Production & Manufacturing

Epirus, Orygen to develop multiple biotechnology products in Brazil

PBR Staff Writer Published 23 October 2013

Epirus Biopharmaceuticals’ wholly-owned subsidiary Epirus Switzerland and Orygen Biotecnologia (Orygen), a joint venture between Eurofarma Laboratorios and Biolab Sanus Farmaceutica, 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.

Epirus will also transfer BOW015 technology to Orygen to facilitate manufacturing in Brazil.

The company recently announced successful Phase 3 data for BOW015.

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 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.

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 $275m in upfront, milestone, and royalty payments and service-based fees.

Epirus president and CEO Amit Munshi noted the company is very pleased to work with Orygen on this important endeavor.

"We share their desire to expand access to BOW015 and other important biotechnology therapeutics in Brazil through local manufacturing," Orygen added.

Orygen president and CEO Dr Andrew Simpson noted the company has been impressed by the Epirus product pipeline and their ability to enable local production.

"We look forward to working closely together to develop and produce these important medicines in Brazil," Dr Simpson added.