Date: 2014-05-14
Type of information: Establishment of a new subsidiary in the EU
Compound: Alferon N Injection®
Company: Hemispherx Biopharma (USA - PA) Swiss Department of Defense, Civil Protection and Sports (Switzerland)
Therapeutic area: Infectious diseases
Type agreement:
Action mechanism:
Disease: infection by wild type and Tamiflu® (oseltamivir)-resistant H7N9 influenza virus
Details: * On May 14, 2014, Hemispherx Biopharma announced that it has entered into a formal collaborative research agreement to test Alferon N Injection®, the only multi-species, natural alpha interferon commercially approved in the U.S. It will now be evaluated against wild type and Tamiflu® (oseltamivir)-resistant H7N9 influenza virus under the DEA (Data Exchange Agreement) Annex for Medical Preparedness and Bio-Defense Agreement between the Swiss Surgeon General and the US Department of Defense. The increasing prevalence of Tamiflu®-resistant Influenza A Virus, particularly against H7N9, has been widely reported and is due in large part to the fact that just a single-step mutation in this genetically unstable virus can make it resistant to Tamiflu®. This collaboration is intended to extend the results announced at the 53rd annual meeting of Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado September 13-15, 2013. These experiments were conducted by Professor Juergen Richt, DVM, Ph.D., Director of the U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD) and demonstrated that Alferon® N is a potent inhibitor of both wild-type influenza virus H7N9 as well as Tamiflu®-resistant influenza strains. According to a new study by the non-profit Cochrane Collaboration, global network of health care academics, Tamiflu® is not proven to reduce flu complications, like pneumonia and hospital stays, raising questions about Tamiflu® use against pandemics. As published in the British Medical Journal (BMJ 2014;348:g2545/Ibid g2547), examination of earlier clinical studies found prophylactic reduction in symptoms of only 55% and no indication that Tamiflu® is effective in reducing complications, key components in reducing the morbidity and rate of pandemic spread of influenza. The studies also question the risk/benefit ratio provided by Tamiflu. The Cochrane reviewers examined all 107 existing clinical reports on Tamiflu® and another less widely used flu drug (Relenza® (zanamivir)). Evidence from the trials reviewed showed Tamiflu® and Relenza® alleviated flu-like symptoms in adults about half a day faster than in those taking a placebo. The Cochrane reviewers and the BMJ have also called on governments and health policy decision makers throughout the world to review their guidance on the use of Tamiflu® in light of the recent findings.
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