Merck plans to file registration applications to the US Food and Drug
Administration for Ragweed and Grass AITs in 2013. 

Copenhagen, 2012-03-05 14:33 CET (GLOBE NEWSWIRE) -- 

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

Merck has issued a news release concerning the findings from one of the
clinical trials. The release is enclosed in full length on the following pages.
Alternatively, it can be found on www.merck.com. 

The trial results showed that the use of ragweed AIT significantly reduced the
total combined score that measured nasal and eye symptoms and use of rescue
allergy medicines, compared to placebo, in ragweed-allergic adults with or
without asthma. 

Merck plans to file registration applications for Ragweed AIT and Grass AIT
with the US Food and Drug Administration in 2013. 

This announcement does not change ALK’s outlook for the financial year 2012.



                                 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, mobile +45 2261 2525

                               Flemming Pedersen, tel. +45 4574 7576

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 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 immunotherapies 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.