BARCELONA, June 7 /PRNewswire/ --

- In Addition to Effects on Allergic Rhinitis (Hayfever), GRAZAX(R) Demonstrated Significant Reductions in Asthma Symptoms in Children Aged 5 to 16 Years Old

ALK-Abelló today presented successful results from a new clinical trial, GT-12, designed to measure the impact of GRAZAX(R) on allergic rhinitis and allergic asthma. GT-12 compared the effects of GRAZAX(R) with symptomatic medication versus symptomatic medication alone on the ability to reduce symptoms of allergic rhinitis and seasonal asthma.

A significant reduction of asthma symptoms was demonstrated. GRAZAX(R) 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).

The study also showed that fewer children required asthma medication when using GRAZAX(R) than those on symptomatic medication alone, however these results were not statistically significant.

"The results are particularly relevant as rhinocojunctivitis is known to be a marker for subsequent development of asthma. Thus hayfever patients who suffer asthma symptoms maybe at risk of worsened asthma outcomes and developing clinically diagnosed asthma if they do not seek treatment," said Prof Albrecht Bufe, lead investigator of the study.

"GRAZAX(R) 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," he continued.

In addition, study results also demonstrated that GRAZAX(R) reduced hay fever symptoms by 28% and reduced the need for symptom-relieving medication by 65% (median values) during the grass pollen season (using a threshold of 30 grains/m3).

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

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

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 progress to have other allergies and/or asthma later in life. Thus, the development of allergic diseases may have life-long implications on the quality of life.

Guidelines recommend treating allergies and keeping a watchful eye out for other symptoms related to lower airways disease. 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(R) 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(R), the GT-12 results with GRAZAX(R) in children show significant effects on asthma symptoms supporting hopes for a way to 'halt' the allergic march.

About GRAZAX(R)

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(R) is a fast-dissolving, once-daily tablet-based allergy vaccine for home administration. The efficacy and safety of GRAZAX(R) 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(R), 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(R) is a trademark owned by ALK-Abelló A/S.

References

(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

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