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ALK in brief Fighting the cause of allergy

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Read about ALK and what we do to improve the quality of life for people living with allergy.


Page 1: ALK Corporate Brochure

ALK in brief

Fighting the cause of allergy

Page 2: ALK Corporate Brochure

— 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.

20% More than 20% of the population

suffer from respiratory


Please scan here to see all literature

references or visit ALK's website

Allergy is one of the

most common chronic



Page 3: ALK Corporate Brochure


The cause of allergy must be treated

More than 20% of the population suffer from respiratory allergies1. 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 costs3,4.

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 BagerPresident and CEO, ALK

WelcomeALK 3

Page 4: ALK Corporate Brochure

Allergy and allergy immunotherapyALK4

Allergy and allergy immunotherapy

Allergy immuno-therapy fights the cause of allergyAllergy 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 lifeAllergy 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.

60%of asthma patients also suffer from

allergic rhinitis1,10,11. An integrated

and unified approach to diagnosis

and treatment of these diseases is

therefore recommended.

One airway – one disease

Patients often suffer from both

allergic rhinitis in the upper

respiratory tract and asthma in the

lower respiratory tract. At least

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".

Allergy is typically divided into respiratory allergy, skin allergy and other allergies

(including food allergy). Respiratory allergy is the most

common type of allergy.

Page 5: ALK Corporate Brochure

Allergy and allergy immunotherapyALK 5

Treating the underlying cause of allergyMany 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 treatmentAllergy 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.

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.

— Up to 62% of patients using optimum symptomatic medication still experience residual symptoms and describe symptom control as partial or poor17.

Fewer than 5% of allergic patients are currently

treated with allergy immunotherapy.


Page 6: ALK Corporate Brochure



Products – from diagnosis to treatmentAllergy 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.

Our portfolio also includes products for diagnosing allergies and an adrenaline pen for the emergency treatment of acute life-threatening allergic reactions.


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 pres-

sure, and the muscles of the lungs are

relaxed, which improves breathing.

— With ALK's adrenaline app you can learn how to use an adrenaline pen and share information about anaphylaxis with your family and friends.

Page 7: ALK Corporate Brochure

ProductsALK 7

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.

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.


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


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, ALK was the

first company to launch SLIT treatment.

This was a decisive step towards making

allergy immunotherapy more convenient.


In 2006, ALK 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 well-

documented allergy treatment.

Allergy immunotherapy

Page 8: ALK Corporate Brochure


Development of tablet based allergy immunotherapy

against the most common allergies worldwide


The development of new treatment concepts that ensure

a faster onset of clinical effect and fewer side effects

Research and developmentALK8

Research and development

Groundbreaking allergy research

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:

Our international partners also conduct clinical studies with ALK's products.

Asthma prevention

ALK is conducting a clinical study,

GRAZAX Asthma Prevention (GAP),

investigating the potential of ALK's

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

2009 – 1,780

2012 – 7,898

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 pro-

gramme is the largest ever conducted

for an allergy immunotherapy product.


Studies into whether the present type of allergy

immunotherapy can fully prevent the onset of respiratory

allergy if treatment is given early in life

2010 – 2,260

2011 – 5,290

Page 9: ALK Corporate Brochure

Research and developmentALK 9

ALK’s pipeline

ALK is a leader in terms of scientific

impact and is cited far more often

than its two major competitors within

allergy immunotherapy:


Competitor 1

Competitor 2

2009 — 1,219

2010 — 1,196

2011 — 1,334

Source: ISI Web of Science, 1 Dec. 2011. The 2011 figures have been adjusted by a factor of 12/11.

ALK’s pipeline includes a portfolio of allergy immunotherapy tablets against the five most common allergies.

20% ALK invests approximately

20% of its revenue in research and development.

Cat (recombinant)

Next generation allergy immunotherapy


House dust mite



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.

