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Hemispherx Biopharma to meet with FDA regarding Ampligen decision


Hemispherx BioPharma (NYSE MKT:HEB) has said it plans to request a meeting with the FDA regarding the regulatory agency's decision to to reject approval for its Ampligen drug for chronic fatigue syndrome (CFS), while also announcing its 2012 financial results.

The company, which ended the year with cash of around $43.95 million, said that its net loss increased year-over-year mainly due to its continued efforts to seek FDA approval of its Ampligen drug for chronic fatigue syndrome (CFS) and preparations for FDA inspections of its expanded New Brunswick, New Jersey manufacturing facility. 

The biopharma business is working on the FDA approval for its Amligen drug for CFS, after the regulatory agency declined approval last month. In the complete response letter, the FDA said the company should conduct at least one additional clinical trial and complete various non-clinical studies, as well as perform a number of data analyses. 

Hemispherx said in its statement on Monday that it plans to request an end-of-review conference with the FDA to discuss the agency's decision regarding this potential treatment. 

The drug, which is a 30-minute infusion into the bloodstream, works by stimulating the immune system through a receptor called TLR-3. 

According to the Center for Disease Control, there are around 4 million people affected by CFS in the US, costing the nation around $9.1 billion per year.  The illness, which has an unknown etiology thought in part to be related to immune dysfunction, causes profound fatigue and other debilitating symptoms, with much of the impacted population bedridden. 

In March last year, a peer reviewed analysis of data from the a trial of Ampligen was published showing that the proportions of Ampligen patients with exercise improvements of at least 25% and at least 50% respectively, were 1.7 and 1.9-fold greater than those patients on placebo, Hemispherx has said. 

Clinical trials of the drug have already been conducted by the company for the potential treatment of CFS, Hepatitis B, HIV and cancer patients. 

As well as getting this drug approved for CFS, Hemispherx has also been working to enhance its manufacturing facility in New Jersey, which is in the final stage, with construction complete. Around $7 million was spent on the project through to the end of last year, financed with a margin loan, the company said. 

The facility is designed to produce Ampligen, as well as its other drug Alferon. 

Earlier this month, the company said that ANMAT, the agency responsible for the regulation of drugs, foods and medical technology in Argentina, has approved the use of its Alferon N injection in the country for any patient that fails or becomes intolerant to treatment with "recombinant interferon" - expanding the indication for the drug widely. 

Alferon N Injection is an FDA-approved natural interferon and, as Naturaferon, was already previously approved in Argentina for the treatment of refractory or recurring external genital warts - one of the main culprits of cervical cancer.  

The timelines for when the drug -- which can now also be used for multiple sclerosis, certain cancers and hepatitis C -- can be shipped to Argentina, and when resulting revenues will occur cannot be determined at this time, the company has said. 

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