ALK - Five-year GRAZAX(R) Asthma Prevention (GAP) Trial Reveals Benefits of Early Treatment Intervention in Children

PR69233

HORSHOLM, Denmark, July 7, 2017 /PRNewswire=KYODO JBN/ --

    - The disease modifying property of GRAZAX(R) (SQ(R) grass SLIT-tablet)

resulted in long-term effect on allergic rhinoconjunctivitis (ARC) and

prevented asthma symptoms, even two years after end of treatment in children

with grass pollen ARC and no existing signs or symptoms of asthma

    - Younger children had a higher probability of developing asthma. The

younger the children were at treatment-start, the greater the percentage was

prevented from having asthma symptoms and using asthma medication during the

two-year follow-up period post discontinuation of treatment

    - Evidence in asthma continues to build for latest generation of allergy

immunotherapy treatments

    ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF) today released further analysis

of data from its landmark five-year GRAZAX(R) Asthma Prevention (GAP) clinical

trial in children. The analysis, which appears online in press in The Journal

of Allergy and Clinical Immunology, shows that the benefits of GRAZAX(R) in

prevention of asthma symptoms were even more pronounced when treatment was

initiated at an earlier age.

          (Logo: http://photos.prnewswire.com/prnh/20160420/357628LOGO )

    The GAP trial, which is the largest double-blind, placebo-controlled trial

ever conducted in allergy immunotherapy in a paediatric population, was

initiated in 2009 to investigate the effect of ALK's sublingual grass allergy

immunotherapy (SLIT) tablet, GRAZAX(R), on the risk of developing asthma when

compared with placebo treatment. The trial involved 812 children aged 5-12

years at 101 sites in 11 European countries and comprised a three-year

treatment phase with a two-year follow-up phase.

    The primary trial endpoint was the time to a first diagnosis of reversible

impairment of lung function. The hypothesis was that fewer children given

GRAZAX(R) would receive this diagnosis or that they would be diagnosed later

than subjects in the placebo group.

    This primary endpoint was not met and the trial indicated that an

appropriate asthma diagnosis in this particular population should not be based

on a single time point evaluation but rather rely on a combined clinical

assessment obtained over a longer observation period, which is normally done in

daily practice. However, the trial did reveal several advantages of early

treatment of children with GRAZAX(R). Including:

    - GRAZAX(R) significantly reduced the proportion of children experiencing

asthma symptoms or using asthma medication - an effect that was observed year

round and       sustained for two years after end of treatment

     - The younger the children were at treatment initiation, the greater the

percentage of children avoiding asthma symptoms and the need for symptomatic

asthma medication during the follow-up period

     - The disease modifying effect on ARC in children was verified

    The GAP trial also confirmed that the safety and tolerability of GRAZAX(R)

were favourable and in line with previous studies, with no new or unexpected

findings.

    Erkka Valovirta, Adjunct professor of clinical and paediatric allergology,

University of Turku, Finland, said: "The landmark GAP trial uncover valuable

data about allergic asthma and the potential for preventing it with a new class

of clinically proven allergy immunotherapy products such as GRAZAX(R). These

data illustrates the importance of early intervention with the right treatment

for children who are at risk of developing this serious condition."

    Asthma affects an estimated 300 million individuals worldwide and is

considered a serious global health problem affecting all age groups. It is one

of the most common chronic childhood diseases and can impose a considerable

burden on patients, their families, and health care systems. Allergic

rhinoconjunctivitis is a recognised risk factor for asthma development.

    GRAZAX(R) is one of a new generation of allergy immunotherapy treatments

that show benefits in respiratory allergy. It reduces ARC symptoms and the need

for allergy pharmacotherapy. In addition, the latest GAP data indicate that the

disease modifying properties of GRAZAX(R) extends to prevent the development of

asthma symptoms in children with grass pollen ARC. GRAZAX(R) is today marketed

in Europe and Australia as the only product with an ARC disease modifying

effect. In North America GRAZAX(R) is available under the brand name

GRASTEK(R)[1].

    In 2015, ALK's ACARIZAX(R) - a sister product to GRAZAX(R) used in the

treatment of house dust mite allergy - became the first SLIT-tablet to be

approved for use in patients with house dust mite allergic asthma in Europe. In

February 2017, clinical data for ACARIZAX(R) led, for the first time, to the

addition of allergy immunotherapy as a recommended additional treatment option

in the Global Initiative for Asthma (GINA) report: Global Strategy for Asthma

Management and Prevention.

                                      ALK-Abello A/S

    About GRAZAX(R)

    GRAZAX(R) was approved in Europe in 2006 and is today marketed in 27

countries including Australia and North America. GRAZAX(R) is the world's best

documented grass allergy immunotherapy product with data from 17 randomised,

double-blind, placebo-controlled clinical trials, covering more than 5,600

patients. In North America GRAZAX(R) is available under the brand name

GRASTEK(R).

    About ALK

    ALK is a research-driven global pharmaceutical company focusing on allergy

prevention, diagnosis and treatment. ALK is a world leader in allergy

immunotherapy - a treatment of the underlying cause of allergy. The company has

approximately 2,300 employees, with subsidiaries, production facilities and

distributors worldwide. ALK has entered into partnership agreements with Torii,

Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets

in Japan, Russia, and South-East Asia, and Australia and New Zealand,

respectively. The company is headquartered in Horsholm, Denmark, and listed on

Nasdaq Copenhagen. Find more information at http://www.alk.net.

    1) GRASTEK(R) trademark is owned by Merck (NYSE: MRK)

     Source: ALK