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Good to hear she's able to get what she needs.
Indeed, timing is everything!
GLTA
Long HEB
I like the point Dr. Carter brought up about how the Japanese government is using only one adjuvant: Ampligen.
N95 masks In Stock and available today:
http://www.masksnmore.com/ge17pare.html
I ordered months ago and they provided quick shipping and support.
A good view about being prepared if Ampligen is approved.
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Article posted:
http://smallcaps.us/blog/?p=336
Hemispherx Biopharma (HEB – $2.03) announced on Wednesday it cancelled its adjourned stockholders’ meeting. The reason was very simple, the Company obtained insufficient votes to pass proposal no. 3. With this proposal being the sole purpose of the adjourned stockholders’ meeting, there was no need to hold the meeting. In proposal 3, shareholders were asked if HEB could increase the number of authorized shares of common stock from 200,000,000 to 350,000,000.
We don’t think this is a big issue, as the Company indicated they didn’t plan to use the shares on a short term basis anyway, which is good, as they have sufficient money in the bank (over $40 million on June 30, 2009).
We also feel management shouldn’t concentrate on increasing the number of authorized shares. They should use all their time and resources on preparing the launch of Ampligen if it’s approved for the treatment of CFS. It doesn’t matter we haven’t heard from the FDA yet, Hemispherx has to be prepared. If the FDA approves Ampligen tomorrow, the Company immediately has to be ready to take the next step.
Some of the most important steps are:
Have all agreements been signed with insurance carriers?
Is the production facility ready to start producing Ampligen in large quantities?
Have the necessary agreements been signed to start distributing Ampligen on a large scale to needing patients?
So far we haven’t heard anything concrete about those items from the Company. These items should be top priority for management at this moment. The time is now and the money is available, so no more delays. And, by the way, if HEB performs well over the next 12 to 24 months, shareholders will be more than happy to increase the number of authorized shares at that moment.
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IMHO, the jobs posted/filled and preparation of the New Brunswick facility for FDA approval shows HEB is on track.
It would be nice to know about the other agreements mentioned.
GLTA
HEB Long
Dianne Will's response to Revere's PDUFA date:
I don’t know where Revere Research got the 8/25 date. You will have to ask them.
The PDUFA date that the company had was 5/25.
I will forward to Rodman & Renshaw for further clarification; they get Revere's report. I will post updates here.
Vol @250,000 for 10 mins is good.
I think you're right about a bullish day.
GLTA
I thought she did the same thing the last CC.
Both happened to be Holiday weekends.
Dianne Will's automated response:
I am out of the office the week of August 31, returning on Tuesday September 8th, after the Labor Day holiday.
There is one other possibility, Revere misread the 3 month extension and added it to the May date instead of the Feb. date.
Good question. Maybe the FDA needs 1-2 weeks from this PDUFA date?
Best if Hemispherx chimes in. I was looking for new news on the Investor Relations webpage but nothing yet.
I sent an email to Diane asking her if she could shed some light on the PDUFA date listed with Revere Research.
I will post her response.
GLTA
HEB Long
I take it to mean the PDUFA submission date is one of the three classifications.
In this case, it lists Confirmed: Yes
So, the date that Revere has is a new confirmed PDUFA date?
Check out Revere's website:
http://www.reveredata.com/about/info/company.html
This is the first I've heard of them.
I finally got it to upload a snapshot from Revere Research:
Hannah Sloane (IR for Rodman & Renshaw) responded with a phone call today and then this follow up email about the PDUFA date:
Rodman gets the information on upcoming PDUFA dates every week from a service called Revere Research. We double checked, and indeed the Revere website lists 8/25/09 as the PDUFA date.
When I get the screenshot she attached to open, I will post.
Apparently Revere knows something?
GLTA
Hannah asked which report in order to clarify. I have sent the hyperlink and a pdf copy of the 66 page balance sheet.
Probably won't hear anything until next week.
Have a good weekend.
GLTA
I have sent an email to Hannah Sloane, investor relations from Rodman & Renshaw, requesting help to confirm the PDUFA date. When I get an answer I will post it here.
GLTA
HEB Long
Thanks for the link, good reading but hope they don't limit the adjuvant testing to only 3. The need would be best served if all possible adjuvants are tested.
GLTA
HEB long
CDC Joint Briefing with NIH & FDA on 2009 H1N1 Influenza
August 21, 2009, 12:00 p.m.
This telephone conference call was an update on the H1N1 flu and included adjuvant testing.
No company names were given about whose adjuvants but it appears that no stone is being left unturned as they prepare for worst case scenario.
The meeting was handled by Glen Nowak who introduced the following 3 people:
Mr. Jay Butler, Director of CDC's H1N1 Vaccine Task Force,
Dr. Jesse Goodman, Acting Chief Scientist and Deputy Commissioner at the Food and Drug Administration,
Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases at the National Institutes for Health
Full Transcript: http://www.cdc.gov/media/transcripts/2009/t090821.htm
Of the six people asking questions, one of particular interest to HEB was asked by Helen Branswell of the Canadian press:
...And my second question relates to adjuvants. Given the yield problem and the fact that vaccine is going to becoming in slower than the U.S. had first anticipated, is the U.S. looking more strongly at the use of adjuvants?
