Breaking News

Hemispherx, GP Pharm to Establish Mfg. Ops in Argentina

May 21, 2014

To supply Ampligen and Alferon N to Latin American market

Hemispherx Biopharma, Inc. has entered a preliminary agreement with GP Pharm for the manufacture of Ampligen in Argentina to serve Latin American markets upon approval. The agreement is a prerequisite to the company starting the manufacture of stability lots and stability testing necessary for approval to manufacture Ampligen, contingent upon ANMAT approval in Mexico.
 
In June 2010, the companies entered into a sales, marketing, distribution and supply agreement for Ampligen in certain Latin American countries, which was extended in December 2010 to include Mexico, where the drug was filed for approval in August 2012 to treat Chronic Fatigue Syndrome.
 
The compnaies are also discussing establishing manufacturing capacity for Hemispherx's natural interferon, Alferon N, the only FDA approved natural interferon for the treatment of refractory HPV genital warts. The drug has also been approved in Mexico for this indication.
 
Jorge Braver, chief executive officer of GP Pharm, said, "This agreement is important for an Argentinian pharmaceutical company because it establishes the potential to manufacture products which originate outside Argentina. This agreement has the potential to create jobs in Argentina and import technology and expertise in the pharmaceutical and biopharmaceutical fields and will expand our presence, over time, in new South American markets pending approval."
 
Thomas Equels, executive vice chairman of Hemispherx, said, "We see this as a logical expansion of our relationship with GP Pharm in Latin America, which also provides Hemispherx with backup manufacturing as well as a means for making and supplying products to Latin America. This is an excellent synergy of the assets of both companies."

blog comments powered by Disqus
  • 16th Annual $alary $urvey

    16th Annual $alary $urvey

    Tim Wright, Editor||June 3, 2015
    Welcome to Contract Pharma’s Sixteenth Annual Salary Survey! This year’s results are derived from more than 500 respondents f

  • Newsmakers: PCI

    Newsmakers: PCI

    Tim Wright, Editor||June 2, 2015
    PCI execs talk about the recent opening of the company’s new North American clinical facility, as well as other trends in the market

  • How Sterilization of Primary Packaging Influences the Results of E&L Studies

    How Sterilization of Primary Packaging Influences the Results of E&L Studies

    Thorsten Sogding, Daniel Canton, Daniel Haines, Uwe Rothhaar, SCHOTT Pharma Services ||June 2, 2015
    As the demands that are being placed on the quality and stability of medications continue to increase, the interactions that take place between the primary packaging container and filled drug product are becoming increasingly important