ALK-Abelló

Regulatory Filings • Dec 25, 2015

Copenhagen, 2015-12-25 09:00 CET (GLOBE NEWSWIRE) --

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that its partner,
Torii, has submitted a New Drug Application in Japan for the Japanese cedar
pollen sublingual allergy immunotherapy tablet for the indication of allergic
rhinitis (hay fever).

ALK's partner for Japan, Torii Pharmaceutical Co. Ltd., has submitted a
registration application – a New Drug Application (NDA) – to the Japanese
Ministry of Health, Labour and Welfare (MHLW), for the Japanese cedar pollen
sublingual allergy immunotherapy tablet (SLIT-tablet).

Jens Bager, ALK’s President and CEO, said: “This regulatory submission in Japan
adds further momentum to our strategy of transforming ALK from a largely
European company to one with global reach. We await the outcome of the
regulatory review process with interest and are confident that, if approved,
this product will prove a valuable new treatment option to allergy doctors and
patients in Japan.”

Japan is the world’s second largest market for allergy medicine after the USA.
An estimated 25-35 million people suffer from allergy caused by Japanese cedar
tree pollen or house dust mites. Japan has a higher level of diagnosed allergic
rhinitis than anywhere in the world. Nevertheless, allergy immunotherapy is not
yet widely used.

“Subject to approval, the Japanese cedar SLIT-tablet could reach the market in
Japan in 2017 meaning that Torii can offer innovative products against the two
most common allergies in Japan to patients whose allergy symptoms are not
well-controlled despite the use of standard symptom-relieving medications,"
said Jens Bager.

ALK’s partnership with Torii covers the development, registration and
commercialisation of the Japanese cedar SLIT-tablet and a SLIT-tablet against
house dust mite (HDM) allergy, which was launched earlier this month under the
name MITICURE™. It also includes collaboration on an HDM injection-based
immunotherapy product and HDM diagnostic product which have recently been
approved for marketing by the authorities.

                             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: Jeppe Ilkjær, tel. +45 7877 4532, mobile 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, 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
that manufactures and sells allergen agents for more than 40 years. Torii’s
principal shareholder is Japan Tobacco Inc. Read more at www.torii.co.jp.