Regulatory Filings • Nov 2, 2009
Regulatory Filings
Open in ViewerOpens in native device viewer
Hørsholm November 2, 2009 GRAZAX® trial in the US meets primary endpoint
Page 1/2 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.
Jens Bager, President & CEO
For further information please contact:
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 quality of life for allergic people 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. ALK has entered into a strategic partnership regarding the tablet programme with Schering-Plough for North America. ALK has approximately 1,500 employees with subsidiaries, production facilities and distributors worldwide. The company is headquartered in Hørsholm, Denmark and listed on NASDAQ OMX Copenhagen A/S. 'ALK' is an abbreviation of 'Allergological Laboratory Copenhagen (København)'. Further information is available at www.alk-abello.com and www.GRAZAX.com.
Investor Relations and press: Per Plotnikof, tel +45 4574 7527, mobile +45 2261 2525
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.