NOVAVAX

[dothedd]

NOVAVAX
New cGMP Manufacturing Site
Additional 74,000 sq ft
Phase 3 and commercial launch

www.wsw.com/webcast/roth26/nvax/3__Slide5.JPG

THERE IS ALSO SOME VERY IMPORTANT INFORMATION ON PAGE "4".

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NOVAVAX Reports Fourth Quarter and 2011 Year-End Financial Results

Rockville, MD (March 09, 2012)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced financial results for the fourth quarter and year ended December 31, 2011.

For the fourth quarter of 2011, Novavax reported a net loss of $3.7 million, or $0.03 per share, compared to a net loss of $6.3 million, or $0.06 per share, in the fourth quarter of 2010. For 2011, the company reported a net loss of $19.4 million, or $0.17 per share, compared to a net loss of $35.7 million, or $0.34 per share, for 2010. The decrease in the net loss in 2011 compared to 2010 was primarily due to revenue recognized under the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) agreement, as well as lower spending as a result of fewer on-going clinical trials during 2011.

At December 31, 2011, Novavax had cash, cash equivalents and short-term investments of $18.3 million compared to $31.7 million at December 31, 2010.

Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: “The past year has been transformational for our company as we landed two government contracts and one commercial partnership, and from a financial perspective reduced our net loss by almost fifty percent.

We now have three promising vaccine candidates in clinical testing, funding from BARDA to take our seasonal and pandemic influenza vaccines through late-stage testing and BLA filing, a new research program in foot-and-mouth disease, advancing international collaborations in India and Asia and new U.S. manufacturing and office facilities to support our expansion and commercial plans. In addition, we have made several significant key hires to strengthen our team in pivotal functional areas of the company including clinical, regulatory, manufacturing and process development. With the caliber of people we are attracting to Novavax, I am confident that we now have the expertise, commitment and vision to execute our vaccine development programs successfully. These achievements reflect the significant progress we have made to realize the clinical and commercial potential of our virus-like particle (VLP) and recombinant nanoparticle vaccine technology platforms.”

Key highlights of 2011:

•In February 2011, we were awarded a $97 million 3-year contract from BARDA to develop and scale-up our seasonal and pandemic influenza vaccine candidates. BARDA has an option to extend our contract for an additional $82 million over a 2-year extension period.

During 2011, we recognized revenue of approximately $15 million, made significant progress in product characterization and
production scale-up and are progressing forward with our multi-year clinical-development program.

•We conducted a Phase I clinical trial testing our vaccine candidate against respiratory syncytial virus (RSV) in 150 healthy adults in a blinded, placebo-controlled, escalating-dose study. In October 2011, we presented interim top-line data from the trial at the 5th Vaccine and ISV Annual Global Conference. The positive results were consistent with pre-clinical studies and showed that the vaccine candidate was well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV.

•During 2011, the company made the following senior-executive appointments: Stanley C. Erck was named President and Chief Executive Officer, Louis Fries III M.D., was named Vice President, Clinical and Medical Affairs, Gregory Glenn, M.D., was named Senior Vice President and Chief Medical Officer, Timothy Hahn, Ph.D., was named Senior Vice President of Manufacturing and Process Development, Jane Halpern, Ph.D., was named Vice President Regulatory Affairs, Erica Shane, Ph.D., was named Vice President Process Development and Russell P. Wilson was named Senior Vice President, Business Development. In early 2012, the company appointed Mervyn L. Hamer as Vice President, Manufacturing and John A. Herrmann III, J.D. as Vice President, General Counsel and Secretary.

•In February 2011, we entered into a licensing agreement with LG Life Sciences (LGLS) that allows LGLS to use our VLP technology to develop and commercialize our influenza vaccines in South Korea and certain other emerging-market countries. LGLS holds an exclusive license to our influenza VLP technology in South Korea and a non-exclusive license in the other specified countries.

•In November, we announced a long-term lease arrangement to occupy 74,000 square feet of manufacturing, laboratory and office space in two facilities in Gaithersburg, MD. The main facility will become the primary commercial-scale manufacturing facility for production of the company’s vaccines after moderate modifications that are expected to be completed in 2012.

•CPL Biologics (CPLB), our joint venture in India with Cadila Pharmaceuticals Ltd., is developing a promising new rabies vaccine developed by Novavax for which it is now conducting toxicology studies prior to initiating human clinical trials. CPLB has also completed validation testing of its new manufacturing facility to produce clinical and commercial supplies of influenza and rabies vaccine candidates and has made excellent early-stage progress with the development of other new vaccine candidates.

•In October, Novavax was awarded a $1.3 million contract with the U.S. Department of Homeland Security to develop a VLP vaccine countermeasure to protect the United States from foot-and-mouth disease (FMD), a highly contagious viral disease of livestock and a potential threat to U.S. agriculture. The company will use these funds over the next two and a half years to develop a VLP that, unlike current FMD vaccines, would not require the use of infectious FMD virus to be manufactured.

•We continued to present our clinical findings at medical and scientific conferences throughout the year, including the 7th World Health Organization Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials at which we presented the final positive results of our H1N1 VLP seasonal influenza study in Mexico. We also published results from this study in the journal Vaccine and the results from our Phase I/IIa pandemic H5N1 influenza study in Journal of Virology.

•In March 2012, we initiated a Phase II trial under our BARDA contract to select the optimal dose of our quadrivalent seasonal influenza VLP vaccine candidate. We also expect to initiate a dose-confirmatory Phase II trial later this year.

•We expect to launch two Phase I trials of our H5N1 VLP influenza vaccine candidate utilizing multiple adjuvants under our BARDA contract.

•We expect to initiate Phase II trial later this year.

