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
"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."
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.
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
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.
Our Philosophy: Quality and Patients First.
REMICADE® is a registered trademark of Johnson and Johnson (www.jnj.com)
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