NOVAVAX

[dothedd]

A good article from Seeking Alpha...APRIL 17, 2011

This article was written by my colleague, Reef Anderson ( See bio on Seeking Alpha), Head of Research at the hedge fund I manage. This article should be published tomorrow under his profile.

Recent news for Novavax (NVAX) was big, but as investors know, the bigger news is yet to come. Novavax is extremely undervalued and the recent pull back from the $3.50 level represents an extraordinary entry opportunity. By the end of summer, I expect Novavax to easily double and I expect to see $11 per share in 2012, returning to its 2002 stock price levels. The details of my analysis will be presented later in this article, but first, I will address the key drivers that make Novavax a compelling “buy and buy more” proposition.

Novel, Patented Technology and Recent Developments

Novavax, Inc. (Novavax) is a biopharmaceutical company focused on developing recombinant vaccines. Recombinant protein-based vaccines are widely used and accepted. Examples of vaccines currently available that use recombinant protein particle technology include Recombivax® HB (Merck: MRK) and Engerix® (GlaxoSmithKline: GSK), which protect against Hepatitis B, and Gardasil® Merk and Cervarix® GlaxoSmithKline which protect against human papillomavirus.

However, the key difference of NVAX is the production technology which uses insect cells rather than chicken eggs or mammalian cells. The technology platform is based on proprietary virus-like particles (VLPs). VLPs are not made from a live virus and have no genetic nucleic material in their inner core, which renders them incapable of replicating and causing disease. This platform offers several potential significant advantages over traditional vaccine production methods, including: (1) higher yields than traditional mammalian or egg-based system, (2) faster facility commissioning time, (3) significantly lower capital expenditures on infrastructure, (4) competitive cost of goods, (5) shorter lead time to produce vaccine than egg-based technology, and (6) a scalable production process that can respond rapidly to pandemic outbreaks, which is a key concern for the U.S. and other Governments.

There are some notable facts and recent developments which attest to the viability, efficacy and superiority of Novavax’s Technology and Pipeline:

1) BARDA Contract Award – In February, 2011, the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) awarded Novavax a contract valued at $97 million for the first 36 month base-period, with an option period of 24 months valued at $82 million, for a total contract value of up to $179 million. The HHS BARDA contract award provides significant funding for the continued ongoing clinical development and product scale-up of seasonal and pandemic influenza vaccine candidates. This is a cost-plus-fixed-fee reimbursement contract in which HHS BARDA will reimburse Novavax for direct contract costs incurred plus allowable indirect costs and a fee earned in the further development of seasonal and pandemic H5N1 influenza vaccines. This award eliminated a significant overhang for the company in that they achieved a significant source of funding and a tremendous increase to its top line revenue. The key to the award is that Novavax’ technology meets HHS’ goals for increasing the capacity to produce flu vaccine in a much shorter time frame, in particular, the ability to enhance pandemic vaccine manufacturing surge capacity. I do not believe Novavax will have any problems achieving the extension of the contract into the second period which will allow them to receive the additional $82 million. The following two examples highlight the company’s ability to achieve shorter time frames and hence increase the probability of the second award:

a. In 2009, using VLP technology, NVAX manufactured an H1N1 VLP vaccine candidate under cGMP at their vaccine manufacturing facility in Rockville, MD within eleven weeks after receiving the gene sequence from the CDC. The company’s named above (Merk and GlaxoSmithKline) typically take over 6 months to ramp up production.

b. Per the company’s form 10-K filed March 28, 2011, “The agreement with Xcellerex expired by its own terms on February 15, 2010. Although the H1N1 manufacturing campaign with Xcellerex did not result in the manufacturing of acceptable vaccine to Novavax, we did achieve proof of concept by scaling-up to a commercial grade bioreactor. The success in scaling-up our VLPs in stir tank bioreactors using single-use disposables potentially provides an additional path to large-scale, commercially viable vaccine production. During 2010, we manufactured multiple large-scale VLP production runs using our 1,000 liter bioreactor in our Rockville, MD facility and have successfully demonstrated that we can produce VLPs at high-yields, a competitive cost per dose of manufactured vaccine at acceptable quality standards.”

2) First Licensing Deal for VLP Vaccine Technology – On March 1, 2011, Novavax announced an exclusive license of its VLP vaccine technology to manufacture, develop and commercialize influenza vaccines in South Korea and certain emerging market countries. Novavax will provide technology transfer and manufacturing support and in return receive upfront and milestone payments from LGLS as well as double-digit royalty rate payments from commercial sales. Dr. Rahul Singhvi, CEO and President of Novavax, commented, “LGLS is an affiliate of LG, a global conglomerate. LGLS is a leading provider of vaccines to supranational health organizations such as UNICEF and the Pan American Health Organization. We welcome this opportunity to develop a recombinant influenza vaccine solution for South Korea and other countries served by LGLS. This new partnership with LGLS is further validation of our VLP technology and, as we have done previously with our joint venture in India with Cadila Pharmaceuticals, further expands our development efforts into new territories. LGLS will help us advance our technology in Korea and other countries, consistent with our commercial strategy of developing regional partnerships and in-country manufacturing solutions with leading pharmaceutical companies around the world.”

3) The company has announced excellent pandemic and seasonal flu vaccine Phase II results.- The Center for Disease Control and Prevention (CDC) has indicated that currently approved seasonal influenza vaccines have shown to be as little as 30% effective in preventing hospitalization for pneumonia and influenza in older adults (CDC link)However, per Dr. Rahul Singhvi, “Data from our Phase IIa trial in healthy adults showed that 50 to 73% of the volunteers immunized with our VLP vaccine had a 4-fold increase in the antibody that blocks NA activity.” This is a marked improvement that increases the probability of FDA approval and subsequent market acceptance.

4) Competing technology remains Egg-based. Below is a table of Novavax’s competitors from the company’s 10-k filed March 28, 2011


Company

Competing Technology Description

sanofi pasteur, Inc.

