Hemispherx Biopharma ( HEB - Get Report) has been shut out of the U.S. government's efforts to stockpile vaccine against the H1N1 flu. Four companies were awarded contracts Monday totaling just under $900 million to supply ingredients for a potential H1N1 vaccine. U.S. Health and Human Services Secretary Kathleen Sebelius announced the contracts, which went to Novartis ( NVS, GlaxoSmithKline ( GSK, Sanofi-Aventis ( SNY and AztraZeneca ( AZN. Hemispherx wasn't necessarily in the running for a U.S. flu contract, but the company has sought, in recent weeks, to promote itself to investors as a player in the global effort to develop an effective vaccine against the latest strain of the flu. Hemispherx CEO Bill Carter claims international partners, including vaccine makers in Japan, are interested in using Hemispherx's drug Ampligen as an adjuvant flu vaccine booster. In an interview with a penny-stock promoter published last month, Carter said, in reference to Ampligen: "The highest level of the Japanese government and public medical community is now focused exclusively on our product. They stopped working on all other adjuvants (boosters) and are only working with this one because they've found that it enhances the vaccines by 100 fold." But Hemispherx hasn't announced a single flu contract to date; nor has the company provided any independent corroboration of its claims that partners are actively working today to develop Ampligen as a vaccine adjuvant. What the company has done, instead, is recycle old clinical data for use in new press releases touting Ampligen's use as a flu vaccine booster. Carter's talk of Ampligen and flu vaccines is more likely yet another attempt to divert attention away from the problems the company is having getting Ampligen approved as a treatment for chronic fatigue syndrome (CFS).
The Food and Drug Administration's review of Ampligen for CFS is now seven weeks overdue. Hemispherx has said little about the delay other than that the agency needed a couple more weeks to issue an approval decision due to staffing shortages. That two-week extension came and went more than a month ago. Hemispherx shares were down 2.8% to $2.06 in recent trading.