Answered by Dr. Anthony Fauci: ...we are planning trials using adjuvants in what we call a mix and match, where we take the antigen from one company, Sinofia CFL and use the adjuvant from another company. Those studies are scheduled to start somewhere in mid to late September. The overall total number of individuals and trials will be approximately 4,500 to 4,600 individuals.
GLTA
HEB long
Thank you and it's possible to win an extension.
GLTA
20 years for utility and plant patents since June 8, 1995
Patents now have a 20 year life. I believe it changed in 1995.
Newsletter about HEB trading today
http://www.transworldnews.com/NewsStory.aspx?id=110189&cat=1
Business News
Hemispherx BioPharma, Inc (AMEX:HEB) – Today’s Mid - Day Top Percentage Mover
Taseko Mines Limited (USA) (AMEX:TGB) and Eldorado Gold Corporation (USA) (AMEX:EGO) – Among Today’s Mid - Day Top Percentage Movers
Dallas, TX 8/13/2009 04:56 PM GMT (TransWorldNews)
Dallas, TX - superhotpennystocks.com is a penny stock newsletter that is pleased to alert investors of top stocks on the move.
Hemispherx BioPharma, Inc (AMEX:HEB) is among the top most traded stock on 5.72 million shares being tradd. It currently trades at 2.05, up about 6.77%. Hemispherx Biopharma, Inc. (Hemispherx) is a biopharmaceutical company engaged in the clinical development, manufacture, marketing and distribution of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders.
_____
It's nice to us in the news, even though we are still waiting.
HEB Long
GLTA
WSJ reported "Drug Chief at the FDA Is Accused Of Conflict"
By ALICIA MUNDY AUGUST 12, 2009
WASHINGTON -- The inspector general of the Department of Health and Human Services is investigating a conflict-of-interest allegation involving the official in charge of drug approvals at the Food and Drug Administration, the FDA said.
The investigation of Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.
http://online.wsj.com/article/SB125003545637224263.html
In the varied comments - two stood out concerning Ampligen:
Vince Capp wrote:
On the same subject...My question is ..”Why is the FDA and the Obama Administration failing to recognize safe products such as Ampligen as an adjuvant? Extensive research has been completed, from both an efficacy and pure biological perspective of products such as Ampligen. According to the Department of Pathology, National Institute of Infectious Diseases in Japan, their studies have concluded that the mucosal adjuvant, poly I:poly C12U Ampligen, a Toll-like receptor 3 agonist was proven to be safe in a Phase III human trial. As an effective adjuvant for H5N1 influenza vaccination these studies showed that it produced cross-protection against variant influenza viruses not seen with the vaccines given alone and also considered “most promising”. For years, the United States regulatory entities including the HHS, FDA and CDC have known about this product and watched Asian and European countries make significant progress using it as a toll like receptor for treatment and research of debilitating diseases such as the bird flu, Aids research and Chronic Fatigue Syndrome (CFS). Although the CDC has several times in documented forums have confirmed the existence of CFS, a sister to the more commonly known “Fibromyalgia”, the FDA has failed to address Ampligen’s approval. In addition, for reasons that the FDA claims is “due to staffing issues”, the approval of this landmark product, which the FDA is late by over 3 months, remains in NDA limbo. It is troubling that Americans who can benefit from its availability outside the spectrum of an experimental status are held hostage to regulatory bureaucracy. Its leads many to be inquire if these regulatory agencies are only catering to “Big Pharma” and possibly focusing more on the depth of purse. For over 5 years the FDA has known of findings related to Ampligen and in my estimation should have fast tracked its studies and approvals accordingly. Ref: this article and meeting notes - http://www.hhs.gov/advcomcfs/sept2004_meeting_min.html .
Ampligen may and should be considered as an adjuvant in combination with seasonal trivalent inactivated influenza vaccine thereby providing cross-protective mucosal immunity against Noval H1N1 as it has been viewed in many tests performed for avian H5N1 viruses. Hemispherx and researchers in Asia and Europe consider that Ampligen as beening "generally well tolerated", with a "low incidence of clinical toxicity", particularly when compared to the toxicity of the diseases it is used to treat. "No serious safety issues have resulted from the administration of ~75,000 doses IV (most commonly 400 mg) twice weekly for up to one year periods or greater. Animal toxicity studies support this observation in humans with primates demonstrating the greatest margin of safety.”
Its time for the United States to once again take a lead in innovation or we will see our Homeland Bio-Pharma industries go the way our auto and electronics manufacturers experienced in the past three decades….” Outsourced and Dependent”. I invite my opinions to be copied by whoever wishes to submit to other blogs and article comments sections, as we must demand the transparency of these regulatory agencies that all Americans deserve.
Robert J. Sobel, M.D. wrote:
Again I ask the question of why we need to spend time worrying about copy-cats. There are many competitors to Lovenox; they are all expensive. How about getting the brand-generic warfare out of the way. Then we can focus on all the new avenues (like the toll receptor referenced above). The FDA would have an easier job if the playing field were less duplicative and the long-term was not destabilized by the drug life cycle roulette.
