The investigational sublingual allergy immunotherapy tablet (GRAZAX®) meets
primary endpoint in a study of adult subjects with a history of grass pollen
allergies.
Schering-Plough Corporation, ALK's strategic partner in North America, today
announced that its investigational sublingual Grass (Phleum Pratense) Allergy
Immunotherapy Tablet (AIT) has met the primary endpoint in a Phase III study of
adult subjects in the U.S. with a history of grass pollen induced
rhinoconjunctivitis with or without asthma. The investigational Grass AIT
treatment is designed to work by inducing a protective immune response against
grass pollen allergy and providing sustained prevention of allergy symptoms,
treating both the symptoms and the underlying cause of the disease.
The study was a U.S. multicenter, randomized, placebo-controlled, double-blind,
parallel-group clinical trial evaluating the efficacy of the grass sublingual
tablet versus placebo in the treatment of grass pollen-induced
rhinoconjunctivitis based on the combined (sum of) rhinoconjunctivitis daily
symptom score and rhinoconjunctivitis daily medication score averaged over the
entire grass pollen season. In the study 439 adults were randomized to receive
either placebo or grass tablet. The study met its primary endpoint.
Additionally, the adverse events experienced by subjects receiving the drug in
this study were similar to previous studies in adults and include oral itching,
with no new or unexpected findings.
These data are planned to be submitted for presentation at a U.S. medical
conference in 2010.
This announcement does not change ALK's outlook for the financial year 2009.
ALK-Abelló A/S
Jens Bager, President & CEO
For further information please contact:
Jens Bager, President and CEO, tel. +45 4574 7576
Investor Relations and press: Per Plotnikof, tel +45 4574 7527,
mobile +45 2261 2525
