ALK in brief. Fighting the cause of allergy

Transcription

1 in brief Fighting the cause of allergy

2 2 Welcome Welcome 3 Welcome 20% The cause of allergy must be treated More than 20% of the population suffer from respiratory allergies 1. Allergy is one of the most common chronic diseases 2. Please scan here to see all literature references or visit 's website At, we fight the cause of allergy and are in the forefront of developing evidence based allergy immunotherapy for the benefit of patients worldwide. More than 20% of the population suffer from respiratory allergies 1. Allergy is a widespread disease, which is becoming increasingly common worldwide. This spread of the disease is often referred to as the "allergic epidemic". For most allergy sufferers, their allergy leads to a significantly reduced quality of life, affecting both work and leisure time. If a patient's allergy is not treated effectively, it may in time develop into additional allergies and asthma. Not only does the fight against itchy eyes and a blocked nose have significant consequences for the individual, but the growing prevalence of allergy also has major economic consequences for society through reduced working capacity and more sick leave, placing a greater burden on healthcare resources and increasing medication costs 3,4. At we fight the cause of allergy. By treating the underlying cause of allergy symptoms, it is possible to improve patients' quality of life and reduce the risk of the disease developing further. We are around 2,000 employees working to improve the quality of life of allergy sufferers through research and development of new, evidence based drugs for allergy immunotherapy. Our aim is to ensure allergy immunotherapy becomes accessible to all patients who may benefit from the treatment. Among other things, we have introduced tablet based immunotherapy to make it easier than ever for patients to complete their course of treatment. And, together with our international partners, we work hard to expand the use of our products worldwide, giving patients all over the world access to treatment of the cause of their allergy. This brochure will tell you more about and what we do to improve the quality of life for people living with allergy. Jens Bager President and CEO,

3 4 Allergy and allergy immunotherapy Allergy and allergy immunotherapy 5 Allergy and allergy immunotherapy Allergy is typically divided into respiratory allergy, skin allergy and other allergies (including food allergy). Respiratory allergy is the most common type of allergy. One airway one disease Allergy immunotherapy fights the cause of allergy International guidelines for the management of respiratory allergy from ARIA (Allergic Rhinitis and its Impact on Asthma) recommend early treatment with allergy immunotherapy in order to prevent further development of allergic rhinitis (hay fever) and/or the development of asthma 16. Patients often suffer from both allergic rhinitis in the upper respiratory tract and asthma in the lower respiratory tract. At least 60% of asthma patients also suffer from allergic rhinitis 1,10,11. An integrated and unified approach to diagnosis and treatment of these diseases is therefore recommended. Allergic march Allergy is a chronic disease. Many Allergy is a widespread disease. One in five people suffers from at least one type of allergy, for instance pollen allergy or house dust mite allergy. Allergy is an overreaction of the immune system to substances that are otherwise harmless. The most common allergies are caused by airborne particles such as grass or tree pollens. For most people these tiny particles are insignificant, but for people with allergy, they can trigger seasonal or chronic respiratory conditions, such as hay fever or allergic asthma. Typically, the symptoms of allergy are a runny or blocked nose, sneezing, itching and irritation of the eyes, and breathing difficulties. Significant impairment of quality of life Allergy significantly reduces patients' quality of life. According to a European survey of diagnosed allergy sufferers, around 80% of the respondents find that their disease considerably affects their daily activities 5. In children with allergic rhinitis the symptoms may lead to learning difficulties. They may experience difficulties in keeping up with schoolwork due to enforced absences and reduced energy levels. In addition, interrupted sleep often leads to daytime fatigue and poor concentration in school, resulting in learning impairment 6-9. Allergy may also lead to the development or aggravation of asthma. Between 20 and 30% of patients with allergic rhinitis suffer from asthma 1. Treating the underlying cause of allergy Many allergy sufferers are primarily treated with symptomatic medication, such as antihistamines and nasal corticosteroids. This medication reduces or removes the symptoms, but does not treat the underlying disease. Patients who experience insufficient effect from symptomatic medication can benefit from specific immunotherapy commonly known as allergy immunotherapy. Allergy immunotherapy is the only treatment that treats the underlying cause of the allergy. Sustained benefit after treatment Allergy immunotherapy is a three year treatment, during which the patient receives controlled doses of the allergens that he or she does not tolerate. The immune system is thereby reprogrammed. Allergy immunotherapy reduces and potentially eliminates the allergic reaction. The effect persists after completion of the treatment. Studies show that by treating the underlying cause of allergy with immunotherapy it is possible to inhibit the development of other allergies and prevent asthma from developing 12,13. Allergy immunotherapy is also effective in preventing severe allergic reactions, typically caused by bee or wasp stings 14,15. Up to 62% of patients using optimum symptomatic medication still experience residual symptoms and describe symptom control as partial or poor 17. 5% Fewer than 5% of allergic patients are currently treated with allergy immunotherapy. adults and children with one type of allergy will develop other allergy types, or even asthma, later in life. This is often referred to as the "allergic march".

