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FDA CalendarClinical TrialsFDA News and ApprovalsMost PopularLatest NewsUser Submitted ArticlesContribute an Article^DJI $8277.32 -14.81 | ^GSPC $887.00 -1.33 | ^IXIC $1692.01 -3.24 | XLV $25.29 0.03 | IBB $65.48 0.02 | XBI $45.24 -0.26 | BBH $88.74 -0.21 | PPH $57.576 0.006 | PJP $14.27 -0.04 | IXJ $42.02 -0.01 | BDSI $5.5029 -0.0971 | VVUS $4.30 0.06 | CYTX $2.88 0.06 | ECLP $13.61 0.08 | MDRX $12.23 -0.02 | CPSI $33.80 0.36 | CBAI.OB $0.0048 -0.0001 | EXAS $1.64 -0.09 | CRXL $22.20 0.00 | CPD $4.88 -0.12 | DYAX $1.96 -0.02 | KOOL $0.553 0.003 | ATHX $0.89 0.00 | MO $16.64 0.00 | BAC $11.07 -0.34 | GE $13.10 -0.14 | DSCO $1.08 0.04 | ISV $0.00 N/A | HEB $1.29 -0.17 | MNTA $8.52 -0.37 | AMAG $51.98 -0.07 | AMGN $49.30 -0.19 | CYNO $6.72 -0.03 | PFE $14.96 0.13 | GENZ $58.37 -0.29 | GERN $6.79 -0.06 | OSIR $12.02 -0.40 | STEM $1.68 -0.02 | HITK $8.01 0.25 | OSUR $3.13 0.02 | JAV $1.24 0.05 | MEDX $6.65 0.15 | NVS $40.08 -0.17 | TEVA $45.47 1.19 | RAD $1.00 -0.03 | JNJ $54.77 -0.22 | IPXL.OB $0.00 N/A | Which Small Biotech Firms Could Reap Benefits From Government's Flu Vaccine Initiative?
Written by Peter DePalma
Sunday, 24 May 2009 00:00
In news that could affect a number of publicly traded companies that hold U.S. licenses for flu vaccines (list below), Health and Human Services Secretary Kathleen Sebelius announced that the department will take important steps necessary to prepare for potential commercial-scale production of a candidate vaccine for the novel Influenza A (H1N1). The Secretary is directing approximately $1 billion in existing funds that will be used for clinical studies that will take place over the summer and for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.
Inching closer to a swine flu vaccine, the government is beginning to analyze two candidates for the key ingredient to brew one.
"While firms that win a contract from the Department of Health and Human Services (HHS) to make a vaccine or therapy against the new flu strain possibly stand to make it big, other companies, too, are reaping the benefits of having their newer, yet unproven, technologies suddenly thrust into the spotlight," said Rodman & Renshaw analyst Elemer Piros.
"A lot of these companies would like to take advantage of this situation because they want to showcase their technology," he said. "What this really means is a great PR campaign."
The government currently is seeking information about new technologies that may possibly act against the H1N1 flu strain. However, HHS only wants companies that meet the criteria for its technology readiness level 7 or greater, meaning those firms with products in Phase II development and GMP manufacturing process capabilities, Piros noted.
The Centers for Disease Control and Prevention hopes to deliver one or both to vaccine manufacturers by the end of next week so scientists can begin the months-long process of producing shots.
“Preparation and planning are critical to keep Americans safe in the face of a potential pandemic,” Secretary Sebelius said. “Our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus. An important part of this effort has been our work to develop a potential vaccine because vaccines can help prevent and control influenza virus outbreaks. The actions we are taking today will help us be prepared if a vaccine is needed.” Related Video Report:
US Swine Flu Deaths Hit Double-digits
Swine flu has sickened more than 11,000 people in 41 countries and killed 85, according to the World Health Organization. Newly released data shows that a substantial portion of older Americans may have some immunity to the swine-origin H1N1 influenza virus, a finding that may prove useful when and if a vaccine to the new flu strain becomes available.
The funds will be used to place new orders on existing contracts with companies that hold U.S. licenses for flu vaccines. With these orders, they will produce a bulk supply of vaccine antigen and adjuvant. Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus. Depending on the results of clinical studies, adjuvants could be added to a vaccine to improve the immune system’s response and potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.
Having both antigen and adjuvant on hand provides maximum flexibility in a future immunization program, if a program is recommended. For example, if needed these ingredients could be used in vaccine to help protect health providers and other members of the critical workforce, as recommended by the National Strategy for Pandemic Influenza.
According to Thomson BioWorld, one firm that Rodman & Renshaw's Piros said may change the whole spectrum of flu response is Philadelphia-based Hemispherx Biopharma Inc. (AMEX: HEB), whose Phase III chronic fatigue syndrome drug Ampligen now is being investigated in Japan as an adjuvant to flu vaccines.
As reported in BioMedReports this past week, HEB is expecting to hear from the FDA this coming week as to whether Ampligen receives approval as a chronic fatigue syndrome treatment.
With the "boats loads" of safety data available, Ampligen could quickly be developed for H1N1 flu strain, Piros said. He noted that Hemispherx already has been in discussions with the CDC about its product.
"This drug (Ampligen) has been available to certain U.S. clinics for several years," says Adrienne Dellwo, About.com's Guide to Fibromyalgia & CFS. "And there's a lot of evidence (both clinical and experiential) showing that it works. Some doctors claim they've seen improvement in 80% of people with ME/CFS who take Ampligen, and significant improvement in about 50%. They say a lot of seriously disabled people have even been able to go back to work because of it."
Results from a recent NewsScore Report survey of working doctors, appear to agree with Dellwo, particularly when the physicians were asked "If approved, do you feel Ampligen will likely become the standard of care for Chronic Fatigue Syndrome patients?" Most responded that the scenario was likely to occur.
But what about Ampligen's role as "a booster" in fighting the flu?
This week, Japan's Council for Science & Technology Policy (CSTP) awarded funds to advance research with influenza vaccines utilizing the adjuvant, Ampligen(r) (Poly I: Poly C12U). This after the number of swine flu confirmed cases in Japan has soared from four to 200 within days.
If the Japanese data is deemed credible, and CDC experiments show protection against the H1N1 virus by using Ampligen as an adjuvant, "then you don't need another vaccine. You just mix in this adjuvant with whatever you make every season," Rodman & Renshaw's Piros said.
While it is all speculation for now, "it could be the biggest surprise ever," he said.
Interestingly, HEB is a past presenter at Rodman & Renshaw's Healthcare Conference and Rodman & Renshaw, LLC acted as the exclusive placement agent for a big investment transaction