Inactivated sub-unit (egg-based)

MedImmune, LLC (a subsidiary of AstraZeneca PLC)(AZN)

Nasal, live attenuated (egg-based)

GlaxoSmithKline plc

Inactivated (egg-based)

Novartis, Inc. (NVS)

Inactivated sub-unit (cell and egg-based)

Merck & Co., Inc. (MRK)

Inactivated sub-unit (egg-based)

Cash availability and cash burn

Seasoned biotech investors know that cash is essential to prevent dilution. As per NVAX’s 10-k released March 28, 2011. “Based on our cash, cash equivalents and short-term investment balances as of December 31, 2010, anticipated revenue under the HHS BARDA contract awarded in February 2011, anticipated proceeds from the sales of our common stock under our At the Market Sales Agreement and our current business operations, we believe we will have adequate capital resources available to operate at planned levels for at least the next twelve months.” There are only approximately 14 million shares left that the company can issue in the “At the Market Sales Agreement” and therefore, dilution is minimal. Note, in my valuation below, I assume a larger share increase through 2014 (approximately 27 million shares). There are a few key factors behind this assumption:

1) The HHS BARDA Contract offers Cost Plus payments, some of which include fixed costs. So the incremental costs of additional research have a minimal impact on margins.

2) The variable cost of vaccine manufacture is truly minimal at approximately 15%. This leaves fixed costs, most of which have been incurred in the ramp up of Novavax’s facilities or will be incurred by licensing partners.

Valuation

Novavax has positioned itself to be a major player in several markets:

1) RSV- The company is on track with its respiratory syncytial virus vaccine which targets a $1 billion market opportunity.

2) Pandemic Viruses- Earlier this month, the company presented excellent immunogenicity data from Novavax’ H1N1 vaccine clinical trial conducted in Mexico. Such pandemics represent multi-billion dollar opportunities as was demonstrated by Swine Flu and Avian Flu outbreaks

3) Influenza- Novavax is positioned to emerge as a major influenza vaccine player. Based on the expanding recommendation of vaccination to new age groups, the growing worldwide population to be vaccinated, and the need of an improved influenza vaccine for the elderly, global market projections of seasonal influenza are estimated to increase from $2.8 billion in 2007 to $6.5 billion by 2013. (click here)

Novavax has many potential applications of its technology and pipeline, and the first two applications given above are large. But to be conservative in the valuation estimate, let’s consider only the Influenza application. It should be noted that I expect submission of the BLA for the Seasonal Flu Vaccine next year and Licensing of the Seasonal Flu VLP by 2013.

If we assume that Novavax licenses its Seasonal Flu VLP vaccine and that its partners capture 10% of the projected $6.5 billion market. Also, to be conservative, let's assume we completely ignore upfront licensing payments and assume a royalty of 18% payable to Novavax:

$6.5 billion x 0.10 x 0.18 = $117 million annual royalties

Now, if we also assume that the BARDA grant is extended for 2014 and 2015. Additional Annual revenues would be $41 million per year, for a total of $117 million from royalties + $41 million from BARDA = $158 million total.

Then, given that the licensing strategy will impose relatively low additional fixed and variable costs, let’s assume that operating expenses increase to $42 million per year. Pre-tax income would be approximately $116 million and net income would be approximately $81 million.

As stated above under the cash burn section, let’s assume the company will issue 26% more additional shares taking the shares outstanding from 105 million to 132 million. We derive an EPS of approximately $0.62 per share in 2014 ($81 million / 132 million shares). Discounting annually at 20% and assuming the stock will trade at 30x2014 EPS, fair value for the influenza application alone could be estimated to be $10.70 per share. Clearly, the stock is very undervalued and I expect to see the stock price triple by the end of this year and quadruple by the end of 2012.

[dothedd]

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

Novavax Announces Change in Leadership

Stanley Erck appointed President & CEO

James Young, Ph.D. becomes Chairman of the Board
Rockville, MD (April 19, 2011)–/PRNewswire-FirstCall/-Novavax, Inc. (NASDAQ:NVAX) announced today that Stanley C. Erck, its former Executive Chairman, has been appointed to the position of President and Chief Executive Officer and will remain as a member of the Board of Directors. In addition, current Board member James Young, Ph.D., will assume the position of Chairman of the Board.

Mr. Erck has been an active member of Novavax’s senior management team for the last year and has had extensive experience in the biotechnology sector and has successfully brought infectious disease product candidates into late-stage clinical trials. He also has had significant experience in managing a large advanced development contract with the Department of Health and Human Services. From 2000-2008 Mr. Erck served as President and Chief Executive Officer of Iomai Corporation, leading the company through an initial public offering and a merger with Intercell, an Austrian vaccine company. Prior to Iomai, he served as President and Chief Executive Officer of Procept, a publicly-traded immunology company; as Vice President-Corporate Development at Integrated Genetics (now Genzyme), and in management positions within Baxter International. Mr. Erck received his undergraduate degree from the University of Illinois and his Masters in Business Administration from the University of Chicago Graduate School of Business. Mr. Erck sits on the Board of Directors of BioCryst Pharmaceuticals, MaxCyte and MdBio Foundation.

Dr. Young, who became a Board member in April 2010, has over 30 years of experience in the fields of molecular genetics, microbiology, immunology and pharmaceutical development. He was previously President of Research and Development, including responsibility for regulatory affairs, at MedImmune where he was instrumental in the development of FluMist® and Synagis®. In 2005, Dr. Young was awarded the Albert B. Sabin Humanitarian Award. Prior to MedImmune, Dr. Young was influential in building the department of molecular genetics at Smith Kline & French Laboratories (now part of GlaxoSmithKline) and culminated as Director, Department of Molecular Genetics.

“As the Company continues its transition into a commercial operation, we are pleased to have attracted high caliber professionals such as Stan and Jim to now take the leadership roles at Novavax,” commented Gary Evans, of Novavax’s Board of Directors. We expect these gentlemen will dynamically lead the Company and its vaccine candidates towards important worldwide products. Their strong leadership skills and broad experience in drug development will be invaluable to Novavax as the Company works to advance its infectious disease pipeline of virus-like particle (VLP) vaccine candidates.”

“I am a strong believer in the potential of recombinant-based VLP vaccine technology and was delighted to join Novavax’s Board of Directors in June 2009,” commented Mr. Erck. “Today, I am honored to assume my new role and to lead Novavax in its next phase of growth, including the clinical, regulatory and business development activities that will be required to bring our vaccine candidates to potential commercialization. I also look forward to working and collaborating with the superb team of employees at Novavax as we strive to bring new medical advances with vaccines for subjects with unmet medical needs.”

Mr. Evans concluded, “We would like to especially thank Dr. Rahul Singhvi for his past leadership during important and challenging phases of Novavax’s growth and development. Rahul has served Novavax as its President & CEO for the past 6 years, and during that time he has been instrumental in positioning the Company for success with our VLP vaccine candidates. We all wish him nothing but the best in his future endeavors and will be anxiously watching for his next achievements.”

About Novavax

Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company’s proprietary VLP technology and single-use bioprocessing system enables rapid vaccine development and production where and when it’s needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India.