•We expect to initiate two dose-ranging Phase I/II trials of our RSV vaccine candidate in the elderly and in women of child-bearing age.


Conference Call

Novavax’s management will host its quarterly conference call today at 10:00 a.m. EDT today. The live conference call will be accessible on Novavax’s website at www.novavax.com under “Investor Info/Events” or by telephone at 1 [phone] (Domestic) or 1 [phone]

(International). A replay of the webcast will be available on the Novavax website for 90 days after the call and a replay of the conference call will be available beginning today at 1:00 pm through May 09, 2012. To access the replay of the conference call, dial 1 [phone] (Domesti c) or 1 [phone] (International) and enter passcode 55983197.

[moon/Laura]

[dothedd]

WOW!!!

Thank you MOON!!!

dot





Take the day off and eat some ... you deserve it!!!

[dothedd]

Mar 15, 2012 10:07:22 GMT -5 moon/Laura said:

NOVAVAX to Present Results From Phase I RSV Study at XIV International Symposium on Respiratory Viral Infections

ROCKVILLE, Md., March 22, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced today that Louis F. Fries III, M.D., its Vice President, Clinical and Medical Affairs, will present results from the company's Phase I clinical trial of its recombinant nanoparticle vaccine candidate against respiratory syncytial virus (RSV) on March 24 and 26, 2012 at the XIV International Symposium on Respiratory Viral Infections in Istanbul, Turkey.

Dr. Fries will discuss results from the blinded, placebo-controlled, escalating-dose trial in separate poster and oral presentations at the conference. In October 2011, Novavax reported interim results from this trial which were consistent with preclinical studies and showed that the vaccine was well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV.

Dr. Fries stated: "These presentations provide Novavax with the opportunity to report on our Phase I safety and immunogenicity data to an audience of international experts in respiratory viral infections and vaccines. We will discuss the short-term and six month safety of the RSV nanoparticle vaccine in young adults. We will also describe the immunogenicity of our RSV vaccine, as measured by virus neutralization activity, and other immune evaluations that may be associated with protection against RSV. RSV is the most important viral respiratory disease of children globally and a cause of significant morbidity and mortality in the elderly. There is a clear need for an RSV vaccine for these age groups. The data from this trial are very encouraging, and suggest that the RSV nanoparticle vaccine has potential to elicit the level and type of immunity required to protect humans."

Later this year, Novavax expects to initiate two separate dose-ranging Phase II trials of its RSV vaccine candidate in the elderly and in women of child-bearing age. These separate trials will be conducted with, and without, an adjuvant and will provide both safety and immunogenicity results in these different age populations.

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 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.

[dothedd]

Novavax, Inc., 9920 Belward Campus Drive, Rockville, MD, USA

"Despite existing vaccines and specific therapies, epidemics of seasonal influenza annually claim 200,000–500,000 lives worldwide. Pandemic influenza represents an even greater threat, with numerous potentially pandemic viruses circulating in nature. Development of multi-specific vaccines against multiple pandemic or seasonal strains is important for human health and the global economy. Here we report a novel virus-like particle (VLP) platform that contains three hemagglutinin (HA) subtypes. This recombinant vaccine design resulted in the expression of three HA subtypes co-localized within a VLP. Experimental triple-HA VLPs containing HA proteins derived from H5N1, H7N2, and H2N3 viruses were immunogenic and protected ferrets from challenge from all three potentially pandemic viruses. Similarly, VLPs containing HA subtypes derived from seasonal H1N1, H3N2, and type B influenza viruses protected ferrets from three seasonal influenza viruses. We conclude that this technology may represent a novel strategy for rapid development of trivalent seasonal and pandemic vaccines."

Influenza virus-like particle can accommodate multiple subtypes of hemagglutinin and protect from multiple influenza types and subtypes Original Research Article

Vaccine, Volume 29, Issue 35, 11 August 2011, Pages 5911-5918
Peter Pushko, Melissa B. Pearce, Attiya Ahmad, Irina Tretyakova, Gale Smith, Jessica A. Belser, Terrence M. Tumpey

The conventional egg-grown influenza vaccines are trivalent. To test the feasibility of using multivalent influenza virus-like particles (VLPs) as an alternative influenza vaccine, we developed cell-derived influenza VLPs containing the hemagglutinin (HA) of the H1 subtype virus A/PR/8/34 or the H3 subtype virus A/Aichi/2/68 (X31). Mice immunized intramuscularly with bivalent influenza VLPs containing H1 and H3 HAs induced neutralizing activities against the homologous and closely related H1N1 strains A/PR/8/34 and A/WSN/33 as well as the H3N2 strains A/Aichi/2/68 (X31) and A/Hong Kong/68, but not the A/Philippines/2/82 strain isolated 14 years later. HA sequence and structure analysis indicated that antigenic distance could be a major factor in predicting cross-protection by VLP vaccines. The bivalent influenza VLP vaccine demonstrated advantages in broadening the protective immunity after lethal challenge infections when compared to a monovalent influenza VLP vaccine. High levels of the inflammatory cytokine IL-6 were observed in naïve or unprotected immunized mice but not in protected mice upon lethal challenge. These results indicate that multivalent influenza VLP vaccines can be an effective antigen for developing safe and alternative vaccine to control the spread of influenza viruses.

