Stallergenes and Shionogi Sign Exclusive Partnership Agreements for Immunotherapy Tablets in Japan

ANTONY, France, September 6, 2010 StallergenesS.A. has announced today the signing of exclusive partnership agreements withShionogi & Co., Ltd. for two sublingual allergen immunotherapy tabletproducts resulting from the Stalair(R) program: Actair(R) house dust mitetablets and Japanese cedar pollen tablets.

With 32 million respiratory allergy sufferers, there is a strong - and asyet unmet - demand for treatment in Japan, where sublingual allergenimmunotherapy is currently not available. House dust mites and Japanese cedarpollen are the two main causes of respiratory allergies and the Japanesecedar allergy is a major public health concern in the country. Thispartnership is the first of its kind in Japan and will bring sublingualimmunotherapy to patients suffering from severe allergic rhinitis,inadequately controlled using symptomatic treatments (antihistamines,corticosteroids).

The agreement covers the development, registration, promotion anddistribution of Actair(R) in Japan and Taiwan, and of the Japanese cedarpollen tablet in Japan. The clinical development of Actair(R) will belaunched in 2011 in order to prepare the license application. For theJapanese cedar pollen tablet, a specific development plan will be initiatedthrough close collaboration between the two partners, since the product isexclusively aimed at the Japanese market.

Furthermore, Stallergenes will be entitled to royalty payments on netsales 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 agreementin Japan. Stallergenes will be responsible for tablet production and supply,and early-stage development.

"We are enthusiastic about the prospect of collaborating withStallergenes, the world leader in sublingual allergen immunotherapy, and arevery looking forward to bringing new treatment options of sublingualimmunotherapy to a huge number of allergic rhinitis patients in Japan, mostof 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'sbiggest pharmaceutical companies, an R&D-based organization and a key playerin the allergy field. Shionogi & Co., Ltd., thanks to its strong allergyfranchise and its well-established presence alongside allergy specialists,and Stallergenes will develop immunotherapy in Japan, particularly for housedust mite allergy, in which it has recently demonstrated its efficacy after 4months of treatment and the persistence of its therapeutic effect after onlyone year of treatment," declared Albert Saporta, Stallergenes' Chairman andCEO.

ABOUT RESPIRATORY ALLERGY IN JAPAN

Allergic rhinitis affects 25%[1] of the population in Japan, and asthma6.7%[2]. House dust mites and Japanese cedar pollen are the two main causesof respiratory allergies.

The Japanese allergy market is the 2nd biggest in the world behind theUSA. There is a very strong - and as yet unmet - demand for allergytreatments in Japan.

ABOUT THE STALAIR(R) PROGRAM

Stalair(R) is the name of the pharmaceutical and clinical developmentprogram for immunotherapy tablets being implemented by Stallergenes with aview to obtaining marketing authorizations for pharmaceutical products inEurope 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 (birchpollen recombinant allergen), ragweed pollen and Japanese cedar pollen.

Oralair(R) is the first project resulting from this program. A MutualRecognition Procedure has been completed in Europe. Oralair(R), which isalready marketed in Germany, will be launched in the fall in the Netherlands,the Czech Republic, Slovakia and Austria. Having recently demonstrated itsefficacy 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 inthe United States (VO61.08).

The second project in the program is Actair(R), house dust miteimmunotherapy tablet. Having recently demonstrated Actair(R) efficacy after 4months of treatment and the persistence of its therapeutic effect after onlyone year of treatment (study VO57.07 conducted in Europe), Stallergenes isnow preparing filing NDA in Germany. A phase III pediatric study has beenlaunched.

The Stalair(R) r Bet v 1 tablet (birch pollen recombinant allergen) hasbeen the subject of a positive phase IIb/III clinical trial conducted inallergic rhinitis caused by birch pollen. A confirmatory phase III study iscurrently being prepared with a view to EMA registration.

The ragweed pollen and Japanese cedar pollen tablets are at an earlystage of development.

Altogether, the program covers 80% of the epidemiology for all markets.

ABOUT SHIONOGI & CO.,LTD

Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a majorresearch-driven pharmaceutical company dedicated to placing the highest valueon patients. Shionogi's Research and Development currently targets threetherapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. TheCompany is the originator of innovative medicines which have beensuccessfully 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 developmentin these therapeutic areas is Shionogi's primary goal. For more details,please visit www.shionogi.co.jp.

ABOUT STALLERGENES

Stallergenes is a European biopharmaceutical company dedicated toimmunotherapy treatments for the prevention and treatment of allergy-relatedrespiratory diseases, such as allergic rhinoconjunctivitis, rhinitis andasthma.

A pioneer and leader in sublingual immunotherapy treatments, Stallergenesdedicates more than 20% of its turnover, in gross terms, to Research andDevelopment and is actively involved in the development of a new therapeuticclass: sublingual immunotherapy tablets. In 2009, Stallergenes had a turnoverof 193 million euros and more than 500,000 patients were treated withStallergenes' immunotherapy products.

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[1] Sakurai Y, Nakamura K, Teruya K, Shimada N, Umeda T, Tanaka H,Yoshizawa N. Prevalence and risk factors of allergic rhinitis and cedarpollinosis among Japanese men. Prev Med. 1998 Jul-Aug;27(4):617-22.

[2] Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for Asthma(GINA) Program. The global burden of asthma: executive summary of the GINADissemination Committee report. Allergy. 2004 May;59 (5):469-78.Stallergenes will receive: - an immediate upfront payment of Euros 24 million, - up to Euros 46 million in development and regulatory milestones payments, - as well as sales milestones.

SOURCE Stallergenes