ALK-Abelló

Regulatory Filings • Jan 27, 2016

Copenhagen, 2016-01-27 10:00 CET (GLOBE NEWSWIRE) --

-- House dust mites are the biggest cause of allergy in France, the world’s
biggest sublingual allergy immunotherapy market
-- ACARIZAX® is the first and only sublingual allergy immunotherapy tablet
approved for both house dust mite allergic rhinitis and allergic asthma

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that authorities in
France, the world’s biggest sublingual allergy immunotherapy market, have
issued a marketing authorisation for ALK’s new house dust mite sublingual
allergy immuno­therapy tablet (SLIT-tablet), ACARIZAX®.

Jens Bager, President and CEO says: “Following the issuance of the marketing
authorisation, we can now initiate a dialogue with the authorities to make the
house dust mite tablet available to doctors and patients.”

ACARIZAX® received regulatory approval in 11 European countries last year and
is indicated for both allergic rhinitis and allergic asthma in adult patients
not well controlled by symptom-relieving medications. ACARIZAX® was recently
launched in Germany and Denmark.

Moreover, the recent, temporary suspension of production by ALK’s main
competitor has led to a shortage of supply for many doctors and allergy
immunotherapy patients, especially in France. As the suspension continues and
more allergy sufferers need to renew their prescriptions, the number of
affected patients is expected to increase.

Jens Bager, President and CEO says: “Right now, our primary concern is for the
many allergy sufferers who are having their treatment interrupted and allergy
protection potentially compromised, and whose health may suffer as a
consequence. ALK will do all we can to help in the current situation and we are
ready to support doctors and health authorities to ensure that patients
continue to have treatment options available.”

In response to the situation, ALK is rapidly ramping up production of both
SLIT-drops and SLIT-tablets. ALK operates a highly automated manufacturing
process for its SLIT-tablets, including ACARIZAX® and grass allergy treatment
GRAZAX®. Unlike production of SLIT-drops, the production of SLIT-tablets can
swiftly be adapted to cope with increase in demand from the unfolding situation
across Europe.

                             ALK-Abelló A/S

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 1,900 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 Seqirus
(previously bioCSL) to commercialise sublingual allergy immunotherapy tablets
in North America, Japan, Russia, 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.

About house dust mite allergy and ACARIZAX®
House dust mites (HDM) 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 ACARIZAX® 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.

In Europe, ACARIZAX® 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.

The product is also being developed and marketed 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
Seqirus for Australia and New Zealand. The 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.