Regulatory Filings • Feb 15, 2010
Regulatory Filings
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allergies.
Company release No 3/2010
The investigational sublingual Grass (Phleum Pratense) Allergy Immunotherapy Tablet (AIT) has met the primary endpoint in a Phase III study of paediatric patients in the U.S. with a history of grass pollen induced rhinoconjunctivitis with or without asthma.
The study was conducted by Merck, ALK's strategic partner in North America, and was a U.S. multicenter, randomized, placebo-controlled, double-blind, parallel-group clinical trial. The trial was evaluating the efficacy of the grass sublingual tablet versus placebo in the treatment of grass pollen-induced rhinoconjunctivitis based on the combined rhinoconjunctivitis daily symptom score and rhinoconjunctivitis daily medication score averaged over the entire grass pollen season. In the study 345 children were randomized to receive either placebo or grass tablet. The study met its primary endpoint.
The data will be presented by Merck at the annual meeting of the American Academy of Allergy Asthma and Immunology (AAAAI), February 26 to March 2, 2010, in New Orleans, USA.
Jens Bager, President & CEO
Jens Bager, President and CEO, tel. +45 4574 7576
ALK is a research-driven global pharmaceutical company focusing on allergy treatment, prevention and diagnosis. Our mission is to improve the quality of life of persons with allergy by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) – a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction. Allergy vaccination is traditionally administered as subcutaneous injections or sublingual droplets. Our aim is to extend the use of allergy vaccination by introducing convenient, tablet-based vaccines, thereby offering many more patients a causal allergy treatment. Following this strategy, the world's first tablet-based vaccine against grass pollen allergy, GRAZAX® , was launched in Europe in 2007 and ALK has entered a strategic partnership with Merck (previously Schering-Plough) regarding the tablet programme in North America. In 2009, GRAZAX® was approved as a disease modifying allergy treatment and GRAZAX® is now the only registered tablet treatment against grass pollen allergy with documented sustained effect after completion of treatment. ALK has approximately 1,500 employees with subsidiaries, production facilities and distributors worldwide. The company is headquartered in Hørsholm, Denmark, and listed on the NASDAQ OMX Copenhagen A/S. Further information is available at www.alk-abello.com and www.GRAZAX.com.
Investor Relations: Per Plotnikof, tel +45 4574 7527, mobile +45 2261 2525 Press: Martin Barlebo, tel. + 45 4574 7901, mobile + 45 2064 1143
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