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

[dothedd]

NOVAVAX Appoints Stanley Erck to Board of Directors
6/26/2009

Novavax Appoints Stanley Erck to Board of Directors

Rockville, MD – June 26, 2009 – Novavax, Inc. (Nasdaq: NVAX) announced today the
appointment of Stanley Erck to the company's Board of Directors. Mr. Erck has more
than twenty five years of experience in the biotechnology and health-care industries and
served most recently as President and Chief Executive Officer of Iomai Corporation, a
developer of vaccines and immune system therapies that was acquired in 2008 by
Intercell. Previously, Mr. Erck was President and Chief Executive Officer of Procept, a
publicly traded immunology company, Vice President of Corporate Development at
Integrated Genetics (now Genzyme), and in management positions at Baxter
International. His appointment brings the number of Novavax board members to nine.
John Lambert, Chairman of the Board of Novavax, stated: "We are pleased to have
Stanley Erck join our board and bring his pharmaceutical knowledge and many years of
experience in vaccine development to our company. He has a strong record of
achievement in building successful companies, a keen understanding of the market for
infectious disease products and valuable experience in working with public health
agencies. We welcome his anticipated contributions to our future success as we expand
our pipeline of promising vaccine candidates."

Mr. Erck is also a Director of BioCryst Pharmaceuticals, MaxCyte, Inc. and MdBio
Foundation. He received his undergraduate degree from the University of Illinois and his
masters in business administration from the University of Chicago.

ABOUT NOVAVAX

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biotechnology company creating novel
vaccines, including H1N1, to address a broad range of infectious diseases worldwide
using advanced proprietary virus-like-particle (VLP) technology. The company produces
these VLP-based, potent, recombinant vaccines utilizing new and efficient manufacturing
approaches. Additional information about Novavax is available at www.novavax.com
and in the company’s various filings with the Securities and Exchange Commission.


Stanley Erck Elected as Executive Chairman
2/16/2010

Stanley Erck Elected as Executive Chairman

ROCKVILLE, MD (February 16, 2010) –/PRNewswire-FirstCall/-Novavax, Inc. (Nasdaq:
NVAX) The Board of Directors of Novavax, Inc., announced today the election of Stanley Erck
as Executive Chairman. The effective date of this leadership change is immediately.
Previously, Mr. Erck served as President and Chief Executive Officer of Iomai Corporation,
leading the company through an initial public offering and a merger with Intercell, an Austrian
vaccine company, and through the development of a late-stage infectious disease product
candidate. Prior to Iomai, Mr. Erck served as President and Chief Executive Officer of Procept,
a publicly traded immunology company; as Vice President of Corporate Development at
Integrated Genetics (now Genzyme), and in management positions at Baxter International. Mr.
Erck currently sits on the Board of Directors of BioCryst, MacCyte, MdBio Foundation and
Novavax.

“We are very pleased to announce the appointment of Stan to the position of Executive
Chairman of the Board,” stated Gary C. Evans, Lead Director of Novavax. “Stan’s business
experience in guiding successful infectious disease and vaccine based biotech companies should
prove invaluable to Novavax as we advance our VLP pipeline into late-stage development and
commercialization.”

“Novavax has a broad vaccine pipeline of cutting edge recombinant technology coupled with a
strong management team and an excellent shareholder base,” said Stan Erck. “I look forward to
sharing my experience in advancing its late-stage VLP influenza vaccine towards
commercialization and progressing its preclinical pipeline into human trials.”
“All board members of Novavax would like to thank John Lambert for his three years of service
as Executive Chairman and look forward to his continuing support as a Director of the company.
John’s oversight during this period has helped our organization evolve our VLP technology from
an early-stage idea to an innovative vaccine that has now been successfully tested in over 1,800
subjects,” said Mr. Evans.

About Novavax

Novavax, Inc. is a clinical-stage biotechnology company creating novel vaccines to address a
broad range of infectious diseases worldwide, including H1N1, using advanced proprietary
virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant
vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using
its VLP technology to create country-specific vaccine solutions. The company has formed a joint
venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture
vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax
is available on the company’s website:


Novavax Announces Change in Leadership
4/19/2011

Novavax Announces Change in Leadership

Stanley Erck appointed President & CEO

James Young, Ph.D. becomes Chairman of the Board
Rockville, MD (April 19, 2011)–/PRNewswire-FirstCall/-Novavax, Inc. (NASDAQ:NVAX) announced today that Stanley C. Erck, its former Executive Chairman, has been appointed to the position of President and Chief Executive Officer and will remain as a member of the Board of Directors. In addition, current Board member James Young, Ph.D., will assume the position of Chairman of the Board.
Mr. Erck has been an active member of Novavax’s senior management team for the last year and has had extensive experience in the biotechnology sector and has successfully brought infectious disease product candidates into late-stage clinical trials. He also has had significant experience in managing a large advanced development contract with the Department of Health and Human Services. From 2000-2008 Mr. Erck served as President and Chief Executive Officer of Iomai Corporation, leading the company through an initial public offering and a merger with Intercell, an Austrian vaccine company. Prior to Iomai, he served as President and Chief Executive Officer of Procept, a publicly-traded immunology company; as Vice President-Corporate Development at Integrated Genetics (now Genzyme), and in management positions within Baxter International. Mr. Erck received his undergraduate degree from the University of Illinois and his Masters in Business Administration from the University of Chicago Graduate School of Business. Mr. Erck sits on the Board of Directors of BioCryst Pharmaceuticals, MaxCyte and MdBio Foundation.

Dr. Young, who became a Board member in April 2010, has over 30 years of experience in the fields of molecular genetics, microbiology, immunology and pharmaceutical development. He was previously President of Research and Development, including responsibility for regulatory affairs, at MedImmune where he was instrumental in the development of FluMist® and Synagis®. In 2005, Dr. Young was awarded the Albert B. Sabin Humanitarian Award. Prior to MedImmune, Dr. Young was influential in building the department of molecular genetics at Smith Kline & French Laboratories (now part of GlaxoSmithKline) and culminated as Director, Department of Molecular Genetics.
“As the Company continues its transition into a commercial operation, we are pleased to have attracted high caliber professionals such as Stan and Jim to now take the leadership roles at Novavax,” commented Gary Evans, of Novavax’s Board of Directors. We expect these
gentlemen will dynamically lead the Company and its vaccine candidates towards important worldwide products. Their strong leadership skills and broad experience in drug development will be invaluable to Novavax as the Company works to advance its infectious disease pipeline of virus-like particle (VLP) vaccine candidates.”
“I am a strong believer in the potential of recombinant-based VLP vaccine technology and was delighted to join Novavax’s Board of Directors in June 2009,” commented Mr. Erck. “Today, I am honored to assume my new role and to lead Novavax in its next phase of growth, including the clinical, regulatory and business development activities that will be required to bring our vaccine candidates to potential commercialization. I also look forward to working and collaborating with the superb team of employees at Novavax as we strive to bring new medical advances with vaccines for subjects with unmet medical needs.”

