ALK-Abelló

Regulatory Filings • Jun 9, 2014

Copenhagen, 2014-06-09 13:45 CEST (GLOBE NEWSWIRE) --

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 to14 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-Abelló 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 Hørsholm, Denmark, and listed on NASDAQ OMX Copenhagen. Find
more information at 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.