ALK-Abelló, the Makers of GRAZAX(R), Present Successful Phase III Clinical Study Results with Children

Horsholm, Denmark (ots/PRNewswire) -

- Results Show Highly Significant Effect on Rhinoconjunctivitis
(Hay Fever) and Asthma Symptoms in Children from age 5 to 16
Years-old

ALK-Abelló yesterday presented successful Phase III clinical
study results with GRAZAX(R) 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(R) 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(R) 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(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).

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

Henrik Jacobi, MD, EVP of Research and Development at ALK-Abelló
stated: 'The data are remarkable and suggest 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. 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(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.

---------------------------------

(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

ots Originaltext: ALK-Abello
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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


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