ALK-Abelló

Regulatory Filings • Oct 8, 2013

Copenhagen, 2013-10-08 15:20 CEST (GLOBE NEWSWIRE) --

ALK (ALK-B.CO / OMX:ALK B / AKABY / AKBLF) today announced that due to the US
government shutdown, the US Food and Drug Administration (FDA) has temporarily
postponed the Allergenic Products Advisory Committee meeting scheduled for 6
November 2013 to discuss the Biologic License Application (BLA) for the
investigational grass allergy immunotherapy (AIT) tablet. The FDA has not yet
confirmed a new date for the Advisory Committee meeting. ALK will provide an
update when additional information becomes available.

FDA advisory committees are panels of independent experts who advise the agency
as they consider regulatory decisions. Advisory committee meetings are open to
the public and are common for new drug classes and/or major pharmaceutical
drugs under review.

In January 2013, ALK’s partner for North America, Merck (NYSE: MRK), known as
MSD outside the United States and Canada, submitted the BLA to the FDA for the
disease-modifying tablet against grass pollen allergy. In March 2013, ALK and
Merck announced that the BLA was accepted for review by the FDA.

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

                             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 1,800 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.