ALK-Abelló

Regulatory Filings • Aug 3, 2011

ALK announces successful outcome of two Phase III clinical studies of the new
innovative ragweed tablet. Both studies met the primary efficacy endpoints and
the efficacy results were consistent between the two studies.

Copenhagen, 2011-08-03 12:53 CEST (GLOBE NEWSWIRE) --

ALK today announces that two pivotal clinical Phase III studies with its
investigational sublingual Ragweed Allergy Immunotherapy Tablet (AIT) met the
combined primary efficacy endpoint of reducing allergy symptoms and use of
concomitant symptom relieving medication. The registration studies also showed
that the treatment was well tolerated, with adverse events experienced by
subjects receiving the drug similar to previous studies in adults, with no new
or unexpected findings. 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.

Jens Bager: “We are very excited by the successful outcome of these important
studies in the first large programme with a sublingual ragweed immunotherapy
tablet. The data analysis shows robust results and we are looking forward to
Merck's dialogue with the health authorities on the registration process for
this new, innovative product.”

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

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.

The data from the two Phase III trials are planned to be submitted for
presentation at a US medical conference in 2011.

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.