In Search of Meaningful GAIN in Renewal of Prescription Drug Act

in half the time to approval compared to the 12-month Standard Review goal most antibiotics are currently afforded.

3. Fast track review. Sponsors of QIDPs would be provided with early and frequent communications with the FDA, in addition to the typical review and communication opportunities, to expedite the review and potential approval process.

4. Updated guidance. The GAIN Act provides for a specific timetable for the FDA to develop and issue draft and final guidance, and provides sponsors with the opportunity to request written recommendations from the Secretary of Health and Human Services on the guidance for antibiotic trials if such guidance is lacking from the FDA.

5. Pathogen-focused drug development. Requires the FDA to issue guidance on pathogen-focused antibacterial drug development.

While all of these provisions are welcome improvements that will facilitate the development of drugs currently in the development pipeline, they are not sufficiently game-changing to encourage large pharmaceutical companies to re-enter antibiotic development—nor will they likely incentivize private or public institutional investors to create new companies or to double down on their current investments in biotech companies developing antibiotics.

Here’s why:

First, the market for hospital-based antibiotics does not scale appropriately to the growth needs of large pharmaceutical companies. The perverse reason for this is that antibiotics cure acute diseases, which limits their sales compared to drugs needed to treat chronic ailment.

For example, growing the nearly $67 billion in revenue that Pfizer reported last year by 5 percent would require an additional $3 billion in new revenues. Peak sales for a hospital antibiotic would likely top out at about $1 billion before patent expiry. Pfizer’s linezolid (Zyvox), approved to

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Author: Jeff Stein

Jeff Stein is the president and CEO of San Diego's Trius Therapeutics. He joined the board of Rx3 Pharmaceuticals, the predecessor of Trius, in 2005 while serving as a Kauffman Fellow with Sofinnova Ventures. He became CEO in 2007 when the company was revamped and reincorporated as Trius. He also served as a Sofinnova venture partner from 2007 until 2010, and as director of venture development at UC San Diego from 2005 to 2006. He was previously executive vice president, chief scientific officer, and a board member of Quorex Pharmaceuticals, an anti-infectives company he founded in Carlsbad, CA, in 1999 that was acquired by Pfizer in 2005. Before that, Stein worked as the principal scientist at Diversa and at the private Agouron Institute. He was a distinguished postdoctoral fellow at the California Institute of Technology, and holds a doctorate in biochemistry and microbiology from UC San Diego.