Epirus hopes to bring its infliximab biosimilar to EU in merger with Zalicus
Epirus Biopharmaceuticals currently has a number of biosimilar drugs in its pipeline, the most promising being its infliximab product, known as BOW015, which the firm hopes will be deemed equivalent to the monoclonal antibody Remicade, marketed by Johnson & Johnson and Merck & Co.
The announced merger with a wholly-owned subsidiary of Zalicus in an all-stock transaction will lead to a publically traded company focused on biosimilar development and - according to spokesperson for Zalicus Andreas Marathis - support for BOW015 going through phase III trials in Europe.
“Epirus is planning a Phase 3 European trial for its lead biosimilar,” she told Biopharma-Reporter.com, “and Zalicus has experience running a large multi-center European Rheumatoid Arthritis (RA) clinical trial as well as RA experience in Eastern Europe and Latin America.”
She added: “Zalicus also has access to leading European Key Opinion Leaderss in RA.”
Whilst the company is in a “quiet period” and Marathis could not tell us more about the biosimilar manufacturing capabilities the new company – which will lead to Zalicus being re-named Epirus Biopharmaceuticals and managed by Epirus’ current management team – will have, new CEO Amit Munshi gave more detail on a conference call to discuss the deal.
“We focus on both the development specific manufacturing platform as well as global commercialisation of these products,” he told stakeholders, and the merger will “bring the robust pipeline to the table,” with BOW015’s European Phase III trial set to commence later this year.
In January, Epirus teamed with Ranbaxy – recently acquired by Sun Pharma – to bring BOW015 to the Indian and other emerging markets later this year.
As for Europe, Hospira and Celltrion’s versions of Remicade became the first monoclonal antibody biosimilars to be approved when they received the thumbs up from the EMA in June 2013.
