ALK-Abelló

Regulatory Filings • Jul 11, 2013

Copenhagen, 2013-07-11 08:58 CEST (GLOBE NEWSWIRE) --

Copenhagen, Denmark; ALK (OMX: ALK.B) announces positive outcome of the second
of two pivotal Phase III trials of its new allergy immunotherapy tablet for the
treatment of house dust mite-induced respiratory diseases. The MITRA[1] trial
meets its primary endpoint and demonstrates a significant reduction in the risk
of moderate-to-severe asthma exacerbations.

Today, ALK announces positive top-line results from the pivotal Phase III MITRA
trial conducted with ALK’s allergy immunotherapy tablet against house dust
mite-induced respiratory diseases. The results demonstrate that the treatment
significantly reduces patients’ risks of moderate to severe asthma
exacerbations. The results were statistically significant (p<0.05).

The trial also demonstrated that the treatment was well tolerated and had a
favourable safety profile.

“House dust mite-induced respiratory diseases, such as allergic rhinitis and
asthma, affect more than 200 million people worldwide. Together with the
successful MERIT[2] trial, these results represent a major step forward in
developing the first clinically documented allergy immunotherapy tablet for
patients severely impacted by house dust mite-induced respiratory diseases
experiencing poor control of their condition,” says CEO Jens Bager, ALK.

The MITRA trial (MT-04) was initiated by ALK in 2011 to evaluate the efficacy
and safety of the allergy immunotherapy tablet compared to placebo in patients
with house dust mite-induced asthma. The primary endpoint of the trial was
reduction in the risk of moderate to severe asthma exacerbations during steroid
reduction as measured by the time to the first exacerbation.

The trial was a randomised, placebo-controlled, double-blind, multi-centre
trial involving 834 patients from 13 European countries. Patients were divided
into three treatment arms. Patients in 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 inhaled corticosteroids (ICS) until the last
part of the trial, where the 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then completely withdrawn for another three months.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 during a
scientific advice prior to trial initiation.

House dust mites are the most common cause of allergic respiratory diseases in
the world. Nearly 50% of all house dust mite-allergic rhinitis patients suffer
from concomitant asthma. House dust mite-induced allergic diseases are
estimated to affect around 90 million people in Europe, North America and
Japan, and more than 100 million people in China. The condition appears early
in life, is present all year round and the prevalence of asthma is increasing
in most countries, especially among children.

Further top-line data from the MITRA trial is expected to be presented in
connection with the publication of ALK’s six-month interim report (Q2) on 14
August 2013.

“The successful outcome of the MERIT and MITRA trials keeps us on course for a
European filing in 2014. It also provides positive news for our partners’
parallel development programmes in North America and Japan, and increases our
confidence that this innovative product will help fuel our future growth,” says
CEO Jens Bager, ALK.

European filing in 2014
On 19 June 2013, ALK announced robust, positive top-line results from the MERIT
trial in the treatment of house dust mite-induced allergic rhinitis. The
results demonstrated that the treatment reduced both symptoms and medication
use in patients with house dust mite-induced allergic rhinitis. The results
were highly statistically significant (p<0.01).

In combination, the MITRA and the MERIT trials will be a pivotal part of ALK's
submission of a registration application in Europe. ALK expects to submit the
registration application in 2014.

Global development programme
The MERIT and MITRA trials are part of the largest clinical development
programme in the history of allergy immunotherapy, with simultaneous
development activities in Europe and the world’s two largest pharmaceutical
markets, Japan and the USA. Once completed, this programme will have involved
more than 6,000 patients.

In Japan, ALK’s partner Torii Pharmaceutical Co., Ltd. is currently undertaking
two parallel pivotal Phase II/III trials to investigate the safety and efficacy
of the allergy immunotherapy tablet in the treatment of house dust mite-induced
allergic rhinitis and allergic asthma, respectively.

In North America, ALK’s partner Merck & Co., Inc. (known as MSD outside the USA
and Canada) is currently performing a Phase IIb trial and has started
preparations for a pivotal Phase III clinical trial to investigate safety and
efficacy in the treatment of house dust mite-induced
rhinitis/rhinoconjunctivitis in adolescents and adults.

This announcement does not impact ALK’s financial guidance for 2013.

                             ALK-Abelló A/S


                               Jens Bager
                        President & CEO

For further information please contact:
Jens Bager, President and CEO, tel. +45 4574 7576

Investor Relations: Flemming Pedersen, mobile +45 2148 0118
Per Plotnikof, mobile +45 2261 2525

Press: Martin Barlebo, tel. +45 4574 7901, mobile +45 2064 1143

[1] The MITRA trial: MITIZAX Treatment of Asthma trial

[2] The MERIT trial: MITIZAX Efficacy in Rhinitis Trial