(RTTNews) -  Monday, Human Genome Sciences, Inc. (HGSI: News ) said it has received a Complete Response Letter from the U.S. Food and Drug Administration or FDA relating to the company's Biologics License Application or BLA seeking approval of raxibacumab for treating inhalational anthrax.

The Rockville, Maryland headquartered biopharmaceutical company said the FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA. Human Genome said it submitted the BLA to the FDA for raxibacumab in May 2009.

The company said raxibacumab is a first-in-class treatment for anthrax, and the first procurement under Project BioShield of a product discovered and developed after the September 11, 2001 terrorist attacks. Raxibacumab is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority or BARDA.

In April 2009, the company fulfilled its commitment under this contract to deliver 20 thousands doses of raxibacumab to the Strategic National Stockpile for emergency use. In July 2009, the U.S. Government exercised its option to purchase an additional 45 thousands doses to be delivered over a three-year period, beginning near the end of 2009, the company said.
James Davis, Executive Vice President and General Counsel, HGS, said, "It is unfortunate that it was not possible to resolve these questions before the PDUFA date passed. However, HGS has delivered 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile under our contract with BARDA, so it is currently available in the Stockpile for use in the event of an emergency while we complete our discussions with the FDA."

The company said its primary focus is toward the commercialization of its two lead drugs, BENLYSTA for lupus and ZALBIN for hepatitis C. BENLYSTA has successfully met its primary endpoint in two pivotal Phase 3 trials in systemic lupus erythematosus, and the submission of marketing applications in the U.S., Europe and other regions is planned in the first half of 2010. ZALBIN has completed Phase 3 development, and the submission of global marketing applications is planned in fourth quarter 2009.

HGSI closed Friday's regular trading session at $27.89.

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by RTT Staff Writer

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