Click
Chat
 
Du kan vedhæfte PDF, JPG, PNG, DOC(X), XLS(X) og TXT-filer. Klik på ikonet, vælg fil og vent til upload er færdig før du indsender eller uploader endnu en fil.
60
Vedhæft Send
DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER

ALK makes progress with MITIZAX® in Japan and Europe

26-09-11 kl. 26/9 2011 06:59 | ALK-Abello 999,00 (-0,05%)

ALK's partner, Torii, initiates clinical development programme in Japan with
MITIZAX®, the new innovative tablet against house dust mite induced hay fever
and asthma. The initiation releases a milestone payment to ALK and full-year
outlook is adjusted upwards. In Europe, ALK accelerates the development and
initiates an additional Phase III clinical study with MITIZAX® to broaden the
therapeutic use of the product. ALK is now conducting two parallel Phase III
studies with 1,700 patients in a total of 17 European countries.

Copenhagen, 2011-09-26 08:59 CEST (GLOBE NEWSWIRE) --

ALK today announces that its strategic partner, Torii, has begun the clinical
development programme with MITIZAX® and initiated a Phase I study in Japan.
MITIZAX® is ALK's new innovative allergy immunotherapy tablet (AIT) against
house dust mite induced hay fever and asthma. The Phase I study will include
approximately 50 subjects and is intended to investigate safety and
tolerability of MITIZAX® in a Japanese population.

Jens Bager, President and CEO of ALK, states: “We are satisfied with our
collaboration with Torii and we have made significant progress in bringing
ALK's products forward in Japan. The initiation of the Phase I study with
MITIZAX® constitutes yet another milestone in ALK's efforts to obtain global
availability of our modern allergy vaccines.”

Development in Europe accelerated
Furthermore, ALK today announces that it is initiating an additional Phase III
study (called the MERIT study) with MITIZAX® in Europe aimed at broadening the
therapeutic use of the product.

Henrik Jacobi, Executive Vice President of R&D at ALK, says: “The MERIT study
will accelerate the development of MITIZAX® and shall ensure a fast market
entry and a broader therapeutic use of the vaccine. This will allow more
patients to benefit from the treatment. The accelerated development is expected
to significantly increase the value of MITIZAX® to patients, society and ALK”.

The MERIT study is a Phase III, randomised, parallel-group, double-blind,
placebo-controlled study and is intended to enrol 900 adult subjects across 86
centres in 12 European countries. The study will evaluate efficacy and safety
of MITIZAX® given once daily compared to placebo in the treatment of house dust
mite induced allergic rhinitis. The study is expected to be completed in 2013.

A few weeks ago, recruitment of patients for another Phase III study (the MITRA
study) with MITIZAX® was initiated. The MITRA study will evaluate the efficacy
and safety of the tablet in the treatment of house dust mite induced allergic
asthma. The study is intended to enrol 800 adult subjects across 105 centres in
12 European countries and is also expected to be completed in 2013.

The study initiation in Japan entitles ALK to an undisclosed milestone payment
from Torii. This payment was not previously included in ALK's financial outlook
for 2011 and consequently ALK now expects total revenue to exceed DKK 2.3
billion and operating profit (EBITDA) to exceed DKK 400 million (previously DKK
385 million), equivalent to an increase of approximately 40% compared to last
year.

ALK-Abelló A/S

Jens Bager
President and CEO

Contact: Jens Bager, President and CEO, tel. (+45) 4574 7576

About MITIZAX®, 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 indoor 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. Moreover, the study
demonstrated that the tablet is convenient, well tolerated and has a good
safety profile. In addition, ALK has carried out two Phase I tolerability
studies in adults and children, respectively. With the two new studies, a total
of 2,500 patients are included in the development programme.

The new tablet, MITIZAX®, is part of ALK's AIT programme which led to the
launch of the world's first AIT, GRAZAX®, 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®. The agreement also covers an injection based immunotherapy product,
Alutard®, 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 1,750 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.

For further information, please contact
Investor Relations: Per Plotnikof, tel. (+45) 4574 7527, mobile (+45) 2261 2525
Press: Martin Barlebo, tel. (+45) 4574 7901, mobile (+45) 2064 1143




Der er endnu ikke skrevet nogen kommentarer til denne artikel.

Skriv en kommentarer til denne artikel:


Send kommentar


Kursinfo - ALK-Abello

PRIS 999,00
ÆNDRING -0,50 (-0,05%)
ÅBEN 999,50
SIDSTE LUK 999,50
DEBAT -
OMX Børsmeddelelser

RELATEREDE NYHEDER