Abstract

Despite existing vaccines and specific therapies, epidemics of seasonal influenza annually claim 200,000–500,000 lives worldwide. Pandemic influenza represents an even greater threat, with numerous potentially pandemic viruses circulating in nature. Development of multi-specific vaccines against multiple pandemic or seasonal strains is important for human health and the global economy. Here we report a novel virus-like particle (VLP) platform that contains three hemagglutinin (HA) subtypes. This recombinant vaccine design resulted in the expression of three HA subtypes co-localized within a VLP. Experimental triple-HA VLPs containing HA proteins derived from H5N1, H7N2, and H2N3 viruses were immunogenic and protected ferrets from challenge from all three potentially pandemic viruses. Similarly, VLPs containing HA subtypes derived from seasonal H1N1, H3N2, and type B influenza viruses protected ferrets from three seasonal influenza viruses. We conclude that this technology may represent a novel strategy for rapid development of trivalent seasonal and pandemic vaccines.

CONTINUED:
www.sciencedirect.com/science/article/pii/S0264410X11009327

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Biotechnology Firm of the Year – Novavax, Inc.

Novavax, Inc., which is based in Rockville, Md., is a clinical-stage biopharmaceutical company that is developing next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza, H1N1 and respiratory syncytial virus (RSV). Most recently, the company's breakthroughs have led to both a landmark flu vaccine multi-year contract with the Department of Health and Human Services Office of Biomedical Advanced Research and Development Authority valued at $179 million and a licensing agreement with a South Korean drug maker for the advanced clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza.

www.tcmtechawards.com/2011winners_2.html

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NOVAVAX Reports Progress Under Joint Venture in India with Cadila Pharmaceuticals

www.novavax.com/download/releases/Novavax%20-%20Cadila%20Joint%20Venture%20Progress%20Report%202012-01-03.pdf

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NOVAVAX Launches Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate

ROCKVILLE, Md., May 2, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced today that it has begun enrollment in a Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent a potential pandemic disease due to A/H5N1 avian influenza viruses ("bird flu"). This randomized, observer-blind, dose-ranging, placebo-controlled trial is being conducted under the company's contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (HHS BARDA). The goal of the trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate Novavax is developing under the HHS BARDA contract and determine the vaccine's immunogenicity with and without the use of an undisclosed adjuvant ("Adjuvant 1").

The Phase I trial will enroll healthy adult subjects, each of whom will be randomized into one of six treatment groups including varying doses of A/H5N1 VLP vaccine, with or without Adjuvant 1, or placebo. The trial is being conducted in a stepwise manner, enrolling increasing number of subjects, until a target of approximately 333 subjects is reached. All subjects will be evaluated for safety and immunogenicity. Trial participants will receive two identical intramuscular injections at a 21-day interval (Day 0 and Day 21) with study follow-up approximately 13 months from the first dose.

Gregory Glenn, M.D., Novavax's Senior Vice President and Chief Medical Officer, stated: "This is an important trial because it will help determine the most appropriate dose for future studies of our avian influenza vaccine candidate, as indicated by the safety of the vaccine, and how closely the vaccine meets the immunogenicity criteria for an accelerated approval of a potential pandemic influenza vaccine set by the FDA's Center for Biologics Evaluation and Research. We remain grateful for HHS BARDA's support for this trial and look forward to completing enrollment and presenting top-line data in the fourth quarter of this year.""

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Responsible Party:

Novavax



ClinicalTrials.gov Identifier:

NCT00519389 History of Changes



Other Study ID Numbers:

H5N1 VLP-1



Study First Received:

August 20, 2007

Last Updated:

March 21, 2012



Health Authority:

United States: Food and Drug Administration



Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

This study has been completed.


First Received on August 20, 2007. Last Updated on March 21, 2012 History of Changes

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This study has been completed.


First Received on August 20, 2007. Last Updated on March 21, 2012 History of Changes

www.novavax.com/go.cfm?do=Page.View&pid=81

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Scroll DOWN to: UPCOMING KEY MILESTONES

www.novavax.com/download/file/Novavax%20Needham%20April%202012.pdf

[dothedd]

FDA

Vaccines, Blood & Biologics

Antibodies From Humans Receiving Investigational Influenza Vaccine Are Effective Against H5N1 (Avian Influenza) and Might Protect Against a Variety of These Viruses

Researchers in the Center for Biologics Evaluation and Research (CBER) have shown that antibodies from people who received high doses of a new type of vaccine against H5N1 (avian influenza or “bird flu”) block the activity of critical parts of this virus. The findings also suggest that the vaccine might protect against a variety of different H5N1 viruses, reducing the need to make new vaccines for each variety of this influenza virus.

Using laboratory tests, the scientists found that these antibodies effectively targeted critical parts of hemagglutinin (HA) and neuraminidase (NA)—the two major proteins on the surface of H5N1 virus. Since HA enables influenza viruses to infect cells and NA helps the infection to spread to new cells, antibodies that disrupt their activity could be effective in protecting against infection by this virus.

CBER previously approved an H5N1 vaccine in 2007. The current report by CBER scientists is the first to describe the quality of the antibody responses in humans to a new H5N1 vaccine that is still undergoing clinical trials sponsored by a pharmaceutical company and is not yet available to the public. Unlike vaccines made from weakened or inactivated whole viruses, the H5N1 vaccine used in these clinical trials is an artificial, virus-like particle (VLP) made up of specific viral proteins. These collections of proteins closely resemble the outside of the H5N1 virus but lack the genes needed for the VLP to reproduce.

Importantly, the VLP in this study was designed to produce several copies of the key section HA and NA linked together, much as they appear on the real H5N1 virus. The CBER scientists found that this arrangement appeared to greatly increase the ability of the vaccine to raise protective antibodies against critical parts of the virus.

Successful development of VLPs as influenza vaccines would offer a rapid, economical response to emerging influenza infections that might cause a pandemic, since it does not require growing viruses in eggs for use as vaccines. The results of the CBER study support further development of vaccines against emerging strains of influenza using this technology.

