Celgene and bluebird bio Team Up in New Deal

Celgene Corporation and bluebird bio have inked a development and promotion deal for bb2121, bluebird’s B-cell maturation antigen (BCMA) CAR-T therapy for relapsed/refractory multiple myeloma (rrMM).

The two companies had already inked a broad strategic research collaboration deal in 2013 to discover, develop and commercialize oncology products, including bb2121. This new deal is focused on bb2121 in the U.S.

"Entering into this co-development and co-promotion partnership with Celgene is a significant step forward in building a fully integrated oncology franchise for bluebird and together, we are committed to rapidly advancing development of bb2121 for patients," said Joanne Smith-Farrell, bluebird’s oncology franchise leader and senior vice president, corporate development and strategy, in a statement. "The collaboration builds upon our extensive research and development capabilities in oncology and is a testament to the strong partnership that exists between our two companies."

The two companies will jointly develop, manufacture and commercialize bb212 in the U.S. Celgene will take over full responsibility for drug manufacturing and commercialization outside the U.S.

The two companies are also working on a second clinical-stage anti-BCMA CAR-T program, bb21217.

Per an SEC filing by bluebird, it is up for a $70 million milestone payment from Celgene for the first indication, with additional milestones pending for other cancer types. Bluebird will also be eligible for tiered mid-single to low-teen royalties on net sales outside the U.S. The two companies will also have a joint operating committee to manage development and marketing.

John Carroll, with Endpoints News, writes, "The partners are arguably in the lead on BCMA, but everyone else in CAR-T has their eye on this one, which will likely deliver some major league competition. One wild card is China’s Legend Biotech, which recently completed a pact with J&J after wowing ASCO with their data."

Legend and Johnson & Johnson’s Janssen Biotech agreed to develop, manufacture and commercialize a CAR-T candidate, LCAR-B38M, which targets BCMA. It is being reviewed by the China Food and Drug Administration (CDFA) and the companies are planning clinical trials in the U.S. for multiple myeloma.

Under the terms of the deal, Janssen has a worldwide license to jointly develop and commercialize LCAR-B38M in multiple myeloma with Legend scientists. Janssen will record global net trade sales except in Greater China. They have a 50/50 cost-sharing/profit-split deal, except in Greater China, where it’s a 30/70 arrangement. Janssen paid Legend $350 million upfront and additional payments are available based on development, regulatory and sales milestones.

Multiple myeloma is an incurable blood cancer caused when malignant plasma cells grow uncontrollably in the bone marrow. Some patients are asymptomatic, but most are diagnosed with symptoms such as broken bones or bone pain, low red blood counts, fatigue, elevated calcium, kidney problems or infections. About 124,225 people globally were diagnosed with MM in 2015, and 87,084 patients died from the disease in the same year.

Of the deal between Celgene and bluebird, Celgene’s Nadim Ahmed, president of Hematology and Oncology, said in a statement, "We are extremely pleased to advance our collaboration with bluebird on bb2121 and we believe this therapy has the potential to significantly impact the treatment approach and outcomes for patients with multiple myeloma."

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