4 6 Products Products 7 Products Diagnosing allergy The prerequisite for optimal treatment of allergy is a specific diagnosis. manufactures allergen extracts for allergy diagnosis, for instance a skin prick test. Acute allergic reaction An acute allergic reaction is treated with an injection of adrenaline into the thigh muscle. Adrenaline works directly on the respiratory system and blood circulation. The blood vessels are narrowed to stabilise the blood pressure, and the muscles of the lungs are relaxed, which improves breathing. Products from diagnosis to treatment Allergy immunotherapy In conjunction with the patient's medical history, a skin prick test can easily and simply show whether the patient is allergic and to what the patient is allergic. Allergy immunotherapy can be administered in three different ways: as injections, drops and tablets. 's product portfolio comprises all three types of treatment and covers each of the most common allergies such as grass, birch, house dust mite, ragweed, cat, dog, as well as bee and wasp. Around 600,000 patients a year are treated with 's products for allergy immunotherapy. Our portfolio also includes products for diagnosing allergies and an adrenaline pen for the emergency treatment of acute life-threatening With 's adrenaline app you can learn how to use an adrenaline pen and share information about anaphylaxis with your family and friends. allergic reactions. Read more at Injections Subcutaneous immunotherapy (SCIT) is allergy immunotherapy given as regular injections under the skin. The treatment is given over a three-year period, during which the patient is injected by a physician with the allergen to which the patient is allergic. The injections are administered approximately every six weeks. Sublingual drops Sublingual immunotherapy (SLIT) is allergy immunotherapy in the form of drops administered under the tongue. Patients administer the drops themselves, thereby avoiding the regular visits to the physician required for injection based allergy immunotherapy. In the 1990s, was the first company to launch SLIT treatment. This was a decisive step towards making allergy immunotherapy more convenient. Tablets In 2006, launched the world's first registered allergy immunotherapy tablet (AIT). This fast-dissolving tablet is administered by the patient at home once daily for three years. Tablet based allergy immunotherapy is the most welldocumented allergy treatment. Treatment of acute allergic reactions anaphylaxis has developed an adrenaline pen for the treatment of acute allergic reactions. The pen is specifically designed to be easy to use for patients as well as their relatives. If you are allergic, exposure to specific foods or a bee or wasp sting may trigger an acute allergic reaction anaphylaxis which may lead to respiratory arrest if quick and effective emergency treatment is not given.

5 8 Research and development Research and development 9 Research and development is a leader in terms of scientific impact and is cited far more often than its two major competitors within allergy immunotherapy: Asthma prevention is conducting a clinical study, GRAZAX Asthma Prevention (GAP), investigating the potential of 's Groundbreaking allergy research s pipeline Competitor 1 Competitor ,219 grass pollen allergy immunotherapy tablet (AIT) in preventing the development of asthma in children and ,196 adolescents. Studies have shown that allergic children are up to seven times more at risk of developing asthma 18. Patients in clinical studies and partnerships is continuously working to increase the quality, safety and efficacy of treatment with allergy immunotherapy and to introduce new, more convenient treatments. 's research and development focuses on three areas in particular: s pipeline includes a portfolio of allergy immunotherapy tablets against the five most common allergies. Tablet based immunotherapy Research Preclinical Phase I Phase II Phase III Marketed ,334 Source: ISI Web of Science, 1 Dec The 2011 figures have been adjusted by a factor of 12/ , ,260 1 Grass Development of tablet based allergy immunotherapy , ,898 against the most common allergies worldwide Ragweed 20% 2 House dust mite invests approximately 20% of its revenue in research and development. Studies into whether the present type of allergy immunotherapy can fully prevent the onset of respiratory allergy if treatment is given early in life Tree 3 Cat (recombinant) The development of new treatment concepts that ensure The world s first immunotherapy tablet a faster onset of clinical effect and fewer side effects Next generation allergy immunotherapy has developed the world's first allergy immunotherapy tablet (AIT) against grass pollen allergy. It was launched in the first European markets Our international partners also conduct clinical studies with 's products. Fast onset of action 82% of patients treated with s grass pollen allergy immunotherapy in The clinical development pro- tablet feel "better" or "much better" in gramme is the largest ever conducted the first treatment season compared for an allergy immunotherapy product. with previous seasons 19.

6 10 Production Production 11 Production 1/ 3 More than one third of the allergy immunotherapy products worldwide are produced by making us world leaders in this field. From the collection of allergens to finished products Comprehensive analyses and quality control at all stages of the manufacturing process ensure that 's products meet the highest manufacturing and quality standards. 1. Raw materials in 2. API production 3. Finished 4. Packaging (Active Pharmaceutical Ingredient) production and distribution Natural allergens such as grass pollen are the main ingredients of our products and every year grows, collects and harvests several tonnes of allergens from our fields, tree orchards and greenhouses. The natural allergens make high demands of analysis, standardisation and quality control. This ensures that the biological variation that will always be present in a natural product does not affect the finished product. It also ensures that it is The active pharmaceutical ingredient is purified in 's automated high-tech production facilities. Subsequently, the excipients are added and the active ingredient is formulated as either sublingual drops, injections or tablets. Following careful quality control, the final stages of the manufacturing process are initiated, i.e. packaging, labelling and distribution. possible to reproduce the product at any time. For instance: Pollen House dust mite Animal hair and dander Analysis Extraction Purification Freeze drying Analysis Formulation Filling Tabletting Analysis Packaging Labelling Storage Shipping handles the entire manufacturing process from the collection of, for instance, pollen to the manufacture of the finished allergy immunotherapy products. The entire manufacturing process is subject to quality assurance in compliance with current quality standards (Good Manufacturing Practice), and 's production facilities are inspected on a regular basis by local and international authorities in order to ensure the best possible quality and safety in the production of allergy immunotherapy products. The world's first quality standard The foundations for standardised and uniform allergy immunotherapy were laid in 1976 with the establishment of Dansk Allergen Standardisering 1976, DAS76. The project was a collaboration between and allergy specialists. It was the first of its kind in the world and established techniques for the quality assurance of allergy immunotherapy products.

