partner Zambon. US WorldMeds holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. In addition to Xadago/safinamide for Parkinsons disease, Newron has a strong pipeline of promising treatments for rare disease patients at various stages of clinical development, including Sarizotan for patients with Rett syndrome and ralfinamide for patients with specific rare pain indications. Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For more information, please visit: www.newron.com.
About the EIB The EIB is the long-term lending institution of the EU. It is owned by and represents the interests of the European Union countries. The Bank makes long-term finance available for sound investment in order to contribute towards EU policy goals. The EIB works closely with other EU institutions to implement EU policy.
The Investment Plan for Europe The Investment Plan for Europe, the so-called Juncker Plan, is one of European Commission President Jean-Claude Juncker’s top priorities. It focuses on boosting European investments to create jobs and growth by making smarter use of new and existing financial resources, removing obstacles to investment and providing visibility and technical assistance to investment projects.
The European Fund for Strategic Investments (EFSI) is the central pillar of the Investment Plan. It allows the EIB to invest in more, often riskier, projects. EFSI is already showing concrete results. The projects and agreements approved for financing until October 2018, three years after EFSI came into being, will mobilise EUR 344.4 bn in total investments and support some 793 000 SMEs across all 28 Member States.
The latest EFSI figures by sector and by country are available here.
This document contains forward-looking statements, including (without limitation) about (1) Newrons ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newrons anticipated future revenues, capital expenditures and financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as will, anticipate, estimate, expect, project, intend, plan, believe, target, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements, and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programmes, development activities, commercialisation plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange, where the shares of Newron are listed. This announcement is not an offer for sale of securities in the United States, Canada, Australia or Japan or any other jurisdiction where such an offer or solicitation would otherwise be unlawful. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Newron does not intend to register any of its securities in the United States or to conduct a public offering of its securities in the United States. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of this document shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.
1 World Health Organization (WHO), Neurological Disorders “ public health challenges, 2006. 2 According to a study published in the European Journal of Neurology, June 2005.
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Keynotes Announced: SAP Financial Services Live 2020
We are delighted to announce our Keynote Speakers & Session Titles for the upcoming free to attend digital event for banking, insurance, capital markets and central banks professionals; SAP Financial Services Live 2020 (17-19 November).
Meet Our Keynote Speakers:
Luka Mucic, CFO & Member of the Board, SAP
Financial Services: An Evolving Landscape
Christoph Böhm, CIO/COO, Deutsche Börse
Financial Markets and Technology in Transition
Maria Surmava, CIO, Discovery Health
Shared-Value Health Platform
Karsten Crede, CEO, ERGO Mobility Solutions
How to Become an Ecosystem Player
Peter Maier, President SAP Industries and Customer Advisory, SAP
Industry Convergence – Keynote Interview
Timo Elliott, VP – Global Innovation Evangelist, SAP
Opening Keynote; The World has Changed, and it’s Time to Adapt to the “Next Normal”
Alongside our keynotes, this event will be packed with SAP user case studies from leading global companies including: Bank of Ireland, Bank of Montreal, Capital One, Cornèr Bank, Discovery, Edelweiss, London Stock Exchange, MB Ageas, Munich Re, Samsung Life, Swiss Re, Vast Bank, Vienna Insurance Group, Zurich Insurance and many more to be announced.
Keep up to date with the latest information on our website >
Ahead of the event, you will have the opportunity to plan your own agenda with multiple live presentations each day to choose from. Then following the event, a library of on-demand content will be at your disposal so you can continue to strengthen your financial services business over the coming months.
Don’t miss the opportunity to connect online to debate, discuss and determine the current trends and hot topics for the financial services industry.
Sounds interesting? Register to join us here >
This is a Sponsored Feature
FinTech in Credit Markets: Efficiency and Potential Risks – Free webinar
With the help of alternative technologies, FinTech firms have begun to challenge the traditional banks’ role in financial services, from payment service to the provision of credits. This taster session aims to provide an overview of this development, with some focus on credit markets. We will discuss the scope and the drives of FinTech, its efficiencies, potential risks, as well as its relationship with traditional banking.
