To: The Copenhagen Stock Exchange
Translation
Announcement no. 19 in 2007
November 22, 2007
Favourable results from GRAZAX® study in children
Summary: The Phase III clinical study (GT-12) of GRAZAX® for children met its
primary endpoint. The study showed a statistically significant clinical effect
corresponding to the results which led to a European marketing approval for
adults in 2006. The study concurrently confirmed the known safety profile. In
2008, ALK-Abelló intends to apply for an expansion of the marketing approval to
include children and adolescents.
ALK-Abelló has completed a Phase III clinical study (GT-12) of its tablet-based
vaccine against grass pollen allergy, GRAZAX®, in children. The study was
conducted with a view to obtaining an expansion of the European marketing
approval from 2006 to include children and adolescents.
The study was conducted in Germany and included 253 patients from 5 to 16 years
of age. The study met its primary endpoint and showed a statistically
significant clinical effect corresponding to the results from the comprehensive
European clinical development program in adult patients. The study concurrently
confirmed the previously documented safety profile.
ALK-Abelló considers the results an important milestone in its development
program for tablet-based allergy vaccines to include the treatment of the large
group of children and adolescents who suffer from grass pollen allergy.
Based on the results, ALK-Abelló expects to file a variation application with
the European regulatory authorities in 2008 with a view to expanding the
marketing approval to include children and adolescents.
This announcement does not change ALK-Abelló's financial outlook for 2007.
Hørsholm, November 22, 2007
ALK-Abelló A/S
Jens Bager
President and CEO
For further information, please contact:
Jens Bager, President and CEO, telephone +45 4574 7576
