With its Bristol Myers-partnered CAR-T therapy under FDA review, bluebird bio is getting a $200 million payout. The Big Pharma is forking over the cash to get out of future payments on the treatment outside the U.S.
The duo retooled their deal to focus on the impending U.S. rollout of the anti-BCMA treatment, known as idecabtagene vicleucel (ide-cel) or bb2121, according to a statement. Bristol Myers Squibb, which inherited the partnership in its $74 billion Celgene takeover, will hand over $200 million upfront to buy out its obligations to pay bluebird ex-U.S. milestones and royalties on ide-cel and its follow-up, bb21217.
The cash will help bluebird build its lentiviral vector manufacturing site in North Carolina “to support the U.S. commercial market for ide-cel and for bluebird bio’s pipeline,” while BMS will pick up vector manufacturing outside the U.S.
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“With bluebird exiting the passive participation as supplier outside the U.S., we and BMS are taking steps to ensure an efficient and robust supply chain for this program,” said Joanne Smith-Farrell, Ph.D., bluebird chief business officer and leader of the company’s oncology unit, in the statement. “This, together with the monetization of our ex-U.S. royalties and milestones will allow bluebird to continue to participate in co-developing and co-commercializing ide-cel within the U.S. and to refocus resources on our internal programs and pipeline.”
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The partners submitted ide-cel to the FDA at the end of March. They’re looking for a nod in multiple myeloma, specifically for patients who have tried at least three types of therapies, including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody.
The application is based on data from a pivotal phase 2 study, which tested three doses of ide-cel in 128 patients. Top-line data reported in December showed that the treatment shrank tumors in nearly three-quarters of patients and eliminated them in nearly one-third. The highest dose did the best, shrinking tumors in 82% and banishing tumors in 35% of patients.
Bluebird first teamed up with Celgene on cancer treatments, including ide-cel, in 2013. Two years later, they narrowed that deal to cover only anti-BCMA treatments and the following year, Celgene exclusively licensed ide-cel for $10 million.
In 2018, the duo agreed to evenly split U.S. profits and costs for the treatment, with Celgene on the hook for up to $70 million in milestone payments for ide-cel’s first indication, as well as more milestones for a second indication. At the time, bluebird stood to pick up royalty payments on sales of ide-cel outside the U.S.