Landmark Study Confirms GRAZAX(R) as the Only Grass Allergy Immunotherapy Tablet to Show Sustained Effect 2 Years After Treatment Completion

June 7, 2010

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 London.

“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 available.

Background Information

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 medications.


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 Kingdom).

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 rhinoconjunctivitis.

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 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 treatment.

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.


Source: newswire

comments powered by Disqus