Written by Nick Paul Taylor
Bluebird bio is planning to spin off its oncology assets into a new publicly traded company. The move follows a series of operational missteps that have delayed patient access to once-hyped therapies.
Today, bluebird’s pipeline features treatments for severe genetic diseases such as beta thalassemia and sickle cell disease alongside oncology prospects led by Bristol Myers Squibb-partnered BCMA CAR T-cell therapy bb2121. Both sides of the pipeline have suffered big setbacks, with manufacturing issues delaying U.S. filings for approval of genetic disease drugs and the FDA hitting the CAR-T with a refuse to file letter.
In the future, separate companies will be responsible for the genetic disease drugs and cancer cell therapies. Bluebird CEO Nick Leschly said the two sides of the pipeline have distinct objectives and will benefit from independent leadership. Leschly fleshed out the thinking in an interview with The Wall Street Journal.
“We built this powerful product engine, and the question is: ‘What is the best way to think about the next five to 10 years?’” Leschly said. “You don’t build an oncology company by hiring people who are experts in severe genetic disease, nor do you do vice versa.”
As Leschly sees it, the overlap between the technology used to develop the cancer and rare disease drugs made the one-company model the right choice in the early years of bluebird. However, Leschly sees significant differences between clinical research, manufacturing and regulatory interactions in the cancer and rare disease spaces, driving bluebird to separate the businesses now it is focused on those later-stage activities.
Bluebird will emerge from the split with a pipeline of rare disease therapies and a management team led by Andrew Obenshain, the current president of the severe genetic disease unit. Leschly will lead the as-yet-unnamed oncology company and become executive chair of bluebird. Both companies will have assets that could be on or near the market by the time the split is completed late this year.
The timing means bluebird will need to work through the separation process while ensuring the lead programs on both sides of the pipeline don’t suffer further delays. The FDA is set to decide whether to approve bb2121 by the end of March, and rare disease filings are scheduled for 2021 and 2022.
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