ALK Corporate Brochure
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Transcript of ALK Corporate Brochure
ALK in brief
Fighting the cause of allergy
— 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
allergies1.
Please scan here to see all literature
references or visit ALK's website
www.alk-abello.com/references.
Allergy is one of the
most common chronic
diseases2.
WelcomeALK2
Welcome
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
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.
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.
5%
ProductsALK6
Products
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.
Read more at www.alk-abello.com
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.
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.
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, ALK was the
first company to launch SLIT treatment.
This was a decisive step towards making
allergy immunotherapy more convenient.
Tablets
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
1
Development of tablet based allergy immunotherapy
against the most common allergies worldwide
3
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.
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
2010 – 2,260
2011 – 5,290
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:
ALK
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
Tree
House dust mite
Grass
Ragweed
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
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
Analyses
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
Analyses
Production
From the collection of allergens to finished products
ProductionALK10
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.
— 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.
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
Analyses
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
products.
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
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
Denmark.
98%
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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Read more at www.alk-abello.com
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
growth.
• 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
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.
Read more at www.alk-abello.com
Codeof ConductThe ALK wayMissionVisionValues
From goose feathers to GRAZAX® – The history of ALKKurt Jacobsen
Curing Allergy
ALK · Bøge Allé 6-8 · 2970 Hørsholm, Denmark · Tel. +45 45 74 75 76 · www.alk-abello.com
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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Read more at www.alk-abello.com