ALK-Abelló

Regulatory Filings • Apr 16, 2017

Copenhagen, 2017-04-16 20:00 CEST (GLOBE NEWSWIRE) --

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that its house dust
mite (HDM) sublingual allergy immunotherapy (SLIT) tablet ACARIZAX® has had its
approval in 12 European countries expanded to include the treatment of
adolescent patients with HDM-induced allergic rhinitis.

The expanded approval, which covers patients who are aged 12-17, is based upon
data from clinical trials conducted in Japan and North America as part of the
global ACARIZAX® clinical development programme. The results confirmed the
favourable efficacy, safety and tolerability profile of ACARIZAX® and were in
line with previous studies in adults.

Henrik Jacobi, ALK’s Executive Vice President, Research and Development, said:
“This expanded approval is important for patients and important to ALK’s
strategy for ACARIZAX®. For patients, it means there can now be an earlier
intervention to treat a condition that has far-reaching consequences for
teenagers whose sleep, education and social lives are blighted by house dust
mite allergy.”

He continued: “For ALK, it continues our strategy of widening patient access to
evidence-based allergy immunotherapy (AIT) and of addressing unmet medical
need."

As a result of today’s announcement, ACARIZAX® is now approved for use in
adolescents in Austria, Czech Republic, Denmark, Finland, Italy, the
Netherlands, Norway, Poland, Sweden, Slovakia, and the key European markets of
France and Germany.

ACARIZAX® first gained European approval for use in adults in 2015, when it
also became the first SLIT product to be approved for use in allergic asthma.
In February 2017, clinical data from the ACARIZAX® development programme led
the Global Initiative for Asthma (GINA), for the first time, to add allergy
immunotherapy as a treatment option in its Global Strategy for Asthma
Management and Prevention.

ACARIZAX® is currently approved in 17 countries worldwide and launched in nine.
Registration reviews are underway in a further nine countries with further
submissions planned.

                             ALK-Abelló A/S

For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014

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 Hørsholm, Denmark, and listed on
Nasdaq Copenhagen. Find more information at www.alk.net.