NOVAVAX

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In the News
Hand, Foot, and Mouth Disease in Vietnam

This information is current as of today, July 23, 2012 at 23:20 EDT

Updated: July 23, 2012

What Is the Current Situation?

As of June 10, 2012, the Vietnam Ministry of Health confirmed that approximately 57,800 people in 63 provinces have had hand, foot, and mouth disease (HFMD) since the beginning of 2012; 29 people in 14 provinces died. More HFMD cases have occurred in the northern region of Vietnam. However, there have been more HFMD-associated deaths in the southern region. The Vietnam Ministry of Health is working with World Health Organization to control the outbreak.

Large outbreaks of severe HFMD occur frequently in some countries in Asia. Thousands of people may get infected during these outbreaks. Some people, particularly young children, may have severe disease requiring hospitalization or even causing death. Maintaining good hygiene, including hand washing, can help lower your risk of getting sick.

To learn more about outbreaks occurring around the world, visit the World Health Organization’s website.

What Is HFMD?

HFMD is a common viral illness that usually affects infants and children under 5 years of age. Adults can also get the disease.

Symptoms of hand, foot, and mouth disease include fever, blister-like sores in the mouth (often painful), and a rash. HFMD is spread from person to person by direct contact with the saliva, nasal secretions, blister fluid, and stool of an infected person. The virus can also be spread when an infected person touches objects and surfaces that are then touched by others.

An infected person is most contagious during the first week of the illness. However, the virus can stay in the stool for weeks after symptoms go away. In addition, people with HFMD do not always show signs of infection, but still could have the potential to spread the disease.

How Can Travelers Protect Themselves?

There is currently no vaccine or medicine to prevent HFMD. However, you can protect yourself from HFMD by practicing healthy personal hygiene.
•Wash your hands often with soap and water, especially before eating and after going to the bathroom or changing a diaper. If soap and water are not available, use an alcohol-based hand cleaner with at least 60% alcohol. Consider packing alcohol-based hand cleaner in your carry-on luggage to ensure you have it when needed.
•Disinfect dirty surfaces and soiled items. If you are able, first wash the items with soap and water; then disinfect them with a solution of chlorine bleach (made by mixing 1 tablespoon of bleach with 4 cups of water) or a cleaning product that contains bleach.
•Avoid close contact such as kissing, hugging, or sharing eating utensils or cups with people who have HFMD.

There is no specific treatment for HFMD. If you do develop mouth sores:
•Take over-the-counter medications to relieve pain and fever. (Caution: Aspirin should not be given to children.)
•Use mouthwashes or sprays that numb mouth pain.
•Drink plenty of liquids to stay hydrated.

Seek medical care:
•If you are sick and unsure if you have HFMD.
•If you cannot swallow liquids to stay hydrated.

Information for Health Care Providers

HFMD is one of many infections that cause mouth sores. Depending on severity of symptoms, samples from the nose, throat, blister-like lesions, or stool may be collected and sent to a laboratory to test for viruses that cause HFMD.

Additional Information:
•Hand, Foot, and Mouth Disease CDC Web site
•CDC feature: Hand, Foot, and Mouth Disease

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Novavax Announces Contract Award From U.s. Department Of Homeland Security To Develop Foot - And - Mouth...
Supplied by: NOVAVAX, INC.


Document Brief

Contact: Frederick W. Driscoll VP, Chief Financial Officer and Treasurer Novavax, Inc. 240 - 268 - 2000 NOVAVAX Announces Contract Award from U.S. Department of Homeland Security to Develop Foot - and - Mouth Disease Vaccine Rockville, MD (October 5, 2011

Document Brief Contact: Frederick W. Driscoll VP, Chief Financial Officer and Treasurer Novavax,
Download This Datasheet

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NOVAVAX Provides Update on Influenza Programs

Primary Endpoints Achieved in Phase II Seasonal Influenza Trial
Two H5N1 Pandemic Influenza Trials Fully Enrolled
ROCKVILLE, Md., July 24, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today reported positive top-line results from the company's Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate. The study's primary objectives of demonstrating safety and immunogenicity of three ascending dose levels of the quadrivalent influenza vaccine were achieved. The VLP vaccine candidate demonstrated immunogenicity against all four viral strains based on hemagglutination inhibition assay (HAI) responses at day 21, was also well-tolerated with no vaccine-related serious adverse events observed and reactogenicity was considered acceptable. Additional safety and immune response follow-up is continuing through six months post-treatment.

A secondary endpoint of the study was to evaluate the potential of the VLP vaccine to fulfill the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) criteria for accelerated approval. In adult populations under 65 years of age, these criteria are based on demonstration of seroconversion rates (the proportion of subjects with a four-fold rise in HAI titer or attaining a titer of ¡Ý1:40 from a negative baseline) and seroprotection rates (the proportion of subjects with HAI titers ¡Ý1:40 post-vaccination) that are ¡Ý40% and ¡Ý70%, respectively, at the lower 95% confidence bound. The VLP vaccine candidate exceeded protocol design expectations by fulfilling the FDA seroprotection criterion at the lower 95% confidence bound for all four viral strains included. The VLP vaccine candidate also demonstrated the potential to fulfill the FDA seroconversion criterion by demonstrating ¡Ý40% seroconversion against three of four viral strains. The fourth virus, B/Brisbane/60/08, despite fulfilling the seroprotection criterion, failed to meet the seroconversion criterion. Inclusion of a fourth viral strain in the quadrivalent formulation did not have a significant impact on the immunogenic performance of the other three strains when compared to a trivalent VLP formulation.

An additional secondary endpoint involved evaluation of the immunogenicity of the VLP vaccine at various dose levels in comparison to a licensed trivalent inactivated vaccine (TIV) produced in eggs. The TIV comparator fulfilled the FDA criteria for seroprotection and seroconversion for each of the included three strains. In general, the comparator TIV reached higher levels of HAI than the company's VLP quadrivalent vaccine. Notably, the egg-derived assay reagents used in the classical HAI assay matched the comparator antigens exactly, but may not be perfectly representative of the VLP vaccine antigens. Novavax is currently evaluating the possibility that using virus antigens in the HAI assay that match the VLP vaccine antigen more closely may improve the detection of immune responses to the VLP vaccine.

"The topline data from our seasonal influenza trial released today show that our VLP quadrivalent vaccine candidate was well-tolerated and produced significant HAI responses. Based on our analysis of these data, we believe we have a path forward for our VLP seasonal influenza vaccine," said Stanley C. Erck, President and CEO of Novavax. "While the data from this trial were positive on balance, we are evaluating both process and assay refinements that we believe will further improve the immunogenicity profile of our vaccine, pushing the start of our next Phase II trial into 2013, rather than the fourth quarter of this year," Mr. Erck continued. "We are pleased to have the continued full support from the U.S. Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority (BARDA) for our development plans."

Novavax expects to present the full findings from this Phase II trial at a future scientific meeting.

About the Phase II Seasonal Influenza Study

The Phase II trial, conducted in Australia, enrolled 500 eligible subjects who were randomized into five treatment groups of approximately 100 subjects stratified by age and receipt of influenza immunization in the 2011 season. At day zero, study participants received a single intramuscular vaccine injection of the quadrivalent vaccine containing one of three ascending doses or one of two trivalent comparators: Novavax VLP vaccine or a standard dose of a licensed TIV. Study participants were evaluated at day 21 for HAI response and safety and tolerability of the vaccine; additional safety and immune response follow-up will continue with the subjects through six months.

This trial is the first trial evaluating the company's quadrivalent seasonal influenza vaccine candidate produced using its single-use bioprocessing production system. This advanced manufacturing technology will be the basis for its commercial production of seasonal and pandemic influenza vaccines, as well as for the company's RSV and rabies vaccines.

H5N1 Pandemic Influenza Vaccine Program

The company also announced completion of enrollment of its two Phase I clinical trials to evaluate the safety and immunogenicity of its monovalent VLP A/H5N1 pandemic influenza vaccine comparing two different adjuvanted vaccine candidates with an unadjuvanted vaccine candidate. Top line data from these trials are expected in the fourth quarter of this year.

The company is developing both seasonal and pandemic vaccine candidates under a multi-million dollar contract with BARDA, who has been an active partner in planning and evaluating the development of these products. Novavax will use the data from these trials in planning the next stage in the development of these products as they progress toward licensure.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces novel vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website: www.novavax.com.

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Question-and-Answer Session

Operator

[Operator Instructions] And our first question, it's from the line of Edward Tenthoff with Piper Jaffray.

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

Lots of progress in the quarter. Perhaps we can start out with the pandemic opportunity here. You mentioned that we've -- that you've completed enrollment and will be getting data in the fourth quarter. What are the steps beyond that, towards commercialization or procurement?

Louis Fries

Okay, this is Louis Fries. We would -- we of course need to continue with the clinical development and this would proceed stepwise through 1 rather quickly accomplished step and then 2 further steps in the clinic. The first will be to look at the results of the 2 Phase II -- Phase I trials -- excuse me, and downselect on one of the adjuvants. To-date, of course, we know nothing about the immune responses because the testing is just getting ready to get started after the receipt of the first set of syrup. We do know, so for, that neither of the adjuvants has been associated with a problematic safety profile. So we will go through a set of decision criteria and downselect on the most advantageous of the 2 adjuvants in consultation with our colleagues at BARDA. We have then elaborated for BARDA and for CBER, a plan for Phase II in which we will optimize the antigen and the adjuvant doses in a trial in young adults of a factorial design in which we'll vary both the antigen and the adjuvant dose. And when we have results from that, when we have the, say, first 3 months results from that, we will take those data and use them to fuel a similar design in elderly subjects. As you are well aware, influenza vaccine responses are generally less in the elderly, and both adjuvant and antigen doses may have to be adjusted for use in elderly subjects. We'll try to do that in a way that we actually use 1 formulation and can simply use different volumes in young adult and elderly subjects. When we have data from the elderly and from young to younger adults to optimize the dose, we'll then proceed to an end of Phase II meeting with CBER, we will design a Phase III trial, which, because there is no pandemic vaccine -- pandemic disease, will be based on immunogenicity and we will target in that the CBER guidance values for both 0 protection and 0 conversion against an H5 strain. Probably in parallel with that study or conceivably after it, depending on CBER's viewpoint, we would do a relatively small study in children, simply to show that children can receive the vaccine safely and have appropriate responses. CBER has been very, very sensitive to the use of pandemic vaccines in children because they receive no immediate benefit from it. But we will establish the basis for approval based on immune responses in young adults and elderly adults. We'll demonstrate that children can receive the vaccine safely in a small study. And that will constitute the data set that we would take forward for accelerated approval under current CBER guidances.

