Gene therapy developer Bluebird bio has sold a voucher that speeds up U.S. drug reviews to Dutch biotechnology company Argenx for $102 million, giving it a much needed cash infusion that will more than double its expected year-end holdings.
The sale, announced by Bluebird Wednesday, comes after the Food and Drug Administration approved two of the company’s rare disease gene therapies, Zynteglo and Skysona, both of which came with so-called priority review vouchers that can be resold to other companies for use on their new drug applications.
The vouchers have recently commanded prices between $100 million and $110 million. For Bluebird, the sale is crucial to its survival. The Massachusetts-based biotech laid off nearly a third of its staff earlier this year and has previously warned investors that it’s at risk of running out of money.
In an earnings update this month, the company said it expects to draw down its cash holdings to around $65 million by year end from the $141 million it held at the end of the third quarter, not counting restricted cash.
“With the sale of our first priority review voucher, we have significantly strengthened our financial outlook,” said Bluebird CEO Andrew Obenshain in a statement Wednesday. The money will allow Bluebird to better support the market launch of its two gene therapies as well as submit an application to the FDA for approval of its sickle cell disease treatment, he said.
Bluebird’s sale of its vouchers has been anticipated, even as its recent approvals have given it two marketed products to sell. Zyntelgo and Skysona, although respectively priced at $2.8 million and $3 million, are not expected to become big sellers because of the small numbers of patients eligible to receive them.
Zynteglo is for severe forms of a rare inherited blood condition called beta thalassemia and Skysona is for an ultra-rare childhood brain disease.
Bluebird’s gene therapy for sickle cell disease, called lovo-cel, could see much wider use if approved. The company said in September it is preparing to file for an approval of the treatment next year.
Bluebird is looking for other ways to shore up its financing, including selling the other voucher, and it expects to provide investors with 2023 guidance early next year.
For its part, Argenx said it expects to use Bluebird’s voucher to speed up the review of its autoimmune drug efgartigimod for one of its current or future indications, CEO Tim Van Hauwermeiren said in a statement. The drug has shown promise for use in four autoimmune diseases.
The FDA approved efgartigimod in 2021 as Vyvgart for the treatment of generalized myasthenia gravis that can cause weakness throughout the body. Argenx reported positive data for a new formulation of the drug in March.