MITIZAX® enters final phase of clinical development in Japan

ALK-Abelló 

31.07.2012 08:00

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ALK's partner, Torii, initiates extensive clinical Phase II/III development
programme in Japan with MITIZAX(R), the new innovative tablet against house dust
mite induced hay fever and asthma. The advancement releases a milestone payment
to ALK. 

Copenhagen, 2012-07-31 08:00 CEST (GLOBE NEWSWIRE) -- 

ALK today announces that its strategic partner, Torii, is advancing the
clinical development programme for MITIZAX(R) by initiating two parallel Phase
II/III trials in Japan. MITIZAX(R) is ALK's new innovative allergy immunotherapy
tablet (AIT) against house dust mite induced hay fever and asthma. 

The two trials will include approximately 1,800 subjects and will investigate
safety and efficacy of MITIZAX(R) in the treatment of house dust mite induced
allergic rhinitis and asthma in a Japanese population. 

Jens Bager, President and CEO of ALK, states: 'The partnership with Torii is an
important part of our strategy to secure global reach for our range of modern
allergy immunotherapies. The news that MITIZAX(R) is entering the final stage of
clinical development in Japan represents important progress and establishes a
clear competitive advantage for ALK and Torii.' 

MITIZAX(R) has the potential to become the first-in-class, disease-modifying
allergy immunotherapy tablet aimed at the most common cause of allergy and
allergic asthma in the world. 

Norihiko Matsuo, President and Representative Director of Torii, states: 'Our
partnership with ALK, established in January 2011, is meeting the expectations
of both companies. We are proud of the speed of our recent progress with
MITIZAX(R) that brings us rapidly and steadily closer to improving the lives of
the many patients who suffer from allergic rhinitis and asthma as a result of
house dust mite allergy.' 

The two Phase II/III trials in Japan are part of the largest development
programme in the history of allergy immunotherapy. In Europe, ALK is currently
conducting two similar clinical Phase III trials which will complete in 2013.
In North America, MITIZAX(R) has been licensed to Merck (known as MSD outside the
USA and Canada) and is currently in Phase II clinical development. 

Initiation of patient dosing in the Phase II/III trials in Japan entitles ALK
to an undisclosed milestone payment from Torii. This payment has already been
included in ALK's financial outlook for 2012 and consequently, this
announcement does not lead ALK to change its financial outlook for the year. 



                                 ALK-Abelló A/S
                                        

                                   Jens Bager
                                President and CEO



For further information, please contact:

President and CEO Jens Bager, tel. (+45) 4574 7576
Investor Relations: Per Plotnikof, tel. (+45) 4574 7527, mobile (+45) 2261 2525
Press: Martin Barlebo, tel. (+45) 4574 7901, mobile (+45) 2064 1143


About MITIZAX(R), House Dust Mite Allergy Immunotherapy Tablet
Allergy immunotherapy is a unique treatment of the underlying cause of the
allergy. The treatment induces a protective immune response which provides
sustained symptom relief and reduces the risk of developing asthma. 

The increasing prevalence of allergy has become a major health issue worldwide.
House dust mite allergy is the most common allergy in the world, affecting
approximately 90 million people in Europe, North America and Japan. 

House dust mite allergy is furthermore a major cause of allergic asthma. Asthma
is a disease of diffuse airway inflammation often resulting in shortness of
breath, cough, wheezing and chest tightness. The symptoms are often associated
with limitations in daily activities, impairment of lung function and
significant use of symptomatic medication. A distinctive characteristic of
asthma is acute deteriorations (exacerbations) triggered by allergens or other
factors. When tested, approximately 48% of people with asthma are sensitised to
house dust mites. It is estimated that more than 30 million people in Europe
alone have asthma. 

ALK is currently developing an allergy immunotherapy tablet (AIT) against house
dust mite induced allergic rhinitis or asthma. In Europe, the clinical
programme is in Phase III and has already demonstrated promising results: A
recent clinical Phase II/III study met its primary endpoint and showed a
significant reduction in the need for asthma medication. ALK is currently
conducting two clinical Phase III trials in Europe investigating the effect of
MITIZAX(R) in the treatment of house dust mite induced allergic rhinitis and
asthma, respectively. A total of 4,300 patients are now included in the global
development programme. 

The new tablet, MITIZAX(R), is part of ALK's AIT programme which led to the
launch of the world's first AIT, GRAZAX(R), for the treatment of grass pollen
allergy in 2007. The AIT programme also includes tablets against ragweed and
tree pollen allergy. 

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 hemodialysis including
pruritus in hemodialysis 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 tablet based immunotherapy product against house dust mite allergy -
MITIZAX(R). 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 tablet
based immunotherapy product against Japanese cedar pollen allergy. 

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 Pharmaceutical Co., Ltd. to commercialise
allergy immunotherapy tablets (AIT) in North America and Japan, respectively.
The company is headquartered in Hørsholm, Denmark, and listed on the NASDAQ OMX
Copenhagen A/S. Find more information at www.alk-abello.com.
News Source: NASDAQ OMX



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Company:      ALK-Abelló
              
               
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