ALK-Abelló

Regulatory Filings • Nov 26, 2015

Copenhagen, 2015-11-26 02:00 CET (GLOBE NEWSWIRE) --

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the sublingual
allergy immunotherapy product MITICURE™ now will be available for prescription
in Japan for adults and adolescents (12-64 years) who suffer from house dust
mite allergic rhinitis.

As of today, MITICURE™ has been placed on the Japanese National Health
Insurance reimbursement list and will be launched in the beginning of December
2015.

MITICURE™ is the Japanese trade name of the sublingual allergy immunotherapy
tablet licensed by ALK to Torii for Japan. MITICURE™ is indicated in adults and
adolescents (12-64 years) for the treatment of allergic rhinitis caused by
house dust mites. With the intention of obtaining approval for pediatric use
(5-11 years), Torii is currently conducting a Phase III clinical trial
involving approximately 400 patients.

Torii has issued a news release concerning the launch of MITICURE™ which can be
found on http://www.torii.co.jp.

The product was recently approved in 11 European countries where it is expected
to soon become available in the first markets under the trade name ACARIZAX®
for the treatment of house dust mite allergic rhinitis and allergic asthma in
adults (18-65 years).

The product is also being developed for a number of other markets around the
world in collaboration with ALK’s partners, MSD (known as Merck in the USA and
Canada) for North America, Abbott for Russia, and Seqirus (previously bioCSL)
for Australia and New Zealand. It is the best documented product in the history
of allergy immunotherapy and the development activities have so far involved
approximately 6,000 patients worldwide.

ALK's partnership with Torii covers the development, registration and
commercialisation of two sublingual allergy immunotherapy tablets for Japan. A
regulatory submission of the second product, a tablet against Japanese cedar
pollen allergy, is currently being prepared following the successful completion
of a Phase II/III clinical trial earlier this year.

                             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
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 1,800 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, 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 Torii Pharmaceutical Co., Ltd
Torii Pharmaceutical Co., Ltd., (Torii) established in 1921, manufactures and
distributes ethical pharmaceutical products. Torii is a quoted company with its
headquarters in Tokyo (TSE:4551), and has about 500 medical representatives
working at 14 branch offices throughout Japan. Torii markets drugs in a number
of priority therapeutic areas: renal diseases and haemodialysis including
pruritus in haemodialysis patients, acute diseases including acute
pancreatitis, HIV, skin diseases including atopic dermatitis, lifestyle-related
diseases including gout, and allergy. Torii has been the only company in Japan
to manufacture and sell allergen agents for more than 40 years. Torii’s
principal shareholder is Japan Tobacco Inc. Read more at www.torii.co.jp.