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

That's very helpful, very detailed update. I appreciate it.

Operator

Our next question in queue is from the line of George Zavoico of MLV & Co.

George B. Zavoico - McNicoll, Lewis & Vlak LLC, Research Division

I'm looking forward to seeing your results later on. I have a similar question in terms -- regarding the RSV. You're going into women of childbearing age, so they're not yet pregnant. If you show safety and -- if you show immunogenicity, would -- the next step is then to go to women who are pregnant? Is that the next step on that one?

Louis Fries

So as you know, we've partnered with PATH and that decision on the full clinic development plan hasn't been -- will be coordinated with their outlook. We would believe that the next trials will involve expanding the safety database in women of childbearing age before we go to pregnancy. But we haven't really determined what that safety database number will look like. But it's likely the next trial would expand and focus on the dosing in the population that are not pregnant. The other piece to that is that the -- this trial in women who are pregnant will require what we call a reprotox study in animals where we would study the vaccine. It's a very routine type of toxicology study to do if you're immunizing in a population like this. We would do a reprotox study as well, which can take approximately a year.

George B. Zavoico - McNicoll, Lewis & Vlak LLC, Research Division

Okay. But ultimately, the $5 billion that you're talking about in terms of market size, what does that include? Does that include maternal immunization, infant and toddler immunizations as well?

Stanley C. Erck

Yes. So what it includes is actually 4 out of the 5 indications that we see. So we've done a market study and we limited it to the U.S. and came up with some pricing estimates and some peak sales estimates and it includes introducing the vaccine for youngsters 0 to 2 years old, for toddlers 2 to 5, for the elderly as an annual seasonal vaccine, and pregnant women to protect the youngest infants. What it doesn't include, but we think is a big opportunity for us to be studied, is the combination of our flu and RSV vaccine for a seasonal respiratory vaccine in the elderly, which we think is a great opportunity but requires a lot more development work.

George B. Zavoico - McNicoll, Lewis & Vlak LLC, Research Division

Okay. In getting -- switching over to seasonal. Quick question about -- in your prior press release, you mentioned you were doing process and assay improvements. So could you elaborate a little bit on that? On the assay part, I think you already covered, you basically want to make sure that the assay is for the right antigen in the VLP versus the egg-based vaccines. Is that correct?

Louis Fries

That's correct. There are a number of ways to do -- the primary assay for -- that's been used to the license influenza vaccines, is the hemagglutination inhibition assay, as Stan said earlier. And that typically uses antigens that are produced in eggs and it's really optimized for egg-derived -- to match egg-derived vaccines. We don't know if that's the best way of assaying the responses to our vaccine. It may, it may be, but it also may not be. And there are a number of possible variations on that. You can use the VLPs themselves as the source of antigen. The VLPs may be somewhat more closely similar to viruses that actually circulate in mammals, than are that egg-derived viruses. And the typical indicator cell in the hemagglutination inhibition assay is an avian cell, either turkey or chicken red cell. And we've also initiated experiments looking at mammalian cells, because they might match the VLPs a little bit better. It's not at all certain what way those results will go, but we need to explore those types of assays. In addition, it's important to remember that the VLPs are designed to deliver with intent and focus on a second antigen, which is neuraminidase. Neuraminidase is always, kind of, the little brother of hemagglutinin in influenza vaccine responses. But neuraminidase has been shown to have significant capacity -- antibodies to neuraminidase, are known to have significant capacity to modulate influenza disease. Our vaccine delivers neuraminidase. It's been shown to produce responses to neuraminidase and those could contribute to -- those can be measured directly and they can also contribute to neutralization of the virus. And so, we're expanding our net to look at neutralization assays and to look at neuraminidase inhibition assays. So we'll examine all aspects of the vaccine's activity. In terms of the process, as we refine our process, we're getting a much better handle on the amount of process residuals that we need to deal with. Baculovirus proteins, proteins in the cellular production system that need to be removed and indeed live insect baculovirus that needs to be removed. Now that's entirely nonpathogenic for mammals, so it's not really a pathogenicity concern, but we do want to control it very closely as evidence of vaccine purity. And as we refine our process, we're learning a lot more about exactly how much of those residuals we have to remove and the steps that you take in the process are not necessarily benign to the vaccine. They may actually impair the ability of some of the proteins in the vaccine to cause an immune response. So the more carefully we can adjust and refine the conditions that we used to remove residuals and inactivate viruses, the more likely we are to be able to deliver a more immunogenic vaccine. And so we're in the process of examining a lot of those variables right now with some positive results.

George B. Zavoico - McNicoll, Lewis & Vlak LLC, Research Division

If the process is changed too much, though, there comes a point where you might have to go back and do a new safety study or is it not going to go that far?

Louis Fries

No, we're very mindful of that. And we're very mindful of staying inside the envelope of adjustments. And I use the word adjustment quite specifically, talking about small changes in the levels of certain reagents that we use, or the conditions under which certain steps are done. But we have quite intentionally avoided anything that would represent a major change in the unit operations in the process. In addition, we are, through a number of new hires that have occurred in the first half of the year, really strengthening our analytical group. And so we're much better able to characterize the product that we have now. And so, we can look at the product that comes out of the old process and look at the product that comes out of the new process by a suite of characterization assays that we didn't have available to us before, and able to give regulatory authorities confidence that, well, this is what we started with and this is what we have now. These are the improvements that we made and it didn't really change the profile of the product. This is not something that needs to go back to square one. So we're paying close attention to that point.

George B. Zavoico - McNicoll, Lewis & Vlak LLC, Research Division

Okay. And 1 final last quick question. If you switch from -- in the assay part, from avian turkey, or chicken cells to mammalian cells. Let's just say, for example, that it gives you a better result, that would have to then -- of course, I would think be approved by CBER as well, as an appropriate test for immunogenicity.

Louis Fries

It would be. But I think that in the long run, the negotiation with CBER as to exactly what is the underpinning of the approval. It's one that we'll have when we have an entire data package. There is nothing in CBER guidances that dictates exactly how you have to do the assay. Every single one of them elaborates, "This is what we do now. If the company can present appropriate data that another assay is appropriate, we'll consider it." So yes, it is easier to do exactly what's done now. But obviously, if it's more advantageous to adjust the methodology and we go with an adequate and convincing package to CBER, I think we can have that negotiation.

Operator

The next question in queue is from Kevin DeGeeter of Ladenberg.

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

A number of my questions have been answered, but maybe a few housekeeping ones, it's going to get Fred in here for a moment. Fred, can you -- what was the share count at the end of the quarter?

Frederick W. Driscoll

Share count at the end of the quarter was -- total shares outstanding, about 132 million.

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

Great. And it looks like from that number, I guess, you were -- relatively used the ATM in a relatively limited way in the quarter. In light of the financing that was done in the quarter, how do you kind of view the utility of that, at least for the remainder of calendar 2012?

Frederick W. Driscoll

Let me say that the capital raised in the quarter was from the raise that we did that Stan mentioned earlier, the $12 million raised through the single investor. As we've said, Kevin, we will continue to be opportunistic about the utilization of the ATM. I think the good news here is that, as Stan mentioned with the collaboration with PATH, $2 million coming in to the coffers nondilutively is what we like to see. And we also ended the -- which, noteworthy, we ended the quarter with a very heavy receivable from the government, so we also will see, again, cash infusion from BARDA coming in early in this -- next month from operations. So I think my view financially, we've -- the BARDA contract, as I said, it's really improved the overall liquidity of the company. We've seen almost a halving of the cash usage in operations, year-over-year. And we certainly expect that to continue and to get better as the program increases. So I think that's the guidance I'd give you on cash.

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

Okay, perfect. I appreciate that. And just maybe one on the clinical side. Have you decided on a final dose range for the RSV programs and whether or not -- plan to include adjuvant in one or both of those studies. And if you have other specific metrics that you're looking at to -- before you make that decision, additional preclinical data, perhaps specific set of discussions with outside advisors, can you just kind of can walk us through the timeline to make that decision so we can kick off the study late this year, Phase II?

Gregory M. Glenn

Kevin, this is Greg. So just that we are -- these next 2 trials, we'll do a trial in women of childbearing age, and a trial in the elderly. And we'll ask very similar questions in both those trials that relate to the dose of the antigen, the role of the adjuvant. And in the case of the women of childbearing age, whether the 1 or 2 doses will be required based on our Phase I data. So that -- those trials will give us guidance for the future dosing and the inclusion of the adjuvant. Now I should mention, our adjuvant is not a novel adjuvant, it's alum. And so that is a relatively benign regulatory pathway in terms of adjuvant evaluation. We do consult with, as you know, we have a very strong outside Scientific Advisory Board. We have a group that advises both for the women of childbearing age maternal immunization effort, as well as the elderly. And we will, with these trial results, our routine is to consult with them, share the data, get their opinions going forward. So those pieces of information will help us determine the upcoming trial designs.

Operator

And our next question in queue is from Chris Marai of Wedbush.

Christopher N. Marai - Wedbush Securities Inc., Research Division

So first, I wanted to ask about the potential for a commercial partnership for RSV. Given the collaboration with the nonprofit organization PATH, I noted that it was just for 1 of the 4 indications that you talked about exploring for RSV. So one, does this suggest that you may be interested in division of responsibility for each RSV indication in a potential commercial partnership, with say, a partner executing on some indications while you guys are executing on others. Two, in a potential commercial partnership, are you looking at maintaining some of the commercial responsibilities as well in terms of marketing and rights in certain jurisdictions? And three, finally, it sounds to me like that $2 million from the PATH organization can go a long way in the Phase II trial in women of childbearing age. For modeling purposes, roughly, how large will that trial be?

