As bluebird bio takes flight with its high-priced gene therapies, the company is enhancing its manufacturing capabilities through a strategic partnership with Swiss Contract Development and Manufacturing Organization (CDMO) Lonza.
Recently, Bluebird and Lonza revisited their production agreement, marking the second amendment to the deal since its initial announcement in the summer of 2016. The updated contract entails Lonza’s commitment to expanding manufacturing capacity to accommodate Bluebird’s therapies, Zynteglo and Skysona, as disclosed in a Securities and Exchange Commission filing published on Wednesday.
Moreover, the partnership has seen revisions to fee scheduling, including adjustments to the payment structure, all aimed at better aligning with Bluebird’s business objectives. While the precise financial terms of this amended agreement have not been publicly disclosed, it underscores the collaborative effort to bolster production capabilities for these critical gene therapies.
The original agreement, unveiled in June 2016, outlined Lonza’s responsibility for manufacturing Zynteglo and Skysona at its facility in Houston. After discontinuing its European operations in 2021, Bluebird Bio secured successive approvals for Zynteglo and Skysona in the United States in 2022.
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Firstly, in August 2022, the FDA granted approval for Zynteglo as a one-time treatment for beta thalassemia, introducing it with a price point of $2.8 million per patient. Shortly thereafter, Bluebird set a new pricing record with Skysona, securing FDA backing for the treatment of the rare neurological disorder cerebral adrenoleukodystrophy. Skysona was priced at $3 million per patient.
These gene therapy launches are pivotal for Bluebird Bio, particularly in the context of its recent cost-cutting measures, including a 30% reduction in workforce in the previous year and a stock sale in January to extend its cash runway. The company now anticipates financial sustainability at least until the end of 2024, with hopes that revenue generated from these drug launches can offset operational expenses.
Concurrently, Bluebird Bio is actively pursuing approval for its gene therapy for sickle cell disease, lovo-cel, which is expected to represent a significant near-term commercial opportunity for the company. The FDA is expected to make a decision on lovo-cel by December 20, marking another crucial milestone for Bluebird’s expanding portfolio of gene therapies.
