Shionogi & Co., Ltd.
License agreements with Stallergenes
regarding sublingual allergen immunotherapy tablets
Osaka, September 7, 2010 – Shionogi & Co., Ltd. (Head Office: Osaka; President: Isao Teshirogi;
hereafter “Shionogi”) and Stallergenes SA (Head Office: Antony, France; Chairman & CEO, Albert
Saporta; hereafter “Stallergenes”) a listed pharmaceutical company, today announced that they
have entered into license agreements to exclusively develop and market two sublingual allergen
immunotherapy tablet products of the Stallergenes’ Stalair® programme: house dust mites
(HDM) sublingual immunotherapy (hereunder “SLIT tablet”) tablet in Japan and Taiwan for house
dust mites-induced allergic rhinitis and Japanese cedar (JC) SLIT tablet with exclusive
development and commercialization in Japan for Japanese cedar pollen induced allergic rhinitis.
Under the terms of agreements, Shionogi will pay an upfront payment of Euros 24 million and up
to Euros 46 million in development and regulatory milestone payments. It will also pay sales
milestone and royalty payments on net sales of the products.
Allergen immunotherapy desensitizes the intrinsic reactivity to allergens by administering small
amounts of the allergenes. A subcutaneous route has been commonly used for immunotherapy
thus far but makes patients at risk of anaphylaxis shock. The sublingual immunotherapy (SLIT)
provides more convenient treatment options with much lower risk of systemic adverse reactions.
“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 the Japan’s biggest
pharmaceutical companies and a R&D-based organization, 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 Stallergenes
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. Stallergenes is the seventh-ranked French
pharmaceutical company.
A pioneer and leader in sublingual immunotherapy treatments, Stallergenes devotes 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 immunotherapy products.
Additional information is available at
http://www.stallergenes.com
Forward-Looking Statements
This announcement contains forward-looking statements. These statements are based on
expectations in light of the information currently available, assumptions that are subject to
risks and uncertainties which could cause actual results to differ materially from these
statements. Risks and uncertainties include general domestic and international economic
conditions such as general industry and market conditions, and changes of interest rate and
currency exchange rate. These risks and uncertainties particularly apply with respect to
product-related forward-looking statements. Product risks and uncertainties include, but are
not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals;
claims and concerns about product safety and efficacy; technological advances; adverse
outcome of important litigation; domestic and foreign healthcare reforms and changes of laws
and regulations. Also for existing products, there are manufacturing and marketing risks,
which include, but are not limited to, inability to build production capacity to meet demand,
unavailability of raw materials and entry of competitive products. The company disclaims any
intention or obligation to update or revise any forward-looking statements whether as a result
of new information, future events or otherwise.
For further information, contact:
Corporate Communications Department
Shionogi & Co., Ltd.
Telephone: +81-6-6209-7885
Fax: +81-6-6229-9596