Stanley C. Erck

Okay. This is Stan. I'll answer the third question first. On the PATH, the $2 million that's coming in, that is designed to support just this 1 trial that's coming up and I think it was 330 -- the patient -- the subject population is 330 women.

Frederick W. Driscoll

This is Fred. I would suggest that we could not disclose that, and we would not disclose it. But I would say that the funding would substantially -- and provide a significant portion of the funding of that trial.

Stanley C. Erck

As we said in the past, and first of all, I don't predict timing of partnering of our programs with pharmaceutical companies. As everybody knows, these are long discussions, data has to be exchanged, there's lots of back-and-forth and the timing of these partnerships are completely unpredictable. So I won't predict. I will say that since we've been disclosing publicly our data, we have suspected -- and found out that all the large vaccine companies are interested in an RSV program, they either already have their own program going on or they're looking for a new one, or both. And as we said, we think we represent the most advanced, at least publicly disclosed, the most advanced program. So we're talking to all of the interested parties and our goal would be, ultimately, to find a partner who could finance the later stage Phase IIs and Phase IIIs for this program. And whether it's on a regional basis or global basis, that will be negotiated. And what residual rights we have depends precisely on those negotiations.

Christopher N. Marai - Wedbush Securities Inc., Research Division

Okay. Great. And then in terms of your responsibilities, though, you talked about a partner that could finance the later stage. Would you also be responsible for some of the execution on those trials and potential commercialization? Or how are you looking at it at that this point in time?

Stanley C. Erck

Yes, again, that depends on what region we're discussing with a partner. It depends on what the partners capabilities are versus ours. We currently have the capability to manufacture sufficient material and sufficient quantities to launch a product. And we have the infrastructure both clinically and regulatory to take it through licensure with what would be an expanded group if we're funded to do that. So I think again it's a negotiation. We're taking it through the manufacturing process and starting into Phase II clinical trials on our own. And how much further we go depends upon the partner.

Operator

And our next question is from Edward Tenthoff of Piper Jaffray.

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

Just a quick follow-up on the new partnership in India and the malaria program. This is pretty interesting, I think. Can you just run through kind of what the process might be there and maybe even add a little bit of detail on how big that opportunity ultimately could be?

Stanley C. Erck

Let me start on that. They actually came to us. The ICGEB is an international research organization based in 3 different countries. One of their bases is in Delhi. They were funded by the Department of Biotechnology, which is part of India's equivalent of Health and Human Services. They know us fairly well. We've been to see them over the past couple of years, as we've gotten to know the Indian health service HHS equivalent. They saw the opportunity using for our VLP technology, our recombinant nanoparticle technology to make an improved vaccine -- what could potentially be an improved malaria vaccine, both more potent and broad. And as you know, India has -- malaria is a large problem within India. So the government has decided to fund the initial stage, which is to take -- for us to clone a malaria vaccine candidate and to purify it and provide material to the ICGEB, who will then -- who has an infrastructure set up to do animal models and based upon the data from those animal models, we would then seek funding for the later stage development in Phase IIs and ultimately in Phase IIIs. I think we envision right now that we would support not only the cloning and purification and process development effort, but we would work with our partner in India, which is Cadila Pharmaceuticals Limited Biologics, CPLB, who has a GMP manufacturing facility all the way through fill and finish who would pick up the manufacturing of this vaccine for late stage clinical trials and in conjunction with ICGEB, we would conduct those trials. We expect the program to be fully funded as we go down the road by the various malaria not-for-profit vaccine institutes and governmental organizations. I don't know. I can't put a number of what the market opportunity is. I think we all know that Malaria is a pathogen that causes hundreds of millions of cases of malaria every year. And I think this is the #1 infectious disease, as Dr. Fries tells me. I believe the numbers on the order of their 0.75 million people die annually of malaria, so it's the #1 disease. Obviously, markets that -- to whom we would be selling the product would be primarily low-income markets and so the pricing would have to be -- reflect that, but lots of organizations who would like to support the distribution of a malaria vaccine in Africa and India.

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

That's really helpful.

Operator

And with that, I'm showing no further questions. I'd like to turn it back to Mr. Herrmann for any further comments.

Stanley C. Erck

This is Stan. Thank you all for listening in. And we look forward to reporting to you next quarter.

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Influenza Vaccines

Novavax is in advanced development of VLP vaccines against both seasonal and pandemic influenza. Novavax produced VLP vaccine against the 2009 H1N1 pandemic “swine flu” influenza. In a clinical trial of more than 4,000 subjects in Mexico – where the pandemic was first recognized, the H1N1 VLP vaccine was well tolerated and immunogenic even at the lowest dose tested of five micrograms and after one immunization.

Transmission of the highly pathogenic avian H5N1 flu virus “bird flu” in domestic poultry and humans is continuing in many countries worldwide and remains a serious pandemic threat with the potential to evolve into new strains where cross-protection and induction of neutralizing antibodies will be essential. Novavax has shown in a human study that its H5N1 VLP vaccine was well tolerated, produced no vaccine-related serious adverse events and induced neutralizing antibodies that were cross-reactive with different avian H5N1 influenza viruses. This is the only report of an unadjuvanted vaccine inducing cross-reactive neutralizing antibodies against multiple clades of H5N1 influenza virus and demonstrates the significant potential of the VLP technology. Novavax is currently pursuing the advanced development of recombinant pandemic and seasonal influenza vaccines, under a contract with the U.S. Department of Health and Human Services’ Office of Biomedical Advanced Research and Development Authority.

CLICK ON THE LINK BELOW AND THEN CLICK ON "PARTNERING" ... to view world class companies such as GE, LG in South Korea, CADILA in India, BARDA, PATH, etc.www.novavax.com/

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2012 Press Releases


•NOVAVAX to Present at the Rodman & Renshaw 14th Annual Healthcare Conference
09/06/12

•NOVAVAX to Present at the 2012 Stifel Nicolaus Healthcare Conference
09/04/12

•NOVAVAX to Present at the 2012 Wedbush Life Sciences Conference
08/13/12

•NOVAVAX Reports Second Quarter 2012 Financial Results
08/03/12

•NOVAVAX to Report Second Quarter 2012 Financial Results
07/27/12

•NOVAVAX Provides Update on Influenza Programs
07/24/12

•NOVAVAX and PATH Announce Partnership on RSV Vaccine
07/18/12

•NOVAVAX, CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology Announce Collaboration to Develop New Malaria Vaccine with Funding from Government of India
07/16/12

•NOVAVAX Reports on Progress with RSV Vaccine at New International Conference on Modern Vaccines
07/05/12

•Novavax to Review RSV Program at New International Conference on Modern Vaccines
06/27/12

•NOVAVAX to Present at Jefferies 2012 Global Healthcare Conference
06/04/12

•Novavax, Inc. Announces $12 Million Equity Offering
05/21/12

•NOVAVAX Launches Additional Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate
05/08/12

•NOVAVAX Reports First Quarter 2012 Financial Results
05/03/12

•NOVAVAX Launches Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate
05/02/12

•NOVAVAX to Report First Quarter 2012 Financial Results on May 4, 2012
04/26/12

•NOVAVAX to Present at the 11th Annual Needham Healthcare Conference
04/03/12

•NOVAVAX to Present Results from Phase I RSV Study at XIV International Symposium on Respiratory Viral Infections
03/22/12

•NOVAVAX to Present at the 24th Annual ROTH Conference
03/12/12

•NOVAVAX Reports Fourth Quarter and 2011 Year-End Financial Results
03/09/12

•NOVAVAX Appoints John A. Herrmann III, Vice President and General Counsel
03/08/12

•NOVAVAX Launches Phase II Clinical Trial of Seasonal Influenza Vaccine
03/01/12

•NOVAVAX to Report 2011 Fourth-Quarter and Year-End Financial Results on March 9, 2012
02/24/12

•NOVAVAX to Present at the 14th Annual Bio CEO & Investor Conference
02/10/12

•NOVAVAX Appoints Mervyn L. Hamer, Vice President of Manufacturing
02/01/12

•NOVAVAX Reports Progress Under Joint Venture in India with Cadila Pharmaceuticals
01/03/12 [/color]

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News for 'NVAX' - (Novavax and PATH partner to develop respiratory syncytial virus vaccine)

Sep 17, 2012 (Datamonitor via COMTEX) -- Novavax, Inc., a biopharmaceutical
company, has announced a clinical development partnership with PATH to develop
its RSV, or respiratory syncytial virus, vaccine to protect infants through
maternal immunization in low-resource countries.

Novavax has been awarded approximately $2 million by PATH for initial funding
under the partnership to partially support a Phase II dose-ranging clinical
trial in women of childbearing age planned for the second half of this year.
Following this initial study, PATH may elect to continue to partner with Novavax
and provide support for the external clinical development costs through
commercialization for this indication.

Under the collaboration, Novavax's Phase II clinical trial planned for later
this year will be designed to evaluate the immune response to different doses of
this vaccine candidate in women of childbearing age. PATH will fund on a
non-dilutive basis approximately $2 million of Novavax's external clinical
development costs for that trial.

PATH and Novavax may then progress the clinical development of Novavax's
recombinant RSV fusion (F) protein vaccine candidate with the goal of immunizing
pregnant women, such that high levels of maternal RSV antibodies will be
transmitted to their offspring through the placenta before birth, providing
protection against infection in the early infancy period, when the disease
burden is the highest. Thereafter, Novavax and PATH can elect to continue to
collaborate on additional phases to develop the vaccine for maternal
immunization in low-resource countries, with PATH potentially funding 50% of
Novavax's external clinical development costs. Novavax will retain global rights
to commercialize the product and has made a commitment to make the product
affordable and available in low-resource countries.

"We are very proud to partner with PATH, an internationally recognized
organization transforming global health through innovation, on our RSV vaccine
candidate that has the potential to impact health conditions in the developing
world. This partnership further validates the promise of our recombinant
nanoparticle vaccines," said Stanley Erck, President and CEO of Novavax. "This
partnership with PATH complements our corporate strategy to develop this RSV
vaccine for multiple indications in affected patient populations, in all markets
throughout the world with multiple partners. We estimate that the world-wide
market for an RSV vaccine could exceed $5 billion."

[dothedd]

Frederick W. Driscoll
VP, Chief Financial Officer and Treasurer
Novavax, Inc.

