Hemispherx Biopharma (HEB) put out a press release.
They announced an invitation, funded entirely by the government of Italy, to present HEB's technology platform for influenza control, at the upcoming 'International Conference on Biotechnologies and Finance' in Rome on July 4-5, 2009. Hemispherx has a broad-based technology platform for confronting the potential of an influenza pandemic, which consists of both preventative (vaccine) components as well as experimental therapeutic interventions. Clinical results from trials conducted in Australia are being evaluated and major vaccine initiatives in Japan are being accelerated in collaboration with the Japanese National Institutes of Health and the Japanese Ministry of Health.
This recognition by the Italian government is obviously great news for the company. The stock surged Tuesday. The surge was apparently industry wide for the swine flu index of stocks. Evidently, those swine flu stocks in the news, such as HEB, got an extra lift. The stock shot up more than $.70 at one point Tuesday from its opening price of $1.74. It has since come down considerably, but is still up $.40+ on the day Tuesday. Considering this is not even the news the market is waiting for, this news (and the reaction to it) is encouraging.
The market is waiting on news about FDA approval of HEB's NDA for ampligen, a treatment for chronic fatigue syndrome. On May 25, 2009 (the original date for an answer), the FDA notified HEB that they would need 1-2 more weeks to finish their evaluation. HEB has been strongly behind their drug publicly. They have been trashed by some people who are not even sure they believe in chronic fatigue syndrome. However, HEB is very insistent. If approved, ampligen would be an orphan drug. This makes it worth even more money to the company.
The acceptance by the Italian government (and the Japanese and Australian governments) of its flu vaccine adjuvant would indicate that HEB is indeed a serious player with leading edge technology. This leads one to believe that the prospects for FDA approval of HEB's ampligen drug are good. Just the positive publicity from the flu acclaim is bound to sway the FDA a little. This story may get better soon. The FDA would not have requested more time, if they were definitely going to reject HEB's NDA. That puts the odds at considerably better than 50% for acceptance.
Hemispherx Biopharma, Inc. is a specialty pharma company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(r) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics, Ampligen(r) and Oragens. Ampligen(r) and Oragens represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 issued patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
I should note the Dr. William Reeves who heads up the Chronic Viral Diseases Branch of the CDC went on record in 2006 as saying they had found a biological basis for Chronic Fatigue Syndrome.
On May 28, 2009,
Reeves was the ring master of what turned out to be an 'Ampligen love-in' at the Health and Human Services event. Not an insignificant fact when you consider that this was the CFSAC's first meeting under the Obama Administration's and that the HHS is at the top of the food chain and rules the FDA, the CDC, The Social Security Administration, National Institute of Health, HRSA, Etc. (M.E. Garza).
In my book, this bodes well for HEB's ampligen NDA.
Disclosure: Author is long HEB
