Date: July 22, 2009
Author: John George
Hemispherx says FDA decision on Ampligen months away
Hemispherx BioPharma said Wednesday it does not expect a decision
on its new drug application for Ampligen - the company?s
experimental drug for patients with chronic fatigue syndrome
- from the Food and Drug Administration until the fall.
The Philadelphia biotechnology company had originally expected a
decision, under FDA guidelines, in late May.
The agency at that time informed Hemispherx it would need another
few weeks to make a ruling. The delay has now stretched into months.
Dr. William Carter, the president and CEO of Hemispherx, said
staffing problems at the FDA this year have resulted in the agency
missing deadlines for making final decisions on about 65 percent of
the new drug applications it has under review.
Carter, during a call with stock analysts Wednesday, said Hemispherx
has been in contact with the FDA since May and has been ''regularly
providing reports to different reviewers.' He said he doesn?t believe
Hemispherx will have to supply any additional documentation to the
agency before its renders its decision.
The company is continuing to talk with potential marketing partners
for Ampligen while the FDA review is ongoing.
Carter said the company expects to spend 'tens of millions of dollars'
on research initiatives studying the ability of Ampligen to boost the
effectiveness of influenza vaccines. Hemispherx has such studies
planned or under way in the United States, South America, Australia
and in the Pacific Rim.
(c) 2009 Philadelphia Business Journal