ALK-Abelló

Regulatory Filings • Aug 31, 2015

Copenhagen, 2015-08-31 12:50 CEST (GLOBE NEWSWIRE) --

Today at 2.00 p.m. (CEST), ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) will
host a conference call for analysts and investors where Henrik Jacobi, EVP
Research & Development, will review the label of the HDM SLIT-tablet. The
conference call will be audio cast on www.alk-abello.com/investor. Participants
in the audio cast are kindly requested to call in before 1.55 p.m. (CEST).
Danish participants should call in on tel. +45 7022 3500 and international
participants should call in on tel. +44 207 572 1187 or +1 646 722 4972. Please
use the following Participant Pin Code: 24344932#.

ALK today announced that it has successfully completed the registration
procedure for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT)
tablet in 11 European countries[1].

The HDM SLIT-tablet 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:

1. Persistent moderate to severe HDM allergic rhinitis despite the use of
   symptom-relieving medication
2. 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.

Jens Bager, President and CEO of ALK says: "The approval of our HDM SLIT-tablet
represents a major landmark for ALK and is the result of 10 years of research
and development work. For the first time, patients in Europe will now have
access to an effective, well documented and home-based treatment for house dust
mite allergy."

He continues: "This new treatment option improves quality of life for patients
with house dust mite allergic rhinitis that is not well controlled despite the
use of symptom-relieving medications. Moreover, we are very pleased to see that
the product was recognised by the authorities for its benefits in patients with
allergic asthma. This highlights the HDM SLIT-tablet as an effective treatment
for both allergic rhinitis and asthma.”

Following today’s completion of the registration procedure, ALK expects the
product to become available in the first European markets within the next six
months, once local market access negotiations have been completed.

House dust mites are the most common cause of allergy in the world, a condition
which is the subject of an unmet medical need. HDM allergy appears early in
life and is present all year round. ALK estimates that one out of ten adults in
Europe suffering from allergic rhinitis has a condition which is not well
controlled and will experience persistent moderate to severe symptoms despite
the use of symptom-relieving medications. For some of these patients, the HDM
SLIT-tablet will be a relevant treatment option which can improve their quality
of life and potentially modify the underlying cause of their disease.

The link between allergic rhinitis and asthma is well established. The vast
majority of patients who have HDM allergic asthma also have allergic rhinitis.
In addition, around 50% of asthmatic patients are reported to be sensitised to
HDM.

The HDM SLIT-tablet is also being developed for a number of other markets
around the world in collaboration with ALK’s partners, MSD (known as Merck in
the USA and Canada) for North America, Torii for Japan, Abbott for Russia and
bioCSL for Australia and New Zealand. These development activities have
involved approximately 6,000 patients worldwide and make ALK's HDM SLIT-tablet
the best documented product in the history of allergy immunotherapy.

                             ALK-Abelló A/S

[1] Austria, Czech Republic, Denmark, Finland, France, Germany, Italy, Norway,
Poland, Slovakia and Sweden

For further information please contact:
Jens Bager, President and CEO, tel. +45 4574 7576
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 1,800 employees, with subsidiaries, production facilities and
distributors worldwide. ALK has entered into partnership agreements with MSD
(known as Merck (NYSE: MRK) in the USA and Canada), Torii, Abbott and bioCSL to
commercialise sublingual allergy immunotherapy tablets in North America, Japan,
Russia, Australia and New Zealand, respectively. The company is headquartered
in Hørsholm, Denmark, and listed on NASDAQ Copenhagen. Find more information at
www.alk.net.