Acadia Prescription drugs dedicated some huge cash for rights to Daybue, which within the biotech’s arms grew to become the primary FDA-approved drug for the uncommon neurological dysfunction Rett syndrome. That approval got here with a regulatory quick cross for a future drug, and Acadia is now capitalizing on it with a deal to promote the voucher for $150 million.
The San Diego-based biotech didn’t disclose the client of the precedence evaluation voucher. However when the deal closes, $50 million of the proceeds from that sale will go to Neuren Prescription drugs, the corporate that licensed Daybue to Acadia.
A precedence evaluation voucher shaves the usual 10-month evaluation for a drug down to 6 months. The FDA created this system in 2012 to incentivize drug improvement in uncommon or uncared for ailments. The FDA awards vouchers to firms that win regulatory approval for a drug that treats a uncommon illness. That firm could apply the voucher towards speedier evaluation of a special drug sooner or later, however most voucher holders monetize them by promoting the regulatory quick cross to bigger firms. Voucher consumers hope the funding pays for itself after which some by enabling them to achieve the market sooner with a brand new drug that has blockbuster potential. Nevertheless, the FDA has determined to wind down this system beginning subsequent month, placing vouchers in excessive demand. The $150 million price ticket for Acadia’s voucher is notably greater than the $100 million that has been the standard worth for voucher gross sales.
The prospect of a precedence evaluation voucher was contemplated by Acadia’s licensing deal for Daybue. The peptide, identified in improvement as trofinetide, was initially developed by Australia-based Neuren Prescription drugs. In 2018, Acadia licensed North American rights to the drug candidate, agreeing to pay $10 million up entrance and as much as $455 million in milestone funds, based on Acadia regulatory filings. The phrases of the licensing settlement additionally require Acadia to pay Neuren one third of the worth of the precedence evaluation voucher on the time it’s offered or used.
Final yr, the FDA authorised Daybue for treating Rett syndrome in adults and in kids age 2 and older. With that approval, Acadia was awarded a precedence evaluation voucher. However Acadia has additionally positioned itself to seize extra of the worth of its new product. Months after FDA approval of Daybue, Acadia secured rights to the drug in the remainder of the world by paying Neuren $100 million up entrance. The deal consists of world rights to NNZ-2591, which Neuren was creating for Rett syndrome and Fragile X syndrome.
In its report of third quarter 2024 monetary outcomes posted on Wednesday, Acadia stated Daybue accounted for $251.7 million in gross sales within the first 9 months of this yr, up from $90.1 million in the identical interval in 2023. Acadia forecasts 2024 gross sales of this product can be within the vary of $340 million and $350 million. The corporate’s money place on the finish of the third quarter was about $565 million. The corporate stated proceeds from the voucher sale will assist business operations, R&D applications in central nervous system and uncommon illness, and future enterprise improvement.
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