Novavax Presents RSV Vaccine Data at the 8th Annual International Respiratory Virus Symposium
•Data Reinforce Previous Clinical and Preclinical Studies
• Successfully Induced F-Protein Specific Neutralizing Antibody Response
• Phase 2 Studies to Begin in the Fourth Quarter of 2012
Rockville, MD (September 27, 2012)–/GlobeNewswire, Inc. /-Novavax, Inc. (NASDAQ: NVAX) today announced that Gregory Glenn, M.D., Senior Vice President and Chief Medical Officer, and Ramadevi Raghunandan, Ph.D., Manager, Preclinical Immunology & Discovery, are presenting recent findings from the company’s respiratory syncytial virus (RSV) vaccine development program at the 8th Annual International Respiratory Virus Symposium (RSV 2012) meeting in Santa Fe, New Mexico.

In its first poster, Novavax reported that recent data from a preclinical study in cotton rats showed that the nanoparticles that comprise its RSV vaccine retain a native structure, a feature considered important for the induction of functional immunity. Neutralizing antibody responses were observed specific to, and with high binding affinities to, multiple neutralizing sites on the fusion (F) protein. The company’s RSV vaccine was found to induce >10 fold higher palivizumab-like antibodies, as well as 14-50 fold higher antibodies against an array of neutralizing sites defined by a known panel of monoclonal antibodies versus a formalin inactivated whole virus RSV (FI-RSV).

Novavax is also presenting a second poster at RSV 2012 related to the immunogenicity of its RSV vaccine candidate and reviewing its previously reported Phase 1 data, which suggests that its vaccine is potentially more protective than live-viral, naturally-induced immunity.

“Our clinical and preclinical data suggest that for RSV, immunization with our nanoparticle vaccine may be superior to live viral infection, as it focuses the immune response on key portions of the virus. Unlike natural infections or immunization with the FI-RSV vaccine, our vaccine candidate demonstrated induction of functional, neutralizing antibodies to multiple sites on the F protein that have a high binding affinity,” said Dr. Glenn. “These findings further support our rationale for additional clinical development, as we plan to begin Phase 2 evaluations in Q4 of this year.”

The following poster presentations will occur on Friday, September 28, 2012 at 3:00pm Mountain Time:
Poster Presentation 34: “A Recombinant RSV Fusion (F) Nanoparticle Vaccine Generates Robust F Specific Antibody Responses that are Functionally more Active than in RSV Infected Cotton Rats.”
Poster Presentation 30: “Immunogenicity of an Sf9 Insect Cell-Derived Respiratory Syncytial Virus Fusion Protein Nanoparticle Vaccine: Insights into Pathogenicity.”

Both posters will be available in the “Our Science/Presentations” tab of the company’s website, www.novavax.com. For more information about the conference, please visit www.rsv2012.org/

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax’s worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company’s website, www.novavax.com.

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Novavax Initiates Phase 2 Clinical Trial of RSV Vaccine Candidate
Rockville, MD (October 8, 2012)–/GlobeNewswire/-Novavax, Inc.

(Nasdaq: NVAX) today announced that enrollment has begun in a Phase 2 dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age. The study is being conducted in collaboration with PATH, an international nonprofit organization that transforms global health through innovation, which is providing approximately $2 million in funding to support the trial.

This randomized, blinded, placebo-controlled Phase 2 study will evaluate the immunogenicity and safety of two dose levels of Novavax’s RSV-F protein nanoparticle vaccine with and without aluminum phosphate as an adjuvant. The study will enroll 330 women of childbearing age who will receive either one or two intramuscular injections at each dose level of vaccine or placebo at days 0 and 28. Safety and immunogenicity will be evaluated over six and four month periods, respectively.

“In addition to evaluating the safety and immunogenicity of our RSV vaccine candidate in an important patient population, this study will be crucial for both the determination of the optimal dosing regimen for future studies and the potential adjuvant effect of aluminum phosphate, an adjuvant used in U.S. licensed products,” said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. “Previous clinical and preclinical findings have suggested that immunization with our nanoparticle vaccine produces functional neutralizing antibodies to multiple sites on the F protein. We expect to report top-line results from this trial, through Day 56 observations, in the first quarter of 2013.”

About RSV and Maternal Immunization

RSV is the most common cause of childhood respiratory infection globally, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease necessitates 3.4 million hospital admissions per year and disproportionately affects infants below six (6) months of age. A severe episode of RSV bronchiolitis can lead to recurrent bouts of reactive airway disease/asthma for many years after the initial event. It is a highly contagious virus that occurs as a predictable epidemic from late autumn through early spring in the U.S. and other northern hemisphere regions and can have more than two annual peaks in tropical climates. RSV disease burden in low-resource countries is significant, and available data indicate that the virus is responsible for a high proportion of childhood acute lower respiratory infection in these settings, particularly in the first few months of life. Currently, there is no approved RSV prophylactic vaccine available. Maternal immunization is a widely practiced strategy for protecting infants in a variety of diseases, such as neonatal tetanus and is currently recommended by the Center for Disease Control’s Advisory Committee on Immunization Practices for battling infant pertussis. Maternal immunization can lead to heightened antibodies in infants and thereby protects them against the targeted disease, and thus may be a key strategy to protect young infants from RSV illness.


About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating
novel vaccines to address a broad range of infectious diseases worldwide. Using
innovative recombinant nanoparticle technology, as well as new and efficient
manufacturing approaches, the company produces vaccine candidates to combat diseases,
with the goal of allowing countries to better prepare for and more effectively respond to
rapidly spreading infections. Novavax is committed to using its technology platforms to
create geographic-specific vaccine solutions and is therefore involved in several
international partnerships, including collaborations with Cadila Pharmaceuticals of India,
LG Life Sciences of Korea and PATH. Together, these organizations support Novavax’s
worldwide commercialization strategy and have the global reach to create real and lasting
change in the biopharmaceutical field. Additional information about Novavax is available
on the company’s website, www.novavax.com.

[dothedd]

Novavax Initiates Phase 1 Clinical Trial of RSV Vaccine Candidate in Elderly Adults

Rockville, MD (October 15, 2012)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced that enrollment has begun in a Phase 1 dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adults 60 years of age and older.

This randomized, blinded, placebo-controlled Phase 1 study will evaluate the immunogenicity and safety of two doses of Novavax’ RSV-F nanoparticle protein micelle vaccine candidate with and without aluminum phosphate as an adjuvant. The study is similar to the recently launched Phase 2 RSV study in women of childbearing age but will enroll 220 adults 60 years of age and older who will receive a single intramuscular injection of Novavax’ RSV-F nanoparticle protein micelle vaccine or placebo plus a single dose of licensed influenza vaccine or placebo at days 0 and 28. Safety and immunogenicity will be evaluated for up to one year.

“Respiratory syncytial virus is a frequent cause of winter respiratory illnesses in the elderly and in some seasons can equal or exceed influenza’s rates of disease requiring medical attention. This study extends our clinical program designed to meet this population’s need for an RSV vaccine. The study will evaluate the safety and immunogenicity of our RSV vaccine candidate in elderly adults and will help us determine the optimal dosing regimen for future studies,” said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. “We expect to report top-line results from this study in the second quarter of 2013.”

About RSV

RSV is a major respiratory pathogen in infants, children, and adults. RSV infections in adults represent re-infections and are generally mild to moderate in severity, except in persons with high-risk conditions including the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11-17,000 adults die of RSV infection annually in the U.S., with and up to 180,000 admitted to hospital with respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax’ worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company’s website, www.novavax.com.

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Novavax Reports Positive Top-Line Results from Two Phase 1 Trials of Pandemic Influenza Vaccine

• Vaccine candidates met safety and immunogenicity endpoints in both trials
• Trials’ results support further development of vaccine in larger trials
o Adjuvanted candidates, at all doses of antigen tested including 3.75 ìg dose, achieved dose-sparing goals with seroconversion and seroprotection rates from 86% to 100%
o Unadjuvanted vaccine candidate, at 45 ìg dose, achieved >82% seroconversion and seroprotection in both trials
o Phase 1 results fulfill FDA criteria for accelerated approval; future confirmatory trials planned
• Cross-reactive antibody responses observed for a second strain of A/H5N1

Rockville, MD (October 17, 2012)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today reported positive top-line results from two Phase 1 clinical trials of its A/H5N1 avian influenza vaccine candidate administered alone or with either one of two undisclosed adjuvants.

The trials’ primary objectives of demonstrating the safety and immunogenicity of varying dose-levels of the vaccine, with and without adjuvant, and the demonstration of statistically significant adjuvant effects on the immune responses were achieved. The vaccine safety was acceptable with no vaccine-related serious adverse events observed.

Stanley C. Erck, President and CEO of Novavax, stated, “The data from these trials represent a landmark event in the history of Novavax. We have demonstrated that Novavax can produce antigens from avian influenza strains that are as, or more, immunogenic than any other described in published results to date. Importantly, as we accelerate our development activities, these results give us tremendous flexibility for pursuing pandemic vaccine products, including vaccines directed at population segments that are sensitive to adjuvant use.”

The two randomized, observer-blind, dose-ranging, placebo-controlled Phase 1 trials were conducted under the company’s contract with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). The primary objectives of the two trials were to demonstrate the safety and immunogenicity of Novavax’ VLP-based H5N1 vaccine candidate at varying dose-levels, with and without an adjuvant, using identical clinical study designs but with a different adjuvant in each study. A total of 666 healthy adults 18 to 49 years old were enrolled in the two trials. Each subject received intramuscular injections of vaccine or placebo at day 0 and day 21, and will be followed for 13 months following the first dose. The current data relate to safety and immune responses over the first 42 days.

The adjuvanted vaccines induced strong immunogenicity at all antigen doses tested,
including the lowest (3.75 μg) dose, based on hemagglutination inhibition assay (HAI)
responses against the vaccine virus at day 42.
• 88 to 100% of subjects receiving adjuvanted vaccine at all dose levels
demonstrated serum HAI titers ≥40, a seroprotection level believed to be
associated with reduced risk of disease.

