Authorities in 27 European countries have approved GRAZAX® as a disease
modifying allergy treatment. GRAZAX® is now the only registered tablet
treatment against grass pollen allergy with documented sustained effect after
completion of treatment.
The approval and the extended marketing authorisation are based on the results
of the first follow-up year in a long-term study (GT-08) with GRAZAX® published
at the European allergy congress in June 2009. The results document that the
significant improvement of the patients' eye and nose symptoms and quality of
life is sustained after completion of the recommended treatment regimen.
The patients in the GT-08 study have adhered to the recommended three-year
GRAZAX® treatment regimen and completed treatment in the autumn of 2007. The
2008 pollen season was thus the first follow-up year in which the patients did
not receive active treatment with GRAZAX®.
The results represent a major breakthrough, since ALK is the first company ever
to document a sustained disease modifying effect of an allergy immunotherapy
tablet (AIT). Patients cannot obtain such a sustained disease modifying effect
with traditional symptom-relieving allergy medication such as antihistamines
and/or nasal corticosteroids.
This announcement does not change ALK's financial outlook for 2009.
President & CEO
For further information please contact:
Per Plotnikof, Head of Investor Relations, tel: +45 2261 2525