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Agreements

Date: 2013-10-22

Type of information: Production agreement

Compound: BOW015 (biosimilar version of Remicade® (infliximab))

Company: EPIRUS Switzerland (Switzerland - USA) - Orygen Biotecnologia (Brazil)

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Type agreement: development manufacturing production commercialisation

Action mechanism: biosimilar/monoclonal antibody. BOW015 is a biosimilar version of infliximab, a biologic therapy marketed under the name Remicade®. Epirus has completed a successful Phase 3 trial which met its predefined endpoint, demonstrating comparability of BOW015 to Remicade® as measured by ACR20 response in severe rheumatoid arthritis patients. The study also showed no meaningful differences between BOW015 and Remicade® with regard to safety or immunogenicity.

Disease: rheumatoid arthritis

Details:

• On October 22, 2013, Epirus Switzerland GmbH, a wholly-owned subsidiary of Boston-based Epirus Biopharmaceuticals, and Orygen Biotecnologia Ltda, a joint venture between the Brazilian pharmaceutical companies Eurofarma Laboratórios SA and Biolab Sanus Farmaceutica Ltda, have announced a broad collaboration for the development, manufacture and commercialization of multiple biotechnology products in Brazil. Epirus and Orygen will pursue the registration of BOW015, the Epirus biosimilar molecule to Remicade®, with Brazil’s National Agency of Sanitary Surveillance (ANVISA). Epirus will also transfer to Orygen its proprietary bio-manufacturing system, SCALE™, which will enable In Market, For Market™ production of BOW015 and the rest of the Epirus pipeline. Epirus and Orygen have also agreed to develop additional biotechnology products for manufacture and commercialization in Brazil. For BOW015 and each of these additional assets, Orygen will hold exclusive rights in Brazil, and Epirus will maintain exclusive global rights for all markets outside of Brazil.
Epirus has completed a successful Phase 3 trial which met its predefined endpoint, demonstrating comparability of BOW015 to Remicade® as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade® with regard to safety or immunogenicity. Epirus plans to submit regulatory filings for BOW015 in targeted emerging markets over the next 12 months.

Financial terms:

Under the terms of the agreement, Orygen will invest in the construction of a manufacturing facility, the transfer of product and manufacturing technology from Epirus to Orygen and the clinical development of the Epirus pipeline. Epirus will earn up to $275 million in upfront, milestone, and royalty payments and service-based fees.

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