“H5N1 virus-like particle vaccine elicit cross-reactive neutralizing antibodies in humans that preferentially bind to oligomeric form for influenza hemagglutinin”


Journal of Virology 2011; 85:10945-10954

Doi:10.1128/JVI.05406-11

Authors


Ramadevi Raghunandan, Eloi Kpamegan, Steven Pincus, Gale Smith, and Gregory Glenn
Novavax Inc., Rockville, Maryland 20850

Surender Khurana, Jian Wu, Nitin Verma, Swati Verma, Jod Manischewitz, Lisa R. King, Hana Golding.
Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, Bethesda, MD 20892

www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm276858.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=novavax&utm_content=3

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Novavax Q1 Earnings Conference Call

ir.novavax.com/eventdetail.cfm?eventid=112930

[dothedd]

This NEWS could positively affect two/three of Novavax's Vaccine Candidates.

U.S. may speed approval of 'breakthrough' drugs
May 9, 2012 8:00am EDT

* Companies may do shorter, fewer trials for approval
* Proposal likely to pass as part of FDA user fee bill

By Anna Yukhananov

WASHINGTON, May 9 (Reuters) - Experimental drugs that show a big effect early in development for treating serious or life-threatening diseases would get a faster and cheaper path to U.S. approval, under a proposal likely to become law this year.

U.S. drug regulators would be able to label such treatments "breakthrough" therapies, and work with companies to speed up clinical trials, for example by testing the drugs for a shorter time or enrolling fewer patients.

The U.S. Food and Drug Administration has said it supports the proposal, which is included in both versions of an FDA "must-pass" funding bill currently working its way through Congress and set to be passed by the end of the summer.

The plan fits with President Barack Obama's aim to foster innovation as a means of spurring job creation, and may pacify some critics who say the FDA lags European countries in approving new medicines or medical devices.

Dr. Janet Woodcock, head of the FDA's drugs center, has said the FDA needs more flexibility to bypass "business as usual" when it sees unexpected effects, or when a new medicine can greatly help patients.

"What happens when you have a breakthrough drug that shows an effect that's never been seen before?" she told reporters in March, discussing the proposal.

"If we'd done business as usual during the AIDS epidemic, we would have never controlled that epidemic," Woodcock said.

During a spike in new cases of AIDS in the early 1990s, the FDA created an "accelerated approval" process to get new AIDS drugs to the market more quickly by allowing companies to show indirect measures of how the drug helped people.

Jeff Allen, executive director of Friends of Cancer Research, said the time was right for another avenue to speed innovative treatments to patients.
Allen said new understanding of human biology and of diseases meant companies could create more effective drugs, but with fewer side effects, because they would be more targeted to specific patients or disease types.

He said a good example was Roche Holding AG's skin cancer drug Zelboraf, approved last year; people taking the pill were 63 percent less likely to die from melanoma than people on standard chemotherapy.
There was also Pfizer Inc's targeted lung cancer drug Xalkori, which could shrink or eliminate tumors in 10 to 12 months for people with a specific genetic mutation.

"The most promising drugs show an effect early," Allen said. "(But) there's a mentality among drug developers or FDA reviewers that you have to go through this multi-step approach" to get a drug to market.
"We're hoping to encourage getting away from that," he said.

Allen said the FDA would retain its power to require companies to do post-approval studies, or withdraw drugs from the market if initial evidence of benefit was not shown in follow-up trials.


NOVAVAX Launches Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate
Rockville, MD (May 2, 2012)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) announced today that it has begun enrollment in a Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent a potential pandemic disease due to A/H5N1 avian influenza viruses (“bird flu”). This randomized, observer-blind, dose-ranging, placebo-controlled trial is being conducted under the company’s contract with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (HHS BARDA). The goal of the trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate Novavax is developing under the HHS BARDA contract and determine the vaccine’s immunogenicity with and without the use of an undisclosed adjuvant (“Adjuvant 1”).
CONTINUED:
www.novavax.com/download/releases/Novavax%20Launches%20Phase%20I%20Pandemic%20Flu%20Study%205-2-2012.pdf

NOVAVAX Launches Additional Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate
Rockville, MD (May 09, 2012)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) announced today that it has begun enrollment in a second Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent potential pandemic disease due to A/H5N1 avian influenza viruses (“bird flu”). This randomized, observer-blind, dose-ranging, placebo-controlled trial is being conducted under the company’s contract with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (HHS BARDA). The goal of this trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate Novavax is developing under the HHS BARDA contract and determine the vaccine’s immunogenicity with and without the use of an undisclosed adjuvant (“Adjuvant 2”).
www.novavax.com/download/releases/Novavax%20Launches%202nd%20Phase%20I%20Pandemic%20Flu%20Study%20JH_LF.pdf

NOVAVAX to Report Top-Line Results from Phase I Respiratory Syncytial Virus Vaccine Clinical Trial on October 3rd at 5th Vaccine and ISV Annual Global Conference
09/26/11
www.novavax.com/go.cfm?do=Press.ListArchive&Year=2011&pid=39

NOVAVAX to Present Results from Phase I RSV Study at XIV International Symposium on Respiratory Viral Infections
03/22/12
www.novavax.com/go.cfm?do=Press.List&Year=2012

[dothedd]

Mar 10, 2012 16:14:06 GMT -5 dothedd said:

Novavax Fourth Quarter and 2011 Year-End Financial Results
Rockville, Maryland

March 9, 2012 10:00 am

Contact: Frederick W. Driscoll
VP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000

NOVAVAX Reports Fourth Quarter and 2011 Year-End Financial Results
Rockville, MD (March 09, 2012)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced financial results for the fourth quarter and year ended December 31, 2011.

