Landmark Study Confirms GRAZAX(R) 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 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.

About GRAZAX(R)

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 ALK