ALK in brief
Fighting the cause of allergy
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ALK
Welcome
20% More than 20% of the population suffer from respiratory allergies1.
Allergy is one of the most common chronic diseases2.
Please scan here to see all literature references or visit ALK's website www.alk-abello.com/references.
— At ALK, we fight the cause of allergy and are in the forefront of developing evidence based allergy immunotherapy for the benefit of patients worldwide.
ALK
Welcome
Welcome
The cause of allergy must be treated 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 ALK, 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 ALK and what we do to improve the quality of life for people living with allergy. Jens Bager President and CEO, ALK
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Allergy and allergy immunotherapy
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
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 rhinitis1,10,11. An integrated and unified approach to diagnosis and treatment of these diseases is
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.
therefore recommended.
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 activities5. 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 impairment6-9. Allergy may also lead to the development or aggravation of asthma. Between 20 and 30% of patients with allergic rhinitis suffer from asthma1.
Allergic march Allergy is a chronic disease. Many 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".
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Allergy and allergy immunotherapy
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 asthma16.
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 to which he or she is allergic. 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 developing12,13. Allergy immunotherapy is also effective in preventing severe allergic reactions, typically caused by bee or wasp stings14,15.
— Up to 62% of patients using optimum symptomatic medication still experience residual symptoms and describe symptom control as partial or poor17.
5% Fewer than 5% of allergic patients are currently treated with allergy immunotherapy.
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Products
Products
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 can be administered in three different ways: as injections, drops and tablets. ALK'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 1.5 million patients a year are treated with ALK's products for allergy immunotherapy.
— With ALK's adrenaline app you can learn how to use an adrenaline pen and share information about anaphylaxis with your family and friends.
Our portfolio also includes products for diagnosing allergies and an adrenaline pen for the emergency treatment of acute life-threatening allergic reactions.
Read more at www.alk-abello.com
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Products
Diagnosing allergy The prerequisite for optimal treatment of allergy is a specific diagnosis. ALK manufactures allergen extracts for allergy diagnosis, for instance a skin prick test. 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
Injections
Sublingual drops
Tablets
Subcutaneous immunotherapy (SCIT) is
Sublingual immunotherapy (SLIT) is allergy
In 2006, ALK launched the world's first
allergy immunotherapy given as regular
immunotherapy in the form of drops
registered allergy immunotherapy
injections under the skin. The treatment
administered under the tongue. Patients
tablet (AIT). This fast-dissolving tablet
is given over a three-year period,
administer the drops themselves, thereby
is administered by the patient at home
during which the patient is injected by
avoiding the regular visits to the physician
once daily for three years. Tablet based
a physician with the allergen to which
required for injection based allergy
allergy immunotherapy is the most well-
the patient is allergic. The injections are
immunotherapy. In the 1990s, ALK was the
documented allergy treatment.
administered approximately every six
first company to launch SLIT treatment.
weeks.
This was a decisive step towards making allergy immunotherapy more convenient.
Treatment of acute allergic reactions – anaphylaxis ALK 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.
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Research and development
Research and development
Asthma prevention ALK is conducting a clinical study, GRAZAX Asthma Prevention (GAP), investigating the potential of ALK's
Groundbreaking allergy research
grass pollen allergy immunotherapy tablet (AIT) in preventing the development of asthma in children and adolescents. Studies have shown that allergic children are up to seven times more at risk of developing asthma18.
Patients in clinical studies ALK and partnerships
ALK is continuously working to increase the quality, safety and efficacy of treatment with allergy immunotherapy and to introduce new, more convenient treatments. ALK's research and development focuses on three areas in particular:
2009 – 1,780
2010 – 2,260
2011 – 5,290
1
Development of tablet based allergy immunotherapy against the most common allergies worldwide
2012 – 7,898
2
Studies into whether the present type of allergy immunotherapy can fully prevent the onset of respiratory allergy if treatment is given early in life
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The development of new treatment concepts that ensure a faster onset of clinical effect and fewer side effects The world’s first immunotherapy tablet ALK has developed the world's first allergy immunotherapy tablet (AIT) against grass pollen allergy. It was launched in the first European markets in 2006. The clinical development programme is the largest ever conducted for an allergy immunotherapy product.
Our international partners also conduct clinical studies with ALK's products.
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Research and development
ALK is a leader in terms of scientific impact and is cited far more often than its two major competitors within allergy immunotherapy: ALK
ALK’s pipeline
Competitor 1 Competitor 2
2009 — 1,219
2010 — 1,196
ALK’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
2011 — 1,334
Source: ISI Web of Science, 1 Dec. 2011. The 2011 figures have been adjusted by a factor of 12/11.
Grass
Ragweed
House dust mite
20% ALK invests approximately 20% of its revenue in research and development.
Tree
Cat (recombinant)
Next generation allergy immunotherapy
Fast onset of action 82% of patients treated with ALK’s grass pollen allergy immunotherapy tablet feel "better" or "much better" in the first treatment season compared with previous seasons19.
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Production
Production
1/3 More than one third of the allergy immunotherapy products worldwide are produced by ALK making us world leaders in this field.
From the collection of allergens to finished products 1. Raw materials in
2. API production
(Active Pharmaceutical Ingredient)
— Comprehensive analyses and quality control at all stages of the manufacturing process ensure that ALK's products meet the highest manufacturing and quality standards. 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 ALK and allergy specialists. It was the first of its kind in the world and established techniques for the quality assurance of allergy immunotherapy products.
