Orygen To Manufacture Epirus' Remicade Biosimilar In Brazil

Oct 22 2013

Orygen Biotecnologia will develop, manufacture, and commercialize several products of Epirus Biopharmaceuticals in Brazil, starting with a biosimilar version of the arthritis drug Remicade (infliximab), in a deal worth up to $275 million, the companies said today.

Under an agreement inked by Orygen and Epirus subsidiary Epirus Switzerland, the companies agreed to pursue registration of BOW015 with Brazil's National Agency of Sanitary Surveillance (ANVISA). Epirus also agreed to transfer BOW015 technology to Orygen to facilitate manufacture of the biosimilar in Brazil.

The agreement comes nearly two months after Epirus' disclosure of successful Phase III data for BOW015, comparing the biosimilar Remicade in patients with severe rheumatoid arthritis. Remicade is marketed by Johnson & Johnson and Merck & Co., with J&J holding U.S. rights.

Trial results released Aug. 28 by Epirus showed 89.8% of patients taking BOW-015 achieved 20% improvement across the "ACR20" diagnostic parameters set by the American College of Rheumatology vs. 86.4% of Remicade patients. The company said it would release complete details "at an upcoming major medical meeting."

Epirus said today it plans to submit regulatory filings for BOW015 over the next 12 months "in targeted emerging markets."

In addition to BOW015, Epirus and Orygen agreed to develop additional biotechnology products for manufacture and commercialization in Brazil. For those products, as with BOW015, Orygen will hold exclusive rights in Brazil, while Epirus will maintain exclusive global rights for the rest of the world.

Orygen agreed to pay Epirus up to $275 million in up-front, milestone, and royalty payments and service-based fees toward the construction of a manufacturing facility, the transfer of product and manufacturing technology from Epirue to Orygen, and the clinical development of the Epirus pipeline.

Epirus also agreed to transfer its SCALE™ biomanufacturing system to Orygen, enabling production of BOW015 and the rest of Epirus' pipeline of biosimilar monoclonal antibodies and therapeutic proteins for commercialization in emerging markets.

SCALE is a standardized platform designed to prepare products for production in regional identical facilities. Epirus teams up with regional partners to manufacture biosimilars by accessing local governmental and institutional support to enhance product access in local markets-;a strategy Epirus calls In Market, For Market™.

The In Market, For Market strategy entails gaining access to regional expertise in regulatory conditions and market environment-;"including preferential tendering and contracting," according to Epirus' website-;as well as access to lower-cost capital through close dialogue with government and local institutional financing vehicles.

Orygen is a joint venture of Brazilian pharmaceutical companies Eurofarma Laboratórios and Biolab Sanus Farmaceutica.

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