COPENHAGEN, Denmark, November 16 /PRNewswire/ -- 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


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 Horsholm, Denmark and listed on NASDAQ OMX Copenhagen A/S. 'ALK' is an abbreviation of 'Allergological Laboratory Copenhagen (Kobenhavn)'.

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CONTACT: For further information, please contact: Mads Boysen, SeniorInternal Communications Manager, ALK, Boge Alle 1, DK-2970 Horsholm,Denmark, Mob: +45-4061-3800, Email:; 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;