Summary: ALK-Abelló announces highly significant and positive third year results from clinical study with GRAZAX® which support expectations of a long-term disease-modifying effect of the therapy. Today, ALK-Abelló announces positive results from the third treatment year of the GT-08 study with GRAZAX®, the company's tablet-based vaccine against grass pollen allergy. The study documents that the highly significant clinical effect from the first and second years of treatment is sustained through the third year and even increases when taking into account the differences between the three pollen seasons. Furthermore, an increasing, positive effect on the immune system is documented. In the third treatment year, GRAZAX® significantly reduces hay fever symptoms and the use of symptom relieving-medication (p<0.001). Hay fever symptoms are reduced by 37% while the use of symptom-relieving medication is reduced by 60%. The reduction of symptoms and use of medication is measured as median values relative to a placebo group in which patients had unrestricted access to symptom-relieving medication. Thus, the effect of GRAZAX® comes in addition to the effect from placebo and symptom-relieving medication. Following the three-year treatment period, a further efficacy analysis has been made taking into account the differences between the three pollen seasons. This analysis documents that the clinical effect increases significantly over the three years of treatment. In addition, blood samples from patients show a significant, increasing effect on the immune system indicating an increasing tolerance to grass pollen. These findings emphasize that treatment with GRAZAX® has a modifying effect on the underlying allergic disease. The tolerability profile was gradually improved during the three years of daily treatment, and the product was also well tolerated by patients in the third year of treatment. The results support ALK-Abelló's expectations that GRAZAX® will have a lasting, significant effect when the recommended three-year treatment period ends. Such a lasting effect cannot be obtained with traditional symptom-relieving allergy medication. In order to finally document this effect, the study will now be concluded by a two-year follow-up period in which patients no longer receive active treatment with GRAZAX®. GRAZAX® is the first allergy tablet that treats the underlying cause of grass pollen allergy as well as the allergy symptoms. Hørsholm, March 1, 2008 ALK-Abelló A/S Jens Bager President and CEO For further information, please contact: Jens Bager, President and CEO, telephone +45 4574 7576 Per Plotnikof, Investor Relations, telephone +45 2261 2525 Jacob Frische, Group Communications, telephone +45 2224 7551
ALK-Abelló announces positive third year results from clinical study with GRAZAX®
| Source: ALK Abello