Erbitux (cetuximab) is an IgG1 monoclonal antibody designed to exclusively target and block the epidermal growth factor receptor (EGFR) and is used for the treatment of metastatic colorectal cancer.
The drug has been marketed in the US for the past 14 years by Bristol-Myers Squibb, but last week the firm agreed to transfer the rights in North America to Eli Lilly, owner of ImClone which manufactures Erbitux from its facilities in Branchburg, New Jersey.
"Bristol-Myers Squibb is focused on ensuring our markets are optimized to drive near-term growth and deliver our current and future pipeline,” spokesman Ken Dominski told Biopharma-Reporter.com, adding it further aligns the firm’s oncology organisation “across both solid tumors and hematologic malignancies.”
He added that currently fill/finish operations are completed by OsoBiopharm and Jubilant Hollister-Stier, but under the agreement, the “rights transferring to Lilly include, but are not limited to, full commercialization and manufacturing operational responsibilities.”
Last year, Erbitux sales added $723m (€677m) to BMS’s total revenues, up 4% on 2013, but in the US data exclusivity is set to expire in 2016 while the method-of-use patent expires in late 2018.
Currently there are two biosimilar versions in early development – from Celltrion and Amgen/Actavis – but Eli Lilly spokesperson Crystal Livers-Powers would not “speculate on if, or when, biosimilars may enter the market.”
However, she did tell this publication adding Erbitux to its portfolio helps “to accelerate Lilly’s commitment and leadership in gastrointestinal cancers to include an effective treatment for advanced colorectal cancer as well as head and neck cancer.”
The deal is set to go through in the fourth quarter of 2015 and BMS will receive tiered royalties based on net product sales in North America after the completion of the transition through to September 2018.