Improved quality of life and sustained symptom control of GRAZAX® after completion of treatment (EAACI 2009)


The clinical benefits of ALK's allergy immunotherapy tablet (AIT) for grass
allergy, GRAZAX®, are sustained after completion of treatment. A follow-up
study covering the first year after treatment demonstrates continued symptom
control as well as improved quality of life in grass pollen allergic people.
For the first time ever, these landmark results are presented to the scientific
community today at the annual congress of the European Academy of Allergy and
Clinical Immunology (EAACI 2009), in Warsaw, Poland. 

"The follow-up results are exciting, as they document that the true benefit of
immunotherapy, the long term effect, is obtained with GRAZAX®. The results are
encouraging to allergic patients as they emphasize that it is worthwhile going
through the continuous all year round treatment course; it pays off, not only
during treatment, but also in the long run," says the study's principal
investigator, professor Stephen R. Durham, National Heart and Lung Institute,
Imperial College, London, UK. 

Sustained relief for patients
During the first year after treatment, GRAZAX® continues to provide significant
reductions in both hay fever symptoms and the patients' use of symptomatic
medication. Sneezing, itchy or watery eyes and a runny, itchy or blocked nose
are the most common symptoms reported by allergic rhinoconjunctivitis patients.
One year after GRAZAX® treatment, these symptoms remain reduced by 25-60%. 

Furthermore, the data shows that quality of life continues to be significantly
improved. Through the first year after treatment, the improvement of quality of
life was sustained at 23% over and above that achieved with symptomatic
medications alone. This implies sustained improvements to the patients' daily
practical activities, emotional well-being and sleep. These are all important
parameters in this disease. 
 
"Allergy is a massively under-diagnosed and under-treated disease. Patients
experience an enormous impact on quality of life - during working hours as well
as leisure time. They suffer from sleep disturbance, leading to daytime
tiredness and increased absence from school and work," says Stephen R. Durham. 

Major breakthrough for patients in causal allergy treatment
The results from the fist follow-up year represent a major breakthrough. ALK is
the first company ever to document a sustained disease modifying effect of an
AIT. Patients cannot obtain such a continued vaccination effect with
traditional symptomatic medication. GRAZAX® is the first allergy tablet to
treat the underlying cause of grass pollen allergy as well as the allergy
symptoms. 

About the GRAZAX® GT08 study
The pivotal GRAZAX® GT08 study is a randomized, parallel-group, double-blind,
placebo-controlled, multicentre study. Patients were randomised to receive
either three years of GRAZAX® treatment or placebo, followed by a two year
follow-up period (the second follow-up year is currently ongoing). Throughout
the study, all patients have free access to symptomatic medication. 

The data form the first follow-up year of the GT08 study is based upon a full
analysis set including 283 participants, with a history of grass pollen
rhinoconjunctivitis uncontrolled by symptomatic medication. 

The main clinical study endpoints were:
-	Rhinoconjunctivitis symptom score
-	Rhinoconjunctivitis medication score
-	Quality of Life (QoL)

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 allergy by developing pharmaceutical products that target the
actual cause of allergy. ALK is the world leader in allergy immunotherapy - a
unique treatment that induces a protective immune response which 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 allergy
immunotherapy tablets (AIT), thereby offering many more patients a causal
allergy treatment. Following this strategy, the world's first allergy
immunotherapy tablet for grass pollen allergy, GRAZAX®, was launched in Europe
in 2007, and ALK has entered into a strategic partnership with Schering-Plough
regarding the tablet programme in 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: 
Jacob Frische, Director, ALK Group Communications, (+45) 45 74 75 51 or (+45)
22 24 75 51

Attachments

finalgzxpreaaci09.pdf