In this interactive session on Tuesday 10 November, Kebin Ma of Warwick Business School will discuss why FinTech has become a buzzword in the financial industry.
When: Tuesday 10 November 2020, 18:00 – 19:00 (UK time)
For information about the Global Central Banking & Financial Regulation qualification from Warwick Business School, in partnership with the Bank of England please visit wbs.ac.uk/go/banking
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Habits to bring back to the boardroom after the holidays
By Royston Guest is a leading authority on growing businesses and unlocking people potential. Entrepreneur, author of #1 best-seller Built to Grow and RISE: Start living the life you were meant to lead, CEO of Pathways Global and founder of The Business Growth PathwayÔ .
After a break from work, you feel refreshed, re-energised and re-focused and the quality downtime has given you the headspace you needed. Take this new energy and focus as an opportunity to introduce four new winning habits…you may be surprised at what you discover both personally and professionally.
Winning Habit #1 – Look At Your Business Through A Fresh Lens
When you’re working in your business every day, it is so easy to become blinkered. You start to see what you want to see, not the reality. I call this ‘focus distortion’.
It’s like at home when you’ve been away for a while and when you return you notice the pile of old magazines in the corner of the lounge or the DVD’s clogging the shelf beneath the TV. You start to question how long they’ve been there as you’ve failed to notice them previously. You decide to do a spring clean and set about creating a new reality as you look at your world through a fresh lens. Apply the same fresh lens to your business.
Post-holiday is a great time to do this, to imagine your first day back as your first day ever in the business. Challenge yourself to imagine you’re a new executive who has been newly appointed. With a fresh lens, challenge yourself to question everything, and I mean everything!
Ask quality WHY questions, review systems, processes and procedures and ask is it adding value, helping us to be a relevant, agile, resilient business? Is it adding value for the customer? Challenge the seven most expensive words in business; ’that’s not the way we do things’ or its sister statement; ’We’ve never done it that way before’.
Walking through your business with a restless curiosity and fresh lens is a cathartic experience and will certainly awaken your senses.
Winning Habit #2 – Question What Is Truly Worthy Of Your Time?
To create the stretch and growth potential for your people and business, you should focus on the things that only you can do. Yes, you’ll have oversight and a contributory role in other areas, but your primary focus should be on the high-value activities which allow you to realise the potential in your business and yourself.
On your return to the office, ask yourself this; what is truly worthy of my time?
If you find you’re spending more time on tasks and activities which quite clearly you shouldn’t be, then now is the time to change this because if you don’t, nobody else will.
Winning Habit #3 – Design Your High Performing Week
We all come back from holiday with good intentions; managing our workload more effectively, being home earlier from work to put the children to bed, not travelling as much. BUT, before you know it, the first few days and weeks pass, you were so busy catching up after your holiday your good intentions are out the window, and you’re back into your old ways of working. One of your highest callings is to be conscious and deliberate in how you set your high performing weeks up for success.
- focus on the things that only you can do, the areas genuinely worthy of your time?
- master the skill of saying NO to the unimportant things so you can say YES to the important things.
- create more time to work ON the business, not just the busy fool working IN the business.
- book quality thinking time in your diary, knowing the time you spend thinking will make the doing more effective.
- are home for bath and story time with your children or a meal out with your loved one.
Time and memories – you will never get back. Remember in life, you make your choices, and then your choices make you.
Winning Habit #4 – Become Your Own Performance Coach
Successful leaders have an insatiable thirst for learning, for showing up every day being the best version of themselves they can be. They spend their life being their own performance coach, ensuring they reach their true and maximum potential.
Maintaining relevance in the fast-moving arena of life is about being fresh, living life with deliberate conscious intent as the architect of your destiny. It’s about learning and developing yourself. Perhaps most importantly, it about applied learning and having the attitude of action.
It’s so easy to get caught up in the mechanics of the working day, and before you know it days, weeks or even months have passed since you spent time on you.
Invest time in you.
One of the six core human needs is the need for growth – for emotional, intellectual or spiritual development. If you are not learning and bettering yourself every day, then you are not growing.
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