Tablet based immunotherapy

Preclinical Phase I Phase II Phase III MarketedResearch

Page 10: ALK Corporate Brochure

1. Raw materials in

Natural allergens such as grass

pollen are the main ingredients of

our products and every year ALK

grows, collects and harvests several

tonnes of allergens from our fields,

tree orchards and greenhouses.

For instance:

— Pollen

— House dust mite

— Animal hair and dander


2. API production(Active Pharmaceutical Ingredient)

The natural allergens make high

demands of analyses, 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

possible to reproduce the product

at any time.

— Extraction

— Purification

— Freeze drying



From the collection of allergens to finished 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 ALK and allergy specialists. It

was the first of its kind in the world and

established techniques for the quality

assurance of allergy immunotherapy


— Comprehensive analyses and quality control at all stages of the manufacturing process ensure that ALK's products meet the highest manufacturing and quality standards.

1/3More than one third of the

allergy immunotherapy products

worldwide are produced by

ALK making us world leaders

in this field.

Page 11: ALK Corporate Brochure

3. Finished production

The active pharmaceutical

ingredient is purified in ALK's

automated high-tech production

facilities. Subsequently, the excipients

are added and the active ingredient

is formulated as either sublingual

drops, injections or tablets.

— Formulation

— Filling

— Tabletting


4. Packaging and distribution

Following careful quality control, the

final stages of the manufacturing

process are initiated, i.e. packaging,

labelling and distribution.

— Packaging

— Labelling

— Storage

— Shipping

ALK handles the entire

manufacturing process – from

the collection of, for instance,

pollen to the manufacture of the

finished allergy immunotherapy


The entire manufacturing

process is subject to quality

assurance in compliance with

current quality standards (Good

Manufacturing Practice), and

ALK'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.

ProductionALK 11

Page 12: ALK Corporate Brochure

The company ALK

ALK experiencing strong growth

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 approxi-mately 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.

Two areas of focusALK’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 commer-cialisation 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.

The company ALKALK12

Subscribe to our newsletter and

get the latest news about allergy

immunotherapy and ALK.

of ALK’s revenue is generated outside



Page 13: ALK Corporate Brochure

The company ALKALK 13

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.



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Page 14: ALK Corporate Brochure

The ALK Way

Allergic to stagnation

Our mission, vision and values define ALK's way of doing business – the ALK Way:

MissionWe improve quality of life by preventing and curing allergy.

Vision• Weareacompanycharacterisedbysignificantandprofitable


• Intheglobalmarketforspecificallergytreatment,westrengthenour leading position through own representation, acquisitions and partnerships.

• Ourfutureissecuredbyastrongpipeline.Wecontinuouslylaunchnew convenient products providing value for patients and society.

• Wearedrivenbycustomerfocusandastrongperformanceculture.We attract and retain dynamic and business-minded employees.

ValuesProgressive, Focused, United, Trustworthy.

These four values describe our corporate culture and set out the framework for our daily conduct and decisions.

The ALK WayALK14

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

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

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

continued growth of ALK.

At ALK, 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.

2009 — 1,554

2010 — 1,694

2011 — 1,781

Development in the number of employees

Page 15: ALK Corporate Brochure

ALK’s corporate social responsibility (CSR)

The ALK WayALK 15

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.

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.

Code of Conduct

With ALK's Code of Conduct we aim

to promote professionalism, honesty

and integrity in all aspects of the

company and in our relationships with

customers, employees, shareholders,

society, suppliers and partners.

— Scan to read the history of ALK – from the foundation in 1923 to the launch of tablet based immunotherapy.


Codeof ConductThe ALK wayMissionVisionValues

From goose feathers to GRAZAX® – The history of ALKKurt Jacobsen

Curing Allergy

Page 16: ALK Corporate Brochure

ALK · Bøge Allé 6-8 · 2970 Hørsholm, Denmark · Tel. +45 45 74 75 76 ·

ALK is a research-driven global pharma-

ceutical company focusing on allergy

prevention, diagnosis and treatment. ALK 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. ALK 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.






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