Hemispherx says plant upgrade will allow it to return its genital wart treatment to market

Hemispherx Biopharma has had a somewhat rocky relationship with both the FDA and the Street. But with a manufacturing upgrade complete and a distribution agreement in hand, it expects to return to the market its only approved product after a 7-year hiatus. The Philadelphia-based Hemispherx quit making and distributing Alferon N, a treatment for genital warts, in 2008 because its manual production process was too expensive. But now it says that an $8 million upgrade and 600 liter bioreactor at its plant in Brunswick, NJ, will allow it to produce the drug at much less expensive cost. Hemispherx has a couple of other products in development including the chronic fatigue syndrome drug Ampligen, approval of which the FDA has twice rejected and sent back for more study. The company has been criticized by some analysts in the past for the way it has characterized its relationship with the FDA. Release | More

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