ALK’s ACARIZAX(R) Data Results in Significant Change to the GINA Asthma Management Strategy

ALK’s ACARIZAX(R) Data Results in Significant Change to the GINA Asthma Management Strategy: Sublingual Allergy Immunotherapy (SLIT) Recommended as a Treatment Option in Patients With House Dust Mite Allergic Asthma

HORSHOLM, Denmark, Feb. 27 /PRNewswire=KYODO JBN/ --

     ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF) today announced that for the

first time, allergy immunotherapy is now recommended as a treatment option in

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

Management and Prevention. This global strategy is a widely recognised

practical resource developed to guide healthcare professionals and policy

makers, and represents the latest clinical evidence and medical practice for

the treatment and management of asthma. The strategy is updated annually based

on review of recent scientific literature by an international panel of experts

on the GINA Science Committee.

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

    The 2017 update, which includes new information regarding the use of

allergy immunotherapy, has just been released and features the following

addition to steps 3 and 4 of GINA's recommended stepwise treatment of asthma in

adult house dust mite (HDM) sensitive patients:

    Consider adding SLIT (sublingual allergy immunotherapy) in adult HDM

sensitive patients with allergic rhinitis who have exacerbations despite ICS

(inhaled corticosteroids), provided FEV1 is ＞70% of predicted lung

function.[1)]

    This change draws upon recently published results from ALK's Phase III

clinical trial evaluating the treatment of HDM allergic asthma with the HDM

SLIT-tablet, ACARIZAX(R) in The Journal of the American Medical Association

(JAMA) [2)]

    Henrik Jacobi, Executive Vice President of Research & Development at ALK,

said: "We are extremely pleased to see the recognition of ACARIZAX(R) clinical

evidence in the management of asthma. This confirms our long-held conviction

that allergy immunotherapy has an important role to play in the treatment of

allergic asthma, a belief confirmed by the unprecedented clinical development

programme for ACARIZAX(R), currently the only HDM SLIT-tablet indicated for use

in patients with house dust mite allergic asthma that is not well controlled."

    House dust mite allergy and asthma often coexist. More than half of

asthmatic patients have been reported to have house dust mite sensitisation.

    He continued: "ALK is committed to gathering further evidence to support

the wider recognition of allergy immunotherapy as a treatment option for

asthma, and to investigating the potential role for allergy immunotherapy in

preventing the onset of asthma"

    Professor J. Christian Virchow, of the University of Rostock and lead

author of the recently published paper in JAMA says: "This is very encouraging.

I am pleased to see findings from this important trial translated into clinical

guidelines. This underlines the importance of performing robust evidence based

trials in allergy immunotherapy."

    ACARIZAX(R) is currently approved for the treatment in HDM allergic asthma

in 12 European countries and Australia.

                                       ALK-Abello A/S

    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.

    About house dust mite allergy and ACARIZAX(R)

    House dust mites (HDM) are the most common cause of allergy in the world.

HDM allergy is estimated to affect around 90 million people in Europe, North

America and Japan, and more than 100 million in China. It is estimated that one

in 10 adults with allergic rhinitis are poorly controlled with current standard

therapies. The condition appears early in life, is present all year round and

patients face an elevated risk of developing asthma and other allergies. For

some of these patients, the HDM SLIT-tablet is a relevant treatment option

which can improve their quality of life and potentially modify the underlying

cause of their disease.

    ALK's HDM SLIT-tablet is a treatment for house dust mite-induced allergic

rhinitis (AR)  with or without conjunctivitis and allergic asthma (AA) that is

not well controlled by symptomatic medication. In Europe, where it is marketed

as ACARIZAX(R), the product has been approved in 14 countries for the treatment

of AR, 12 of which also include the HDM AA indication. It is also approved in

Japan for AR, where it is licensed by ALK to Torii and marketed under the trade

name MITICURE[TM] and in Australia for HDM AR and AA, where it is licensed by

ALK to Seqirus. The product is also being developed for a number of other

markets around the world, including China, North America and countries in

Southeast Asia. Altogether, clinical development activities for the HDM

SLIT-tablet have involved more than 6,000 patients worldwide.

    In the 12 European countries where ACARIZAX(R) has been approved for HDM AR

and AA, ACARIZAX(R) is indicated in adult patients (18-65 years) diagnosed by a

clinical history and by a positive test for HDM sensitisation with at least one

of the following conditions:

    - Persistent moderate to severe HDM allergic rhinitis despite the use of

symptom-relieving medication

     - HDM allergic asthma not well controlled by inhaled corticosteroids and

associated with mild to severe HDM allergic rhinitis and where patients' asthma

status has been carefully evaluated before initiation of treatment.

    Asthma relevant contraindications:

     - Patients with FEV1 ＜70% of predicted value at initiation of treatment

     - Patients who have experienced a severe asthma exacerbation within the

last 3 months

     - Patients with asthma who are currently experiencing an acute respiratory

tract infection

    Treating physicians should refer to full summary of product characteristics

before considering ACARIZAX(R) for treatment in patients with house dust mite

allergic asthma.[3)]

    About GINA[4)]

    GINA was launched in 1993 in collaboration with the National Heart, Lung,

and Blood Institute, National Institutes of Health, USA, and the World Health

Organization. GINA's programme is determined and its strategies for asthma care

are shaped by committees made up of leading asthma experts from around the

world.

    The GINA Scientific Committee prepares updates to their reports and

guidelines each year, which are made available on the GINA Website as they are

completed. The Scientific Committee has developed a sophisticated set of

procedures to review the world's literature with regards to asthma management

and to update the GINA documents to reflect this state-of-the-art information.

    References:

    1) GINA, Global Strategy for Asthma Management and Prevention (2017

update), http://ginasthma.org/

    2) Virchow JC, Backer V, Kuna P, et al. JAMA 2016;315(16):1715-25. doi:  

10.1001/jama.2016.3964

     3) ACARIZAX(R) 12 SQ-HDM oral lyophilsate Summary of Product

Characteristics. ALK Abello A/S, August 2015

     4) http://ginasthma.org/ [http://ginasthma.org ]

SOURCE: ALK