Novo strikes $110M deal for regulatory fast pass

Danish drugmaker Novo Nordisk has agreed to pay $110 million to acquire a voucher that speeds up Food and Drug Administration reviews, reaching a deal with Pennsylvania-based Marinus Pharmaceuticals that was disclosed Thursday.

The regulatory fast pass, known as a priority review voucher, can be applied to a new drug application and shortens the time the FDA spends reviewing an experimental treatment to six months from the standard 10 months. The FDA grants priority review vouchers to companies that win approval of drugs for certain rare pediatric or tropical diseases, as well as for medical countermeasures to public health threats. Recipients can then sell the voucher to other companies.

Marinus secured a voucher when it won FDA clearance for its drug Ztalmy in infants with a rare type of genetic epilepsy.

While the prices paid for priority review vouchers have fluctuated since their introduction, sales over the past two years have consistently brought in between $100 million and $110 million. There have been at least eight other deals for priority review vouchers since December 2020, including sales by BioMarin Pharmaceutical, BridgeBio Pharma and Mallinckrodt.

The shortened reviews that the vouchers bring can be particularly valuable for large drugmakers, especially those that may be bringing a new product to a competitive market. Novo has in the past used vouchers to speed reviews of an oral formulation of its diabetes drug semaglutide, as well as for its weight loss medicine Wegovy. The drugmaker has plans this year to seek approval of its experimental hemophilia treatment concizumab as well to broaden the clearances for its approved medicines Rybelsus and Sogroya.

For Marinus, the cash infusion helps extend its operating runway through the fourth quarter of next year. “This non-dilutive funding will allow us to maintain momentum advancing our clinical pipeline … and focus on the commercial launch of Ztalmy,” Chief Financial Officer Steven Pfanstiel said in a July 14 statement.

The stable prices that recent voucher sales have commanded should benefit Bluebird bio, which hopes to win two through approvals of two gene therapies now under review by the FDA. The regulator is expected to make its decisions by mid-August and September, respectively, on the treatments. Bluebird has said it intends to sell any vouchers it receives, as it faces a rapidly dwindling cash balance and has warned of risk to its future solvency.

Biotechnology companies, which in recent years have been able to count on obtaining funds through secondary stock offerings, have had a harder time raising money amid a sharp market downturn for the sector. Recently, there have been some signs of stabilization, as shares in a widely followed biotech fund have risen by 20% over the past month.

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