7 12 The company The company 13 The company s revenue, EUR million round figures experiencing strong growth was founded in Denmark in 1923, and ever since has been a pioneer within allergy immunotherapy has seen strong growth in recent years. Today has approximately 2,000 employees and an annual revenue of more than EUR 300 million. We have affiliates, production facilities and distributors worldwide. The company is headquartered in Hørsholm in Denmark, and is listed on the NASDAQ OMX Copenhagen A/S. Two areas of focus % of s revenue is generated outside Denmark s activities are focused on two main areas. One area of 's activities is the marketing and sales of our existing products. In the global market for allergy immunotherapy our market share is around one third. The primary markets are in Western Europe. We are currently experiencing significant growth outside Europe. The other area of 's activities is the development and commercialisation of new products. In Europe undertakes the clinical development itself, but outside Europe, for instance in North America and Japan, has entered into partnerships with leading pharmaceutical companies. In cooperation with, our partners undertake the clinical development of the products in 's pipeline in their markets. receives payments on a regular basis from our partners for the rights to these products and for 's efforts in the development work. Following development of the products they will be marketed and sold by 's partners. will produce the allergy immunotherapy products and make sure that they comply with the requirements of the local authorities in terms of production and quality. will receive payment for the products and royalties from the sale. Well prepared for the future In the years ahead, expects to continue to grow its revenue, earnings and number of employees. With a competitive product portfolio, a strong pipeline with new products, and global partnerships, holds a unique position in the allergy industry, and is well placed to maintain its position as the world s leading allergy company. Read more at Subscribe to our newsletter and get the latest news about allergy immunotherapy and.

8 14 The Way The Way 15 The Way Employee at is a place of challenge and change and we have maintained our pioneering spirit. We are large enough to offer our employees challenges and opportunities for development, but not so large that our people disappear in the crowd. Allergic to stagnation s corporate social responsibility (CSR) Code of Conduct The way Mission Vision Values Code of Conduct With 's Code of Conduct we aim The working environment is characterised by a desire to make a difference and cooperate across departments to achieve the best possible results. Our performance culture is focused on ensuring that we set ambitious targets and that the employees have the environment and support to contribute to the Our mission, vision and values define 's way of doing business the Way: Mission We improve quality of life by preventing and curing allergy. As the world leader in allergy immunotherapy, has a special responsibility and is committed to the fight against allergy. Under the headline of Fighting allergy shares its expertise and resources and cooperates with all relevant stakeholders to promote the prevention, diagnosis and treatment of allergy. A special focus area is children suffering from allergy, including their risk of developing to promote professionalism, honesty and integrity in all aspects of the company and in our relationships with customers, employees, shareholders, society, suppliers and partners. continued growth of. At, we are always interested in employees with both the drive and the ability to make a difference, which is why we give our employees sufficient space to develop their talents to the full. Vision We are a company characterised by significant and profitable growth. In the global market for specific allergy treatment, we strengthen our leading position through own representation, acquisitions and asthma. aims to run its business in a socially responsible manner and has set ambitious targets for reducing energy consumption as well as for the continued development and well-being of its employees. Since 2009, 's social responsibility efforts have been modelled upon Curing Allergy From goose feathers to GRAZAX The history of Kurt Jacobsen partnerships. the UN Global Compact's ten principles in the areas of human rights, labour, the environment and anti-corruption. Development in the number of employees Our future is secured by a strong pipeline. We continuously launch new convenient products providing value for patients and society. We are driven by customer focus and a strong performance culture. We attract and retain dynamic and business-minded employees. Values Progressive, Focused, United, Trustworthy. These four values describe our corporate culture and set out the Read more at Scan to read the history of from the foundation in 1923 to the launch of tablet based immunotherapy ,554 framework for our daily conduct and decisions , ,767

9 is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. is the world leader in allergy immunotherapy a unique treatment that targets the actual cause of the allergy. The company has approximately 2,000 employees with affiliates, production facilities and distributors worldwide. has entered into partnership agreements on the commercialisation of allergy immunotherapy tablets outside Europe. The company is headquartered in Hørsholm, Denmark, and listed on the NASDAQ OMX Copenhagen A/S. Read more at Bøge Allé Hørsholm, Denmark Tel