For the fourth quarter of 2011, Novavax reported a net loss of $3.7 million, or $0.03 per share, compared to a net loss of $6.3 million, or $0.06 per share, in the fourth quarter of 2010. For 2011, the company reported a net loss of $19.4 million, or $0.17 per share, compared to a net loss of $35.7 million, or $0.34 per share, for 2010. The decrease in the net loss in 2011 compared to 2010 was primarily due to revenue recognized under the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) agreement, as well as lower spending as a result of fewer on-going clinical trials during 2011.

At December 31, 2011, Novavax had cash, cash equivalents and short-term investments of $18.3 million compared to $31.7 million at December 31, 2010.

Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: “The past year has been transformational for our company as we landed two government contracts and one commercial partnership, and from a financial perspective reduced our net loss by almost fifty percent. We now have three promising vaccine candidates in clinical testing, funding from BARDA to take our seasonal and pandemic influenza vaccines through late-stage testing and BLA filing, a new research program in foot-and-mouth disease, advancing international collaborations in India and Asia and new U.S. manufacturing and office facilities to support our expansion and commercial plans. In addition, we have made several significant key hires to strengthen our team in pivotal functional areas of the company including clinical, regulatory, manufacturing and process development. With the caliber of people we are attracting to Novavax, I am confident that we now have the expertise, commitment and vision to execute our vaccine development programs successfully. These achievements reflect the significant progress we have made to realize the clinical and commercial potential of our virus-like particle (VLP) and recombinant nanoparticle vaccine technology platforms.”

Key highlights of 2011:

• In February 2011, we were awarded a $97 million 3-year contract from BARDA to develop and scale-up our seasonal and pandemic influenza vaccine candidates. BARDA has an option to extend our contract for an additional $82 million over a 2-year extension period. During 2011, we recognized revenue of approximately $15 million, made significant progress in product characterization and production scale-up and are progressing forward with our multi-year clinical-development program.

• We conducted a Phase I clinical trial testing our vaccine candidate against respiratory syncytial virus (RSV) in 150 healthy adults in a blinded, placebo-controlled, escalating-dose study. In October 2011, we presented interim top-line data from the trial at the 5th Vaccine and ISV Annual Global Conference. The positive results were consistent with pre-clinical studies and showed that the vaccine candidate was well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV.

• During 2011, the company made the following senior-executive appointments: Stanley C. Erck was named President and Chief Executive Officer, Louis Fries III M.D., was named Vice President, Clinical and Medical Affairs, Gregory Glenn, M.D., was named Senior Vice President and Chief Medical Officer, Timothy Hahn, Ph.D., was named Senior Vice President of Manufacturing and Process Development, Jane Halpern, Ph.D., was named Vice President Regulatory Affairs, Erica Shane, Ph.D., was named Vice President Process Development and Russell P. Wilson was named Senior Vice President, Business Development. In early 2012, the company appointed Mervyn L. Hamer as Vice President, Manufacturing and John A. Herrmann III, J.D. as Vice President, General Counsel and Secretary.

• In February 2011, we entered into a licensing agreement with LG Life Sciences (LGLS) that allows LGLS to use our VLP technology to develop and commercialize our influenza vaccines in South Korea and certain other emerging-market countries. LGLS holds an exclusive license to our influenza VLP technology in South Korea and a non-exclusive license in the other specified countries.
• In November, we announced a long-term lease arrangement to occupy 74,000 square feet of manufacturing, laboratory and office space in two facilities in Gaithersburg, MD. The main facility will become the primary commercial-scale manufacturing facility for production of the company’s vaccines after moderate modifications that are expected to be completed in 2012.

• CPL Biologics (CPLB), our joint venture in India with Cadila Pharmaceuticals Ltd., is developing a promising new rabies vaccine developed by Novavax for which it is now conducting toxicology studies prior to initiating human clinical trials. CPLB has also completed validation testing of its new manufacturing facility to produce clinical and commercial supplies of influenza and rabies vaccine candidates and has made excellent early-stage progress with the development of other new vaccine candidates.

• In October, Novavax was awarded a $1.3 million contract with the U.S. Department of Homeland Security to develop a VLP vaccine countermeasure to protect the United States from foot-and-mouth disease (FMD), a highly contagious viral disease of livestock and a potential threat to U.S. agriculture. The company will use these funds over the next two and a half years to develop a VLP that, unlike current FMD vaccines, would not require the use of infectious FMD virus to be manufactured.

• We continued to present our clinical findings at medical and scientific conferences throughout the year, including the 7th World Health Organization Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials at which we presented the final positive results of our H1N1 VLP seasonal influenza study in Mexico. We also published results from this study in the journal Vaccine and the results from our Phase I/IIa pandemic H5N1 influenza study in Journal of Virology.

Anticipated events in 2012:

• In March 2012, we initiated a Phase II trial under our BARDA contract to select the optimal dose of our quadrivalent seasonal influenza VLP vaccine candidate. We also expect to initiate a dose-confirmatory Phase II trial later this year.
• We expect to launch two Phase I trials of our H5N1 VLP influenza vaccine candidate utilizing multiple adjuvants under our BARDA contract.
• We expect to initiate two dose-ranging Phase I/II trials of our RSV vaccine candidate in the elderly and in women of child-bearing age.

