To: The Copenhagen Stock Exchange
Announcement No. 16 in 2007
November 16, 2007
ALK-Abelló reports phase III results from US clinical study
Summary: The US clinical study (GT-14) with ALK-Abelló's grass tablet did not
meet its primary endpoint. An analysis in a subset of patients, however, showed
a positive clinical effect that is consistent with the results from the
European clinical study program. Schering-Plough continues the development
program and is initiating an additional one-year study, to be conducted in
conjunction with the 2008 grass pollen season.
ALK-Abelló has completed a phase III clinical study (GT-14) with the
tablet-based immunotherapy for grass pollen allergy in the USA. The study was
designed to confirm the positive results from the European clinical study
program, which led to a pan-European registration of the tablet in 2006. The
GT-14 study enrolled a total of 329 patients and the primary endpoint was the
reduction of patients' allergy symptoms during the grass pollen season.
The majority of patients in the active and placebo arms did not record an
increase in rhinoconjunctivitis symptoms during the grass pollen season, and as
a result the trial did not meet its primary endpoint. An analysis in a subset
of patients, however, showed a positive clinical effect that is consistent with
the results from the European clinical study program.
The safety profile was consistent with the previous European clinical studies.
Schering-Plough is initiating a one-year efficacy and safety study of the grass
tablet-based immunotherapy in adults in connection with the 2008 grass pollen
season. In addition, Schering-Plough will as planned initiate an efficacy and
safety study of the grass tablet in children in connection with the 2008 grass
pollen season.
Schering-Plough signed an agreement on January 2, 2007, with ALK-Abelló to
develop and market in the United States, Canada and Mexico tablet-based
immunotherapy compounds for grass pollen allergies, house dust mite allergies
and ragweed allergies.
This announcement does not change ALK-Abelló's financial outlook for 2007.
Hørsholm, November 16, 2007
ALK-Abelló A/S
Jens Bager
President and CEO
For further information please contact:
Jens Bager, President and CEO, telephone +45 4574 7576
