Tetraphase's lead antibiotic wins special status at the FDA

Tetraphase Pharmaceuticals has snagged a special federal designation for its lead antibiotic in the clinic, putting the biotech in line for some extra incentives--like an extended period of market exclusivity if it goes on to an approval.

Watertown, MA-based Tetraphase is in this year's class of biotech IPOs, though it had to significantly trim its share price to make the leap. This new regulatory coup spotlights the FDA's Qualified Infectious Disease Product designation, which offers a shot at an added 5-year period of marketing exclusivity along with a 6-month priority review and fast-track status.

The designation is part of the Generating Antibiotic Incentives Now provision, which Congress whipped up to encourage developers to target new antibiotics after Big Pharma largely bailed on the field and new approvals almost stopped between 2008 and 2010. Trius ($TSRX), Rib-X and Durata Therapeutics ($DRTX) have all won this special FDA track as well.

For Tetraphase, a 2010 Fierce 15 company, the regulatory advance helps push along eravacycline, which won the feds' QIDP designation for complicated intra-abdominal and complicated urinary tract infections.

"We believe it is the first product candidate to receive this designation in cIAI," said Tetraphase CEO Guy Macdonald. "Antibiotic resistance, particularly among the difficult-to-treat populations with Gram-negative infections, represents a potential global health crisis."

- here's the press release

Special Report: Tetraphase Pharmaceuticals - 2010 Fierce 15

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