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New Study Reinforces Safety And Clinical Efficacy Of ALK-Abello A/S's Tablet Against Grass Pollen Allergy


10/19/2005 5:11:56 PM

COPENHAGEN, Denmark, January 6 /PRNewswire-FirstCall/ -- According to preliminary results from a new study (GT-07) announced today, ALK-Abello's ground-breaking tablet-based allergy immunotherapy treatment reduces rhino-conjunctivitis (hay fever) symptoms by 37%, whilst reducing the need for symptom relieving medication by 41% (compared with placebo).

The GT-07 study demonstrates the efficacy and confirms the favourable safety profile of the grass tablet, recently reported in the phase IIb/III trial (GT-02) - the largest allergy immunotherapy study ever performed[1].

"These are exciting results for ALK-Abello," commented Jens Bager, CEO, ALK-Abello A/S. "This study clearly reinforces our strategy of investment in the tablet programme. ALK-Abello is committed to bringing the grass tablet to market so that more patients can gain access to the benefits of immunotherapy. We now look forward to the results of the ongoing study (GT-08), which includes more than 600 patients allergic to grass pollen," he says.

The World Health Organisation (WHO) estimates that in the Western world more than 20% of the population suffer from allergy, of which approximately 50% are allergic to grass pollen, and the prevalence continues to increase[2],[3]. Compared with traditional symptom relieving medications, immunotherapy is a unique treatment that is recognised by the WHO to target the immunological cause of allergy and alter the natural course of the disease[4]. Until now, only a small proportion of patients have traditionally been offered allergy immunotherapy.

"The most effective way to prevent the symptoms of allergy is to treat the allergic condition. The availability of a safe and easy-to-use tablet form of immunotherapy will fulfil a real treatment need," says principal investigator of the study, Professor Ronald Dahl, Aarhus University Hospital, Denmark. "With an effective tablet, more grass allergic patients will have access to a baseline allergy treatment, which provides sustained prevention of allergy symptoms and reduces the need for symptomatic medication," he says.

About the study

The GT-07 study was a double-blind, placebo-controlled, multi-centre study comparing the safety and efficacy of ALK-Abello's once-daily, tablet-based grass allergy immunotherapy treatment with placebo.

The study involved 114 patients diagnosed with moderate-to-severe rhinoconjunctivitis and grass pollen induced mild-to-moderate asthma in Sweden and Denmark. Subjects were randomized to receive 75,000 SQ-T units of Phleum pratense (grass tablet) or placebo. The pre-pollen treatment period was extended compared to that in the GT-02 study. Thus all patients received a pre-pollen season treatment period of at least 10 weeks, with no up-dosing.

About ALK-Abello

ALK-Abello has been active in allergy immunotherapy since 1923. In recent years, it has pursued a product development strategy of extending the current market of specialist-administered subcutaneous immunotherapy to orally delivered alternatives. ALK-Abello's pipeline contains tablet-based products based on natural allergens against grass and house dust mites. ALK-Abello is headquartered in Hoersholm, north of Copenhagen, Denmark. It is wholly owned by Chr. Hansen Holding A/S , a company listed on the Copenhagen Stock Exchange.

[1] Presented at the Symposium of Specific Allergy (SOSA) 2004, London 22-April, 2004.

[2] Bousquet J, van Cauwenberge PB, Khaltaev N, et al. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001; 108 (Suppl 5): S147-334.

[3] Dahl R, et al. National prevalence of respiratory allergic disorders. Respiratory Medicine 2004; 98: 398-403.

[4] Bousquet J, Lockey RF, Malling HJ. Allergen immunotherapy: therapeutic vaccines for allergic diseases. WHO position paper. Allergy 1998; 53: 1-42.

ALK-Abello

CONTACT: For further information please contact: President & CEO, JensBager: +45-45-74-75-07, mobile: +45-22-99-03-04 CommunicationsManager, Jytte Wolff-Sneedorff: +45-45-74-75-50, mobile:+45-40-94-27-06


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