• 86 to 100% of subjects receiving adjuvanted vaccine at all dose levels
demonstrated seroconversion rates with either a four-fold rise in HAI titer or a titer
of ≥1:40 from a negative baseline.
• Immune responses would fulfill U.S. Food and Drug Administration (FDA)
Center for Biologics Evaluation and Research (CBER) seroprotection and
seroconversion criteria for accelerated approval at the lower bound of the 95%
confidence level.
• When tested against another avian A/H5N1 virus different from that in the
vaccine, up to 80% of subjects receiving adjuvanted vaccine developed HAI titers
≥40 against the drifted virus.
Notably, in both trials the unadjuvanted vaccine elicited HAI titers ≥ 40 in >82% of
subjects at a dose of 45 μg, which would fulfill CBER criteria for accelerated approval.
The unadjuvanted vaccine also elicited HAI titers ≥40 in more than 52% of subjects against the drifted virus.

Gregory Glenn, M.D., Novavax’ Senior Vice President and Chief Medical Officer, stated, “We have reviewed the preliminary top-line results of these trials and believe that achieving similar immune responses to our vaccine in future clinical trials, regardless of
which of the two adjuvants is used, if any, would meet the immunogenicity criteria for accelerated approval of a pandemic influenza vaccine set by CBER. These data would also fulfill immunogenicity criteria set forth by the European Medicines Agency.” Dr. Glenn added, “The response measured to the drift variant antigen is especially encouraging as the data suggest that our vaccine can be protective when the vaccine strain did not perfectly match a pandemic virus strain, which is an important
consideration in the emergent response to a pandemic. We believe that with the results from these trials we have sufficient data to advance our avian influenza vaccine program into later-stage clinical testing.”

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax’ worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field.

Additional information about Novavax is available on the company’s website,
www.novavax.com.

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Novavax is an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

Listed below are the current open positions with our company. To view the open positions in detail please click on the position listing below:
•Associate Director, Analytical Development
•Associate Director of Quality Operations
•Associate Scientist/Scientist, Analytical Development
•Associate Scientist/Scientist, Analytical Development
•Clinical Research Coordinator
•Director of Quality Control
•HPLC Scientist
•Manager, Downstream Process Development (Early Stage)
•Manager, Downstream Process Development (Late Stage)
•Manufacturing Associate (Downstream)
•Manufacturing Associate (Upstream)
•Manufacturing Process Specialist
•Process Equipment Technician
•Production Planner - Materials Management
•Project Associate/Project Manager
•Research Assistant - Clinical
•Scientist - Upstream Process Development
•Sr. Associate Scientist/Scientist, Analytical Development

We invite you to click here and apply to our open positions.

www.novavax.com/go.cfm?do=Page.View&pid=19

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Novavax Publishes Preclinical Efficacy Study of its RSV Protein Nanoparticle Vaccine Candidate
Dec 3, 2012 10:11:00 AM

2012 GlobeNewswire, Inc.

ROCKVILLE, Md., Dec. 3, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that the journal PLOS ONE (http://dx.plos.org/10.1371/journal.pone.0050852) published data from a preclinical study of its recombinant nanoparticle vaccine candidate against respiratory syncytial virus (RSV), demonstrating efficacy and safety in a well-established animal model. These data indicated that the use of an RSV fusion (F) protein nanoparticle vaccine that induced high levels of specific neutralizing antibodies protected animals from both RSV replication and disease.

"The data from this preclinical model demonstrated the potential of our RSV F nanoparticle vaccine candidate to elicit the level and type of immunity required to protect humans as measured by virus neutralization activity," said Gale Smith, PhD, Novavax' Vice President of Vaccine Development. "Furthermore, our RSV vaccine candidate showed no sign of immunological disease enhancement which has plagued RSV vaccine development to date."

Severe RSV infection is the leading cause of infant hospitalization in the U.S., and globally there are 64 million cases and 160,000 deaths annually. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children are infected at least once by the time they reach their second birthday. RSV also accounts for significant morbidity and mortality among the elderly, and adults with cardio-pulmonary compromise. There is currently no approved RSV prophylactic vaccine to address this critical unmet health care need.

"This publication describes important supportive evidence of the potential safety and efficacy of our RSV nanoparticle vaccine, and the rationale for the choice of the specific vaccine antigen," said Dr. Gregory Glenn, MD and Chief Scientific Officer for Novavax. "We have completed a Phase I trial and recently initiated two separate dose-ranging clinical trials of the RSV F nanoparticle vaccine candidate in the elderly (Phase I) and in women of child-bearing age (Phase II). These preclinical observations are consistent with the promising safety and immunogenicity seen in our clinical trials reported to date and suggest that this vaccine should continue to be developed."

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.

[dothedd]

FDA Considering Faster Approval Process for Developers of Drugs for Deadly or Debilitating Diseases

NEW YORK, NY--(Marketwire - Oct 29, 2012) - The Food and Drug Administration Commissioner Margaret Hamburg has told scientific advisers that the FDA is considering a faster pathway for obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit. The Paragon Report examines investing opportunities in the Biotech Industry and provides equity research on Novavax, Inc. (NASDAQ: NVAX) and Cardium Therapeutics Inc. (NYSE: CXM).

Access to the full company reports can be found at:
www.ParagonReport.com/NVAX
www.ParagonReport.com/CXM

Under the new pathway the FDA would allow developers of such drugs to conduct smaller, faster clinical trial, and provide a "special medical use" label which would allow doctors to administer drugs to patients with critical need. Hamburg has said that the FDA needs to take into account the needs people with deadly or debilitating diseases that may be willing to take on the risks of unproven drugs.

"A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good," said Pew Health Group's Allan Coukell, deputy director of medical programs. "It would be good for developers, for companies and it would be good for public health."

Paragon Report releases regular market updates on the Biotech Industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.ParagonReport.com and get exclusive access to our numerous stock reports and industry newsletters.

Novavax is a clinical-stage biopharmaceutical company creating recombinant protein nanoparticle vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle and recombinant protein micelle technologies, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections.

Cardium is an asset-based health sciences and regenerative medicine company focused on the acquisition and strategic development of innovative products and businesses with the potential to address significant unmet medical needs and having definable pathways to commercialization, partnering or other economic monetization. The company recently announced the acquisition of To Go Brands, who reported approximately 1.7 in revenues during the first six months of 2012.

The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at:
www.paragonreport.com/disclaimer

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'Super' Novavax: Company Outshines Stars Of Pandemic Influenza Vaccine Production
November 14, 2012

seekingalpha.com/article/1006621-super-novavax-company-outshines-stars-of-pandemic-influenza-vaccine-production?source=feed


“In summary, what this trial demonstrated is that we can produce antigens from avian influenza strains that are at least as, or more immunogenic as any descripted in medical literature to date.”

President Stanley Erck
Novavax, Inc.
November 2, 2012

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NVAX manufacturing advantages are highly competitive and impressive...

They lead us into a new vaccine era... and by the end of this year I believe the share price will reflect them, in a big way... a $10 buyout price would be a low price...

Advantages:
•Simple and secure supply chain compared to egg-based production
•Uses non-infectious, non-pathogenic organisms for humans, which removes the need for containment facilities
•Suspension cell culture for easy scale-up
•High-yielding cell culture system (compared to mammalian cell lines)
•Reduces process and facility complexity compared to traditional approaches
•Reduced capital equipment and facility costs
•Reduced validation costs and time
•Rapid expansion of capacity relative to traditional systems
•Supports manufacturing with less labor
•Fixed costs decreased
•Smaller facilities feasible, supporting regional versus central supply
•Single-use “closed” bioreactor manufacturing system preventing environmental product contamination
•Insect cells do not support mammalian viruses; cell line qualification is streamlined

Advantages specific to influenza:
•Faster availability of product from new strains
•Recombinant baculovirus production seed and reagents are available more quickly than influenza virus processes
•High fidelity antigen match to wild-type (circulating) strains
•Process supports selection of most cross-protective strain in vaccine formula; no need to compromise strain selection for productivity concerns
•Low risk of microbial product contamination (sterility failures) relative to egg-based production
•Facilities easily adapted for multiple products when not making influenza

[dothedd]

• January 17, 2013, 7:44 a.m. ET
Research and Markets: Influenza VLP Vaccine (Seasonal Influenza Vaccines) Forecast and Market Analysis


DUBLIN--(BUSINESS WIRE)--January 17, 2013--
Research and Markets (http://www.researchandmarkets.com/research/2d32j6/influenza_vlp) has announced the addition of GlobalData's new report "Influenza VLP Vaccine (Seasonal Influenza Vaccines) Forecast and Market Analysis" to their offering.

GlobalData has released its new PharmaPoint Drug Evaluation report, Influenza VLP Vaccine (Seasonal Influenza Vaccines) Forecast and Market Analysis. Seasonal Influenza is a respiratory infection caused by influenza virus that results in mild to severe symptoms, such as fever, cold and cough.

The market is heavily driven by the sales of prophylactic vaccine treatments to prevent infection. Currently, trivalent intramuscular vaccines such as Sanofi's Fluzone and Vaxigrip, GlaxoSmithKline's Fluarix and FluLaval and Novartis' Fluvirin garner the majority stake of the market.

However, with the entrance of vaccines with novel routes of administration, such as AstraZeneca's intranasal FluMist and Sanofi's Fluzone IntraDermal, GlobalData projects a dramatic shift favoring the adoption of such vaccines over the traditional intramuscular vaccines. GlobalData also anticipates that manufacturers that launch quadrivalent formulations will steal market share, patient share, and revenue from the trivalent influenza vaccines currently available.

Novavax, a clinical stage biopharmaceutical company, is focused on developing vaccines against diseases such as influenza and respiratory syncytial virus infection. The company employs VLP nanotechnology as the foundation of its vaccine portfolio. Novavax's VLP vaccine is expected to be the second recombinant vaccine against influenza available within the US market, shortly after PSC's FluBlok. Novavax also has multiple development agreements with companies such as GE Healthcare and LG Life Sciences as well as government entities such as the US Office of Biomedical Advanced Research and Development Authority (BARDA).

[dothedd]

<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p>NEW "Novavax" U-TUBE 3 days ago ON U-TUBE, as well as, on Novavax's updated website.

