Acadia Pharmaceuticals committed a lot of money for rights to Daybue, which in the biotech’s hands became the first FDA-approved drug for the rare neurological disorder Rett syndrome. That approval came with a regulatory fast pass for a future drug, and Acadia is now capitalizing on it with a deal to sell the voucher for $150 million.
The San Diego-based biotech did not disclose the buyer of the priority review voucher. But when the deal closes, $50 million of the proceeds from that sale will go to Neuren Pharmaceuticals, the company that licensed Daybue to Acadia.
A priority review voucher shaves the standard 10-month review for a drug down to six months. The FDA created the program in 2012 to incentivize drug development in rare or neglected diseases. The FDA awards vouchers to companies that win regulatory approval for a drug that treats a rare disease. That company may apply the voucher toward speedier review of a different drug in the future, but most voucher holders monetize them by selling the regulatory fast pass to larger companies. Voucher buyers hope the investment pays for itself and then some by enabling them to reach the market sooner with a new drug that has blockbuster potential. However, the FDA has decided to wind down the program starting next month, putting vouchers in high demand. The $150 million price tag for Acadia’s voucher is notably higher than the $100 million that has been the typical price for voucher sales.
The prospect of a priority review voucher was contemplated by Acadia’s licensing deal for Daybue. The peptide, known in development as trofinetide, was initially developed by Australia-based Neuren Pharmaceuticals. In 2018, Acadia licensed North American rights to the drug candidate, agreeing to pay $10 million up front and up to $455 million in milestone payments, according to Acadia regulatory filings. The terms of the licensing agreement also require Acadia to pay Neuren one third of the value of the priority review voucher at the time it is sold or used.
Last year, the FDA approved Daybue for treating Rett syndrome in adults and in children age 2 and older. With that approval, Acadia was awarded a priority review voucher. But Acadia has also positioned itself to capture more of the value of its new product. Months after FDA approval of Daybue, Acadia secured rights to the drug in the rest of the world by paying Neuren $100 million up front. The deal includes global rights to NNZ-2591, which Neuren was developing for Rett syndrome and Fragile X syndrome.
In its report of third quarter 2024 financial results posted on Wednesday, Acadia said Daybue accounted for $251.7 million in sales in the first nine months of this year, up from $90.1 million in the same period in 2023. Acadia forecasts 2024 sales of this product will be in the range of $340 million to $350 million. The company’s cash position at the end of the third quarter was about $565 million. The company said proceeds from the voucher sale will support commercial operations, R&D programs in central nervous system and rare disease, and future business development.
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