BRIEF: Northfield asks FDA for quick PolyHeme review

Thu. October 30, 2008; Posted: 07:07 AM

Oct 30, 2008 (Chicago Tribune - McClatchy-Tribune Information Services via COMTEX) -- NFLD | Quote | Chart | News | PowerRating -- In a race against the clock to get U.S. approval of its only product, Northfield Laboratories Inc. on Wednesday submitted an application to the Food and Drug Administration for a speedy review of its experimental blood substitute, despite last year's disappointing clinical results.

An expedited review of PolyHeme is critical for the Evanston-based biotech company, which has been developing the blood substitute for more than two decades. Northfield has about $15 million in cash, enough to fund operations through May, the company has said.

Since its inception in 1985, Northfield has incurred losses of $220 million.

A "priority" evaluation for PolyHeme would net a review by the FDA within six months. Reviews usually take 10 months after applications are submitted.

The agency has two months to decide whether Northfield will be given a priority review.

Northfield last year reported clinical results that revealed more trauma patients died within 30 days of receiving PolyHeme than those who received standard care. After that report in May 2007, shares of Northfield plummeted to a new 52-week low. On Wednesday, Northfield shares jumped 39.5 percent, or 17 cents, to 60 cents.

bjapsen@tribune.com

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