Regulated Royalties would eliminate the brand-generic dichotomy and extend indefinite exclusivity in exchange for a fee schedule arrangement in Medicare. This would allow new drugs and technologies to have their income prorated over time, proportionate to how long they last in the market. Billion dollar babies are killing health care. The FDA could be at the forefront if it did not have to police the unethical practices of brand-generic cycling.
As a physician affected daily by pharmacy benefit company harassment and insurance/pharmacy pettiness, I implore everyone to pay attention to the Hatch-Waxman Act. Let's achieve real reform and rewrite some bad laws. I need a steady playing field. I can only integrate new into the care of patients if it is introduced without the marketing insanity of the "billion dollar baby" syndrome. Introductory pricing would allow us to use cautiously early without bankrupting the system. Health care pricing is not like the rest of the world. It is not to be commoditized.
The FDA is essential and efforts to improve it are appreciated. I would argue that eliminating the brand-generic distraction would allow us to focus on true innovation, without short-changing implementation. Rewarding the long-term would even the playing field, so physicians and services could be reimbursed at rates that don't need to be incessantly squeezed.
The health care bubble is largely explained by the lack of price controls on new technology and pharmaceuticals and the failure of behavior modification (i.e., the managed care fallacy) to save money (savings offeset by administrative tangles). Financial coercion is currently working but is unethical (it disincentives doing the right things as well). Regulated Royalties on a modified Baucus and you've got health care reform that will work.
I agree with you. There is a timeline of obligations whenever the decision is given to HEB management. The FDA will publish approvals shortly after notifying the company. Somewhere I read about a four day window for the company to announce approval news before it's on the FDA's website. On the other hand, I also read that denials are up to the company to position the timing. 30 days? Anyone know if there is a time constraint?
We do know that the FDA put a request in for animal toxic studies. From the 10-Q pg.22 signed Aug.7, 2009:
On September 19, 2008, we executed an agreement with Lovelace Respiratory Research Institute in Albuquerque, New Mexico to perform certain animal toxic studies in support of our Ampligen® NDA. These studies were requested by the FDA and will be done in collaboration with the resources of the New Brunswick facility. These studies have been substantially completed with summary reports expected to be issued to the FDA during the third quarter of 2009. Data for final FDA reports are presently undergoing internal auditing at Lovelace and Hemispherx with a projected completion of the final report for late 2009 to early 2010.
To the best of my knowledge the study has not been released or made public. If they wanted that last bit of information before decision time, then what Dr. Carter said about expecting news early this fall would make sense.
We only have a small bit of knowledge about what the FDA wants or needs to complete their decision.
IMO, we'll have their decision by October.
Look how many times the FDA was in contact about Savella (as shown in the Savella NDA Approval letter).
August had the most with 11 times and from Aug - Oct there were 24 contacts:
Complete letter found here:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256ltr.pdf
NDA 22-256
NDA APPROVAL
Cypress Bioscience, Inc.
c/o Forest Laboratories, Inc.
Harborside Financial Center
Plaza III, Suite 602
Jersey City, NJ 07311
Attention: Michael K. Olchaskey, PharmD
Director, Regulatory Affairs
Dear Dr. Olchaskey:
Please refer to your new drug application (NDA) dated and received December 18, 2007, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Savella (milnacipran HCl) 12.5 mg, 25 mg, 50 mg, and 100 mg Tablets.
We acknowledge receipt of your submissions dated January 18 and 30, February 8, 11, 13, 15, and 28, March 17 and 31, April 10, 17, 22, 28, and 30, May 30, June 2, 9, 10, 11, and 26, July 3, 15, 28, and 30, August 6, 7, 8, 11, 12, 13, 19, 20, 25, 26, and 27, September 2, 5, 16, 17, and 23, and October 8, 9, 10, 14, 15, 16, 17, and 24, 2008, and January 2 and 8, 2009.
This new drug application provides for the use of Savella (milnacipran HCl) Tablets for the management of fibromyalgia.
We have completed our review of this application, as amended, and it is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
Your application was not referred to an advisory committee because, although Savella is a new molecular entity, it is not the first drug in the class of norepinephrine-serotonin reuptake inhibitors (NSRIs) indicated for the management of fibromyalgia, the clinical study design was acceptable, and the product did not pose unique concerns beyond those applicable to other members of this class.
--------------------------------------------------------------
Notice the last paragraph, Savella was not the first drug in the class, whereas Ampligen is. Just an observation that probably has some bearing. IMO, end of October is more likely. But I'd rather believe before Labor Day.
HEB long
GLTA
I agree with you, they don't know. It's just a good estimate.
It would be better to know how many times and the dates that the FDA has been in touch with Dr. Strayer over the past 3 months.
GLTA
Thanks for the update and email.
I too spoke with Diane and she said the same thing about Dr. Carter's choice of words.
The person in contact with the FDA is Dr. Strayer and any speculation of when a decision will come is just that; at best it's an educated guess.
Sooner would be better,
GLTA
During my conversation with Diane she mentioned the FDA Advisory Committee meetings taking place and apparently there is a PDUFA date in October associated with that agenda.
