ALK-Abelló

Regulatory Filings • Sep 14, 2017

Copenhagen, 2017-09-14 13:15 CEST (GLOBE NEWSWIRE) --

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced the successful
outcome of a pivotal Phase III clinical trial of its tree allergy sublingual
immunotherapy (SLIT) tablet, with the trial meeting its primary efficacy
endpoint. The tree SLIT-tablet is important to ALK's efforts to develop a full
tablet portfolio for people suffering from the most common respiratory
allergies. ALK is currently the only company that has completed Phase III
clinical development with a tree SLIT-tablet.

The primary endpoint of the trial was the daily total combined score, which is
the sum of the allergic symptom score and the use of symptom-relieving
medication, measured during the birch pollen season. Treatment with the tree
SLIT-tablet reduced the total combined score (primary endpoint) by 39.6%
compared to placebo. The results were highly statistically significant (p <
0.0001). The efficacy was similar when analysing data for the entire tree
pollen season (i.e. including the alder and hazel pollen seasons). The trial
also showed that the treatment was well-tolerated by patients, with no new or
unexpected adverse events reported compared to previous clinical trials with
SLIT-tablets.

Henrik Jacobi, ALK’s Executive Vice President, Research and Development, says:
"We are extremely pleased to see such a clear and clinically meaningful
treatment effect of the tree allergy immunotherapy tablet. In fact, the
clinical effect seen in this trial was among the most significant that we have
ever seen in field studies of allergy immunotherapy, which means that we have
developed a unique compound.”

He continues: “With SLIT-tablets for house dust mite, grass, ragweed and
Japanese cedar allergies already filed or marketed, these trial results
represent an important step forward for ALK in completing its tablet portfolio.
With these five tablets, we will be able to effectively cover more than 80% of
global respiratory allergies."

ALK initiated the Phase III clinical trial in 2016 to evaluate the efficacy and
safety of the tree SLIT-tablet compared with placebo in adult and adolescent
patients with birch pollen allergic rhinitis and/or conjunctivitis. The trial
was a randomised, placebo-controlled, double-blind, multi-centre trial
involving 634 patients aged 12-65 years in eight European countries. A
preceding Phase II trial in an environmental exposure chamber showed that the
tablet significantly reduced patients’ symptoms in response to both birch and
oak pollen compared with placebo.

Allergic rhinitis (with or without conjunctivitis) represents a global health
problem affecting 10 to 25% of the population. The prevalence in the general
population in Europe and North America is ~20%. In Northern and Central Europe,
USA and Canada, respiratory allergies are commonly caused by allergens from the
birch homologous group of trees, which also includes alder, beech, hazel and
oak. ALK estimates that around 15 million Europeans have tree allergies of
which ~10% are believed to have symptoms that are not well controlled by
conventional symptom-relieving medications. For some of these people with
uncontrolled allergies to tree pollen, ALK’s tablet may become a relevant
treatment option.

ALK expects to submit a European and possibly also a Canadian registration
application for the tree SLIT-tablet in 2018.

                             ALK-Abelló A/S

For further information please contact:
Henrik Jacobi, Executive Vice President, Research and Development, 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 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.