ALK-Abelló

Regulatory Filings • Nov 9, 2013

Copenhagen, 2013-11-09 18:36 CET (GLOBE NEWSWIRE) --

ALK's (ALKB:DC / OMX: ALK B / AKABY / AKBLF) partner for North America, Merck
(NYSE: MRK) reported that data from a pivotal Phase III clinical trial with its
investigational grass sublingual allergy immunotherapy (AIT) tablet were
presented at the 2013 annual meeting of the American College of Allergy, Asthma
& Immunology (ACAAI) in Baltimore, USA during 7-11 November.

Merck has issued a news release concerning the findings from the clinical
trial. The release can be found on http://www.mercknewsroom.com

The trial met its primary endpoint and the results showed that the use of grass
AIT tablets significantly reduced the total combined score that measured nasal
and eye symptoms and use of rescue allergy medicines, compared to placebo, in
grass-allergic patients. Initiated in 2011, the trial, which included
approximately 1,500 North American patients, is the largest trial of grass AIT
tablets to date.

In January 2013, Merck submitted a Biologic License Application (BLA) to the US
Food and Drug Administration (FDA) for the disease-modifying grass AIT tablet
and the regulatory review is currently ongoing. The product is marketed as
GRAZAX® in Europe.

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

About ALK
ALK is a research-driven global pharmaceutical company focusing on allergy
prevention, diagnosis and treatment. ALK is the world leader in allergy
immunotherapy – a unique treatment of the underlying cause of allergy. The
company has approximately 1,800 employees with subsidiaries, production
facilities and distributors worldwide. ALK has entered into partnership
agreements with Merck and Torii to commercialise allergy immunotherapy tablets
in North America and Japan, respectively. The company is headquartered in
Hørsholm, Denmark, and listed on NASDAQ OMX Copenhagen. Find more information
at www.alk.net.

About the partnership with Merck in North America

ALK has entered into a strategic partnership with Merck to develop, register
and commercialise a portfolio of allergy immunotherapy (AIT) tablets against
grass pollen, ragweed and house dust mite allergy in the USA, Canada and
Mexico. Under the agreement, ALK will receive up to DKK 1.6 billion (USD 290
million) in milestone payments from Merck, of which approximately DKK 300
million has already been recognised in the years 2007-12. In addition, ALK is
entitled to royalty payments on the net sales of the products on the North
American market as well as payments for product supply. Merck will be
responsible for all costs of clinical development, registration, marketing and
sales of the products on the North American markets. ALK will be responsible
for tablet production and supply.