Mr. Evans concluded, “We would like to especially thank Dr. Rahul Singhvi for his past leadership during important and challenging phases of Novavax’s growth and development. Rahul has served Novavax as its President & CEO for the past 6 years, and during that time he has been instrumental in positioning the Company for success with our VLP vaccine candidates. We all wish him nothing but the best in his future endeavors and will be anxiously watching for his next achievements.”

About Novavax
Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company’s proprietary VLP technology and single-use bioprocessing system enables rapid vaccine development and production where and when it’s needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company’s website:

www.novavax.com.

[dothedd]

UPMC hopes to build vaccine center in Hazelwood
Officials 'cautiously optimistic' that government will accept proposal

Friday, January 21, 2011

By David Templeton, Pittsburgh Post-Gazette
Larry Roberts/Post-GazetteMedical assistant Khaliah Gilbert, right, and Becky Stratman of Squirrel Hill work together to make sure that Ms. Stratman's month-old son Xavier is comfortable as he receives a hepatitis vaccination at the Kids Plus Pediatrics office in Greenfield.University of Pittsburgh Medical Center officials and others are "cautiously optimistic" that the federal government will accept the center's proposal to construct a $600 million to $800 million vaccine development and production center in Hazelwood.

U.S. Rep. Mike Doyle, D-Forest Hills, said UPMC is working to secure 30 acres at the 178-acre LTV Steel site, between Second Avenue and the Monongahela River, that's under development by Almono LP in conjunction with the Regional Industrial Development Corp.

"We have a site and are waiting to move forward," Mr. Doyle said, noting discussions about the project with the White House almost on a weekly basis. "We are cautiously optimistic, but it certainly is not a bird in the hand."

Original plans called for construction at the old Greater Pittsburgh International Airport property Moon, but UPMC officials said they preferred a spot that's close to the University of Pittsburgh and UPMC facilities and other technology centers.

The U.S. Departments of Health and Human Services and Defense are planning to request proposals in coming weeks for a public-private partnership to build and operate one or two vaccine centers.

Robert Cindrich, senior adviser to the UPMC president, said the medical center proposes to pay 51 percent of development and construction costs, or $300 million to $400 million, but only if the federal government, in turn, agrees to provide sufficient startup and annual funding.

The request for proposals will detail the size, scope and initial and annual funding totals and "give us a better idea of what they have in mind," Mr. Cindrich said.

But he said UPMC will be ready to submit a proposal that officials say they are confident will exceed any submitted by their competitors.

The vaccine center, which UPMC already has named "21st Century Biodefense," or 21CB, would develop and manufacture vaccines to provide countermeasures against bioterror agents and "strengthen the nation's public health preparedness."

It also could develop vaccines for rarer but still dangerous diseases that commercial vaccine producers are unwilling to produce.

Mr. Cindrich said vaccines could be developed, produced and stockpiled in advance of need. UPMC partners in the project include GE Healthcare, IBM, Merck & Co. Inc., and Battelle.

If the federal government accepts UPMC's proposal, the facility could be operating within three to five years. Construction would create 1,000 to 2,000 temporary jobs with a permanent work force of 1,000, including many positions requiring a high school diploma and associate or technical degree to work in clean laboratories and pharmaceutical facilities.

Many positions would require college, graduate and doctoral degrees, he said. Jobs likely would pay $40,000 and higher. The project also could create 6,000 additional jobs for the region in spin-off companies, suppliers, contractors and pharmaceutical firms interested in moving close to 21CB.

In its proposal, UPMC will be required to show it already has secured a site. Even if the government decides to develop two sites, UPMC would be more than happy to get the bid to build one such facility.

"We have to show them and begin to employ people now," Mr. Cindrich said. "We are doing engineering work and all kinds of things in the hope of being adequately prepared.

"If we get this one, I'll be a happy person and our CEO [Jeffrey Romoff] will be very pleased," he said. "I don't want people to think this is a done deal. There are so many hurdles. But I think we've done everything right."

Read more: www.post-gazette.com/pg/11021/1119641-53.stm#ixzz1Kv4SvEey

[dothedd]

The Miscreants’ Global Bust-Out (Chapter One): Was the United States Attacked By Financial Terrorists?
29 April 2011 by Mark Mitchell

Chapter 1 of a book-length story about the financial underworld and the vulnerability of the U.S. markets to deliberate attacks.

Read the full story:

www.deepcapture.com/the-miscreants-global-bust-out-chapter-one-was-the-united-states-attacked-by-financial-terrorists/

The Miscreants’ Global Bust-Out: Preface
28 April 2011 by Patrick Byrne

Stay tuned for a multi-chapter story, the result of a year-long investigation of the financial underworld

Read the full story:

www.deepcapture.com/the-miscreants-global-bust-out-preface/


AN INTERESTING THE WEBPAGE:


www.deepcapture.com/

[dothedd]

Novavax to Report First Quarter 2011 Financial Results on May 9, 2011

ROCKVILLE, Md., May 3, 2011 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) will report financial results for the first quarter of 2011 on Monday, May 9, 2011, before the U.S. financial markets open. The announcement will be followed by a webcast and conference call hosted by Stanley C. Erck, President and Chief Executive Officer, and other members of senior management at 10:00 a.m. Eastern time.

The webcast and conference call will be available at www.novavax.com under Investors/Events. The dial-in number for the conference call is 1-877-212-6076 (domestic) or 1-707-287-9331 (international). Webcast and telephone replays of the conference call will be available shortly after the completion of the call. To access the replay, dial 1-800-642-1687 (domestic) or 1-706-645-9291 (international) and use passcode 63923693.

About Novavax

Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company's proprietary virus-like-particle (VLP) technology and single-use bioprocessing system enable rapid vaccine development and production where and when they are needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.


CONTACT: Frederick W. Driscoll, VP, Chief Financial Officer and Treasurer, Novavax, Inc., [phone]

[dothedd]

Novavax Named Biotechnology Firm of the Year by Tech Council of Maryland

Rockville, MD (May 11, 2011)–/PRNewswire-FirstCall/-Novavax, Inc. (Nasdaq: NVAX) has been named Biotechnology Firm of the Year by the Tech Council of Maryland (TCM), the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. Novavax was recognized as the firm that best exemplifies the spirit of the Maryland biotechnology community and for its presence and leadership in Maryland.

