Lilly snaps up regulatory 'fast pass' for bargain price
- Siga Technologies has sold a priority review voucher to Eli Lilly for a lump sum of $80 million, a price far lower than the hundreds of millions the regulatory "fast passes" commanded a few years ago.
- Siga picked up the voucher as an incentive from the Food and Drug Administration for securing approval of TPOXX, an oral smallpox treatment, through its medical countermeasures voucher program.
- The vouchers, or PRVs, are allocated to companies that have gained product approval for certain rare tropical or pediatric diseases, emerging infectious diseases, or for treatments aimed at counteracting chemical, biological, radiological, and nuclear threats.
Priority review vouchers used to be highly sought: Back in 2015, for example, AbbVie paid United Therapeutics $350 million for one.
While they still are valuable commodities, the price has fallen dramatically as supply has increased, with $80 million the apparent going rate if this and a recent deal between Ultragenyx and Kyowa Hakko Kirin deal are anything to go by.
Lilly hasn't stated how it will use the PRV, which can shorten review times for New Drug Applications from 10 to six months. The money will be a boost for Siga Technologies, which currently has a market cap of about $380 million, and a focus on products aimed at emerging pathogens and biodefense threats. TPOXX is its only approved product, and it has further smallpox antiviral candidates in its pipeline.
"Transactions like this [are] an important incentive for the continued development of products like TPOXX and will help us continue to drive value for our partners in Health Security as well as our own business," said Phil Gomez, CEO of SIGA.
- BioPharma Dive DIA18: How much are PRVs even worth?
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