ALK Presents Phase III Data on House Dust Mite SLIT-tablet at EAACI Annual Congress in Copenhagen

Hørsholm, Denmark (ots/PRNewswire) -

First sublingual allergy immunotherapy tablet with robust results
in allergic rhinitis and allergic asthma. Data supports European
regulatory filing in 2H 2014

Today, ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) has presented
key trial results on its new sublingual allergy immunotherapy tablet
(SLIT-tablet) for house dust mite (HDM) respiratory allergic diseases
at the 2014 Annual Congress of the European Academy of Allergy and
Clinical Immunology (EAACI), in Copenhagen, Denmark.

The ALK HDM SLIT-tablet works by addressing the underlying causes
of HDM respiratory allergic diseases. It is the first allergy
immunotherapy product with a comprehensive clinical development
programme aimed at treating both upper and lower airway
manifestations of HDM induced allergic respiratory diseases (namely
allergic rhinitis and allergic asthma, respectively).

Together, the MITRA and MERIT trials involved more than 1,800
patients. The trials form part of the largest clinical development
programme in the history of allergy immunotherapy, involving more
than 5,000 patients from Europe, North America and Japan.

MITRA trial in allergic asthma

The MITRA trial (MT-04) was initiated by ALK in 2011 to evaluate
the efficacy and safety of the HDM SLIT-tablet compared to placebo in
patients with HDM-induced asthma not fully controlled with medium to
high dose inhaled corticosteroid (ICS). The primary endpoint of the
trial was reduction in the risk of moderate-to-severe asthma
exacerbation during ICS reduction as measured by the time to the
first exacerbation.

The MITRA trial met its primary clinical endpoint. Patients who
received the dose of 12 SQ-HDM experienced a significant improvement
in their asthma control as evident by a 34% reduction in risk of
suffering a moderate-to-severe asthma exacerbation during the
withdrawal of inhaled corticosteroids.

Furthermore, the risk of patients experiencing nocturnal
awakenings due to their asthma was significantly reduced in the
observation period immediately preceding as well as after ICS
withdrawal with the 12 SQ-HDM dose.

At randomisation, 28% of patients had uncontrolled asthma,
according to the Global Initiative for Asthma (GINA) control
assessment criteria, despite using medium to high dose ICS. The
safety profile for uncontrolled patients was consistent with that of
the general population with no increased risk identified. This
finding may be of high clinical significance as uncontrolled asthma
is considered a contraindication to presently available allergy
immunotherapy products.

MERIT trial in allergic rhinitis

The MERIT trial was initiated by ALK in 2011 to evaluate the
efficacy and safety of the HDM SLIT-tablet compared to placebo in the
treatment of HDM-induced allergic rhinitis. The primary endpoint of
the trial was a reduction in the combined rhinitis symptom and
medication score.

Patients selected for the trial had all been diagnosed with
moderate-to-severe HDM-induced allergic rhinitis and were highly
symptomatic and requiring regular pharmacotherapy prior to receiving
treatment. These symptoms were associated with sleep disturbance,
impairment of daily activities or impairment of school or work.

The MERIT trial met its primary clinical endpoint. The median
combined rhinitis symptom and medication score was reduced by 22% in
patients treated with the 12 SQ-HDM dose versus placebo. Furthermore,
patients experienced significantly fewer days with rhinitis
exacerbation (defined as a day with severe rhinitis symptoms). The
risk of experiencing a day with rhinitis exacerbation was halved,
equating on average to approximately 20 fewer days annually with
severe rhinitis symptoms.

The phase 2 and 3 data presented demonstrated an onset of action
with the 12 SQ-HDM dose as early as 8 to 14 weeks post initiation of
treatment.

Both the MITRA and MERIT trials also demonstrated that the
treatment was well tolerated and had a favourable safety profile.

European regulatory filing on schedule

Henrik Jacobi, Executive Vice President, Research & Development at
ALK, said: "These trials show very positive results for ALK's new
SLIT-tablet in treating both manifestations of house dust
mite-induced respiratory allergic diseases - allergic rhinitis and
allergic asthma. They show that this new treatment could reduce
allergy symptoms so that moderate-to-severe cases become mild. Based
on these findings, we expect to submit a regulatory filing to the
European authorities in the second half of 2014."

Professor Pascal Demoly, Head of the Respiratory & Allergy
Department at the University Hospital of Montpellier and Principal
Investigator on the MERIT trial, said: "This is the first time we
have seen robust data on the use of allergy immunotherapy for the
treatment of both HDM allergic rhinitis and allergic asthma."

He continued: "The HDM SLIT-tablet can be an important new
treatment option for doctors involved in the management of patients
with HDM respiratory allergic diseases whose condition is not well
controlled by existing pharmacotherapy. For patients, it offers hope
of relief from the burden of chronic respiratory allergy, and a
potential release from the constant need to take symptomatic
medication."

ALK-Abello A/S

For further information please contact:

Press:
Martin Barlebo, tel. +45-4574-7901, mobile +45-2064-1143

Investor Relations:
Per Plotnikof, tel. +45-4574-7527, mobile +45-2261-2525

About ALK

ALK is a research-driven global pharmaceutical company focusing on
allergy prevention, diagnosis and treatment. ALK is the world leader
in allergy immunotherapy - a unique treatment of the underlying cause
of allergy. The company has approximately 1,800 employees with
subsidiaries, production facilities and distributors worldwide. ALK
has entered into partnership agreements with Merck and Torii to
commercialise sublingual allergy immunotherapy tablets in North
America and Japan, respectively. The company is headquartered in
Horsholm, Denmark, and listed on NASDAQ OMX Copenhagen. Find more
information at http://www.alk.net.

About the MITRA trial

The trial was a randomised, placebo-controlled, double-blind,
multi-national, multi-centre trial involving 834 patients from 13
European countries. Patients were divided into three treatment arms.
Patients from the first two groups received two different doses of
the tablet, while patients in the third group received placebo.
Patients were dosed once daily for up to 18 months. Additionally, all
patients received treatment with ICS until the last part of the
trial, when ICS usage was reduced by 50% for three months, and then
completely withdrawn for another three months. The trial design and
success criteria were discussed with the European Medicines Agency
(EMA) as scientific advice prior to trial initiation.

About the MERIT trial

The trial was a randomised, placebo-controlled, double-blind,
multi-national, multi-centre trial involving 992 patients from 12
European countries. Patients were divided into three treatment arms
of equal size. Patients in the first two groups received two
different doses of the tablet, while patients in the third group
received placebo but had unrestricted access to symptom-relieving
medication. The patients received treatment once daily for one year.

About house dust mite allergy

House dust mites are the most common cause of allergy in the
world. HDM-induced 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 up to 20% are facing moderate to
severe symptoms. The condition appears early in life, is present all
year round and patients face an elevated risk of developing asthma
and other allergies.

ots Originaltext: ALK
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