Hemispherx Defers Executive Bonuses Until Manufacturing Goals are Met

Hemispherx Biopharma Defers Executive Bonuses Until Manufacturing Goals are Met
September 1, 2015
By Alex Keown, BioSpace.com Breaking News Staff

NEW BRUNSWICK, N.J. – In order to complete manufacturing goals at its newly renovated facility, which includes resuming production of its Alferon N Injection, Hemispherx Biopharma will defer all executive bonus programs, including contract bonuses, the company announced this morning.

Tom Equels, president of Hemispherx and a major stockholder in the company, said by deferring all bonuses until a biomarker for Ampligen, the company’s treatment for Chronic Fatigue Syndrome (CFS), is achieved “we are putting our money where our mouth is.”

The only goals the company disclosed in its announcement was securing regulatory approval for resuming production of Alferon and Ampligen. The company did not specify steps to achieving those goals, or how much funding would be needed to complete them.

Hemispherx invested $8 million into its New Jersey facility to resume production of Alferon and Ampligen. The company said additional funding will be required to complete the construction project as well as take the drugs through the regulatory hurdles. That extra funding will come, in part, by deferring those bonuses. The largest bonuses are expected to be paid out to Equels and William Carter, Hemispherx chief executive officer, both of whom were slated to receive bonuses of up to 25 percent of their base salary, the Philadelphia Business Journal reported. In 2014 Carter earned total pay of just under $2.4 million, while Equels earned just under $1.7 million, the Journal said.

The new facility and equipment upgrades should lead to an innovative and efficient process for producing Alferon N Injection, currently the only available FDA -approved natural alpha interferon, Hemispherx said. Alferon was originally produced, at the time of FDA approval, in six-liter volume flasks, equivalent to twelve vials at a time, using a manual process that was extremely labor intensive.

The new facility in New Jersey is expected to lower production costs, produce greater production yields, allow real-time monitoring, create flexibility for tailored batch sizes, and improve operational safety, the company said.

“Based upon more than ten successful test batches using the new system, we know the new 600 liter bioreactor can produce 1,200 vials at a time, creating a larger amount of product with heightened efficiency, production run reliability and safety,” Equels said.

For its Ampligen process, the company said it is developing data on the relationship between natural killer (NK) cells and severe CFS.

“We are also in the process of evaluating the relationship between responders to our experimental therapeutic, Ampligen, and NK cell levels in severe CFS victims,” Equels said in a statement. “We believe that this further evaluation of the potential use of NK as a biomarker for severe CFS victims is an important component in moving Ampligen, an experimental therapeutic, along the path to approval in the United States and in other countries.”

Equels added the company’s business relationships with Emerge and myTomorrows provide an early access platform for Ampligen in Europe and Australia.

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