ALK-Abelló

Regulatory Filings • Feb 10, 2016

Copenhagen, 2016-02-10 08:30 CET (GLOBE NEWSWIRE) --

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

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).

Jens Bager, President & CEO of ALK, said: “If the investigational HDM
SLIT-tablet is approved in the USA, it would allow MSD to offer a broader
portfolio of SLIT-tablets to the physicians and patients following the
approvals of GRASTEK® and RAGWITEK® in 2014.”

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.

The submission of the BLA entitles ALK to a minor non-disclosed milestone
payment from MSD. The payment does not change ALK’s financial outlook for 2016
as the outlook is based on EBITDA before sales royalties and milestone payments
from partners.

                             ALK-Abelló A/S

For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: 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 (NYSE: MRK) in the USA and Canada), Torii, Abbott and Seqirus
(previously bioCSL) to commercialise sublingual allergy immunotherapy tablets
in North America, Japan, Russia, and 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 for North America
ALK has entered into a strategic partnership with MSD, known as Merck (NYSE:
MRK) in the USA and Canada, 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.