Natural allergens such as grass
The natural allergens make high
pollen are the main ingredients of
demands of analyses, standardisation
our products and every year ALK
and quality control. This ensures
grows, collects and harvests several
that the biological variation that
tonnes of allergens from our fields,
will always be present in a natural
tree orchards and greenhouses.
product does not affect the finished product. It also ensures that it is possible to reproduce the product at any time.
For instance:
— Extraction
— Pollen
— Purification
— House dust mite
— Freeze drying
— Animal hair and dander Analyses
Analyses
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Production
ALK handles the entire
3. Finished production
4. Packaging and distribution
manufacturing process – from the collection of, for instance, pollen to the manufacture of the
The active pharmaceutical
Following careful quality control, the
ingredient is purified in ALK's
final stages of the manufacturing
automated high-tech production
process are initiated, i.e. packaging,
facilities. Subsequently, the excipients
labelling and distribution.
finished allergy immunotherapy products.
are added and the active ingredient
The entire manufacturing
is formulated as either sublingual
process is subject to quality
drops, injections or tablets.
assurance in compliance with current quality standards (Good Manufacturing Practice), and
— Formulation
— Packaging
ALK's production facilities are
— Filling
— Labelling
inspected on a regular basis
— Tabletting
— Storage
by local and international
— Shipping
authorities in order to ensure the
Analyses
best possible quality and safety in the production of allergy immunotherapy products.
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The company ALK
The company ALK
ALK experiencing strong growth
98%
ALK was founded in Denmark in 1923, and ever since ALK has been a pioneer within allergy immunotherapy. ALK has seen strong growth in recent years. Today ALK 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 ALK is listed on the NASDAQ OMX Copenhagen A/S.
of ALK’s revenue is generated outside Denmark.
Two areas of focus ALK’s activities are focused on two main areas. One area of ALK'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 ALK's activities is the development and commercialisation of new products. In Europe ALK undertakes the clinical development itself, but outside Europe, for instance in North America and Japan, ALK has entered into partnerships with leading pharmaceutical companies. In cooperation with ALK, our partners undertake the clinical development of the products in ALK's pipeline in their markets. ALK receives payments on a regular basis from our partners for the rights to these products and for ALK's efforts in the development work. Following development of the products they will be marketed and sold by ALK's partners. ALK 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. ALK will receive payment for the products and royalties from the sale.
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The company ALK
2007 — 220
2008 — 240
2009 — 260
2010 — 285
2011— 310
ALK's revenue, EUR million – round figures
Well prepared for the future In the years ahead, ALK 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, ALK 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 www.alk-abello.com
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ALK
The ALK Way
The ALK Way
Employee at ALK ALK is a place of challenge and change and we have maintained our pioneering spirit. We are large enough to offer our employees challenges and
Allergic to stagnation
opportunities for development, but not so large that our people disappear in the crowd. The working environment is characterised by a desire to make a difference and cooperate across departments to achieve the best
Our mission, vision and values define ALK's way of doing business – the ALK Way:
possible results. Our performance culture is focused on ensuring that we set ambitious targets and that the employees have the environment
Mission We improve quality of life by preventing and curing allergy.
and support to contribute to the continued growth of ALK. At ALK, we are always interested in employees with both the drive and the
Vision •
e are a company characterised by significant and profitable W growth.
•
I n the global market for specific allergy treatment, we strengthen our leading position through own representation, acquisitions and partnerships.
•
Our future is secured by a strong pipeline. We continuously launch new convenient products providing value for patients and society.
•
e are driven by customer focus and a strong performance culture. W We attract and retain dynamic and business-minded employees.
ability to make a difference, which is why we give our employees sufficient space to develop their talents to the full.
Values Development in the number of employees 2009 — 1,554 2010 — 1,694 2011 — 1,781
Progressive, Focused, United, Trustworthy. These four values describe our corporate culture and set out the framework for our daily conduct and decisions.
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The ALK Way
ALK’s corporate social responsibility (CSR)
Code of Conduct The ALK way Mission Vision Values
Code of Conduct With ALK's Code of Conduct we aim to promote professionalism, honesty and integrity in all aspects of the
As the world leader in allergy immunotherapy, ALK has a special responsibility and is committed to the fight against allergy. Under the headline of “Fighting allergy” ALK 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 asthma. ALK aims to run its business in a socially responsible manner and has set ambitious targets for e.g. reducing energy consumption as well as for the continued development and well-being of its employees.
company and in our relationships with customers, employees, shareholders, society, suppliers and partners.
Curing Allergy
From goose feathers to GRAZAX® – The history of ALK Kurt Jacobsen
Since 2009, ALK's social responsibility efforts have been modelled upon the UN Global Compact's ten principles in the areas of human rights, labour, the environment and anti-corruption.
Read more at www.alk-abello.com
— Scan to read the history of ALK – from the foundation in 1923 to the launch of tablet based immunotherapy.
www.mazarin.dk · 2012
ALK is a research-driven global pharma-
with affiliates, production facilities and
ceutical company focusing on allergy
distributors worldwide. ALK has entered
prevention, diagnosis and treatment. ALK is
into partnership agreements on the
the world leader in allergy immunotherapy
commercialisation of allergy immunotherapy
– a unique treatment that targets the
tablets outside Europe. The company is
actual cause of the allergy. The company
headquartered in Hørsholm, Denmark, and
has approximately 2,000 employees
listed on the NASDAQ OMX Copenhagen A/S.
ALK · Bøge Allé 6-8 · 2970 Hørsholm, Denmark · Tel. +45 45 74 75 76 · www.alk-abello.com
Read more at www.alk-abello.com