KU-created sedative expected to reach FDA in 2006

A sedative created at Kansas University, spun-off into a commercial operation and recently sold to a national pharmaceutical company, is poised to seek federal approval next year.

Aquavan, the sedative injection born through KU’s Higuchi Biosciences Center and developed by Lawrence-based ProQuest Pharmaceuticals, remains in late-stage clinical trials, said Dean Mitchell, president and CEO of Guilford Pharmaceuticals Inc., the company that bought ProQuest in December for $7 million in stock.

Pending successful results in the trials later this year, he said, the drug’s next step would be review from the U.S. Food and Drug Administration.

“We expect to submit a new drug application in the first half of 2006, seeking approval for Aquavan for procedural sedation,” Mitchell said this week, as the company reported financial results.

Aquavan’s current trials involve its use in colonoscopies and other brief diagnostic and therapeutic procedures.

Guilford looks to thrive in a growing market for such products, Mitchell has said. More than 50 million such procedures are conducted annually, and the number rises each year as baby boomers age and technology permits more procedures to be completed on an outpatient basis.

KU’s Center for Research holds a stake in Guilford stock, having owned 10 percent of ProQuest when it was sold to the Baltimore-based company.

Guilford reported financial results Wednesday for its fiscal year ended Dec. 31. The company last year posted a net loss of $87.9 million, or $2.25 per share, compared to a net loss of $53.9 million, or $1.82, a year earlier.

Total revenues increased to $47.9 million last year, up from $27.6 million a year earlier. The company spent $46.6 million on research and development last year, up from $33.6 million a year earlier.

Guilford shares closed Wednesday at $4.41, down 12 cents, on the Nasdaq.