ALK-Abelló

Regulatory Filings • May 8, 2013

Copenhagen, 2013-05-08 14:32 CEST (GLOBE NEWSWIRE) --

Today, ALK’s partner for North America, Merck (known as MSD outside the USA and
Canada), announced that the U.S. Food and Drug Administration (FDA) has
accepted the Biologics License Application (BLA) for its ragweed allergy
immunotherapy tablet (AIT) for review. Merck submitted the BLA, for a tablet
against ragweed allergy, to the FDA in March 2013.

The application to the FDA is based on results from an extensive clinical
development programme. Data from the clinical trials have demonstrated that
treatment with ragweed AIT reduces patients’ allergy symptoms and their
concomitant use of symptom-relieving medication and that the treatment is well
tolerated. 20-30 million North Americans are estimated to suffer from seasonal
ragweed allergy.

In March, the FDA accepted the BLA for grass AIT for review. Grass AIT is
marketed by ALK in Europe as GRAZAX®.

“The FDA is now reviewing two registration applications for allergy
immunotherapy tablets against the most common pollen allergies in North
America: ragweed and grass. This is a significant step forward in ALK’s efforts
to globalise allergy immunotherapy and help the many allergy sufferers in need
of better treatment options,” says Jens Bager, President and CEO, ALK.

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 and 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 (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.