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Agreements

Date: 2016-12-28

Type of information: Development agreement

Compound: Effi-7

Company: OSE Immunotherapeutics (France) Servier (France)

Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases

Type agreement:

development

licensing

commercialisation

Action mechanism:

monoclonal antibody. Effi-7 is a monoclonal immunomodulatory antibody targeting the alpha chain of the interleukin-7 receptor (IL-7R-alpha or CD127 receptor). Effi-7 blocks both the IL-7 and the internalization of the receptor, thus inducing a powerful antagonist effect on the pathogenic T lymphocytes involved in autoimmune diseases. This mechanism has been confirmed recently through multiple in vitro studies.

 

Disease: ulcerative colitis, Sjögren syndrome.

Details:

* On December 28 , 2016, OSE Immunotherapeutics announced that the company has entered into a worldwide license option agreement with Servier for the development and commercialization of Effi-7, an antagonist of the interleukin-7 receptor. Under the terms of the agreement, OSE Immunotherapeutics grants Servier a license option on the exclusive worldwide rights for the development and commercialization of its product Effi-7. OSE Immunotherapeutics is eligible to receive up to €272 million including an upfront payment of €10.25 million and additional payments of €30 million upon the exercise of a two-steps option license. These steps will enable the development of Effi-7 up to the completion of a phase 2 clinical trial planned in ulcerative colitis, an autoimmune bowel disease. Further payments will be linked to the achievement of clinical development and registration in multipleindications, as well as sales milestones with double-digit royalties on sales.

Currently in preclinical stage for ulcerative colitis, the development of Effi-7 will also be pursued until the clinical phase 2 as part of the EFFImab consortium, led by OSE Immunotherapeutics and including the University Hospital of Nantes and the company PxTherapeutics. This development is co-financed by Bpifrance for €9.1 million (ona total amount of €20 million). Servier will take further development in charge after this phase 2.

In parallel, Servier plans to start preclinical studies in the Sjögren syndrome. This disease, which provokes dryness of salivary and lacrimal glands, is the second most frequent auto-immune disease, with an incidence of 0.6 for 1,000 adults. A third of the patients have a systemic syndrome and the pathology leads to an increased risk of B lymphoma and pulmonary fibrosis (by lymphocyte infiltration). Sjödren syndrome has no curative treatment as of today. This parallel approach will allow, in line with Servier's strategy, to speed up the development of promising drugs for diseases with strong unmet medical needs.

 

Financial terms:

OSE Immunotherapeutics is eligible to receive up to €272 million including an upfront payment of €10.25 million and additional payments of €30 million upon the exercise of a two-steps option license.

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