Lilly, Bristol-Myers Squibb Restructure Erbitux (cetuximab) Collaboration in North America

The companies' decision comes after a 14-year successful collaboration.

PRESS RELEASE

INDIANAPOLIS & NEW YORK--(BUSINESS WIRE)-- Eli Lilly and Company (NYSE:LLY) and Bristol-Myers Squibb Company (NYSE:BMY) today announced that the companies have agreed to transfer rights to Erbitux® (cetuximab) in North America, including the U.S., Canada, and Puerto Rico, from Bristol-Myers Squibb to Lilly. Rights include, but are not limited to, full commercialization and manufacturing operational responsibilities. The companies' decision comes after a 14-year successful collaboration, which includes Lilly's wholly-owned subsidiary ImClone LLC. Bristol-Myers Squibb and Lilly will work closely to ensure a smooth transition on this important product for patients with certain advanced colorectal and head and neck cancers.

"Fully bringing Erbitux into the Lilly Oncology portfolio accelerates Lilly's commitment and leadership in gastrointestinal cancers to include an effective treatment for advanced colorectal cancer as well as head and neck cancer," said Sue Mahony, Ph.D., senior vice president and president of Lilly Oncology. "Our good work on Erbitux began with its development at ImClone and has continued with Bristol-Myers Squibb. We look forward to carrying on these efforts for people battling select advanced colorectal and head and neck cancers."

"Bristol-Myers Squibb is incredibly proud to have built Erbitux into a major brand and an important therapy for so many patients with certain colorectal and head and neck cancers," said Murdo Gordon, head of worldwide markets, Bristol-Myers Squibb. "This agreement further aligns our Oncology organization with our prioritized opportunities in immuno-oncology, across both solid tumors and hematologic malignancies."

The transition is expected to be completed in the fourth quarter of 2015. Bristol-Myers Squibb will receive tiered royalties based on net product sales in North America after the completion of the transition through September 2018.

About Erbitux

Erbitux is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of:

Head and Neck Cancer

  • Erbitux, in combination with radiation therapy, is indicated for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN)
  • Erbitux is indicated in combination with platinum-based therapy with 5-FU for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
  • Erbitux, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed

Colorectal Cancer

Erbitux is indicated for the treatment of KRAS (wild-type), epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use:

  • in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment
  • in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy
  • as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan

Limitation of Use: Erbitux is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.