Collaboration with General Electric Healthcare

As announced in December 2007, Novavax is partnered with GE Healthcare to co-market a pandemic solution that can quickly scale-up production of influenza VLP vaccines at high yields using fully closed, disposable, and mobile equipment. Such an integrated production approach could address issues of cost and timely supply, both relevant for preparing a global vaccine solution for a pandemic situation. A traditional egg-based inactivated influenza vaccine plant with 50 million doses/annum capacity may cost $150-200 million, take four years to build and commission. Furthermore, the only planned U.S. cell-culture facility with capacity of 100 million doses/annum of seasonal flu vaccine has been projected to cost over $1 billion. By way of comparison, a Novavax VLP vaccine plant capacity of 75 to 100 million doses could be built and commissioned for $35-40 million within 24 months. Importantly, this plant would be able to begin shipping VLP vaccine within 12 weeks ensuring a rapid response during a pandemic. And unlike other traditional vaccine plants, the Novavax facility can support other vaccines beyond pandemic. This creates even greater value and vaccine self-sufficiency for the country and its citizens.
www.novavax.com/go.cfm?do=Page.View&pid=10



Press Release: GE Healthcare – 5/10/12
GE Healthcare Life Sciences Completes Acquisition of Xcellerex, Inc.

CHALFONT ST GILES, England--(BUSINESS WIRE)--

GE Healthcare, the healthcare business of GE (NYSE: GE - News) announced today that it has completed the acquisition of Xcellerex, Inc., a supplier of innovative manufacturing technologies for the fast-growing biopharmaceutical industry.

The acquisition expands GE Healthcare’s offering of technologies and services for the manufacture of biopharmaceuticals such as recombinant proteins, antibodies and vaccines, a key area of growth for the company. The strong strategic fit between the two companies, combined with expanded capabilities in product development and marketing, will offer significant customer benefits through complementary product and service offerings.

Commenting on the close, Dr. Nigel Darby, Vice President of BioTechnologies, and Chief Technology Officer, GE Healthcare Life Sciences said, “Xcellerex’s expertise and reputation in technologies for biopharmaceutical manufacturing is a great fit with our business. GE and Xcellerex share a vision that an integrated approach, where we can help customers optimize every stage of their manufacturing process - from start to finish - has the potential to increase production flexibility and to deliver higher yields of finished product while reducing time to market. We believe that combining the skills of the two companies will bring great benefits for our customers in the industry.”

For more information about GE Healthcare Life Sciences’ technologies and services please visit www.gelifesciences.com

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems. Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE - News). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

About Xcellerex, Inc.

Xcellerex is commercializing turnkey biomanufacturing solutions that transform the speed and economics of producing therapeutic proteins, including biosimilars and vaccines. The company’s FlexFactory® is a complete modular and portable production train based on single-use technologies, advanced process automation, and compact clean room architecture.

FlexFactory allows deployment of GMP manufacturing capacity more rapidly and at greatly reduced costs compared with traditional facilities. Through its BridgeSourcing™ services, Xcellerex manufactures a partner’s biomolecules while the partner prepares for commissioning of its own new FlexFactory. When the partner’s facility is ready, Xcellerex deploys its TransPlant™ process to install, validate and train partner personnel in their own FlexFactory. This parallel-path model both accelerates time to clinical and commercial manufacturing and allows partners to manage the development and market risks associated with adding manufacturing capacity.

Xcellerex also leverages its proprietary single use technologies through the sale of XDR bioreactors, XDM Quad Mixers, and related single-use assemblies. To date, more than 20 therapeutic proteins and vaccines have been manufactured for clinical trials using Xcellerex technology. The company employs approximately 135 people and had revenues of approximately $50 million in 2011. For more information, please visit www.xcellerex.com

I have long envisioned GE Healthcare entering the vaccine business and buying Novavax.

[dothedd]

NOVAVAX Launches Additional Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate
Wed May 9, 2012 8:00 AM | about: NVAX

ROCKVILLE, Md., May 9, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX) announced today that it has begun enrollment in a second Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent potential pandemic disease due to A/H5N1 avian influenza viruses ("bird flu"). This randomized, observer-blind, dose-ranging, placebo-controlled trial is being conducted under the company's contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (HHS BARDA). The goal of this trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate Novavax is developing under the HHS BARDA contract and determine the vaccine's immunogenicity with and without the use of an undisclosed adjuvant ("Adjuvant 2").

This Phase I trial is identical in design to the Phase I study launched on May 1, 2012; it will enroll healthy subjects, each of whom will be randomized into one of six treatment groups including varying doses of A/H5N1 VLP vaccine, with or without Adjuvant 2, or a placebo. The trial is being conducted in a stepwise manner, enrolling increasing number of subjects, until a target of approximately 333 subjects is reached. All subjects will be evaluated for safety and immunogenicity. Trial participants will receive two identical intramuscular injections at a 21-day interval (Day 0 and Day 21) with study follow-up approximately 13 months from the first dose.

Gregory Glenn, M.D., Novavax's Senior Vice President and Chief Medical Officer, stated: "This second clinical trial is supporting our efforts to determine the most appropriate dose of our VLP A/H5N1 avian influenza vaccine candidate and which adjuvant, if any, will be used in our future clinical trials. Like the first A/H5N1 trial we initiated on May 1, we believe this trial will provide the data to determine whether our vaccine will fulfill the criteria for an accelerated approval of a potential pandemic influenza vaccine set by the FDA's Center for Biologics Evaluation and Research. Once again, we extend our thanks for HHS BARDA's support for these trials and look forward to completing enrollment and presenting top-line data in the fourth quarter of this year."

About Novavax

Novavax, Inc. 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 .

[dothedd]

Rahul Singhvi, Sc.D., MBA

Dr. Rahul Singhvi is a business leader in the vaccine and pharmaceutical industry. He is Managing Partner and co-Founder of MLV Healthcare Partners (MLVHCP), a New York based merchant bank. [/color]Prior to cofounding MLVHCP, Dr. Singhvi served as the President & CEO of Novavax, Inc, a NASDAQ listed, development stage biotechnology company. During his tenure at Novavax, he transformed Novavax from a distressed specialty pharmaceutical company into a premier vaccine development company. Under his leadership, Novavax’s valuation rose from $35M to almost $300M and enjoyed a robust pipeline of important clinical and preclinical stage vaccine candidates, including those against influenza, respiratory syncytial virus (RSV), and other infectious diseases.

