ZUG, Switzerland & NEW DELHI, India I January 7, 2014 I EPIRUS Switzerland GmbH, a wholly-owned subsidiary of Boston-based EPIRUS Biopharmaceuticals, Inc. (“EPIRUS”), and Ranbaxy Laboratories Limited (“RANBAXY”) a division of Daiichi Sankyo Company, Tokyo, today announced the signing of a licensing agreement for BOW015, a biosimilar infliximab, for the broad range of territories including India, selected South East Asian markets, North Africa and several other markets.
Under the terms of the agreement EPIRUS and Ranbaxy will initially pursue the commercialization of BOW015, the EPIRUS biosimilar molecule to REMICADE®, in India. EPIRUS recently announced successful Phase 3 data for BOW015 and, in November, filed for market approval.
Subsequent to launch in India, Ranbaxy will pursue registration and commercialization of BOW015 in other territories in South East Asia, North Africa and selected other markets.
In exchange for the rights to BOW015 in the territories, EPIRUS will receive upfront, milestone, and royalty payments over the term of the agreement.
“We are very pleased to work with Ranbaxy to register and commercialize this important medicine. Ranbaxy has the right focus and infrastructure in these markets to effectively bring this medicine to these markets”, said Amit Munshi, President and CEO of EPIRUS.
Arun Sawhney, CEO & Managing Director, Ranbaxy said, “We are excited to partner with EPIRUS for the supply of this important high-quality biosimilar medicine. We will utilise our strong front-end capabilities in making this product available in India and other parts of world.”
About BOW015
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.
About EPIRUS
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.
In regions where the In Market, For Market™ strategy is not being pursued Epirus is working with leading commercial partners to license and bring the products to market.
Through coordinated global development and local production of its pipeline, EPIRUS will accelerate patient access to these important medicines.
About Ranbaxy
Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.
Ranbaxy’s continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries.
Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company’s commitment to increase penetration and improve access to medicines, across the globe. For more information, please visit www.ranbaxy.com.
SOURCE: EPIRUS
Post Views: 134
ZUG, Switzerland & NEW DELHI, India I January 7, 2014 I EPIRUS Switzerland GmbH, a wholly-owned subsidiary of Boston-based EPIRUS Biopharmaceuticals, Inc. (“EPIRUS”), and Ranbaxy Laboratories Limited (“RANBAXY”) a division of Daiichi Sankyo Company, Tokyo, today announced the signing of a licensing agreement for BOW015, a biosimilar infliximab, for the broad range of territories including India, selected South East Asian markets, North Africa and several other markets.
Under the terms of the agreement EPIRUS and Ranbaxy will initially pursue the commercialization of BOW015, the EPIRUS biosimilar molecule to REMICADE®, in India. EPIRUS recently announced successful Phase 3 data for BOW015 and, in November, filed for market approval.
Subsequent to launch in India, Ranbaxy will pursue registration and commercialization of BOW015 in other territories in South East Asia, North Africa and selected other markets.
In exchange for the rights to BOW015 in the territories, EPIRUS will receive upfront, milestone, and royalty payments over the term of the agreement.
“We are very pleased to work with Ranbaxy to register and commercialize this important medicine. Ranbaxy has the right focus and infrastructure in these markets to effectively bring this medicine to these markets”, said Amit Munshi, President and CEO of EPIRUS.
Arun Sawhney, CEO & Managing Director, Ranbaxy said, “We are excited to partner with EPIRUS for the supply of this important high-quality biosimilar medicine. We will utilise our strong front-end capabilities in making this product available in India and other parts of world.”
About BOW015
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.
About EPIRUS
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.
In regions where the In Market, For Market™ strategy is not being pursued Epirus is working with leading commercial partners to license and bring the products to market.
Through coordinated global development and local production of its pipeline, EPIRUS will accelerate patient access to these important medicines.
About Ranbaxy
Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.
Ranbaxy’s continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries.
Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company’s commitment to increase penetration and improve access to medicines, across the globe. For more information, please visit www.ranbaxy.com.
SOURCE: EPIRUS
Post Views: 134