I looked up the calendar of Advisory Committee meetings but it was not clear which board had a two day meeting Tue-Wed. The calendar was not up to date and any changes are emailed.
Diane Will and I had a conversation late Wednesday afternoon. She called after I emailed her requesting clarification of Dr. Carter's statement about the FDA decision.
From our discussion I felt that this was important:
The FDA had two days of Advisory Committee meetings that ended Wednesday.
Preparation leading into those seldom held meetings were paramount.
The PDUFA date from those meetings is in October.
Our NDA is in a rather small department of the FDA.
Manpower issues are a factor.
We surmised that with the meetings over our rather small world should be right up front and addressed. Should be...
You be the judge from these 2 additional factors:
1) A vacation in May caused a delay since no one else addressed HEB's PDUFA.
2) The FDA's performance continues to suffer under the reins of the newly appointed Dr. Hamburg.
Should we have our decision before October?
What Dr. Carter said about our decision is just a good conjecture, IMO.
GLTA
Does anyone know if HEB has ties with Sinovac (AMEX:SVA)?
They have begun testing of 3 types of pandemic flu vaccines; 2 have adjuvants.
Sinovac Initiates Dosing in Human Clinical Trial of Panflu for Pandemic Influenza A (H1N1)
Press Release
Source: Sinovac Biotech Ltd.
On Wednesday July 22, 2009, 10:33 am EDT
BEIJING, July 22 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE AMEX: SVA), a leading provider of vaccines in China, today announced that it has initiated dosing today in its clinical trial of various Panflu vaccine candidates for pandemic influenza A (H1N1). Results are expected in September 2009.
Three types of vaccines, including split viron vaccine, split viron vaccine with adjuvant, and whole viron vaccine with adjuvant, will be tested in the trial. Dosage will range from 5ug to 30ug per dose with an immunization schedule of 0, 21 days. The clinical trial will enroll 1,600 healthy volunteers aged 3 years or older. Dosing is expected to be completed this week.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "In order to prevent the influenza pandemic for a large population in China and other developing countries, it is necessary to prepare for multiple circumstances. Therefore, we are examining H1N1 vaccines that provide safety, efficacy, and high volume scalability and can perform for different levels of prevalence and pathogenicity. The purpose of this clinical trial is to provide scientific evidence for the vaccine formulation and dosage through systematic clinical observation."
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac's commercialized vaccines include Healive® (hepatitis A), Bilive® (combined hepatitis A and B), Anflu® (influenza) and Panflu(TM) (H5N1). Sinovac is currently developing Universal Pandemic Influenza vaccine and Japanese encephalitis vaccine. Additional information about Sinovac is available on its website, http://www.sinovac.com . To be added to our distribution list, please email: info@sinovac.com .
I hope you are right and the flu turns mild. Although, IMO, prudence calls for overpreparation by using adjuvant(s).
I did read that the vaccine ingredients are not as abundant as expected and they are attempting a second wave but no one knows if it will be enough.
We (HEB) really need to see solid results from human trials soon. Maybe then the world will approve it's use with the vaccine.
GLTA
WHO says pandemic gaining speed, sees winter risks
Fri Jul 24, 2009 12:28pm EDT
By Laura MacInnis and Stephanie Nebehay
GENEVA (Reuters) - The H1N1 flu virus is starting to infect older people, and pregnant women and the obese are at highest risk, the World Health Organization said on Friday.
In a statement, the United Nations agency said school-age children remain most affected by the newly discovered virus that has been spreading fast in schools and is gaining momentum in broad communities alongside seasonal flu.
"It remains a top priority to determine which groups of people are at highest risk of serious disease so steps to best protect them can be taken," it said, estimating that vaccine manufacturers should have H1N1 shots ready soon.
"Manufacturers are expected to have vaccines for use around September. A number of companies are working on the pandemic vaccine production and have different timelines," the statement on the WHO website read.
About 800 people have died from the new virus whose fast international transmission caused the WHO to declare in June that a flu pandemic is under way. But for most patients, H1N1 is causing mild and manageable symptoms.
"For the moment we haven't seen any changes in the behavior of the virus," WHO spokesman Gregory Hartl said earlier on Friday, while warning the virus could change as it circulates, especially in flu-conducive wintry conditions.
"We do have to be aware that there could be changes and we have to be prepared for those," he told a Geneva news briefing.
VACCINE SUPPLIES
At least 50 governments have placed orders or are currently negotiating with pharmaceutical companies to secure supplies of H1N1 vaccines, which are still being developed.
The U.S. Food and Drug Administration is helping companies design ways to quickly test experimental versions of pandemic shots, and the European Medicines Agency is aiming to approve H1N1 vaccines before the onset of northern hemisphere winter, the traditional "flu season" in Europe.
The WHO is trying to ensure that health workers in poor countries can be vaccinated so hospitals can stay open if the flu becomes more debilitating as it spreads. Sanofi-Aventis and GlaxoSmithKline have promised to donate 150 million doses to this aim to date.
Other leading flu vaccine makers include Novartis, Baxter, and Solvay.
Clinical trials of H1N1 shots "will give a better idea of the number of doses required for a person to be immunized, as well as the quantity of active principle (antigen) needed in each vaccine dose," the WHO said.
