ZUG, Switzerland & SAO PAULO--(BUSINESS WIRE)--EPIRUS Switzerland GmbH, a wholly-owned subsidiary of Boston-based Epirus Biopharmaceuticals, Inc. (EPIRUS), and Orygen Biotecnologia Ltda (ORYGEN), a joint venture between the Brazilian pharmaceutical companies Eurofarma Laboratórios SA and Biolab Sanus Farmaceutica Ltda, 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 BOW015 technology to ORYGEN to facilitate manufacturing in Brazil. EPIRUS 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 $275 million in upfront, milestone, and royalty payments and service-based fees.
“We are 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,” said Amit Munshi, President and CEO of EPIRUS.
Dr. Andrew Simpson, President and CEO of ORYGEN, added, “We have 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.”
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 (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.
EPIRUS is developing a broad pipeline of biosimilar monoclonal antibodies and therapeutic proteins for commercialization in emerging markets.
This pipeline is designed for deployment in an In Market, For Market™ manufacturing configuration, which confers strategic and economic advantages in many key markets and regions.
In close partnership with companies in Brazil, South Africa, Russia, Turkey, and other target markets, EPIRUS transfers product technology, designs and builds manufacturing capabilities, navigates local regulatory environments, and commercializes products.
Through coordinated global development and local production of its pipeline, EPIRUS will accelerate patient access to these important medicines.
ORYGEN is a biotechnology company created and jointly owned by Eurofarma Laboratórios SA and Biolab Sanus Farmaceutica Ltda, with its headquarters in Sao Paulo, Brazil. ORYGEN is developing a pipeline of biosimilar monoclonal antibodies and other biologic medicines with an initial focus on supplying these to the Federal Government of Brazil for use within the nation’s universal health program.
ORYGEN’s core focus is in the local manufacture of biological pharmaceutical products enabling improved access to this important class of medicines by the people of Brazil and those of other emerging markets around the world.
REMICADE® is a registered trademark of Johnson and Johnson (www.jnj.com)