Hemispherx finalizing fatigue drug filing - Philadelphia Business Journal:

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Dr. William Carter, the Center City biotechnology company'xs chairman and CEO, said he expectsa the application will be completed inearly April. Cartee said he is "cautiously the company will be able to secur an accelerated review from the Food and Drug given the absence of any approvecd treatments for chronicfatigue syndrome. The Centers for Diseasr Control and Prevention estimates the disorder afflicts 1 million people in theUnited States.
Acceleratec reviews are typically conducted insix months, as opposedx to the one-year review for most new drug If the company gets such status for its Ampligenb filing, and the FDA approves the application withouf raising any issues, Hemispherx would be in a positiobn to launch the product by the end of this year or earlyy 2008, Carter said. Carter expressed a sense of vindication that his companyu has reachedthis point. "It's been a long and arduoues journey. ... There were a lot of skeptics," he The skepticism remains evident inthe company's stocmk price. Hemispherx's stock was trading recently at $1.
68 a share, near its 52-week low of According to documents filed earlier this month with the Securitied andExchange Commission, Hemispherx has recorded an accumulatec deficit of about $167 million since its Hemispherx posted a net loss of $19.4 millionn last year, up from a deficig of $12.4 million in 2005. The increasr was due primarily to higher research and developmentf costs associated with Ampligen andAlferon N, whic h the company acquired in 2003, is a treatment for genitalp warts and Hemispherx's only FDA-approved producrt in the market. The company is testing both Ampligen and Alferojn N as potential treatments for viral infections such asavian flu.
Carte r co-invented Ampligen in the early 1970s when he was a researched at JohnsHopkins University. Ampligen is a synthetic, specifically configured double-stranded RNA compound designede to work by stimulatingg and enhancing the ability ofa patient's immune system to fight disease. Initially, the drug was testes as a potential treatmenr for cancer and later for AIDS then for chronidcfatigue syndrome.
Carter even tinkered with the idea of usingf the compound to treat tobacco and createa "healthy" Hemispherx has spent the past 15 years testingy the drug as a treatment for patient with chronic fatigue The company estimates the globakl market for an effective treatment for the disordert to be in excess of $1 billion. "We're not the firsft company to go into thisdisease category," Carter said.
In a presentation with stock analystslast month, the company noted drugs developed by a half-dozeh major pharmaceutical and biotechnology companies -- including , and -- have been considereed as potential treatments for chronic fatigue syndrome, but said none provec to be effective. Jenifer Antonacci, a Cephalon spokeswoman, said the company'sw flagship drug Provigil, approved as a treatment for narcolepsgy andother sleep-related disorders, was tested in patients with chronic fatigue syndrome about two yearsz ago. She said the study was conducteed by researchers from outside ofthe company, with Cephalojn support.
The clinical trial, whicy involved 14 patients, did not produce sufficieny resultsfor Frazer-based Cephalon to consider seekingg approval to expand Provigil's label to include the disorder. Matt Cabrey, a Shire spokesman, said that while companh executives have discussed the potential of testing its products for chronicfatigue syndrome, Shire neve r launched any formal product development program and has no current plands to do so. Based in England, Shire'sx U.S. headquarters are in Wayne. COMPANY: Hemispherx BioPharma Inc. CHAIRMAN AND CEO: Dr. William Carter 2006 NET LOSS: $19.4 milliomn 2006 REVENUE: $933,000 52-WEEK $3.85, $1.65 RECENT PRICE: $1.69 MARKET CAPITALIZATION: $122.
67 million EMPLOYEES: 52 full time, 19 part time BIG Finalizing new drug application for an experimental treatment for chroniccfatigue syndrome. Source: SEC, company, Yahoo! Finance