ALK-Abelló

Regulatory Filings • Mar 10, 2014

Copenhagen, 2014-03-10 08:00 CET (GLOBE NEWSWIRE) --

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that its partner for
Japan, Torii Pharmaceutical Co., Ltd. (TSE: 4551), has reported positive
results from its Phase II/III trial into ALK’s sublingual allergy immunotherapy
tablet (SLIT-tablet) for house dust mite-induced allergic rhinitis (hay fever).

The trial met its primary efficacy endpoint by showing a significantly lower
‘Total Combined Rhinitis Score’ (TCRS) when compared with patients who received
placebo. The trial also showed that the treatment was well tolerated and had a
favourable safety profile.

ALK’s President and CEO Jens Bager said: “These results mark another step on
our journey towards globalising ALK’s portfolio of SLIT-tablets. Our
partnership with Torii continues to progress rapidly and we are getting closer
to a launch of these products in the world’s second largest pharmaceutical
market.”

House dust mites are the most common cause of allergy in the world, affecting
around 90 million people in Europe, North America and Japan, and more than 100
million people in China. The condition appears early in life, is present all
year round and patients face an elevated risk of developing asthma and other
allergies.

The trial was initiated by Torii in 2012 as a randomised, multi-centre,
placebo-controlled, double-blind comparative trial, looking at both the safety
and efficacy of the drug in patients with house dust mite-induced allergic
rhinitis.

A second, parallel trial, looking at safety and efficacy in house dust
mite-induced allergic asthma, was initiated at the same time and is expected to
report in the coming months. In all, approximately 1,800 patients participated
in the two trials, the results of which will determine whether Torii will
submit a New Drug Application in Japan.

                             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: 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 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.

About the partnership with Torii
In January 2011, ALK and Torii entered into an exclusive license agreement to
develop, register and commercialise ALK’s house dust mite allergy immunotherapy
products for asthma and allergic rhinitis in Japan, which is the world’s second
largest market for allergy medicine after the USA. The agreement gave Torii
exclusive license rights for the development, marketing and distribution of
ALK’s sublingual allergy immunotherapy tablet against house dust mite allergy.
The agreement also covers an injection-based immunotherapy product and
diagnostic products against house dust mite allergy. Moreover, the agreement
includes a research and development collaboration targeting a sublingual
allergy immunotherapy tablet against Japanese cedar pollen allergy.