Novavax: Message From CEO Stanley Erck - March 2013

On U-Tube:

Website: www.novavax.com/

It has been noted that the up coming events in March and April could certainly indicate "Positive RSV" results are expected as soon as April. "It only makes sense that Novavax wants too promote what the are confident they have."

Upcoming Events

ISBioTech 3rd Annual Meeting
Rosslyn, Virginia, Waterview Conference Center
March 11, 2013, 3:00 P.M.
Presenter: Gale Smith, Ph.D.

XV International Symposium on Respiratory Viral Infections
Rotterdam, The Netherlands
March 14-17, 2013
Presenter: Gregory M. Glenn, M.D.

The 25th Annual ROTH Conference
Laguna Niguel, CA, The Ritz-Carlton
March 19, 2013, 8:30 A.M.
Presenter: Stanley C. Erck

BIT's 5th Annual World Congress of Vaccine-2013
Hangzhou, China
March 19, 2013, 9:00 A.M.
Presenter: Russell P. Wilson

World Vaccine Congress and Expo
Washington, DC
April 16-18, 2013
Presenter: Gregory Glenn, MD

12th Annual Needham Healthcare Conference
New York, NY, The Westin Grand Central Hotel
April 30 - May 1, 2013
Presenter: Stanley C. Erck

I have owned and traded Novavax since 2005 and never have they scheduled so many EVENTS this close together.

For what it is worth to anyone's interest in the future of vaccine development.

Have a good day.

[dothedd]

 

March 8 2013

By: George Zavoico

NOVAVAX Life Science Report 10 Biotech Stocks Poised to Run by

TICKERS: ACAD, AMGN, ARQL, BIBB,CELG, CERS, CYTK, MKGAY, NVAX, PPHM,PBT, RVX, SNTA, THLD

Source: George S. Mack of TheLife Sciences Report (3/7/13)

Companies Mentioned: Acadia Pharmaceuticals Inc. : Amgen Inc. : ArQule Inc. : Biogen Idec Inc. :Celgene Corp. : Cerus Corp. : Cytokinetics Inc. : Merck KGaA : Novavax Inc. : PeregrinePharmaceuticals Inc. : Prana Biotechnology Ltd. : ResverlogixCorp. : Synta Pharmaceuticals Corp. : ThresholdPharmaceuticals

TLSR: We've talked a lot about cardiovascular disease andoncology. You have some other areas in your coverage. Are there any you mightmention before we wrap things up?

GZ: Sure. I'd like to mention two companies whose shareshave not appreciated much in the past six months, both of which may be poisedfor a breakout this year or next. They warrant a close look. These are NovavaxInc. (NVAX:NASDAQ) and CerusCorp. (CERS:NASDAQ).

Novavax is in a really good place right now, in my view. It has novelvaccines under development. It has two influenza vaccine programs—one seasonal,which is in phase 2, and one pandemic, which is in phase 1. Both of theprograms are locked up with the U.S. government under the Biomedical AdvancedResearch and Development Authority, which is likely to fund the development ofboth vaccines to the point of commercialization.

But the very interesting wild card here is a nanoparticle vaccine thatNovavax is developing for respiratory syncytial virus (RSV), which is now inphase 2. This virus causes very serious respiratory problems in young childrenall over the world. Last summer, the company reported phase 1 data that showedthe vaccine was able to generate sufficiently high levels of anti-RSVantibodies, or antibody titers, in healthy volunteers to protect against RSVinfection. Novavax must now show that the vaccine can protect kids and theelderly from RSV infection. Right now, with no existing vaccine for RSV, thisis a wide open and potentially large market opportunity. Novavax is developingthe RSV vaccine on its own, and has started a phase 2 trial in women ofchildbearing age with the intent of looking at different ways to protectneonates and infants. One way to do that is to vaccinate the mother to protectthe child.

TLSR: A child born to an RSV-immunized mother will havepassive immunity conferred by the mother?

GZ: Yes. The antibodies cross the placenta into the fetalcirculation. The RSV program is unpartnered, but the company has funding froman international nonprofit organization called PATH,which will fund 50% of its development. These are fairly quick trials.

Novavax also has a rabies vaccine that's being developed as a joint venturepartnership with Cadila Pharmaceuticals Ltd. (private) in India. It is apreclinical program. The joint venture is called CPL Biologicals (CPLB), and isdeveloping several of Novavax's viruslike particle (VLP) vaccine candidates, aswell as a number of Cadila's therapeutic vaccine projects for India. The rabiesvaccine could be a huge product in some Third World and emerging countries,since rabies is a major problem in these areas.

TLSR: This rabies vaccine would not be a prophylactic—itwould be a therapeutic vaccine, right?

GZ: Both, actually. It is being developed as a prophylacticvaccine for residents in high-risk areas and travelers going to thoselocations. It is also being developed as a therapeutic, or, more specifically,as a "post-exposure prophylactic" vaccine, administered after ananimal bite but before symptoms arise. The patient would not have to go throughthe series of four or five painful vaccinations that is the current standard ofcare. The Novavax vaccine is expected to require fewer doses. Some preclinicalstudies suggest that the vaccine prevents the rabies virus from crossing theblood-brain barrier into the central nervous system. The company is guiding tocommence the first phase 1 trial in India this year.

www.thelifesciencesreport.com/pub/na/15064?utm_source=delivra&utm_medium=email&utm_campaign=Life+Sci+final+streetwise-reports+03%2F07%2F2013+13%3A01%3A29

</a></p>

[dothedd]

Novavax,CPLB and ICGEB Collaboration Honored for Malaria Vaccine Progress at VaccineWorld Summit India 2013

By GlobeNewswire, March 08, 2013, 09:30:00 AM EDT

Read more: www.nasdaq.com/article/novavax-cplb-and-icgeb-collaboration-honored-for-malaria-vaccine-progress-at-vaccine-world-summit-india-2013-20130308-00399#ixzz2N0TqLgCS

 

 

[dothedd]

Novavax, CPLB and ICGEB Collaboration Honored for Malaria Vaccine Progress at Vaccine World Summit India 2013

03/08/13
Novavax Reports Fourth Quarter and Year-End 2012 Financial Results

03/01/13
Novavax to Report 2012 Fourth-Quarter and Year-End Financial Results on March 1, 2013

02/22/13
NOVAVAX to Present at the 15th Annual Bio CEO & Investor Conference

02/07/13
BARDA Continues Novavax’ Influenza Vaccine Programs Following In-Process Review

[dothedd]

Novavax Reports Positive Top-Line Results From Phase II Clinical Trial of RSV Vaccine Candidate in Women of Childbearing Age
04/02/13

Rockville, MD (April 02,2013)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced thattop-line data from the Phase II dose-ranging clinical trial of its respiratorysyncytial virus (RSV) vaccine candidate in women of childbearing ageaccomplished the trial’s protocol-specified objectives and supports progressionto the next stage of advanced clinical testing. The trial represents animportant step towards establishing the safety and immunogenicity of thevaccine candidate for use in a maternal immunization strategy. In such astrategy, the antibodies in vaccinated women can be expected to be naturallytransferred to their infants in utero and thereby may confer passive protectionat the earliest stage of life when these infants are extremely vulnerable tosevere respiratory disease due to RSV.

This randomized, blinded,placebo-controlled Phase II clinical trial evaluated the safety andimmunogenicity of two-dose levels of Novavax’ RSV F protein nanoparticlevaccine candidate with and without aluminum phosphate (alum) as an adjuvant.The study enrolled 330 women of childbearing age who received either one or twointramuscular injections of a single-dose of vaccine or placebo, at study day 0and day 28. Doses of 60 and 90 μg were tested, either with or without alum asan adjuvant. Safety and immunogenicity data for this clinical trial have beenevaluated through day 56. Safety will continue to be evaluated over a totalperiod of six months and immunogenicity for four months for each participant.The clinical trial is being conducted in collaboration with PATH, aninternational nonprofit organization that transforms global health throughinnovation. PATH committed funding of approximately $2 million to support thistrial with the aim of advancing the development of an RSV vaccine to protectinfants through maternal immunization in low-resource countries.

In this trial, the vaccinecandidate was generally well-tolerated and the safety profile was similar tothat observed previously in the Phase I clinical trial. The principalobservation was transient mild to moderate injection site pain, predictablysomewhat more frequent in the adjuvanted vaccine recipients. There were noclinically important differences in systemic adverse events between placebo andactive vaccine recipients and no vaccine related SAEs. The most commonlyreported systemic reactogenicity was comprised mainly of mild to moderateheadache, fatigue and muscle ache, which are frequently noted after treatmentby many vaccines. There were no differences in safety assessments across doses(60 and 90 μg) or worsening of reactogenicity with a second-dose. Laboratorytesting did not reveal clinically significant changes in normal bloodchemistries or hematology parameters. 

The primary objectives of thestudy measured the difference in anti-F IgG elicited by the use of alumadjuvant, one versus two immunizations, and across doses (60 and 90 μg). Theuse of alum enhanced both the single and two-dose regimen anti-F IgG responses,with the greatest responses observed using a two-dose regimen. Peak geometricmean titers of anti-F IgG in the two-dose alum groups ranged from 12,000-14,000representing a 13 to 16-fold rise, compared to a 6 to10-fold rise in thenon-alum groups. Minimal increases were observed by increasing the doses (60 to90 μg). Peak geometric mean RSV A neutralizing antibodies in the alum groupsranged from log2 9.5-10.5, representing a 3.1 to 3.8-fold rise.Palivizumab-like antibody titers rose 8 to 9-fold, with four-fold rises in ≥92%of vaccinees in the two-dose alum adjuvanted vaccine groups. Overall, theimmune responses observed in this Phase II clinical trial were similar to, orexceeded immune responses seen in the Phase I clinical trial using the Novavaxnanoparticle vaccine.

