Eli Lilly Snags North American Rights to Erbitux From Bristol-Myers Squibb
April 16, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
After a 14-year marriage, Bristol-Myers Squibb Company said Thursday that it will transfer the North American rights to cancer drug Erbitux (cetuximab) to partner Eli Lilly and Company, as the companies look to streamline their individual portfolios and strengthen oncology assets.
“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, 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 Company . We look forward to carrying on these efforts for people battling select advanced colorectal and head and neck cancers.”
Erbitux treats advanced colorectal and head and neck cancers and the companies said 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. A spokesman queried for the total dollar amount did not respond to a request for comment.
“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.”
So far, 2015 has been a solid success for Bristol’s drug pipeline. In mid-January the company halted a late-stage study of immunotherapy lung cancer drug Opdivo after it had shown so much success further study was superfluous.
Opdivo (nivolumab) is PD-1 inhibitor that uses the body’s own immune system to help target and destroy tumors. Bristol-Myers said it stopped the trial early because the study had met its primary endpoint and had shown a survival advantage that was significant enough to review the data and perhaps push into regulatory approval faster than expected.
Bristol-Myers had parsed the data from a randomized lung cancer study pitting Opdivo against chemotherapy drug docetaxel, and found a better survival rate for the 272 patients who got doses of Opdivo every two weeks, compared to docetaxel every three.
“CheckMate -017 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival,” said the company in a statement. “The company will complete a full evaluation of the final CheckMate -017 data and work with investigators on the future presentation and publication of the results.”
In related news, competitor Merck & Co. said Monday that its own PD-1 drug, Kytruda, which was the first anti-PD drug approved by the U.S. Food and Drug Administration (FDA) in September, could soon be approved for more uses. Merck said Monday it is on track to ask the FDA for a biologics license for Keytruda to treat additional types of small lung cancer. Both Opdivo and Keytruda are approved to treat patients who have not responded to other treatments previously.
Merck & Co. made the announcement ahead of the opening of the J.P. Morgan Healthcare Conference in San Francisco and the oldest and largest conference of its type. It included 300 of the largest biotech, healthcare and biopharma companies presenting their top-line data and estimates to a sea of eager bankers, analysts, institutional investors, hedge funds and journalists.
The FDA gave breakthrough status to Opdivo breakthrough in May, and green-lit the drug to treat skin cancer last month.
BioSpace Temperature Poll
After last week's news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?