ALK-Abelló

Legal Proceedings Report • Apr 13, 2016

Copenhagen, 2016-04-13 07:00 CEST (GLOBE NEWSWIRE) --

Today, ALK’s (ALKB:DC / OMX: ALK B / AKABY / AKBLF) partner for North America,
MSD (known as Merck (NYSE: MRK) in the United States and Canada), announced
that the U.S. Food and Drug Administration (FDA) has accepted the Biologics
License Application (BLA) for its house dust mite (HDM) sublingual allergy
immunotherapy (SLIT) tablet for review. MSD submitted the BLA, for a tablet
against HDM allergy, to the FDA in February 2016.

The application to the FDA is based on results from an extensive clinical
development programme that has involved approximately 4,400 patients in North
America and Europe and has already seen the product approved in 11 European
countries, where it is known as ACARIZAX®. The product has also been launched
in Japan, where it is marketed by Torii under the brand name MITICURE(TM).

House dust mites are one of the most common causes of allergy, likely affecting
more than 200 million people worldwide. The condition appears early in life and
is present all year round.

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

MSD has also issued a news release, which can be found on the MSD corporate
website: www.merck.com. This announcement does not change ALK’s outlook for the
financial year 2016.

                             ALK-Abelló A/S

For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Press: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014

About ALK
ALK is a research-driven global pharmaceutical company focusing on allergy
prevention, diagnosis and treatment. ALK is a world leader in allergy
immunotherapy – a treatment of the underlying cause of allergy. The company has
approximately 1,900 employees with subsidiaries, production facilities and
distributors worldwide. ALK has entered into partnership agreements with MSD
(known as Merck in the USA and Canada), Torii, Abbott and Seqirus to
commercialise sublingual allergy immunotherapy tablets in North America, Japan,
Russia, Southeast Asia, Australia and New Zealand, respectively. The company is
headquartered in Hørsholm, Denmark, and listed on NASDAQ Copenhagen. Find more
information at www.alk.net.

About the partnership with MSD (known as Merck in the USA and Canada) for North
America
ALK has entered into a strategic partnership with MSD to develop, register and
commercialise a portfolio of sublingual allergy immunotherapy tablets against
grass pollen (GRASTEK®), ragweed (RAGWITEK®) 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 MSD, of which,
approximately DKK 400 million has already been recognised in the years 2007-15.
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.
MSD 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.