ALK Today Announced the Initiation of its Landmark GRAZAX(R) Asthma Prevention (GAP) Trial.
COPENHAGEN, Denmark, November 16 - GAP will be the largest ever trial to investigate the asthma preventive
effect of specific immunotherapy in children (5-12 years old) with allergic
grass pollen rhinoconjunctivitis, commonly known as 'hay fever'. The
European, multicentre, placebo-controlled, double-blind trial will follow
approximately 600 children with a diagnosis of grass pollen allergic
rhinoconjunctivitis over a period of 5 years. It will assess the asthma
preventive effect of Grazax after a 3-year course of therapy. The children
will then be followed for a further 2 years to determine if this effect is
sustained after completion of Grazax treatment.
Erkka Valovirta, GAP Lead Investigator & Chief Paediatrician and
Paediatric Allergist, Turku, Finland, highlighted that "Many children with
allergic rhinoconjunctivitis go on to develop asthma, which represents a
significant burden of disease often resulting in days off school, reduced
school performance, increased physician visits and even hospitalisations. If
positive, the trial could significantly change the way children with hay
fever are treated in the future. For the first time we will have conclusive
evidence from a suitably designed trial showing that treating hay fever with
the grass allergy immunotherapy tablet Grazax prevents the progression of the
condition into asthma".
Childhood allergic rhinoconjunctivitis increases the risk for asthma
development in later life by up to 7-fold. The progression of allergic
rhinoconjunctivitis into asthma is often known as the 'Allergic March'.
Authorities in 27 European countries recently approved Grazax as the
first registered disease-modifying allergy immunotherapy tablet (AIT) for the
management of grass pollen allergic rhinoconjunctivitis in both children and
adults. This was based on data demonstrating that adults treated with a
3-year course of Grazax experienced a sustained reduction in symptoms after
the completion of treatment.
If positive, the GAP trial will demonstrate that the recognised
disease-modifying properties of Grazax extend to preventing the development
of asthma in children with a diagnosis of grass pollen allergic
rhinoconjunctivitis. By providing the first tablet-based therapy to prevent
the progression of allergy to asthma, ALK will confirm its continued
commitment to advancing care for people with allergy and asthma.
Background Information
About GRAZAX(R)
The majority of grass pollen allergic rhinoconjunctivitis patients are
only offered symptomatic medications such as antihistamine tablets and/or
nasal steroid sprays, which reduce symptoms temporarily, but do not treat the
cause of the allergy itself. Around two-thirds (60-68%) of patients using
symptomatic medications perceive them to be in the range of 'not at all
effective' to 'moderately effective' on individual symptoms, according to a
survey conducted by the European Federation of Allergy and Airway Diseases
Patients Associations (EFA).
Grazax is a fast-dissolving, once-daily grass allergy immunotherapy
tablet (AIT) that is suitable for home administration.
In 2006, Grazax was the first AIT to be approved via the European Mutual
Recognition Process (MRP) in 27 countries. Subsequently, Grazax has been made
available throughout Europe (Austria, Denmark, Germany, Greece, Finland,
Holland, Ireland, Italy, Norway, Sweden, Spain, Switzerland and the United
Kingdom).
In 2008, the Grazax licence indication was extended to include the
treatment of children and adolescents (5-17 years old) with grass pollen
allergic rhinoconjunctivitis. More recently, in September 2009, Grazax was
approved as the first registered disease-modifying AIT for grass pollen
allergic rhinoconjunctivitis.
About ALK
ALK is a research-driven, global pharmaceutical company focusing on
allergy treatment, prevention and diagnosis. Our mission is to improve
quality of life for people with allergies by developing pharmaceutical
products that target the actual cause of the condition. ALK is the world
leader in allergy immunotherapy - a unique treatment that induces a
protective immune response that reduces and potentially halts the allergic
reaction. Allergy immunotherapy is traditionally administered as subcutaneous
injections or sublingual droplets. Our aim is to extend the use of allergy
immunotherapy by introducing convenient, tablet-based options, thereby
offering many more patients a causal allergy treatment.
ALK has entered into a strategic partnership regarding the tablet
programme with Schering-Plough for North America. ALK has approximately 1,500
employees with subsidiaries, production facilities and distributors
worldwide. The company is headquartered in Hørsholm, Denmark and listed on
NASDAQ OMX Copenhagen A/S. 'ALK' is an abbreviation of 'Allergological
Laboratory Copenhagen (København)'.
Further information is available at
www.alk-abello.com and www.GRAZAX.com.
For further information, please contact: Mads Boysen, Senior Internal Communications Manager, ALK, Bøge Allé 1, DK-2970 Hørsholm, Denmark, Mob: +45-4061-3800, Email: mbydk at alk-abello.com; Jenny Barrett, Senior Programme Executive, Axon Communications, Hill House, Heron Square, Richmond upon Thames, Surrey TW9 1EP, United Kingdom, Direct: +44(0)20-8439-9408, Email; jbarrett at axon-com.com
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