CAMBRIDGE, Mass.—Big changes are in store for bluebird bio, Inc., which has announced that it will be separating its severe genetic disease (SGD) and oncology businesses into independent publicly traded companies. The company will maintain its focus on SGD, while its oncology business will be spun out as a separate entity, which for the time being will be known as Oncology Newco. bluebird’s board of directors approved the plan.
bluebird plans on both companies being headquartered in Cambridge, Mass., with facilities, research, and manufacturing operations in Seattle and Durham, N.C. migrating with the new oncology business. The official name of the new company will be released at a later date, with the separation expected to close in Q4 2021. The transaction is subject to customary closing conditions.
Once the separation is finalized, Nick Leschly, chief bluebird, will lead Oncology Newco as its CEO and will serve as executive chair for bluebird. Andrew Obenshain, president of the SGD business, will maintain his position as bluebird’s CEO, while Daniel Lynch, chair of bluebird’s board of directors, will assume the position of chair of the board for Oncology Newco. A full roster of the executive management teams and boards of directors for both entities will be released at a later date.
“In close collaboration with the Board of Directors, bluebird bio leadership has conducted a thorough assessment of the business overall and examined a range of options for the future,” Lynch said in a press release. “Based on this review, we collectively believe this strategic decision is in the best interest of patients, employees, investors, and other stakeholders. We are committed to working together through this transformative process to ensure each company is optimized with the right teams in place for progressing these therapies through the regulatory process into commercialization, harnessing the power of the pipeline to continue creation of innovative medicines, establishing and rapidly growing product revenue, and creating value for shareholders.”
bluebird noted in a press release about the transaction that it believes the separation will ensure both its SGD business and Oncology Newco can achieve “Enhanced resource allocation and capital considerations for each company; therapeutic expertise and focus to more effectively execute and deliver on milestones; streamlined and simplified operations; tailored investment theses to attract an appropriately suited shareholder base; sustained patients first culture and innovation mindset; [and] increased strategic flexibility.”
With the new dedicated organizations, bluebird’s SGD business will be centered on a variety of goals, including a focus on delivering Core 3 therapies in β-thalassemia, cerebral adrenoleukodystrophy, and sickle cell disease in the United States and Europe, and expanding access to and reimbursement for ZYNTEGLO (betibeglogene autotemcel) in Europe. bluebird also aims to drive growth through geographic and label expansions, and further develop its expertise in gene therapy manufacturing.
As for Oncology Newco, bluebird stated that the spin-out company will work to deliver on its oncology pipeline, particularly in the areas of non-Hodgkin’s lymphoma, acute myeloid leukemia, next-generation multiple myeloma, and solid tumors. Oncology Newco will also aim to capitalize on the investigational B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell therapy, idecabtagene vicleucel (ide-cel), in multiple myeloma, and continue development of bb21217. bluebird is setting an ambitious goal for the spin-out of one to two INDs in both 2021 and 2022.
“We are excited and energized to begin this new year with so much opportunity ahead. Over the last decade, bluebird bio has pioneered development of gene and cell therapies for severe genetic diseases and oncology—delivering transformative outcomes for patients. Through the tenacity and incredible work of our bluebirds, our first commercial product is now approved in Europe, and we are now on the cusp of several potential product approvals with a strong pipeline of earlier oncology research candidates on the horizon. This is a position few biotech companies have been able to attain,” commented Leschly. “After careful strategic review, it is clear to us that the two businesses are best served by independent leadership and teams to drive distinct strategic and operational objectives. Specifically, we believe it is the right time to double down on the respective businesses to fully enable and optimize the continued innovation, development, and deployment of transformative gene and cell therapies for the patients we serve.”