Estimates of the global supply of vaccines will be based on how many jabs are needed to protect each person.
The H1N1 virus, first discovered in Mexico and the United States, is a never-before-seen combination of swine, bird and human flu strains, and initially infected mainly young people.
Concerns about the way it was spreading, and about deaths reported among healthy people in North America, caused the WHO to declare that a flu pandemic is under way. Some 160 countries have now reported infections.
Last week, the WHO described H1N1 as the fastest-moving pandemic ever seen. On Friday, it said infections were "still increasing substantially in many countries, even in countries that have already been affected for some time."
(Additional reporting by Madeline Chambers in Berlin and Michael Kahn in London; editing by Robin Pomeroy)
I am from the medical field in the lab and understand the virology at focus.
Please read what I wrote.
1st) Saturday I posted the article you keep referring to and if you read the quote I posted, there are no predictions a mutated virus coming.
"...some experts have shied away from a forecast. At a CDC swine flu briefing Friday, one official declined to answer repeated questions about her agency's own estimate."
2nd) This article is from WHO 24JUL09 "For the moment we haven't seen any changes in the behavior of the virus," WHO spokesman Gregory Hartl said earlier on Friday, while warning the virus could change as it circulates, especially in flu-conducive wintry conditions.
"We do have to be aware that there could be changes and we have to be prepared for those," he told a Geneva news briefing.
You are spreading a rumor by saying "...this fall the mutated virus is expected..." Put IMO.
All I am saying is your opinion should have been noted as such.
You are right to be concerned, it could be bad. Preparation for the H1N1 is what is current.
If you have a quote from someone actually stating they expect a mutated virus to hit, please share it. I would be interested in seeing it.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39881706
http://www.reuters.com/article/GCA-SwineFlu/idUSTRE56N1QJ20090724
I have been investing with HEB for over 2 yrs. This board came to my attention about 5 months ago and as a whole there are great people here, up to the minute information and enthusiastic opinions. I still welcome yours and will continue to read them.
GLTA
Please do not spread rumors here. There have only been 5 confirmed cases of a mutated swine flu virus and none had sustainability.
See this quote from the article I posted on Saturday (the one you referenced):
"Influenza is notoriously hard to predict, and some experts have shied away from a forecast. At a CDC swine flu briefing Friday, one official declined to answer repeated questions about her agency's own estimate."
No officials are predicting what is going to happen.
The main concern is the extreme quickness of the virus to spread.
This virus spread in 6 weeks what usually takes 6 months.
I agree with your concern, it could be bad.
The potential for a problem is as high as the potential for it to fizzle out.
Being prepared is still the wise course of action.
Swine flu may hit 40 percent if vaccine fails
By MIKE STOBBE, Associated Press | Posted: Saturday, July 25, 2009
ATLANTA - U.S. health officials say swine flu could strike as much as 40 percent of Americans over the next two years and as many as several hundred thousand could die if a vaccine campaign and other measures are unsuccessful.
Those estimates from the Centers for Disease Control and Prevention mean about twice the number of people who usually get sick in a normal flu season would be struck by swine flu. Officials said those projections would drop if a new vaccine is ready and widely available, as U.S. officials expect.
The U.S. may have as many as 160 million doses of swine flu vaccine available sometime in October, and U.S. tests of the new vaccine are to start shortly, federal officials said this week.
The infection estimates are based on a flu pandemic from 1957, which killed nearly 70,000 in the United States but was not as severe as the infamous Spanish flu pandemic of 1918-19. But influenza is notoriously hard to predict. The number of deaths and illnesses would drop if the pandemic peters out or if efforts to slow its spread are successful, CDC spokesman Tom Skinner said.
A CDC official said the agency came up with the estimate last month, but it was first disclosed in an interview with The Associated Press.
"Hopefully, mitigation efforts will have a big impact on future cases," Skinner said.
In a normal flu season, about 36,000 people die from flu and its complications, according to American Medical Association estimates. Because so many more people are expected to catch the new flu, the number of deaths over two years could range from 90,000 to several hundred thousand, the CDC calculated. Again, that is if a new vaccine and other efforts fail.
The World Health Organization says as many as 2 billion people could become infected over the next two years - nearly one-third of the world population. The estimates look at potential impacts over a two-year period because past flu pandemics have occurred in waves over more than one year.
WHO officials believe the world is in the early phase of the new pandemic.
State health officials, doctors, hospital staff and other health care workers throughout New Jersey met last week to discuss planning for a swine flu pandemic. However, the state also is reassuring its residents that the estimates do not account for the development of a vaccine and a thorough education campaign that is in place.
"The CDC estimate is just that, an estimate based on the 1957 flu pandemic, of what could happen if no action was taken," Donna Leusner, a spokeswoman for the state's Department of Health and Senior Services, said in a statement Friday. "That is clearly not the case now."
The state has scheduled additional summits in August and September to continue to discuss preparation for more cases of swine flu.
First identified in April, swine flu has likely infected more than 1 million Americans, the CDC believes, with many of those suffering mild cases never reported. There have been 302 deaths and nearly 44,000 reported cases, according to numbers released Friday morning.