The criteria for selection as biotechnology firm of the year include achieving significant and measurable success, contributing to the advancement of biosciences through cutting-edge research and development, executing a successful growth strategy, and helping to foster a vibrant biotech community.

Stanley Erck, President and Chief Executive Officer of Novavax, stated: “We are honored to be recognized by the Tech Council of Maryland for our work to develop innovative vaccines to prevent the spread of infectious diseases worldwide. We have made substantial clinical and corporate progress in the past year and are now in a very strong position to pursue the development of vaccines derived from our unique virus-like particle technology. My colleagues and I are particularly grateful to the Maryland biotechnology community, including state and county officials, for their strong support of our efforts.”

About Novavax

Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company’s proprietary virus-like-particle (VLP) technology and single-use bioprocessing system enable rapid vaccine development and production where and when they are needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company’s website: www.novavax.com.

www.novavax.com/go.cfm?do=Press.List

[dothedd]

Novavax Named Biotechnology Firm of the Year by Tech Council of Maryland

Rockville, MD (May 11, 2011)–/PRNewswire-FirstCall/-Novavax, Inc. (Nasdaq: NVAX) has been named Biotechnology Firm of the Year by the Tech Council of Maryland (TCM), the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. Novavax was recognized as the firm that best exemplifies the spirit of the Maryland biotechnology community and for its presence and leadership in Maryland.

The criteria for selection as biotechnology firm of the year include achieving significant and measurable success, contributing to the advancement of biosciences through cutting-edge research and development, executing a successful growth strategy, and helping to foster a vibrant biotech community.

Stanley Erck, President and Chief Executive Officer of Novavax, stated: “We are honored to be recognized by the Tech Council of Maryland for our work to develop innovative vaccines to prevent the spread of infectious diseases worldwide. We have made substantial clinical and corporate progress in the past year and are now in a very strong position to pursue the development of vaccines derived from our unique virus-like particle technology. My colleagues and I are particularly grateful to the Maryland biotechnology community, including state and county officials, for their strong support of our efforts.”

About Novavax

Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company’s proprietary virus-like-particle (VLP) technology and single-use bioprocessing system enable rapid vaccine development and production where and when they are needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company’s website: www.novavax.com.

www.novavax.com/go.cfm?do=Press.List

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NOVAVAX to Present at the NOBLE FINANCIAL 7th Annual Equity Conference

Rockville, MD (May 13, 2011)–/PRNewswire-FirstCall/-Novavax, Inc. (Nasdaq: NVAX) a clinical-stage vaccine company, announced today that Frederick Driscoll, Chief Financial Officer of Novavax, will be presenting at the NOBLE FINANCIAL 7th Annual Equity Conference on May 16, 2011 at 10:30am at The Hard Rock Hotel, Hollywood, FL. A live audio-only webcast link for the presentation can be accessed via the Company website at www.novavax.com under Investors/Events.

About Novavax

Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company’s proprietary virus-like-particle (VLP) technology and single-use bioprocessing system enable rapid vaccine development and production where and when they are needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company’s website: www.novavax.com.

[dothedd]

EVERYTHING YOU EVER WANTED TO KNOW ABOUT NOVAVAX!

BEST EVER!

Noble Financial 7th Annual Equity Conference
Hollywood, FL
May 16, 2011 10:30 am
Presenter: Frederick W. Driscoll

WEBCAST ... CLICK ON THE LINK BELOW:

noble.mediasite.com/mediasite/SilverlightPlayer/Default.aspx?peid=84278b402a5748d892dcdf8c03bf76f11d

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News for 'NVAX' - (MLV Creates Advisory Board and Names Dr. Rahul Singhvi Founding Director)


Jun 08, 2011 (Close-Up Media via COMTEX) -- McNicoll, Lewis & Vlak (MLV), a
boutique investment bank focused on providing independent financial advice and
capital markets expertise to corporate and institutional clients in capital
intensive industries, announced the formation of an MLV Advisory Board comprised
of industry leaders with expertise and experience in a range of businesses
relevant to MLV's goal of providing efficient capital raising and growth
solutions for its clients.

According to a release, at the same time, it announced the appointment of Dr.
Rahul Singhvi, former President & CEO of Novavax, Inc., a development stage
vaccine company, as MLV Advisory Board's founding director.

In making the announcement, Patrice McNicoll, CEO of MLV noted, "MLV's mission
is to create a new paradigm on Wall Street. As a leader in At-the-Market (ATM)
issuance, we are already delivering to clients the most efficient and
cost-effective means of raising equity capital in the public markets. We are
creating our Advisory Board to bring together innovative business leaders to
help us continue to develop new and unique growth and capital solutions for both
public and private companies in capital intensive sectors."

"We are extremely pleased to have attracted someone of Dr. Singhvi's stature to
spearhead our Advisory Board efforts," added Dean Colucci, President of MLV.
"Dr. Singhvi has been a visionary and a business leader in the vaccine and
pharmaceutical industry. During his tenure as CEO of Novavax, he transformed
Novavax from a distressed specialty pharmaceutical Company into a premier
vaccine development company. Under his leadership, Novavax rapidly advanced a
robust pipeline of technologically innovative and important clinical and
preclinical stage vaccine candidates. With Dr. Singhvi's assistance, MLV will
seek to expand the MLV Advisory Board to include other executives with a similar
track record of growth, success, and innovation."

The company noted that, 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, a vaccine to prevent shingles.

In 2010, The Daily Record in Maryland recognized Dr. Singhvi as one of the most
influential Marylanders in the healthcare field. Dr. Singhvi has participated in
the Clinton Global Initiative and serves on the Board of Directors of
Immunocellular Therapeutics, a US public company working on cancer vaccines.

More Information:

mlvco.com/

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Novovax: Long-Term Value In Vaccines

By: TheStockAdvisors.com | May 31, 2011

by John McCamant, editor The Medical Technology Stock Letter

New management team members at Novovax (NVAX : 2.13, 0.01) have the experiences and skill sets necessary to drive the company's vaccines to commercialization.

We expect this to result in substantial creation of shareholder value for investors in this biotechnology stock.

The company reported a net loss of $7.5 million, or $0.07 per share for the first quarter of 2011, compared to a net loss of $10.3 million, or $0.10 per share, for the first quarter of 2010.