“These results confirm that ourRSV vaccine candidate has the potential to induce clinically useful immunityand has raised no safety concerns. The primary immunogenicity measuresconfirmed that the vaccine is a potent antigen and the aluminum phosphateadjuvant further enhanced the antibody responses. The results answered keyquestions regarding dose regimens and the use of aluminum phosphate asadjuvant,” said Gregory Glenn M.D., Senior Vice President and Chief MedicalOfficer of Novavax. “With respect to secondary and exploratory objectives, wealso observed that the vaccine induced peak neutralizing antibodies in excessof those seen in our Phase I trial, as well as reproducing palivizumab-likeantibody responses. Neutralizing antibodies have been associated with decreasedrisk of hospitalization in infants and palivizumab is a licensed monoclonalantibody, marketed as Synagis®, that is used to prevent high-risk infanthospitalization due to RSV. The findings from this clinical trial indicate thatour RSV F vaccine candidate has the potential to induce functional immune responsesat levels that would be predicted to protect infants through maternalimmunization. Overall, we are buoyed by these data and believe these findingswarrant the pursuit of later-stage clinical trials.”

Webcast and Conference Call

An audiowebcast and conference call will be held with Novavax’ senior management todiscuss the results on April 3, 2013 at 10:00am EDT and available atwww.novavax.com

[dothedd]

Novavax to Review Recent Findings from Vaccine Programs at World Vaccine Congress and Expo in Washington, DC

Rockville, MD (April 15, 2013)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) announced today that it will review recent clinical results from the company’s vaccine development programs at the World Vaccine Congress and Expo this week in Washington, DC.

On April 16 at 5:55pm (ET) during the session on prophylactic vaccines, Dr. Gregory Glenn, Novavax’ Senior Vice President and Chief Medical Officer, will discuss results from the company’s respiratory syncytial virus (RSV) nanoparticle vaccine development program, including recently announced positive results from a Phase II clinical trial in women of childbearing age. In that trial, Novavax’ vaccine candidate was well-tolerated and demonstrated sufficient immunogenicity with and without aluminum phosphate as an adjuvant to support plans for later-stage clinical testing. The company believes its RSV vaccine candidate has the potential to induce functional immune responses at levels that may protect infants through maternal immunization.

On April 17 at noon (ET) during the session on influenza vaccines, Dr. Louis Fries, Novavax’ Vice President, Clinical and Medical Affairs, will review results from the company’s virus-like particle pandemic H5N1 influenza vaccine clinical program. In a recent Phase I clinical trial, Novavax’ vaccine candidate was well-tolerated and demonstrated sufficient immunogenicity at multiple dose levels with and without an adjuvant to support advancement into Phase II testing. The company believes its Phase I findings suggest that the adjuvanted vaccine candidate could provide antigen dose sparing and strong immune responses to the targeted virus.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax’ worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field.

[dothedd]

China's H7N9 Bird Flu And Novavax
May 3 2013, 17:22 by: Trent MacDonald

Disclosure: I am long NVAX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

On March 31, 2013, the Chinese Government confirmed the presence of a new strain of bird flu, that being H7N9. Since that time, and as of the date of writing this article, there have been 127 confirmed cases resulting in 27 deaths. The most recent World Health Organization's Disease Outbreak News was posted on their website on April 29th, at which time there had been 126 confirmed cases resulting in 24 deaths. Over this time frame, the growth in confirmed cases has been fairly consistent, as per the chart below on the following link:

seekingalpha.com/article/1401311-china-s-h7n9-bird-flu-and-novavax

There are a number of very disconcerting issues related this particular strain of bird flu that make it worrisome:

1) While there are several reports that "most" of those who have become infected had direct contact with infected birds, there is no known cited source for such a conclusion. The WHO updated its FAQ's on April 30th, and, according to Question 7, they are still unable to say with any certainty that most cases came in direct contact with infected birds.

2) The number of confirmed cases has grown over the first 30 days in dramatic fashion comparative to H5N1 in 2005/2006 and since

3) Unlike the pandemic related to swine flu H1N1 in 2008 which had a mortality rate in the 0.2-0.6% range, the current mortality rate of H7N9 appears to be approximately 20%

4) While the WHO has continually said there is no evidence of "sustained" human to human transmission, Dr. Michael O'Leary of the WHO confirmed that " . . of the many hundreds of people who were in close contact with the H7N9 patients, all the care-givers, neighbors, family members, and so on, there are only a very few cases where these contacts have become ill as well." He confirmed this fact on April 19th, so it can be assumed he was basing his statement on investigations that had taken place over the weeks preceding the press conference. As such, there had been fewer than 60 confirmed cases forming the basis of his statement, of which at least a "few" were human to human. Given the absolute rarity of human to human transmission found in the more than 600 world-wide confirmed cases of H5N1 over the past several years, it is worrisome that a "few" of the first 60 cases were human to human already.

5) Unlike H5N1 which impacted those under 35 more severely than elderly, H7N9 has been impacting all ages and severely impacting elderly. This is important because, if elderly are being impacted, it speaks to how little our human immune systems have built themselves up to combat this new strain.

6) So far, chickens, ducks and captive bread pigeons are being blamed for transmission of the disease. Those infected who have not come in direct contact with these birds are estimated to have contracted the disease from coming in close proximity to them while at a fresh market where live poultry would have been for sale. As such, unlike H5N1 where "direct" contact was the key to infection, simple "proximity" to diseased poultry can seemingly cause infection with H7N9. Perhaps one of the reasons for the rapid spread versus H5N1.

7) Once H5N1 infected a bird, symptoms became readily apparent often ending in the birds death. Not so with H7N9 which can seemingly be carried by an infected bird without showing itself, thus making it extraordinarily more difficult to detect a carrier of the disease.

So how does any of this have anything to do with Novavax (NVAX)?

I have been following Novavax since late fall 2005 when the world experienced the scare associated with Avian Flu strain H5N1. At that time, Novavax had been transitioning itself into a vaccine development company over the two preceding years, led by then President and CEO Dr. Rahul Singhvi. The company had developed a proprietary methodology of creating vaccines using Virus Like Particles, or VLP. While the science involved differed dramatically from other vaccine development technologies at the time, (predominantly egg-based), what made it most interesting was the short time required to develop and manufacture a vaccine using VLP, which was under 12 weeks from the time of mapping the strain. Comparatively, it can take more than 6 months to produce an egg-based vaccine against the same strain.

In August of 2005, Novavax first reported preclinical results for a potential pandemic flu vaccine relating to the H9N2 strain. Given the apparent ability of VLP technology to develop immunogenic vaccines against flu strains, it came as no surprise that, in late fall 2005 when Indonesia was hit with a new clad of H5N1, Novavax shares went through the roof, going from under $1.00 in mid-August of 2005, to over $8.00 by mid-March 2006. It helped that NVAX was announcing strategic collaborations and partnerships in February of 2006, thus adding fuel to investors fire, hoping NVAX would be called upon by Government to develop vaccines in the event of a pandemic. While great for day-traders and short-term investors, the run-up was unfortunately all hype for any long-term investors hoping to hold NVAX shares through to the ultimate development and FDA approval of a marketable pandemic flu vaccine. Over the following three years, the share price slowly retreated to pre-H5N1 levels, reaching $0.85 by February 2009.

Again in 2008, and well into 2009, the world once again had a legitimate threat from a flu outbreak, this time H1N1. While not nearly as deadly, the spread of the virus was substantial enough to have the WHO actually deem it a pandemic. Again, Novavax was focused on by investors due to their vaccine development technology. Unlike in 2005/2006, NVAX had actually gone through a great deal of clinical testing on both H5N1 and seasonal influenza vaccines, completing Phase I and Phase IIa trials of various types on both by the time of the H1N1 outbreak. In addition, Novavax had announced strategic partnerships with Cadila Pharmaceuticals of India and GE Healthcare to develop pandemic influenza vaccines. While they had made great strides, the company was still not in a position to profit from any type of pandemic influenza. Despite this fact, investors once again bought into the hype, (partially brought on by NVAX's publication of pre-clinical trial results relating to H1N1 in April of 2009), which pushed the price per share to over $6.00 by August of 2009.

Fast-forward four years to today. What has changed that would make Novavax any more capable of profiting from a potential pandemic than in 2008/2009? Well, a number of things:

1) In late 2009, Novavax conducted a pivotal study, in partnership with Avimax Laboratories of Mexico, wherein they tested safety and immunogenicity of their VLP vaccine against H1N1 on 1000 healthy adults using three separate doses. The results were resoundingly positive. As such, Novavax had now proven safety and immunogenicity of their VLP based vaccines for H5N1, H1N1 and seasonal influenza on humans across several separate Phase I and II studies.

2) In February 2011, Novavax announced a licensing and manufacturing agreement with LG Life Sciences (LGLS) for predominantly the South Korean market as it related to Novavax's VLP based influenza vaccines. Under the agreement, LGLS was to provide up-front capital and milestone payments, as well as royalty payments once any vaccine was commercialized. It was quickly becoming NVAX's strategy to regionalize their manufacturing and commercialization efforts to better position themselves for any future pandemic in the event they would be called upon by any country's government to quickly develop a vaccine.

3) In March of 2011, Novavax announced a seasonal and pandemic influenza vaccine development contract with the US Department of Health's Office of Biomedical Advanced Research and Development Authority (BARDA). Under the terms of the contract, Novavax would receive $97M over the first three years, throughout which time the company would be responsible for conducting three additional clinical trials of their VLP pandemic influenza vaccine using different adjuvents, a phase II dose ranging trial and a phase III registration trial for their seasonal influenza vaccine, as well as being responsible for the development of a manufacturing facility capable of producing finished vaccine within 12 weeks and at least 60M doses within 6 months of a pandemic declaration. Clearly Novavax was being taken seriously by the US Government and had proved the legitimacy of their technology.

4) In April 2011, the company announced a change in leadership, appointing Stanley Erck to the position of President and CEO, the same position he had held at another vaccine development company, (Iomai Corporation), from 2000-2008. The change signaled Novavax's seriousness in not only managing the BARDA contract, but in establishing a solidified strategic direction for the company, something that had been lacking for years on end.

Since the BARDA contract was announced, Novavax has:

a) Completed a Phase II seasonal influenza trial under the contract and is about to begin another phase II dosing trial.

b) Completed two clinical trials of their pandemic influenza vaccine using two different adjuvents.

c) Secured a suitable manufacturing facility and are very near to having it fully set up to meet the requirements of the BARDA contract

As a result of the above, Novavax recently announced that BARDA had conducted an in-process review and decided progress to date was sufficient to continue under the terms of the contract.

