By Chelsea Stevenson
Human Genome Sciences Inc. (HGSI) said the U.S. Food and Drug
Administration set a Dec. 15 action date for its resubmitted
biologics license application for the anthrax treatment
raxibacumab.
The biotechnology company said the FDA deemed its resubmission a
complete response to the agency's November 2009 request for further
analyses of existing data as well as additional information.
The company said the resubmission included additional
examinations of abnormal or diseased tissue in animal studies,
additional evaluation of the benefits from the combined use of
raxibacumab with antibiotics rather than antibiotics alone, and
more validation of previous data.
Raxibacumab is a human monoclonal antibody which targets anthrax
toxins after they are released by bacteria into blood and tissues.
Unlike antibiotics, raxibacumab doesn't kill the anthrax
bacteria.
Human Genome in April reported its first-quarter loss narrowed
as revenue grew 77% and research and developments costs eased.
In May, the company adopted a shareholder rights plan with a 15%
trigger in the wake of GlaxoSmithKline PLC's (GSK, GSK.LN) $2.6
billion hostile takeover bid as it continued to suggest its
shareholders reject the offer.
Shares closed Monday at $13.67 and were inactive premarket. The
stock has soared 85% since the start of the year.
Write to Chelsea Stevenson at chelsea.stevenson@dowjones.com