At Novavax, Dr. Singhvi developed a non-dilutive financing strategy through partnerships with governments and international companies. These partnerships included a major contract with the United States government agency HHS-BARDA worth over $179MM that was critical for Novavax to finance its pandemic and seasonal flu vaccines through late stage clinical development. Other key partnerships included those with GE Healthcare (manufacturing), LG Life Sciences (Korea), Cadila Pharmaceuticals Limited (India) and Avimex (Mexico). In addition, Dr. Singhvi raised over $100 million for Novavax through multiple equity financings.

Prior to joining Novavax in 2005, Dr. Singhvi served in a number of positions at Merck & Co., where he helped develop several vaccines, including Zostavax®, the only vaccine on the market to prevent shingles.

Dr. Singhvi was named one of the most influential Marylanders in the healthcare field by The Daily Record in 2010. During the same year, Novavax was named one of the ten most innovative companies in the biotechnology industry by Fast Company magazine. Dr. Singhvi has served as a member of the Clinton Global Initiative and currently serves on the Board of Directors of Immunocellular Therapeutics (OTCBB: IMUC), a US public company working on cancer vaccines.

Dr. Singhvi graduated as the top ranked chemical engineer from IIT, Kanpur, India and obtained both his M.S. and Sc.D degrees in chemical engineering from MIT. He also received an MBA degree from the Wharton School of the University of Pennsylvania where he graduated as a Palmer Scholar.[/b]

submissions.marylandtedco.org/sites/default/files/webform/Rahul%20Singhvi%20Bio.pdf

[dothedd]

NOVAVAX CLINICAL TRIALS

clinicaltrials.gov/ct2/show/NCT01594320?term=novavax&rank=2

clinicaltrials.gov/ct2/show?term=novavax&rank=3

clinicaltrials.gov/ct2/show?term=novavax&rank=4

[dothedd]

Patent application title: RECOMBINANT E-SELECTIN MADE IN INSECT CELLS
Inventors: Gale Smith (Rockville, MD, US) Peter Pushko (Rockville, MD, US) Vittoria Cioce (Rockville, MD, US)
Assignees: NOVAVAX, INC.
IPC8 Class: AA61K3816FI
USPC Class: 514 212
Class name:
Publication date: 10/06/2011
Patent application number: 20110245186


Read more: www.faqs.org/patents/app/20110245186#ixzz1wMMx02fh

www.faqs.org/patents/app/20110245186

COULD BE THE ANSWER FOR ... Multiple Sclerosis?

[dothedd]

3 Reasons To Buy Novavax
June 25, 2012

Novavax (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 technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections.

CONTINUED:

seekingalpha.com/article/680981-3-reasons-to-buy-novavax?source=yahoo

[dothedd]

103. (WO2012061815) RABIES GLYCOPROTEIN VIRUS-LIKE PARTICLES (VLPs)

Latest bibliographic data on file with the International Bureau
PermaLink Bookmark

--------------------------------------------------------------------------------


Pub. No.: WO/2012/061815 International Application No.: PCT/US2011/059602
Publication Date: 10.05.2012 International Filing Date: 07.11.2011

IPC: A61K 39/205 (2006.01)
A HUMAN NECESSITIES
61 MEDICAL OR VETERINARY SCIENCE; HYGIENE
K PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39 Medicinal preparations containing antigens or antibodies
12 Viral antigens
205 Rhabdoviridae, e.g. rabies virus


Applicants: NOVAVAX INC. [US/US]; 9920 Belward Campus Drive Rockville, Maryland 20850 (US) (For All Designated States Except US).
SMITH, Gale [US/US]; (US) (For US Only).
LIU, Ye [US/US]; (US) (For US Only)
Inventors: SMITH, Gale; (US).
LIU, Ye; (US)
Agent: TUSCAN, Michael, S.; Cooley LLP 777 6th Street, N.W. Suite 1100 Washington, District of Columbia 20001 (US)
Priority Data: 61/410,767 05.11.2010 US

Title (EN) RABIES GLYCOPROTEIN VIRUS-LIKE PARTICLES (VLPs)
(FR) PARTICULES DE TYPE VIRAL DE GLYCOPROTÉINE DE LA RAGE (VLP)

patentscope.wipo.int/search/en/detail.jsf?docId=WO2012061815&recNum=103&maxRec=85502&office=&prevFilter=&sortOption=&queryString=oligonucleotide&tab=PCT+Biblio

[dothedd]

NOVAVAX Launches Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate

ROCKVILLE, Md., May 2, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced today that it has begun enrollment in a Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent a potential pandemic disease due to A/H5N1 avian influenza viruses ("bird flu"). This randomized, observer-blind, dose-ranging, placebo-controlled trial is being conducted under the company's contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (HHS BARDA). The goal of the trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate Novavax is developing under the HHS BARDA contract and determine the vaccine's immunogenicity with and without the use of an undisclosed adjuvant ("Adjuvant 1").

The Phase I trial will enroll healthy adult subjects, each of whom will be randomized into one of six treatment groups including varying doses of A/H5N1 VLP vaccine, with or without Adjuvant 1, or placebo. The trial is being conducted in a stepwise manner, enrolling increasing number of subjects, until a target of approximately 333 subjects is reached. All subjects will be evaluated for safety and immunogenicity. Trial participants will receive two identical intramuscular injections at a 21-day interval (Day 0 and Day 21) with study follow-up approximately 13 months from the first dose.

