Landmark Study Confirms Grazax as the Only Grass Allergy Immunotherapy Tablet to Show Sustained Effect 2 Years After Treatment Completion
LONDON, June 7, 2010/PRNewswire-FirstCall/ -- Data published at
the European Allergy, Asthma & Clinical Immunology (EAACI)
congress in London today documents that GRAZAX(R) is the only
allergy immunotherapy tablet (AIT) to show sustained disease
control 2 years after treatment completion. Leading specialists
emphasise the relevance of the data with regard to inclusion in
guidelines for treatment of grass pollen allergy.
Traditional symptomatic medications, such as antihistamine
tablets and nasal corticosteroid sprays, only treat the symptoms of
grass pollen rhinoconjunctivitis or 'hay fever'. GRAZAX(R) tablet
immunotherapy targets the underlying cause of the disease, leading
to a long-term disease modifying effect in patients previously
uncontrolled on symptomatic treatments.
"Two years after completion of treatment, we see that GRAZAX(R)
reduced hay fever symptoms with the same magnitude as in the
previous year of the clinical study. Completion of the GT-08 study
brings us more evidence that this efficacy is sustained during and
two years after treatment with GRAZAX(R)" highlights Professor
Stephen R. Durham, the GT-08 study Lead Investigator and Head of
Section for Allergy and Clinical Immunology at the National Heart
& Lung Institute, Imperial College London and Professor of
Allergy and Respiratory Medicine at Royal Brompton Hospital
"Allergic rhinoconjunctivitis is a chronic disease with
increasing prevalence all over Europe. By 2015, every second person
might be suffering from at least one form of allergic disease" said
Marianella Salapatas, President of the European Federation of
Allergy and Airways Diseases Patients Association (EFA). "Symptoms
can be very bothersome, inevitably resulting in a reduced ability
of the patients to actively participate in social and professional
life. Unfortunately, allergic rhinitis is considered trivial and
often mistaken for viral. This then may lead to patients being
under diagnosed and undertreated."
Discussion on treatment guidelines needed
The new data presented at EAACI represent a potential
breakthrough for the future management of grass-allergic
rhinoconjunctivitis. "A fact that we have to take into account for
future treatment of grass-allergic rhinoconjunctivitis patients"
concluded Erkka Valovirta, Chief Pediatrician and Pediatric
Allergist, Allergy Center Turku, Finland. "It has been acknowledged
by European regulatory authorities that treatment with GRAZAX(R) is
disease-modifying. By that GRAZAX(R) fulfills the EMEA demands for
robust clinical data on Specific Immunotherapy in treating allergic
symptoms, showing long-term efficacy and sustained clinical effect
during and after treatment completion."
A landmark study has been completed, and the results confirm
that AIT for grass pollen induced rhinoconjunctivitis provides the
treating physician with the strongest levels of evidence presently
About the GRAZAX(R) GT-08 study
The pivotal GRAZAX(R) GT-08 study is a randomized,
parallel-group, double-blind, placebo-controlled multicentre study.
Patients were randomised to receive either 3 years of GRAZAX(R) or
placebo, followed by a 2 year follow up period. Throughout the
study all patients had free access to symptomatic
GRAZAX(R) is a fast dissolving, once-daily allergy immunotherapy
tablet (AIT) that is suitable for home administration.
In 2006, GRAZAX(R) was the first AIT to be approved via the
European Mutual Recognition Process (MRP) in 27 countries.
Subsequently, GRAZAX(R) has been made available throughout Europe
(Austria, Denmark, Germany, Greece, Finland, Holland, Ireland,
Italy, Norway, Sweden, Spain, Switzerland and the United
In 2008 the GRAZAX(R) license 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(R) was approved as the first registered
disease-modifying AIT for grass pollen allergic
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 a 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
ALK has entered into a strategic partnership regarding the
tablet programme with Schering-Plough in 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)'. Further information is available at
http://www.alk-abello.com and http://www.GRAZAX(R).com.
For further information, please contact: Journalists: Martin
Barlebo, Director, ALK Group Communications, +45-20-6411-43.
Analysts and investors: Per Plotnikof, Director ALK Investor
Posted: June 2010