ALK-Abelló

Regulatory Filings • Mar 27, 2013

Copenhagen, 2013-03-27 13:00 CET (GLOBE NEWSWIRE) --

ALK’s partner for North America, Merck (known as MSD outside the USA and
Canada), today announced that the Biologics License Application (BLA) for its
investigational grass allergy immunotherapy tablet (AIT) has been accepted for
review by the U.S. Food and Drug Administration (FDA). The BLA, for a
disease-modifying tablet against grass pollen allergy, was first submitted to
the FDA in January 2013. The product is marketed as GRAZAX® in Europe.

Merck’s application is based upon results from an extensive clinical
development programme which demonstrates that treatment with grass AIT reduces
patients’ allergy symptoms and their need for symptom-relieving medication. The
data also show that grass AIT provides a long-term effect for patients, which
is sustained beyond the period of treatment.

ALK’s partnership with Merck covers the development, registration and
commercialisation of a portfolio of allergy immunotherapy tablets in North
America.

Merck has also issued a news release, which follows in full, and which can also
be found on the Merck corporate website: www.merck.com. This announcement does
not change ALK’s outlook for the financial year 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: Per Plotnikof, tel. +45 4574 7527, 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 1,850 employees with subsidiaries, production
facilities and distributors worldwide. ALK has entered into partnership
agreements with Merck (MSD outside the USA and Canada) 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 tablets (AITs) 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.