In New Jersey, 934 confirmed cases of swine flu have been identified as of July 22. Fifteen of those patients died due to complications from the virus.
Because the swine flu virus is new, most people have not developed an immunity against it. So far, most of those who have died from it in the United States have had other health problems, such as asthma.
The virus has caused an unusual number of serious illnesses in teens and young adults. Seasonal flu usually is toughest on the elderly and very young children.
New swine flu illnesses have erupted through the summer, which also is unusual, although cases were less widespread this month. Officials fear an explosion of cases in the fall, when children return to school and the weather turns cold, making the virus easier to spread.
Staff writer Ben Leach contributed to this report.
Complete Yahoo post: PLEASE READ THIS BEFORE YOU SELL 22-Jul-09 06:34 pm
Today AP reported that Andy Burnham, the British Health Minister, said the UK could have up to 100,000 new cases of swine flu per day by the end of August. Currently we have seen only about 100,000 reported cases worldwide. If the cries of Andy Burnham are anywhere close to accurate, the world may be in for a huge health crisis. The UK won't be the only country that has big problems. The North American countries seem like a sure bet to join in. Japan is very worried. I'm sure many European countries, the former USSR countries, and China will get their share too.
One solution (or ameliorating factor for this problem) may be to use adjuvants. The Japanese Institute of Health has been doing considerable research in this area lately. Japan seems likely to try this. Ampligen (from Hemispherx BioPharma (HEB)), the same factor that is being put forth to combat Chronic Fatigue Syndrome (CFS), has proven to be the most successful adjuvant in trials with flu virus vaccines. It has made the flu vaccines up to 100 times more effective. The Japanese seem likely to use it as part of their flu vaccine (i.e. so they can use less "flu material" per vaccine shot). The US might even be forced to use it, even though the FDA has approved no adjuvant for use with flu vaccines yet.
How does this effect Ampligen for CFS approval? Ampligen has proven reasonably safe for use to combat CFS. It has also been shown to be effective. If the FDA approves Ampligen for use against CFS, it will be much easier for the US (if it has to) to approve the use of Ampligen with flu vaccine. It is my understanding that Ampligen can make the flu vaccine approximately 100 times more effective. If this is so, flu vaccine providers could use much less "flu material" to make up the vaccine (say 1/5 or even 1/10 as much). This would make the vaccine material the US received early go a much longer way. This might help avert a major pandemic. From the HEB studies for Ampligen for CFS, Ampligen is safe. From the Japanese studies, Ampligen is safe; and it is effective as a flu vaccine adjuvant. There does not appear to be a good reason not to use it.
If the FDA denies Ampligen approval for CFS, they will have a hard time approving it for use in a flu vaccine. If the Japanese use Ampligen successfully in their flu vaccines, the US will look extremely foolish if US citizens in the 100,000's or millions get swine flu because they were unable to get a vaccination in time. The FDA will likely want to leave their options open. This latest news from the UK Health Minister should tip the scales in favor of Ampligen approval for CFS (if there was a question in the first place).
There is very limited downside to Ampligen approval. It is apparently safe. It is reasonably effective. The only gripe that I have heard is the price. The FDA should realize their decision is not cast in stone. They can always re-evaluate. They should realize that they may be taking a bigger risk by not approving Ampligen for CFS.
Already there is an 80% chance of aproval for drugs that make it as far as Ampligen for CFS has. It will be an orphan drug. This pushes the odds of approval still higher. The need for Ampligen near term as a flu virus vaccine adjuvant may push Ampligen approval for CFS odds to nearly 100%. The approval decision is overdue by many weeks. The FDA should take action soon. Plus HEB will soon get a big step up in the use of Ampligen as a flu vaccine adjuvant. Both of these things should make HEB a lot more profitable in the very near future. This should positively impact the stock price.
We may hear that Human Studies of a vaccine with Ampligen has been approved, IMO.
1) July 20, 2009 PR: “Investigational products and protocols to be discussed will include Hemispherx’s Ampligen® (poly I: poly C12U), Alferon N (a natural cocktail of alpha 2 type interferons, FDA approved for treatment of refractory HPV) and Alferon LDO, an experimental formulation of Alferon-N for oral delivery.”
2) April 27, 2009 PR: Japanese Government Accelerates Hemispherx Biopharma’s Ampligen® Research Programs for Influenza Protection
Philadelphia, PA, Monday, April 27, 2009: Hemispherx Biopharma, Inc. (NYSE Amex: HEB) announced today that it had received notice of an Annual Report (April, 2008- March 2009) prepared by a Director of the National Institute of Infectious Diseases (NIID) to the governing organization of the Japanese Ministry of Health (acronym, MHLW) reporting a series of successful preclinical studies in new pandemic vaccines which rely critically on Ampligen® (Poly I : Poly C12U) an experimental therapeutic for efficacy. The efficacy was demonstrated both within the airways themselves as well as systemically.
Note: As a result, the program is expected to be accelerated into human volunteers promptly under supervision of NIID staff.
The project is officially titled: “Clinical Application of the Influenza Virus Vaccine in the Intranasal Dosage Form for Mucosal Administration.”