The primary reason for the decreased loss during the quarter was due to lower research and development spending to support clinical trials of the company's seasonal and pandemic influenza vaccine candidates.

Research and development expenses for the first quarter of 2011 decreased by $3.6 million to $5.4 million as compared to $9.0 million in the same period in 2010.

The company has $23.9 million of cash compared to $31.7 million as of December 31, 2010. However, this is not counting the large government contract that adds at least another $100 million over three years for vaccine development.

The company had a very productive Q1, but the stock price has been under pressure since the announcement of the government contract.

What is frustrating is that the partnership with LG Life Sciences was almost completely overlooked by the Street.

The Q1 conference call provided the new CEO an opportunity to introduce himself and the new upper level hires at NVAX.

Importantly, the new CEO and the new hires have significant experience in all facets of vaccine development.

The smooth development of vaccines is critical as we believe that the vaccines will show positive clinical results, i.e. the risk is not whether the vaccines work.

The major clinical risk for NVAX is making mistakes, and the new hires at the company have a very broad base of experience in vaccine development and actually bringing vaccines to the market.

The Phase I RSV vaccine trial will soon complete dosing, and we can expect to see data at the end of the third quarter.
We recommend buying NVAX as vaccine play to hold for the long haul. The stock is currently undervalued. NVAX is a buy under $3.

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Novavax Appoints Dr. Timothy Hahn Senior Vice President of Manufacturing

Press Release Source: Novavax, Inc. On Tuesday June 28, 2011, 8:00 am EDT

ROCKVILLE, Md., June 28, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX - News) announced today the appointment of Timothy J. Hahn, Ph.D., as Senior Vice President of Manufacturing. Dr. Hahn will oversee production of the company's vaccines and vaccine candidates and be responsible for all manufacturing operations at its pilot and commercial launch facility in Rockville, MD. He will report to Novavax's President and CEO Stanley Erck.

Mr. Erck stated: "Tim is a very talented manufacturing executive who brings to Novavax extraordinary experience in vaccine development, production and distribution. We look forward to applying his unique expertise to our proprietary vaccine production methods as we and our international partners work toward regulatory approval and launch of our vaccine candidates to prevent the spread of influenza and other infectious diseases worldwide."

Dr. Hahn commented: "I am honored to join Novavax and lead its manufacturing team. Virus-like particles represent an important innovation in the development and delivery of effective vaccines, and I look forward to advancing this technology and Novavax's manufacturing network so that we can deliver our vaccines wherever they are needed."

Prior to joining Novavax, Dr. Hahn was Vice President of Antibody Manufacturing and later Vice President of Vaccine Manufacturing at MedImmune, LLC. In these roles and as a member of the operations manufacturing team, Dr. Hahn oversaw MedImmune's U.S. manufacturing sites in Frederick, MD and Philadelphia, PA and non-U.S. sites in Nijmegen, The Netherlands and Speke, UK with responsibility for bulk and fill production of commercial antibody and vaccine products as well as fill manufacturing of clinical trial materials. Dr. Hahn also coordinated the management of the integrated production processes for the seasonal production of Synagis(R) and FluMist(R). As part of the leadership team for the start-up of a new antibody manufacturing facility in Frederick, MD, Dr. Hahn was responsible for the process validation and start-up strategy and execution for the project, which was recognized as the 2011 ISPE Facility of the Year Award Winner for Project Execution.

Previously, Dr. Hahn spent more than 15 years in vaccine manufacturing with Merck & Co. He received his doctorate and Master of Science degrees in chemical engineering from Stanford University and his Bachelor of Science degree in chemical engineering from Lehigh University.

About Novavax

Novavax, Inc. (Nasdaq:NVAX - News), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company's proprietary virus-like-particle (VLP) technology and single-use bioprocessing system enable rapid vaccine development and production where and when they are needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.

NOTE: The NOVAVAX Website is being revised and updated.

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IT'S ABOUT TIME THIS CLINICAL DATA WAS PUBLISHED!!!!

NOVAVAX and the Mexican Social Security Institute Publish Results From H1N1 Influenza Vaccine Trial in Mexico

ROCKVILLE, Md., Aug. 4, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX - News) and Specialties Hospital of the National Medical Center, Mexico City, today announced the publication of safety and immunogenicity results from a clinical study of Novavax's A/H1N1 virus-like-particle (VLP) pandemic influenza vaccine candidate in the journal Vaccine. The two-stage, Phase 2, randomized, double-blind, placebo-controlled study was conducted in Mexico during the 2009 pandemic to evaluate the safety and immunogenicity of one or two doses of a monovalent recombinant A/California/04/2009-like influenza VLP vaccine in 4,563 healthy adults, 18-64 years of age.

The study data showed that hemagglutination-inhibiting (HAI) antibody responses to the vaccine fulfilled the immunogenicity criteria that are required to be considered for accelerated approval of seasonal and pandemic influenza vaccines by the US FDA Center for Biologics Evaluation and Research. These criteria were met at all dose levels after a single injection, including the lowest dose of 5 micrograms. Single administrations of the VLP vaccine induced high levels of HAI titers in subjects without pre-existing detectable immunity to the pandemic strain. Overall, the data indicated that Novavax's H1N1 VLP vaccine was well-tolerated and immunogenic.

VLPs mimic the external structure of viruses but lack the genetic material that is responsible for viral replication and infection. Novavax's VLP vaccines are designed to match individual viral strains using proprietary, portable, recombinant cell-culture technology.

The study's principal investigator, Dr. Constantino Lopez-Macias, Professor of Medical Research-Mexican Social Security Institute, stated: "The immune response demonstrated in this study suggests that VLPs can be highly immunogenic and that protective levels of virus-neutralizing immunity can be achieved even with only a 5 microgram dose of the H1N1 VLP vaccine without the use of adjuvants. This is an important advance which we hope will lead to eventual licensure of a VLP vaccine so that we may protect citizens against both seasonal and pandemic influenza viruses."

Dr. Gregory Glenn, Chief Medical Officer of Novavax, stated: "This publication represents the first peer-reviewed publication of clinical data generated using Novavax's influenza VLPs. We demonstrated that our H1N1 influenza VLP vaccine candidate was well-tolerated and generated robust immune responses at antigen doses at or below those administered for egg-derived A/California/04/09 vaccines. This provides important new information supporting our ongoing efforts to develop novel seasonal and pandemic influenza vaccines based on recombinant technology that offers an alternative to eggs and that has potential to be both rapid and cost-effective."

