Epirus Biopharmaceuticals said today it will partner with Polpharma Group to commercialize a pipeline of biosimilar drug candidates in the European Union, Middle East, Turkey, Russia and Commonwealth of Independent States.
The pipeline includes biosimilar versions of three blockbuster drugs—BOW015 (infliximab, whose reference biologic is the Johnson & Johnson drug Remicade®), BOW050 (adalimumab, AbbVie’s Humira®), and BOW070 (tocilizumab, Roche’s Actemra®). All three focus on treating inflammatory and immune mediated disorders.
Epirus plans to expand that pipeline mid- to long-term through biosimilar versions of at least some of the more than 20 Immunoglobulin G (IgG), Chinese Hamster Ovary monoclonal antibody drugs with soon-to-expire patents, clustered in five therapeutic areas.
Both companies will split clinical development costs and eventual operating profit, with 51% going to Polpharma and the remaining 49%, Epirus.
“This profit-sharing collaboration with Polpharma Group enables us to better direct our business and retain future value,” Amit Munshi, Epirus’ president and CEO, said in a statement. “We have an aggressive plan to bring our products to markets globally and to build a pure-play, sustainable and profitable biosimilar business.”
Polpharma has agreed to pay Epirus approximately $30 million towards clinical development costs, as well as cover product launch costs across all three programs. Polpharma will also be responsible for commercialization across the territories covered by the agreement.
Epirus will lead the global product development and clinical programs, and also oversee process development, scale-up and manufacturing. Both companies will jointly collaborate on regulatory filings.
Epirus retains the commercial rights to the biosimilar products in Switzerland and Norway along with select EU countries including Austria, Belgium, Denmark, Finland, Luxembourg, the Netherlands and Sweden. Epirus also retains rights to North America and other global markets not addressed by the agreement. A joint management board will oversee the collaboration.
Biosimilars are the focus of publicly-traded Epirus, which has its headquarters and product development team in Boston, with clinical, regulatory and business development infrastructure in Zug, Switzerland.
The company in November launched its first biosimilar, BOW015, in India with commercialization partner Ranbaxy Laboratories. Last month at the European League Against Rheumatism Annual Congress (EULAR 2015) in Rome, Epirus presented additional data showing biosimilarity between BOW015 and infliximab from a Phase I study in healthy volunteers and a Phase III trial in active rheumatoid arthritis (RA) patients.
Headquartered in Poland, Polpharma is among the world’s top 20 generic drug manufacturers with annual sales of approximately $1 billion, a global salesforce of more than 1,700 employees, and a portfolio of about 600 products, with another 200 under development.