Novavax presented a corporate update on May 1, 2013 at the Needham Annual Healthcare Conference held in New York. In discussing BARDA's goals in supporting NVAX, Stanley Erck explained that BARDA wanted four things:

a non-egg based system of producing pandemic influenza vaccines
a vaccine having a robust immunogenic response
a vaccine that could be developed using an adjuvent that would reduce the dosage required while still achieving a high immunogenic response
a vaccine that can be manufactured quickly (comparative to current egg-based vaccines)
Novavax meets all four of these requirements. In fact, with the adjuvent, NVAX's vaccine had seroconversion and seroprotection rates of 87% to 100% at all doses, including a 3.75ug dose, which represents an extraordinarily high immunogenic response.

What investors may find interesting is on page 27 of the slide presentation where two extremely important points were made:

1) Novavax's avian influenza antigen is as, or more, immunogenic than any other similar antigen described in any published material to date

2) Their pandemic influenza vaccine has met regulatory immunogenic criteria for accelerated approval in the event of a pandemic, both in the US and Europe

Given the BARDA contract, clinical trial results, manufacturing readiness, (which should be fully completed within the next several months), and their qualification for accelerated regulatory approval, investors may want to consider NVAX as part of their investment portfolio this time around. Unlike in 2005/2006, and again in 2008/2009, NVAX is no longer hype. The company could definitely be in a position to profit from H7N9 in the event this influenza strain continues to spread.

In the meantime, however, NVAX has implemented what will be a much more lucrative long-term strategy than they had 3 years ago, that being the development of a vaccine for Respiratory Syncytial Virus (RSV). While a flu pandemic would certainly be profitable, a company should not depend on such an event for its financial future. As such, NVAX has chose to focus on a virus which currently has no available vaccine, yet there are more than 12 million RSV related illnesses across the world's largest markets each year, including more than 3 million in the US alone. Each year in the US, there are 75,000 to 125,000 hospitalizations of infants due to RSV and 175,000 hospitalizations for elderly, (leading to approximately 14,000 deaths).

Novavax partnered with PATH on the development of the vaccine and has so far completed a phase I study in healthy adults, have reported top-line data for a phase II clinical trial in women of child bearing age and have fully enrolled their phase I trial for healthy individuals over the age of sixty, which will be starting in the coming weeks. Given the very positive safety and efficacy profile of the vaccine to date, it would appear Novavax is on its way to the first approved vaccine treatment for RSV. Although ultimate approval based on phase III studies and an NDA submission to the FDA should not be expected anytime before 2015, it should be noted that the possibility of more than $1B in annual revenues associated with such an approved vaccine is not out of the question.

Beyond their more focused and sustainable strategy, NVAX, due to partnerships with PATH and BARDA, as well as the timely issuance of shares, have enough cash to get them through to 2015. As such, there should not be any near-term dilutive share offerings.

So, does NVAX present a much better investment now than ever before . . . without question. When investors flocked to NVAX in 2005/2006 due to H5N1, then again in 2008/2009 due to H1N1, the gains were based on hope, not tangible value. This time around, Novavax is a much different company and in a much more advanced phase of development. If H7N9 continues to escalate, it is not at all improbable that the US Department of Health or any other foreign government agency would call upon Novavax to quickly develop and manufacture a suitable vaccine on an accelerated basis. As such, as news continues to come out of China, I would look to NVAX for a potential investment. Given the current price-point and recent pull-back, I really don't see a great deal of downside, even for long-term investors who see the value in their RSV vaccine development. In the end, their current market cap only sits at a very minimal $325M and could potentially reach over $1B in the coming 18-24 months just on the valuation associated with RSV alone, meaning a share price over $6.50. If a pandemic scare becomes more realistic, and as evidenced in the past, the price will get to $6.50 much, much sooner, only this time, it would be deservedly so.

[dothedd]

May 10, 2013, 8:00 a.m. ET. Novavax H7N9 VLP Influenza Vaccine Enters Animal Testing

Novavax H7N9 VLP Influenza Vaccine Enters Animal Testing

-- Novavax H7N9 VLP vaccine produced, purified and entered into preclinical
immunogenicity and efficacy studies in less than a month

-- Production of GMP H7N9 clinical trial materials underway ROCKVILLE, Md., May 10, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that it has completed purification of a lot of A/Anhui/1/13 H7N9 virus-like particle (VLP) vaccine and initiated animal immunogenicity and efficacy studies, including studies intended to evaluate protection against wild-type viral challenges. Novavax began work on the strain in early April. Analysis and optimization of the gene sequences for the key viral hemagglutinin (HA) and neuraminidase proteins, synthesis of the genes, construction of a recombinant baculovirus vector, infection of insect cells, purification of the first batches of VLP vaccine, and administration to animals were all completed in 28 days.

In October 2012, the company reported top-line data from its two Phase I clinical trials of A/H5N1 vaccine conducted under the company's $179 million contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). These trials showed that the VLP avian influenza vaccine was immunogenic at conventional doses without adjuvant and induced strong immunogenicity in all its adjuvanted dose groups including the lowest dose of 3.75ug. In addition to vaccine homologous antibody responses, cross clade immunity was also demonstrated. Such immunity could be important if a pandemic virus undergoes antigenic drift during a vaccine campaign.

"The Novavax team has demonstrated that recombinant vaccine technology can be used to rapidly move from identification of a lethal virus, to production of a vaccine," said Dr. Gregory Glenn, Novavax' Chief Medical Officer. "Based on our recent clinical trials with A/H5N1 vaccine that induced 100% seroprotection using low doses of an otherwise poorly immunogenic vaccine, we are optimistic that our A/H7N9 VLP may induce strong immune responses and perform well in animal efficacy testing."

"While our recent A/H5N1 clinical results help demonstrate the potential efficacy and immunogenicity of our pandemic VLP vaccines, we always believed the true test of our platform would be its ability to respond rapidly to an emerging pandemic threat," added Stanley C. Erck, President and Chief Executive Officer. "We have committed to this A/H7N9 campaign without outside funding."

About VLPs and Novavax' Vaccine Program

VLPs are self-assembling protein structures that resemble the external structure of viruses, elicit broad and strong antibody and cellular immune responses but lack the live genetic material that causes viral replication and infection. VLPs contain three of the major structural virus proteins that are important for fighting influenza: hemagglutinin and neuraminidase, both of which stimulate the body to produce antibodies that neutralize the influenza virus and prevent its spread through the cells in the respiratory tract, and matrix 1, which stimulates cytotoxic T lymphocytes to kill cells that may already be infected. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable recombinant cell-culture technology. Novavax' VLP-based vaccine candidates are produced more rapidly than egg-based vaccines because of our cell-culture technology platform combined with single-use bioprocessing technology employed strategically throughout the manufacturing process.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com

[dothedd]

Novavax Produces MERS-CoV Vaccine Candidate

ROCKVILLE, Md., June 6, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced today that it had successfully produced a vaccine candidate designed to provide protection against the recently emerging Middle East Respiratory Syndrome Coronavirus (MERS-CoV). The vaccine candidate, which was made using Novavax' recombinant nanoparticle vaccine technology, is based on the major surface spike (S) protein. The Company believes that its MERS-CoV vaccine candidate may provide a path forward for a vaccine for this emerging threat.

MERS-CoV is a novel coronavirus first identified in September 2012 by an Egyptian virologist, who isolated the previously unknown coronavirus from the lungs of a 60-year-old patient with pneumonia and renal failure. To date, the World Health Organization (WHO) has reported a total of 53 laboratory-confirmed cases of infection with MERS-CoV, including 30 deaths. The newly emergent virus is a part of the coronavirus family that includes the severe acute respiratory syndrome coronavirus (SARS-CoV), first recognized as a global threat in March 2003 and by July 2003, had resulted in 8,098 SARS cases in 26 countries, with 774 deaths.

Novavax had previously produced a recombinant nanoparticle vaccine candidate for the SARS-CoV virus which was similarly based on its major surface S protein. Novavax' SARS-CoV vaccine candidate study demonstrated immunogenicity and complete protection of animals in a live viral challenge; the study was published in the journal Vaccine (online 14 July, 2011).

MERS-CoV was first reported in Saudi Arabia and has spread to Europe, including England, France, Germany and most recently Italy. Health officials do not know how the newly discovered MERS-CoV spreads, making the development of an effective vaccine an important public health priority.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.

[dothedd]

VERY GREAT NEWS: 

Novavax Appoints Barclay “Buck” Phillips as Senior Vice President and Chief Financial Officer

Rockville, MD (June 24, 2013)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced the appointment of Barclay A. “Buck” Phillips to the position of Senior Vice President and Chief Financial Officer, effective June 24, 2013. He will be responsible for managing Novavax’ finance, treasury and communications functions.

Prior to joining Novavax, Mr. Phillips was Senior Vice President and Chief Financial Officer of Micromet, Inc. which was acquired by Amgen in 2012. Previously, he was Managing Director of Vector Fund Management and a Biotechnology Analyst and Director of Venture Investments at Invesco Funds Group, Inc.

“Buck is a well-known and talented executive with more than 20 years of experience in life-science investing and financial management,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “His insights into the biotechnology industry, corporate finance and the development of novel biotechnology products will be invaluable as we continue to develop and expand our pipeline of vaccine candidates and move toward commercial operations. I am delighted to welcome Buck to our executive team and look forward to his contributions to our future success.”
“I believe Novavax has the right platform technology, product candidates and people to rapidly deliver novel vaccines to the market,” said Mr. Phillips. “I am very excited to join the team that has the opportunity to contribute to the company’s future success.”

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax’ worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company’s website, www.novavax.com.

[dothedd]

June 25, 2013, 5:01 PM ET

Novavax Inc. , a vaccine developer based in Rockville, Md., hired Barclay A. “Buck” Phillips as its chief financial officer. He was most recently CFO of Micromet Inc., according to a press release. His predecessor, Frederick W. Driscoll, received compensation in 2012 valued at $496,835, according to a proxy filing.

[jarrett1]

Hey you its me....but its not the id you see come and visit me and the "pack" at Market Talk...like the old daze!

[dothedd]

I'd recognize those wings anywhere ... on my way over for a quick chat.