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ALK-Abello A/S Present Successful Phase III Clinical Study Results with Children


3/17/2008 6:31:38 AM

HORSHOLM, Denmark, March 17 /PRNewswire/ -- ALK-Abelló yesterday presented successful Phase III clinical study results with GRAZAX® in children at the American Academy of Allergy, Asthma & Immunology (AAAAI 2008) taking place in Philadelphia, Pennsylvania this week.

The main results from the GRAZAX® GT-12 study were presented to the scientific community. More than 250 patients participated in the randomized, double blind, placebo controlled trial.

In the grass pollen season (using a threshold of 30 grains/m3), GRAZAX® reduced hay fever symptoms by 28% and reduced the need for symptom relieving medication by 65% (median values).

The results show corresponding effect to the results from the largest clinical trial programme ever conducted within allergy immunotherapy in adults which led to a European marketing approval for adults in 2006.

In addition, a significant effect on asthma symptoms were observed. GRAZAX® reduced the combined asthma symptom score by 64%. The asthma symptoms included were: coughing, wheezing, chest tightening/shortness of breath (dyspnoea) and exercise induced symptoms. Participants in the study also experienced a 67% reduction in the number of days with asthma symptoms (median).

Currently a registration application for the pediatric use of GRAZAX® is under submission in Europe.

Henrik Jacobi, MD, EVP of Research and Development at ALK-Abelló stated: 'The data are remarkable and suggest GRAZAX® has the potential to provide a new treatment choice in this area particularly among young patients whose symptoms may not be controlled adequately with available treatments. New therapy options are needed for treating grass pollen allergy because currently available therapies apart from allergy immunotherapy do not achieve long-term symptom remission. In addition, immunotherapy has the added bonus that it may prevent asthma in at risk children and halt the allergic march.'

Correlation between Rhinitis and Asthma

Allergies often come in a series called the "allergic march". A proportion of adults and children with one type of allergy, such as grass pollen (the most common), will then progress to have other allergies and/or asthma later in life. Thus, the development of allergic diseases can be a life-long-struggle.

Guidelines recommend treating allergies and keeping a watchful eye out for other symptoms related to lower airways disease. While several treatment modalities exist, symptomatic medications (e.g. antihistamines and local steroids) aim only at controlling the symptoms of hayfever temporarily but do not treat the actual cause of the disease.

GRAZAX® is the first immunotherapy tablet that treats the underlying cause of grass pollen allergy and not only the symptoms. Only immunotherapy targets the underlying cause of the allergic disease, having the potential to result in long-term remission. (i)

Several controlled clinical studies have also demonstrated the added benefits of immunotherapy in treating asthma symptoms in patients suffering from allergic asthma, and in preventing the development new allergies and asthma.(ii)(iii)

In particular, Novembre et al. demonstrated that sublingual (under the tongue) immunotherapy over three years not only improved seasonal rhinitis symptoms but also reduced the development of seasonal asthma in children with hay fever.(iv)

While long term studies are still being conducted on GRAZAX®, the GT-12 results with GRAZAX® in children show significant effects on asthma symptoms supporting hopes for a way to 'halt' the allergic march.

About GRAZAX®

Grass pollen allergy is a health problem representing a significant social burden. At least 75 million people in the USA and Europe suffer from grass pollen allergy in the form of allergic rhinitis (hay fever) or allergic asthma - or both.

The majority of patients are only offered symptom-relieving medications that reduce symptoms temporarily but do not treat the allergy itself. In addition, 60-68% of patients using symptom-relieving 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).(v)

GRAZAX® is a fast-dissolving, once-daily tablet-based allergy vaccine for home administration.

The efficacy and safety of GRAZAX® has been documented in the largest adult clinical study programme ever conducted within allergy vaccination.

About ALK-Abelló

ALK-Abelló is devoted to improving the lives of people with allergies by developing pharmaceutical products that target the cause of allergy. ALK-Abelló is the world leader in allergy vaccination (immunotherapy) - a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction. Allergy vaccination is traditionally administered as subcutaneous injections or sublingual droplets. ALK-Abelló aims to extend the use of allergy vaccination by introducing convenient, tablet-based vaccines, thereby offering many more patients a causal allergy treatment. GRAZAX®, the world's first tablet-based vaccine against grass pollen allergy, was launched in Europe in 2006, and ALK-Abelló has entered into partnerships regarding the tablet program with the Menarini Group for central and Eastern Europe and with Schering-Plough for North America. ALK-Abelló has more than 1,400 employees with subsidiaries, production facilities and distributors worldwide. The company is headquartered in Hørsholm, Denmark and listed on the OMX Nordic Exchange Copenhagen. Further information is available at http://www.alk-abello.com and http://www.GRAZAX.com.

GRAZAX® is a trademark owned by ALK-Abelló A/S.

(i) Linneberg A, Nielsen NH, Madsen F, Frolund L, Dirksen A, Jorgensen T. Increasing prevalence of specific IgE to aeroallergens in an adult population: two cross-sectional surveys 8 years apart: the Copenhagen Allergy Study. J Allergy Clin Immunol 2000;106(2):247-52

(ii) Bousquet J, Van Cauwenberge P, Khaltaev N. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001;108(5 Suppl):S147-334

(iii) Jacobsen L CT, Anderson P, Valovirta E, Dahl R, de Monchy J. The co-morbidity of allergic hay fever and asthma in randomly selected patients with respiratory allergic diseases. Allergy 2002;57(23).

(iv) Novembre E, Galli E, Landi F, Caffarelli C, Pifferi M, De Marco E, et al. Coseasonal sublingual immunotherapy reduces the development of asthma in children with allergic rhinoconjunctivitis. J Allergy Clin Immunol 2004;114(4):851-7

(v) EFA web site. 2008.

For further information, please contact:

Sharmi Albrechtsen, International Brand Communication Manager, ALK-Abelló Phone +45-45747551

Jacob Frische, Director, ALK-Abelló Group Communications Phone +45-45747551 or +45-22247551

Source: ALK-Abello A/S


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