Antony, France (ots/PRNewswire) - Stallergenes S.A.
has announced today the signing of exclusive partnership agreements
with Shionogi & Co., Ltd. for two sublingual allergen immunotherapy
tablet products resulting from the Stalair(R) program: Actair(R)
house dust mite tablets and Japanese cedar pollen tablets.
With 32 million respiratory allergy sufferers, there is a strong
- and as yet unmet - demand for treatment in Japan, where sublingual
allergen immunotherapy is currently not available. House dust mites
and Japanese cedar pollen are the two main causes of respiratory
allergies and the Japanese cedar allergy is a major public health
concern in the country. This partnership is the first of its kind in
Japan and will bring sublingual immunotherapy to patients suffering
from severe allergic rhinitis, inadequately controlled using
symptomatic treatments (antihistamines, corticosteroids).
The agreement covers the development, registration, promotion and
distribution of Actair(R) in Japan and Taiwan, and of the Japanese
cedar pollen tablet in Japan. The clinical development of Actair(R)
will be launched in 2011 in order to prepare the license application.
For the Japanese cedar pollen tablet, a specific development plan
will be initiated through close collaboration between the two
partners, since the product is exclusively aimed at the Japanese
Stallergenes will receive:
- an immediate upfront payment of Euros 24 million,
- up to Euros 46 million in development and regulatory
- as well as sales milestones.
Furthermore, Stallergenes will be entitled to royalty payments on
net sales of the products by Shionogi & Co., Ltd.
Shionogi & Co., Ltd. will be responsible for the clinical
development, registration, marketing and sales of the products
covered by this agreement in Japan. Stallergenes will be responsible
for tablet production and supply, and early-stage development.
"We are enthusiastic about the prospect of collaborating with
Stallergenes, the world leader in sublingual allergen immunotherapy,
and are very looking forward to bringing new treatment options of
sublingual immunotherapy to a huge number of allergic rhinitis
patients in Japan, most of whom suffer from allergy to house dust
mite and/or Japanese cedar," declared Dr. Isao Teshirogi, President
of Shionogi & Co., Ltd.
"We are delighted to team up with Shionogi & Co., Ltd., one of
Japan's biggest pharmaceutical companies, an R&D-based organization
and a key player in the allergy field. Shionogi & Co., Ltd., thanks
to its strong allergy franchise and its well-established presence
alongside allergy specialists, and Stallergenes will develop
immunotherapy in Japan, particularly for house dust mite allergy, in
which it has recently demonstrated its efficacy after 4 months of
treatment and the persistence of its therapeutic effect after only
one year of treatment," declared Albert Saporta, Stallergenes'
Chairman and CEO.
ABOUT RESPIRATORY ALLERGY IN JAPAN
Allergic rhinitis affects 25% of the population in Japan, and
asthma 6.7%. House dust mites and Japanese cedar pollen are the
two main causes of respiratory allergies.
The Japanese allergy market is the 2nd biggest in the world
behind the USA. There is a very strong - and as yet unmet - demand
for allergy treatments in Japan.
ABOUT THE STALAIR(R) PROGRAM
Stalair(R) is the name of the pharmaceutical and clinical
development program for immunotherapy tablets being implemented by
Stallergenes with a view to obtaining marketing authorizations for
pharmaceutical products in Europe and in other strategic markets.
The Stalair(R) development program includes 5 immunotherapy
tablets: Oralair(R) (grass pollen), Actair(R) (house dust mites), r
Bet v 1 (birch pollen recombinant allergen), ragweed pollen and
Japanese cedar pollen.
Oralair(R) is the first project resulting from this program. A
Mutual Recognition Procedure has been completed in Europe.
Oralair(R), which is already marketed in Germany, will be launched in
the fall in the Netherlands, the Czech Republic, Slovakia and
Austria. Having recently demonstrated its efficacy after 3 years of
treatment (study VO53.06 conducted in Europe), Oralair(R) has been
the subject of a positive phase III trial in adults in the United
The second project in the program is Actair(R), house dust mite
immunotherapy tablet. Having recently demonstrated Actair(R) efficacy
after 4 months of treatment and the persistence of its therapeutic
effect after only one year of treatment (study VO57.07 conducted in
Europe), Stallergenes is now preparing filing NDA in Germany. A phase
III pediatric study has been launched.
The Stalair(R) r Bet v 1 tablet (birch pollen recombinant
allergen) has been the subject of a positive phase IIb/III clinical
trial conducted in allergic rhinitis caused by birch pollen. A
confirmatory phase III study is currently being prepared with a view
to EMA registration.
The ragweed pollen and Japanese cedar pollen tablets are at an
early stage of development.
Altogether, the program covers 80% of the epidemiology for all
ABOUT SHIONOGI & CO.,LTD
Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major
research-driven pharmaceutical company dedicated to placing the
highest value on patients. Shionogi's Research and Development
currently targets three therapeutic areas: Infectious Diseases, Pain,
and Metabolic Syndrome. The Company is the originator of innovative
medicines which have been successfully delivered to millions of
patients worldwide. In addition, Shionogi is engaged in new research
areas such as allergy and cancer. Contributing to the health of
patients around the world through development in these therapeutic
areas is Shionogi's primary goal. For more details, please visit
Stallergenes is a European biopharmaceutical company dedicated to
immunotherapy treatments for the prevention and treatment of
allergy-related respiratory diseases, such as allergic
rhinoconjunctivitis, rhinitis and asthma.
A pioneer and leader in sublingual immunotherapy treatments,
Stallergenes dedicates more than 20% of its turnover, in gross terms,
to Research and Development and is actively involved in the
development of a new therapeutic class: sublingual immunotherapy
tablets. In 2009, Stallergenes had a turnover of 193 million euros
and more than 500,000 patients were treated with Stallergenes'
@@start.t1@@ Euronext Paris (Compartment B)
ISIN code: FR0000065674
Reuters code: GEN.PA
Bloomberg code: GEN.FP
Additional information is available at http://www.stallergenes.com@@end@@
 Sakurai Y, Nakamura K, Teruya K, Shimada N, Umeda T, Tanaka
H, Yoshizawa N. Prevalence and risk factors of allergic rhinitis and
cedar pollinosis among Japanese men. Prev Med. 1998
 Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for
Asthma (GINA) Program. The global burden of asthma: executive summary
of the GINA Dissemination Committee report. Allergy. 2004 May;59
ots Originaltext: Stallergenes
Im Internet recherchierbar: http://www.presseportal.ch
CONTACT: Contacts: Albert Saporta - Chairman and CEO,
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