ALK-Abelló

Regulatory Filings • Dec 10, 2013

Copenhagen, 2013-12-10 14:16 CET (GLOBE NEWSWIRE) --

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the US Food and
Drug Administration (FDA) has posted briefing documents for the Allergenic
Products Advisory Committee meeting on 12 December to review Merck’s Biologic
License Application (BLA) for the investigational grass sublingual allergy
immunotherapy (AIT) tablet (marketed in Europe as GRAZAX®).

The briefing materials for the Allergenic Products Advisory Committee meeting
can be found on the FDA website at:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesan
dOtherBiologics/AllergenicProductsAdvisoryCommittee/ucm367268.htm

At the meeting, the Committee will be asked:

-- Whether the available data support the safety and the efficacy of the
product in persons of five years of age and older. In addressing this
question, the Committee should address safety and efficacy for adult and
paediatric patients separately
-- To discuss recommendations regarding the need, if any, for additional
trials

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 sublingual tablet against grass pollen allergy. In March, ALK
and Merck announced that the BLA was accepted for review by the FDA. In
September, it was announced that an FDA Advisory Committee would review the
application.

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.

Under US Freedom of Information legislation, Advisory Committee materials must
be made available for public inspection, usually no later than two business
days before the meeting takes place.

ALK’s partnership with Merck covers the development, registration and
commercialisation of a portfolio of sublingual allergy immunotherapy tablets in
North America. The grass sublingual AIT tablet is the first of these products
to be reviewed by the FDA.

Conference call
On 13 December at 8.00 a.m. (CET), ALK will host a conference call for analysts
and investors. The conference call will be audio cast on
www.alk-abello.com/investor. Participants in the audio cast are kindly
requested to call in before 7.55 a.m. (CET). Danish participants should call in
on tel. +45 7026 5040 or +45 7027 9009 and international participants should
call in on tel. +44 208 817 9301.

                             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
Media: 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 immunotherapy 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.