See link for full PR: http://www.hemispherx.net/content/investor/default.asp?goto=626
3) May 21, 2009 PR: Japan’s Council Awards Innovative Technology Grants for Pandemic Influenza Vaccines Adjuvanted by Hemispherx’s Ampligen®
…“Super Special Consortia” to promote key technologies
Philadelphia, PA, Thursday, May 21, 2009: Hemispherx Biopharma (NYSE AMEX: HEB) announced that it has learned that Japan’s Council for Science & Technology Policy (CSTP) awarded to the National Institute of Biomedical Innovation (NIBIO) funds to advance research with influenza vaccines utilizing a new experimental adjuvant, Ampligen® (Poly I: Poly C12U).
The PR goes on to say:
NIBIO’s research entitled “Innovation Project for Anti-infectious vaccines in Next Generation” is aimed at the development of high-value-added vaccines for various infections such as pandemic influenza, malaria and AIDS. With regards to influenza vaccines in particular, NIBIO has worked jointly with researchers at the National Institute of Infectious Diseases (NIID), with whom Hemispherx has been collaborating in various studies.
NIBIO / NIID common goal is to develop the pandemic influenza vaccine formulated with an adjuvant, Ampligen®, an experimental therapeutic, to be administered by intranasal routes. They expect the intranasal vaccine may exert broad cross protection against the mutated viruses of pandemic influenza based on results to date.
Study of this unique vaccine preparation combined with Ampligen® (Poly I: Poly C12U), an experimental therapeutic, started in April 2007 under a research grant by Japan’s Ministry of Health, Labor and Welfare (MHLW).
Note: The efforts in the last 2 years are now culminating in encouraging results in rodents and monkeys wherein a dramatic increase of IgA secretion was found which leads to a broadly cross-protective effect against various pandemic influenza strains.
See link for full PR: http://www.hemispherx.net/content/investor/default.asp?goto=630
4) June 4, 2009 PR: Japanese National Institute of Infectious Diseases Scientists Identify Hemispherx Biopharma’s Drug Technology as the “Most Promising Mucosal Adjuvant for Influenza”
Philadelphia, PA, Thursday, June 04, 2009: Hemispherx Biopharma (NYSE AMEX: HEB) announced today that a new peer reviewed publication titled “Development of mucosal adjuvants for intranasal vaccine for H5N1 influenza viruses” was published in Therapeutics and Clinical Risk Management 2009:5 125-132.
Note: The article summarizes ongoing research in which researchers conclude that Poly I:PolyC12U (Ampligen®), an experimental therapeutic, is the “most promising adjuvant candidate for mucosal vaccines.”
Poly I:PolyC12U (Ampligen®), an experimental therapeutic, was also ”extremely important” in these studies in that it produced cross-protection against variant influenza viruses not seen with the vaccines given alone.
See link for full PR: http://www.hemispherx.net/content/investor/default.asp?goto=637
The U.S. Dept. of HHS Pandemic Planning Update VI from January 8, 2009 (pg. 10) shows the intended adjuvant purchase of 5.2 Mil doses from GSK (see below). On the timeline it shows: January 2007 – HHS awards $132.5 million to develop H5N1 adjuvanted influenza vaccines
The use of the funds in not clear but maybe Diane can shed some light on the subject; sent her an email with questions. HEB should be right there, IMO.
The pdf can be found at http://www.flu.gov/plan/pdf/panflureport6.pdf (19 pgs.).
Adjuvants
When adjuvants are successfully paired with influenza vaccines, the vaccines can be stretched to protect many more Americans and the vaccines may provide broader protection.
In 2005, HHS set a goal of providing pandemic influenza vaccine for 20 million people. Since then, planning efforts have also included identifying and testing adjuvants that could be combined with the pre-pandemic and pandemic vaccines to make those original 20 million available doses extend to protect more people.
Early research results have been promising and have pointed to the possibility of combining an H5N1 vaccine manufactured by one company with adjuvants from another company. The resulting “joint” vaccine could boost the effectiveness of each adjuvanted dose and lead to a far larger stockpile of vaccine. Further research is now underway to test this preliminary result, in what is known as a “mix-and-match” study of adjuvants among different vaccine manufacturers.
In the meantime, HHS will continue to purchase and stockpile additional doses of pre-pandemic vaccine. HHS is moving forward with the purchase of 5.2 million doses of adjuvant from GSK that will be paired with GSK antigen, currently held in bulk form in the HHS pre-pandemic vaccine stockpile.
US just added additional $884 Mil for vacine production and it's not enough. US has contracts with 4 different companies (2 with plants here and 2 in Europe). HEB adjuvant booster should be considered as an elective, IMO.
Fight for swine flu vaccine could get ugly
MARIA CHENG | Posted: Thursday, July 16, 2009
An ugly scramble is brewing over the swine flu vaccine _ and when it becomes available, Britain, the United States and other nations could find that the contracts they signed with pharmaceutical companies are easily broken.
Experts warn that during a global epidemic, which the world is in now, governments may be under tremendous pressure to protect their own citizens first before allowing companies to ship doses of vaccine out of the country.
That does not bode well for many nations, including the United States, which makes only 20 percent of the regular flu vaccines it uses, or Britain, where all of its flu vaccines are produced abroad.