Novavax was awarded an advanced development contract by the Biologics Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services earlier this year. Within the next 12 months, Novavax expects to initiate further clinical evaluations of both seasonal and H5N1 pandemic VLP vaccines under the initial phase of the BARDA contract; a 3 year, $97 million award.

About Novavax

Novavax, Inc. (Nasdaq:NVAX - News), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company's proprietary virus-like-particle (VLP) technology and single-use bioprocessing system enable rapid vaccine development and production where and when they are needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website:

www.novavax.com

On Thursday August 4, 2011, 10:02 am

NEW YORK (Reuters) - Major stock indexes tumbled, with the Nasdaq briefly falling more than 2 percent on Thursday, resuming their downturn after a labor market report became the latest datapoint to show the economy has stalled.

The Dow Jones industrial average (DJI:^DJI - News) slid 155.65 points, or 1.31 percent, at 11,740.79. The Standard & Poor's 500 Index (^SPX - News) was down 20.64 points, or 1.64 percent, at 1,239.70. The Nasdaq Composite Index (Nasdaq:^IXIC - News) dropped 48.47 points, or 1.80 percent, at 2,644.60.

New U.S. claims for unemployment benefits edged down last week, pointing to a marginal improvement in the labor market, the Labor Department said.


Price Target Summary
Mean Target: 6.25
Median Target: 5.00
High Target: 11.00
Low Target: 4.00
No. of Brokers: 4

Date Research Firm Action From To
Mar 15, 2011 Wedbush Initiated Outperform

(10:20 am 8 5 11 1.67 down 0.05)

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StockScouter rates stocks from 1 to 10, with 10 being the best, using a system of advanced mathematics to determine a stock's expected risk and return.

STOCKSCOUTER .

NOVAVAX RATING: 6 ()

Rating: 6 out of 10
How StockScouter Works

NOVAVAX INC: STOCK RATING SUMMARY.

6

StockScouter

Novavax Inc, a small-cap unknown style company in the health care sector, is expected to match the market over the next six months with above average risk.

10 is the best possible rating.

QUICK SUMMARY:

Pro
Earnings growth in the past year has accelerated moderately compared to earnings growth in the past three years. Positive

Previous day’s closing price for NVAX was significantly below its 50-day moving average, a level from which prices frequently rebound over the long term. Positive

Con
The price-to-earnings multiple is a negative number. No effect

The StockScouter measure of relative price change and consistency is very low. Very negative

8/5/2011 | Briefing.com

Market Report -- In Play (NVAX)
Novavax beats by $0.04, beats on revs Reports Q2 (Jun) loss of $0.04 per share, $0.04 better than the Capital IQ Consensus Estimate of ($0.08); revenues fell 21.1%...

chart: moneycentral.msn.com/investor/charts/chartdl.aspx?symbol=NVAX&CP=0&PT=8

Stocks plummet as traders seek safety

The Dow dives more than 500 points on the US credit downgrade and fears about Europe's financial system. Gold tops $1,700. Oil sinks.

Bank of America (BAC) was off 18.2% to $6.68 as fears mounted it won't be able to handle all the problems created by its mortgage business. The selling accelerated after a big hedge-fund manager sold out his stake.

Gold soars; Treasury yields drop
What investors really, really wanted today was safety, especially in light of increasing evidence that the U.S. and global economy are slowing.

So, they bought Treasury securities, the very obligations that S&P downgraded from AAA to AA+. The 10-year Treasury yield fell to to 2.358% from Friday's 2.558%.

And, of course, they wanted gold (-GC). Gold topped $1,700 for the first time, hitting as high as $1,718.20 in overnight trading. It settled at $1,713.20 in New York this afternoon. Silver (-SI) was up $1.17 an ounce to $39.38 an ounce. Copper (-HG) was off 15.6 cents to $3.9615 a pound.

The Dow may close below 11,000
Since safety was the only game around, the Dow was off 517 points, or 4.5%, to 10,928 at 2:53 p.m. ET. Today's will almost certainly be the blue chips' 10th loss in the last 12 days, with the Dow looking at its first close below 11,000 since October. The index has fallen about 1,800 points since July 22.

The S&P 500 was off 69 points, or 5.8%, to 1,130. The Nasdaq was off 147 points, or 5.8%, to 2,386. Both were facing their worst losses since Dec. 1, 2008.

Volume was more than 2 billion shares on Nasdaq and 1.3 billion shares on the New York Stock Exchange. Decliners were ahead of gainst 50-to-1 on the NYSE and 12.5-to-1 on Nasdaq.

The situation was serious enough that many investors were buying insurance against further drops. The CBOE Volatility Index ($VIX) was up 32.2% to $42.30, its highest level since April 2009.

"Not only is the economy not growing as most would like, but there is a concern that fiscal and monetary authorities are powerless to do more for the economy," Michael Pond, co-head of interest-rate strategy for British bank Barclays (BCS).

Crude oil (-CL) was at $83.48 a barrel, down $3.32, or 3.8%. It was its lowest level since November. Brent crude was off $3.43, or 3.1%, to $105.94.

Meanwhile S&P said it was downgrading the debt of Fannie Mae (FNMA) and Freddie Mac (FMCC), the big providers of mortgage capital, and other U.S. agencies.

Europe's problems may be more serious
While Americans can be excused for thinking the S&P downgrade was the big event, the European debt crisis was more dangerous.

That's because the European Central Bank has been forced for the first time to prop up the debt of Italy and Spain, two of its biggest member nations. Italy's and Spain's bond have been under attack from speculators who aren't convinced either nation can keep current on their debts.

As a result, Germany's Dax Index ($DE:DAX) was off 5% to 5,923. Britain's FTSE-100 Index ($GB:UKX) was off 3.4% to 5,069.

Only one Dow stock in the black
Procter & Gamble (PG), the classic consumer staples stock, was alone among the 30 Dow stocks to show a gain. Shares are up 1.1% to $61.26. The company, which beat Street estimates for fiscal-fourth-quarter results on Friday, sells products that people buy regardless of the state of the economy -- soap, detergents, cleaning supplies and the like.

Procter & Gamble was also one of just three S&P 500 stocks in the black. The leader was Newmont Mining, one of the largest producers of gold, up 4.4% to $56.80, followed by O'Reilly Automotive (ORLY), up 1% to $58.91.

O'Reilly was the only stock in the Nasdaq-100 Index ($NDX.X) to show a gain. The index was off 78 points, or 3.6% to 2,116.

Apple (AAPL), down 2.6% to $363.78, contributed 8 points to the Nasdaq-100's decline. Apple and six other stocks -- Oracle (ORCL), Microsoft (MSFT), Google (GOOG), Qualcomm (QCOM), Cisco Systems (CSCO) and Amazon.com (AMZN) -- combined to subtract 31 points from the index.

