Acadia Pharma Sells FDA Priority Review Voucher for $150M

Acadia Pharmaceuticals, a biotechnology firm based in San Diego, has recently executed a significant financial maneuver by selling a priority review voucher for $150 million. This voucher was awarded following the FDA's approval of Daybue, the first drug sanctioned for the treatment of Rett syndrome, a rare neurological disorder. Daybue's development and subsequent approval have been transformative milestones for Acadia.

The buyer of the priority review voucher has not been disclosed. However, it is known that $50 million of the sale proceeds will be directed to Neuren Pharmaceuticals, the Australian company that originally developed and licensed Daybue to Acadia. The voucher accelerates the review process of a drug from the standard 10 months to just six months. This regulatory provision was introduced by the FDA in 2012 to encourage the development of treatments for rare or neglected diseases. Companies that achieve regulatory approval for such treatments are awarded these vouchers, which they can either use for expedited review of another drug or sell to other companies. Many pharmaceutical firms find it advantageous to purchase these vouchers, as the faster market entry could potentially lead to significant financial returns, especially for drugs with high market potential. The impending conclusion of the FDA’s voucher program, slated for next month, has heightened demand for these vouchers, pushing their price higher. Acadia's $150 million deal notably exceeds the usual $100 million price point for these transactions.

Acadia’s acquisition of North American rights to Daybue, also known as trofinetide, began in 2018 under a licensing agreement with Neuren Pharmaceuticals. The deal included an initial payment of $10 million and potential milestone payments amounting to $455 million. Additionally, the terms stipulated that Neuren would receive a third of the voucher’s value upon its sale or use. The FDA's approval of Daybue last year, for use in adults and children aged two and older, was a pivotal achievement for Acadia, resulting in the award of the priority review voucher.

Following the approval of Daybue, Acadia further solidified its position by securing global rights to the drug, as well as NNZ-2591, another Neuren-developed treatment for Rett syndrome and Fragile X syndrome, through a $100 million upfront payment. This strategic move allowed Acadia to extend its reach beyond North America, potentially boosting its revenue and market presence worldwide.

Financially, Daybue has been a robust contributor to Acadia’s revenue stream. In the first nine months of this year, the drug generated $251.7 million in sales, a significant increase from the $90.1 million recorded during the same period in 2023. For the entirety of 2024, Acadia projects that sales of Daybue will fall between $340 million and $350 million. As of the end of the third quarter, Acadia reported a cash reserve of approximately $565 million. The revenue from the sale of the priority review voucher is expected to bolster Acadia’s commercial operations, research and development initiatives, particularly in the areas of central nervous system and rare diseases, and support future business development efforts.

Acadia’s strategic decisions and financial transactions underscore its commitment to advancing treatments for rare neurological disorders and maximizing the commercial potential of its innovative therapies. The company's efforts in securing, developing, and capitalizing on Daybue highlight its strategic foresight and dedication to addressing unmet medical needs.