"This isn't rocket science," said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota. "If there is severe disease, countries will want to hang onto the vaccine for their own citizens."
Experts say politicians would not be able to withstand the pressure.
"The consequences of shipping vaccine to another country when your own people don't have it would be devastating," added David Fedson, a retired vaccine industry executive.
About 70 percent of the world's existing flu vaccines are made in Europe, and only a handful of countries are self-sufficient in vaccines. The U.S. has limited flu vaccine facilities, and because factories can't be built overnight, there is no quick fix to boost vaccine supplies.
Earlier this week, the U.S. Department of Health and Human Services announced it was spending $884 million to buy extra supplies of two key ingredients for a swine flu vaccine. The U.S. has contracts to get swine flu vaccines from Sanofi Pasteur, MedImmune, GlaxoSmithKline and Novartis. Sanofi Pasteur and MedImmune both have vaccine plants in the U.S., while GlaxoSmithKline and Novartis have plants in Europe.
Even if the U.S. held onto all the swine flu vaccine produced domestically, it would still not be enough for all Americans.
About 80 million Americans are vaccinated against the seasonal flu every year. In 2004, when problems with the U.S.' flu vaccine supply at a British factory hit, there were less than 54 million shots available. Flu vaccines were saved for those in high-risk groups like the elderly and pregnant women, and officials asked other people to simply forgo their usual flu shot.
If there are limited swine flu shots during a pandemic that turns more serious, experts are not sure people will be as willing to skip getting a vaccine.
Last week, the World Health Organization reported nearly 95,000 cases of swine flu, including 429 deaths worldwide. If swine flu turns deadlier in the winter, the main flu season in the Northern Hemisphere, countries will likely be clamoring for any available vaccines.
"Pandemic vaccine will be a valuable and scarce resource, like oil or food during a famine," said David Fidler, a professor of law at Indiana University who has consulted for WHO. "We've seen how countries behave in those situations, and it's not encouraging."
Britain claims it will start vaccinating people in August, Italy says it will begin by the end of the year, and many other countries have similar strategies. Those mass vaccination plans could be derailed by problems making the vaccine and by other countries' refusal to ship it abroad.
If the virus remains mild, this could all be moot. Experts estimate swine flu to be about as dangerous as seasonal flu, and there usually isn't a high demand for those vaccines. Still, regular flu kills up to 500,000 people a year.
In past pandemics, or global epidemics, vaccines were never exported before the country that produced them got enough for its own population first.
Unlike the last two pandemics in 1957 and 1968, however, many more countries this time around have struck deals with companies which they say guarantee them first access to vaccine. Yet in a global health emergency, those contracts may ultimately be meaningless.
Countries with flu vaccine plants might decide to seize all vaccines and ban their export, thus breaking the pharmaceutical contracts promising other countries vaccine supplies. These private contracts are not binding international law between two countries, according to Fidler.
He said most vaccine contracts include a clause allowing them to be broken under extraordinary circumstances, such as a health emergency. That would leave the countries who had brokered such deals not only without vaccine, but without legal recourse.
"There's nothing in international law that helps you resolve this, it's just a political nightmare happening in the midst of an epidemiological nightmare," Fidler said.
Britain has ordered 60 million doses, enough to cover its entire population. But those doses are being manufactured by GlaxoSmithKline PLC and Baxter International Inc., whose production plants are in Germany, Austria and the Czech Republic. Neither Britain's department of health or the vaccine manufacturers would comment on delivery plans.
On Thursday, Britain's chief medical officer estimated that as many as 75,000 Britons could eventually be killed by the swine flu pandemic, if 1 in 3 people are infected.
Osterholm said about 80 percent of the United States' pandemic vaccine supply will be coming from abroad and he is very concerned about when it might arrive. Timing could be everything to avoid a vaccine spat.
"It's easy to move vaccine around if the disease is relatively mild. But if it is more severe, countries may not be willing to let it go," he said.
So far, swine flu remains a relatively mild disease, and most people don't need medical treatment to get better. But experts fear the virus could mutate into a more dangerous form. And during the flu season, when the virus spreads more easily, more people will probably fall sick and die.
Public health officials are aware that so-called "vaccine wars" might break out if the swine flu outbreak worsens, but are loathe to even discuss the topic.
The European Centre for Disease Prevention and Control, an agency of the European Union, said it had no mandate to advise countries in such circumstances. WHO said it was not aware of any nations planning to block the shipment of vaccines and said it would work to ensure all countries get enough doses to protect their health workers.
Questions also remain about when a swine flu vaccine will even be available, as WHO reported this week that a fully licensed vaccine might not be ready until the end of the year.
With little or no safety data about a swine flu vaccine, governments that are planning to roll out mass campaigns are taking a gamble, since any rare side effects won't show up until millions of people start getting the shots.
Experts say government promises about when vaccines will arrive should be taken with a huge grain of salt.
"Many pieces of the puzzle are missing," Osterholm said. "Anyone who pretends to have a well-defined schedule of vaccine delivery is obviously very poorly informed."
.Posted in World on Thursday, July 16, 2009 2:05 pm Updated: 4:01 pm.
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