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Agreement

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Date: 2010-09-06
Biotech partner: Stallergènes (France)
Pharma Partner: Shionogi (Japan)
Type of agreement: * commercialization/ distribution
* development
* marketing/ promotion
Compound: Actair® house dust mite tablets and Japanese cedar pollen tablets These two immunotherapy tablets are included in Stalair®, 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 three other development programs are Oralair® (grass pollen), r Bet v 1 (birch pollen recombinant allergen), and ragweed pollen.
Disease area: allergy
Development phase: Actair® has recently demonstrated its 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 Japanese cedar pollen tablets are at an early stage of development.
Nature of the agreement: Stallergenes and Shionogi have signed exclusive partnership agreements for two sublingual allergen immunotherapy tablet products resulting from the Stalair® program: Actair® house dust mite tablets and Japanese cedar pollen tablets.
The agreement covers the development, registration, promotion and distribution of Actair® in Japan and Taiwan, and of the Japanese cedar pollen tablet in Japan. Shionogi 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.
The clinical development of Actair® 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 market.
Termes financiers

Financial terms of the agreement: Stallergenes will receive an immediate upfront payment of € 24 million, and up to € 46 million in development and regulatory milestones payments, as well as sales milestones.
Stallergenes will also be entitled to royalty payments on net sales of the products by Shionogi.


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