Epirus, Polpharma Form Biosimilars Pact

Epirus Biopharmaceuticals, Inc., a Boston-based biosimilars company, and Polpharma Group, a Polish generics company, have formed a multi-product, multi-region profit-sharing collaboration for select Epirus biosimilars, including BOW015 (infliximab, reference biologic Remicade), BOW050 (adalimumab, reference biologic Humira, and BOW070 (tocilizumab, reference biologic Actemra). Polpharma Group is a generics company based in Poland .

Under the agreement, both parties will jointly fund clinical development and collaborate on regulatory filings in the specified territories. Epirus will also be responsible for process development, scale-up, and manufacturing, with Polpharma Group overseeing commercialization across the territories. Clinical development costs and eventual operating profit will be split 51% Polpharma Group and 49% Epirus. Polpharma Group will contribute approximately $30 million toward clinical development costs as well as cover product launch costs across all three programs.

Epirus retains the commercial rights to Switzerland and Norway along with select European Union countries,including Austria, Belgium, Denmark, Finland, Luxembourg, the Netherlands, and Sweden. Epirus also retains rights to North America and other global markets not addressed in this agreement. A joint management board will oversee the collaboration.

Polpharma had annual sales of approximately $1 billion and has a salesforce of over 1,700 employees globally. The comany’s portfolio includes about 600 products with another 200 in the pipeline. In June 2015, the European Investment Bank (EIB), the long-term lending institution of the European Union (EU) that is owned by the EU member state, reported that it was lending EUR 45 million ($51 million) to Polpharma for research and development of biosimilar drugs. The financing was the first EIB operation in Poland supported by the new financial instruments for innovative and growth companies, “InnovFin: EU Finance for Innovators,” with the financial backing of the EU under Horizon 2020, a large EU research and innovation program with nearly EUR 80 billion ($90 billion) of funding available over seven years (2014 to 2020). Polopharma operates in the markets of Central and Eastern Europe, the Caucasus, and Central Asia with seven manufacturing plants and six research and development centers.

Source: Epirus

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