ALK-Abelló

Earnings Release • Mar 20, 2014

ALK's (ALKB:DC / OMX: ALK B / AKABY / AKBLF) partner, Merck initiates Phase III
clinical development programme in North America with the new allergy
immunotherapy tablet for the treatment of house dust mite-induced respiratory
diseases. The advancement triggers a milestone payment to ALK.

Copenhagen, 2014-03-20 07:54 CET (GLOBE NEWSWIRE) -- ALK's (ALKB:DC / OMX: ALK
B / AKABY / AKBLF) partner, Merck initiates Phase III clinical development
programme in North America with the new allergy immunotherapy tablet for the
treatment of house dust mite-induced respiratory diseases. The advancement
triggers a milestone payment to ALK.

ALK today announces that its strategic partner, Merck (known as MSD outside the
USA and Canada), is advancing the clinical development programme for the house
dust mite (HDM) SLIT-tablet by initiating a Phase III clinical trial in the USA
and Canada. The HDM SLIT-tablet is ALK’s new allergy immunotherapy tablet for
the treatment of HDM-induced respiratory diseases.

The trial is expected to include approximately 1,500 subjects and will
investigate safety and efficacy of the tablet in the treatment of HDM-induced
allergic rhinitis in North American patients.

Jens Bager, President and CEO of ALK, commented: “The partnership with Merck is
an important part of our strategy to bring our SLIT-tablet portfolio to
patients all over the world. The news that the HDM SLIT-tablet is entering the
final stage of clinical development in North America represents important
progress in a market that offers a significant commercial potential.”

The HDM SLIT-tablet has the potential to become the first-in-class,
disease-modifying allergy immunotherapy tablet aimed at the most common cause
of allergy and allergic asthma in the world.

The Phase III trial in North America is part of the largest development
programme in the history of allergy immunotherapy. In 2013, ALK successfully
completed two Phase III clinical trials in Europe, the MERIT and the MITRA
trials, investigating the efficacy and safety of the HDM SLIT-tablet in the
treatment of HDM-induced allergic rhinitis and allergic asthma, respectively.
In Japan, ALK’s strategic partner, Torii, is undertaking a similar development
programme and has recently announced successful outcome of a Phase II/III
clinical trial into allergic rhinitis. Another Phase II/III clinical trial into
allergic asthma is expected to complete in 2014.

Initiation of patient dosing in the Phase III trial in the USA and Canada
entitles ALK to a milestone payment from Merck. Consequently, ALK is updating
its financial outlook for 2014. The milestone payment will be booked as revenue
from SLIT-Tablets in North America and ALK now expects operating profit
(EBITDA) to be DKK 300-400 million (previously 225-400) before special items,
income from product supply, and potential sales royalties in North America. The
higher end of this range assumes two additional product development milestone
payments from Merck.

                             ALK-Abelló A/S

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 sublingual 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 sublingual allergy immunoterapy 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 2007-13. 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.