Gregory Glenn, M.D., Novavax's Senior Vice President and Chief Medical Officer, stated: "This is an important trial because it will help determine the most appropriate dose for future studies of our avian influenza vaccine candidate, as indicated by the safety of the vaccine, and how closely the vaccine meets the immunogenicity criteria for an accelerated approval of a potential pandemic influenza vaccine set by the FDA's Center for Biologics Evaluation and Research. We remain grateful for HHS BARDA's support for this trial and look forward to completing enrollment and presenting top-line data in the fourth quarter of this year.""

[Colleenz]

HI DOTT!!!! I Don't read much of it, but please kep posting!

[dothedd]

Morning C....

Thanks for stopping by.

I'm just too busy to Post much, but will when I can.

dot

[dothedd]

Jun 29, 2012 7:37:54 GMT -5 dothedd said:

Morning C....

Thanks for stopping by.

I'm just too busy to Post much, but will when I can.

dot

LOTS GOING ON WITH NOVAVAX ... Check-out the Website Additiions...

www.novavax.com/


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.

[dothedd]

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
Rockville, MD (July 16, 2012)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX), CPL Biologicals (CPLB) and the International Centre for Genetic Engineering and Biotechnology (ICGEB), today announced that they have formed a new collaboration to develop a novel malaria vaccine in India. This unique public-private partnership will combine the advanced vaccine technology of Novavax with the malaria vaccine research capabilities of ICGEB and vaccine manufacturing capability of CPLB, to develop a new and effective malaria vaccine. The project is being funded by India’s Department of Biotechnology Vaccine Grand Challenge Program and will be managed by the Malaria Vaccine Development Program, a New Delhi-based not-for-profit organization established to support the development of malaria vaccines.
CONTINUED:
www.novavax.com/download/releases/Malaria%20ICGEB%20CPLB%20PR%20Final.pdf

[dothedd]

NOVAVAX AND PATH ANNOUNCE PARTNERSHIP
ON RSV VACCINE
....Novavax initially awarded approximately $2 million by PATH
....Potential for future PATH funding of 50% of external costs to develop maternal RSV vaccine available for low-resource countries
....Novavax retains global rights to commercialize RSV vaccine

Rockville, MD (July 18, 2012)–/GlobeNewswire, Inc./-Novavax, Inc. (Nasdaq: NVAX) announced a clinical development partnership with PATH to develop its RSV (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.

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 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 fall 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. Maternal immunization leads to heightened antibodies in infants and thereby protects them against the targeted disease, and thus may be a viable strategy to protect young infants from RSV illness.

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 C. 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.”
“Based on Novavax’s Phase I clinical trial results, we view this RSV vaccine as a promising candidate to address a very large unmet need in infant populations throughout the world, but particularly in low-resource countries,” said Dr. Kathleen Neuzil, director of PATH’s RSV vaccine project. “This collaboration with Novavax also fits well with our goal to collaborate with private and public-sector partners to advance the development of promising vaccines that can be affordable and accessible for people in low-resource countries.”

About Novavax’s RSV Program

Novavax’s recombinant nanoparticle vaccine for the prevention of RSV is comprised of a highly purified RSV fusion (F) protein. In 2011, Novavax announced the results from a blinded, placebo-controlled, dose-escalating Phase I trial to assess the safety and tolerability of aluminum phosphate-adjuvanted and unadjuvanted formulations of our RSV vaccine candidate. The primary safety findings were local pain and tenderness at the site of injection, the majority of which were mild in nature with no dose-related increase observed. There were no observed vaccine-related serious adverse events or trends for related systemic side effects. A secondary objective of the study was to evaluate total and neutralizing anti-RSV antibody responses and assess the impact of the adjuvant. The study enrolled 150 healthy adults 18 to 49 years old who were allocated to six cohorts that included four dose levels of vaccine. The antibody response to the RSV F protein was significantly increased compared to placebo (p<0.001) in all groups and increased by 19-fold in the highest-dose group at day 60. A significant dose-response pattern was observed. High rates of seroconversion were seen at all doses including a rate of 100% at the highest-dose-adjuvant group.

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 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 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.

About PATH
PATH is an international nonprofit organization that transforms global health through innovation. PATH takes an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines and devices to collaborative programs with communities. Through its work in more than 70 countries, PATH and its partners empower people to achieve their full potential. For more information, please visit www.path.org.

[dothedd]

2 Biotech Lottery Tickets, Each For Less Than $2
July 10, 2012

seekingalpha.com/article/712091-2-biotech-lottery-tickets-each-for-less-than-2?source=marketwatch

After Hours

NVAX
/quotes/zigman/55054/quotes/nls/nvax
$
2.14


Change
0.00 0.00%

Volume
Volume 14,932

Jul 18, 2012, 5:21 p.m.

Real time quotes

/quotes/zigman/55054/quotes/nls/nvax Today's close
$ 2.13

$ 2.14

Change
+0.01 +0.47%

Day low
Day high

$2.06
$2.16

Open: 2.12
52 week low
52 week high

$1.12
$2.16


Market cap
$270.56M

Average volume
963,637

P/E ratio
N/A

Rev. per Employee
$165,143

EPS
N/A

Dividend
N/A

Div yield
N/A

Ex dividend date
N/A

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2.202.152.102.0510a11a12p1p2p3p4p5p1d5d3m6m1y3y5y /news/marketwatch/company/us/nvax
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[dothedd]

Recombinant, Insect Cell-Derived
RSV Nanoparticle Vaccine
Gregory Glenn
Chief Medical Officer
MVADS-Copenhagen
4 July 2012

www.novavax.com/download/file/pdf/Our%20Science%20Presentations/RSV%20Nanoparticle%20Vaccine-MVADs%20July%202012%20Nuance.pdf