Regulatory Filings • Feb 8, 2010
Regulatory Filings
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Company release No 1/2010
| Hørsholm | Disease-modifying effect of GRAZAX® verified |
|---|---|
| February 8, 2010 |
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Results from the fifth year of a long-term clinical study verify the disease modifying effect of GRAZAX® . For the first time ever, it is documented that the positive clinical effect of the tablet is sustained two years after completion of treatment.
Today, ALK announces positive top-line results from the second and final follow-up year in a long-term study (GT-08) with GRAZAX® , the company's grass allergy immunotherapy tablet. The results verify that the disease-modifying effect of GRAZAX® is sustained after completion of the recommended three-year treatment regimen.
Two years after completed treatment, GRAZAX® reduced hay fever symptoms with the same magnitude as in the previous year of the clinical study. The significant reduction in hay fever symptoms was accompanied by less use of symptomatic medications and consequently, a significant reduction in combined symptom and medication score was obtained. Furthermore, the immunological assessment continues to show a sustained, positive effect on the immune system indicating a lasting tolerance to grass pollen.
The positive results were obtained despite a markedly lower grass pollen exposure during 2009 compared to the previous pollen seasons in 2005-08.
In 2009, authorities in Europe approved GRAZAX® as a disease modifying allergy treatment. The approval was based on the results of the first follow-up year in the GT-08 study and the latest findings therefore reinforce the scientific and clinical rationale of the product. GRAZAX® is the only registered tablet treatment against grass pollen allergy with documented sustained effect after completion of treatment.
Jens Bager
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 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, tlf. + 45 4574 7901, mobile + 45 2064 1143
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