ALK-Abelló

Regulatory Filings • Nov 5, 2011

Copenhagen, 2011-11-05 10:21 CET (GLOBE NEWSWIRE) --

ALK's partner in North America, Merck, presents data from two pivotal clinical
Phase III studies with its investigational sublingual Ragweed Allergy
Immunotherapy Tablet (AIT) at the annual meeting of the American College of
Allergy, Asthma & Immunology (ACAAI) in Boston, USA.

Both Phase III studies met the combined primary efficacy endpoint of reducing
allergy symptoms and use of concomitant symptom relieving medication and the
efficacy results were consistent between the two studies. At the meeting in
Boston, Merck presents, among other things, data showing that patients treated
with the highest dose in the two studies experienced a 24% and 27% reduction
(p<0.05), respectively, in the combined primary efficacy endpoint. The
registration studies also shows that the treatment was well tolerated, with
adverse events (AEs) experienced by subjects receiving the drug similar to
previous studies in adults, with no new or unexpected findings. The most
commonly reported treatment-related AEs in both studies were as expected,
transient local application site reactions in the throat, ear, and mouth
(throat irritation (29% and 21%), ear pruritus (16% and 12%) and oral pruritus
(19% and 8%)). The studies were conducted by Merck, ALK's strategic partner in
North America. A total of approximately 1,350 subjects were included in the
studies.

It is estimated that some 60 million people in North America suffer from
allergies. Ragweed is a significant North American seasonal, airborne allergen
affecting an estimated 50% of American allergy sufferers.

In the clinical development programme to date, two pivotal efficacy and safety
studies and two safety studies have been completed for Ragweed AIT.

This announcement does not change ALK's outlook for the financial year 2011.

                             ALK-Abelló A/S


                               Jens Bager
                            President and CEO

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

About Ragweed AIT and the Phase III studies
The investigational Ragweed AIT treatment is designed to work by inducing a
protective immune response against ragweed allergy and providing sustained
prevention of allergy symptoms, treating both the symptoms and the underlying
cause of the disease.

The studies were North American multicenter, randomised, placebo-controlled,
double-blind, parallel-group clinical trials evaluating the efficacy and long
term safety of the ragweed sublingual tablet versus placebo in the treatment of
ragweed-induced rhinoconjunctivitis over a one year period based on the
combined (sum of) rhinoconjunctivitis daily symptom score and
rhinoconjunctivitis daily medication score. In the studies, approximately 1,350
adults received either placebo or ragweed tablet.

About the partnership with Merck, known as MSD outside the USA and Canada
In January 2007, Schering-Plough (merged with Merck in November 2009) signed an
agreement with ALK to develop, register and commercialise a combined portfolio
of tablet based allergy immunotherapy against grass, ragweed and house dust
mite allergy in North America.

It is estimated that some 60 million people suffer from allergy in North
America alone, an estimated 25 million of whom have been diagnosed as suffering
from moderate to severe allergy. The majority of these patients suffer from an
allergy to grass, ragweed or house dust mites, and in many cases the disease
and allergy symptoms are not well-controlled. Thus there is a significant unmet
need for better treatment.

At present, up to three million Americans are being treated with a special form
of injection based immunotherapy preparations. The treating physicians prepare
the named patient products after having received the active allergen
ingredients from, for instance, ALK. No registered products for allergy
immunotherapy are currently available in North America.