Acadia Pharma Sells $150 Million in Faster FDA Drug Review Voucher

Acadia Pharmaceuticals invested heavily in the 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 fast-track regulatory access for a future drug, and Acadia is now capitalizing on that with a deal to sell the voucher for $150 million.

The San Diego-based biotech company did not disclose the buyer of the Priority Review voucher. But when the deal closes, $50 million of the sale proceeds will go to Neuren Pharmaceuticals, the company that licensed Daybue to Acadia.

With a priority review voucher, the standard 10-month review of a drug is reduced to six months. The FDA created the program in 2012 to incentivize drug development for rare or neglected diseases. The FDA awards vouchers to companies that receive regulatory approval for a drug to treat a rare disease. That company may use the voucher for faster review of another drug in the future, but most voucher holders make money by selling the regulatory Fast Pass to larger companies. Voucher buyers hope that the investment will be recouped by getting a new drug with blockbuster potential to market more quickly. However, the FDA has decided to discontinue the program starting next month, creating high demand for vouchers. The $150 million price tag for Acadia's voucher is significantly higher than the typical $100 million price tag for voucher sales.

The prospect of a priority review voucher was considered as part of Acadia's licensing agreement for Daybue. The peptide, known in development as trofinetide, was originally developed by Australia-based Neuren Pharmaceuticals. In 2018, Acadia licensed the North American rights to the drug candidate and agreed to pay $10 million upfront and up to $455 million in milestone payments, according to Acadia's regulatory filings. The terms of the License Agreement also require Acadia to pay Neuren one-third of the value of the Priority Review Voucher at the time of sale or use.

Last year, the FDA approved Daybue to treat Rett syndrome in adults and children ages 2 and older. With this approval, Acadia received a priority review voucher. But Acadia has also positioned itself to capture even more value from its new product. Months after Daybue's FDA approval, Acadia secured rights to the drug in the rest of the world by paying Neuren $100 million upfront. The deal includes global rights to NNZ-2591, which Neuren developed for the treatment of Rett syndrome and Fragile X syndrome.

In its third-quarter 2024 financial results report released Wednesday, Acadia said Daybue had revenue of $251.7 million in the first nine months of this year, up from $90.1 million in the same period of the year 2023. Acadia predicts that sales of this product will increase in 2024 to be in the range of $340 million to $350 million. The company's cash balance at the end of the third quarter was approximately $565 million. The company said proceeds from the voucher sales will support commercial operations, central nervous system and rare disease research and development programs, and future business development.

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