ALK-Abelló

Regulatory Filings • Jun 16, 2014

Copenhagen, 2014-06-16 09:00 CEST (GLOBE NEWSWIRE) --

Based on the available data, Torii expects to submit a registration application
to the authorities within the next six-to-ten months.

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that its partner for
Japan, Torii Pharmaceutical Co., Ltd. (TSE: 4551), has completed its second of
two Phase II/III trials into ALK’s sublingual allergy immunotherapy tablet
(SLIT-tablet) for the treatment of house dust mite (HDM)-induced respiratory
diseases.

Torii initiated the trial 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
asthma.

While the trial confirmed that the treatment was well tolerated by patients,
with no new or unexpected findings reported, the trial did not meet the primary
efficacy endpoint of showing a statistically significantly lower risk of
moderate to severe asthma exacerbations when compared with patients who
received placebo.

A parallel trial, investigating the safety and efficacy in HDM-induced allergic
rhinitis was successfully completed in March 2014 and met its primary efficacy
endpoint. In all, approximately 1,800 patients have participated in the two
Japanese clinical trials.

Torii will now seek to discuss the trial results, along with relevant
supportive documentation from ALK's European development programme, with the
Japanese health authorities. Based on the available data, Torii expects to
submit a registration application to the authorities within the next six-to-ten
months.

ALK’s President and CEO Jens Bager said: “We do know from numerous trials that
our SLIT-tablet treatments have delivered positive safety and efficacy results
in thousands of patients across the world. We will work closely with our
partner Torii to analyse these results and we remain committed to our
partnership’s goal – of bringing ALK’s portfolio of new, innovative allergy
immunotherapy treatments to patients in Japan.”

Torii’s two trials were similar in design to ALK’s successfully completed
European trials. ALK targets a regulatory filing for the house dust mite
SLIT-tablet in H2 2014 in Europe.

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.

                             ALK-Abelló A/S

For further information please contact:
Jens Bager, President and CEO, tel. +45 4574 7576
Henrik Jacobi, EVP Research & Development, 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.