Why Bank of of America is tanking
Bank of America was the biggest loser among Dow and S&P 500 stocks.

It's not clear if the collapse today of Bank of America's stock price means the government may be forced to extend assistance again. Most of its problems are mortgage-related and directly the result of its disastrous 2008 acquisition of Countrywide Financial.

It was hit with two bits of bad news today: American International Group (AIG) sued the company for more than $10 billion over what it called a "massive fraud" on mortgage debt, deepening the litigation morass facing the largest U.S. bank.

AIG said it expects to pursue other litigation to recover losses from counterparties that "sought to profit at our expense." Taxpayers still own 77% of AIG, which received $182.3 billion of government bailouts.

The other was that hedge-fund manager David Tepper, who won big in 2009 betting on battered bank shares, now is bailing out on some battered bank shares.

CNBC said Tepper’s Appaloosa Management sold its position in the banking company.

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Date Insider Shares Type Transaction Value*

Aug 10, 2011 ERCK STANLEY C
Officer 16,552 Direct Purchase at $1.24 per share. 20,524

Aug 9, 2011 TRIZZINO JOHN
Officer 20,000 Direct Purchase at $1.18 - $1.2 per share. 24,0002

Aug 9, 2011 ERCK STANLEY C
Officer 33,448 Direct Purchase at $1.24 per share. 41,475

Aug 9, 2011 DOUGLAS RICHARD
Director 50,000 Direct Purchase at $1.20 per share. 60,000

Aug 9, 2011 DRISCOLL FREDERICK W
Officer 20,000 Direct Purchase at $1.18 per share. 23,600

Jun 20, 2011 DOUGLAS RICHARD
Director 50,000 Direct Purchase at $2.04 per share.

Thank you for the vote of confidence in the DOWN MARKET!

[dothedd]

Stock Research - Analyst Summary




NVAX
Novavax, Inc. NASDAQ-GM

Read more:

www.nasdaq.com/symbol/nvax/analyst-research#ixzz1UxyMzLbn

[dothedd]

2011 Events

Wedbush 2011 Life Sciences Conference
New York City, NY
August 16-17, 2011
Presenter: Stanley C. Erck


A very informative presentation.

Webcast: wsw.com/webcast/wedbush17/nvax/

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J Virol. 2011 Aug 24. [Epub ahead of print]

H5N1 virus-like particle vaccine elicits cross-reactive neutralizing antibodies in humans that preferentially bind to oligomeric form of influenza hemagglutinin.

Khurana S, Wu J, Verma N, Verma S, Raghunandan R, Manischewitz J, King LR, Kpamegan E, Pincus S, Smith G, Glenn G, Golding H.


Source

Division of Viral Products, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, Bethesda, MD 20892, USA.


Abstract

Transmission of pathogenic avian influenza viruses (AIV) from wild birds to domestic poultry and humans is continuing in multiple countries around the world. In preparation for a potential AIV pandemic, multiple vaccine candidates are under development. In the case of H5N1 AIV, a clear shift in transmission from clade 1 to clade 2 viruses occurred in recent years. Virus like particle (VLP) represents an economical approach to pandemic vaccine development. In the current study, we evaluated the humoral immune response in humans vaccinated with H5N1 A/Indonesia/05/2005 (clade 2.1) VLP vaccine manufactured in Sf9 insect cells. The VLPs were comprised of the influenza hemagglutinin (HA), neuraminidase (NA) and matrix (M1) proteins. In a FDA approved Phase 1/2 human clinical study, two doses of H5N1 VLPs at 15, 45 or 90 ìg HA/dose resulted in seroconversion and production of functional antibodies. Moreover, cross-reactivity against other clade 2 subtypes was demonstrated using virus neutralization assays. H5N1 whole genome-fragment phage display libraries (GFPDL) were used to elucidate the antibody epitope repertoire in post-vaccination human sera. Diverse epitopes in HA1/HA2 and NA were recognized by post-vaccination sera from the two high-dose groups, including large segments spanning the HA1 receptor binding domain. Importantly, the vaccine elicited sera that preferentially bound to an oligomeric form of recombinant HA1 compared with monomeric HA1. The oligomeric/monomeric HA1 binding ratios of the sera correlated with the virus neutralizing titers. Additionally, the two high dose VLP vaccine groups generated NA inhibiting antibodies that were associated with binding to a C-terminal epitope close to the sialic acid binding site. These findings represent the first report describing the quality of the antibody responses in humans following AIV VLP immunization and support further development of such vaccines against emerging influenza strains.

PMID: 21865396

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NOVAVAX Announces Publication of Results From H5N1 Influenza Virus-Like Particle Vaccine Phase I/IIa Clinical Trial

VLP vaccine candidate was well-tolerated, immunogenic and generated cross-reactive neutralizing antibodies

ROCKVILLE, Md., Sept. 8, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced today the publication of an article that reported new safety, immunogenicity and cross-reactivity results from a Phase I/IIa clinical study of the company's H5N1 influenza virus-like particle (VLP) vaccine candidate that was conducted in 2008. According to the report in the current issue of Journal of Virology, Novavax's VLP-based vaccine targeted against a highly pathogenic avian H5N1 influenza virus was well-tolerated, produced no vaccine-related serious adverse events and induced neutralizing antibodies that were cross-reactive with different avian A/H5N1 influenza viruses. This is the first report of a unadjuvanted vaccine inducing cross-reactive neutralizing antibodies against multiple clades of H5N1 influenza virus.

Novavax's A/H5N1 VLP influenza vaccine candidate was administered to 230 adults immunized with two injections of 15, 45 or 90 micrograms of vaccine; the 2008 study was blinded, randomized and placebo-controlled. Recent analyses show that there was a dose-related immune response and 40%, 57% and 61% of the subjects developed a four-fold or higher increase in hemagglutination inhibition (HAI) and 39%, 52% and 76% of the subjects developed a four-fold rise in microneutralizing (MN) antibodies to the 15, 45 and 90 microgram dose, respectively.

Scientists at the FDA's Center for Biologics Evaluation & Research (CBER) developed new molecular tools for in depth analyses of antibody targets and affinity maturation. Novavax entered into a separate collaborative study with CBER using these tools to analyze a subset of serum samples representative of each vaccine dose for cross-reacting and binding specificity. These studies revealed a broad repertoire of antibody binding to hemagglutinin (HA) and neuraminidase (NA) that map to regions important for proper folding and critical for virus neutralization and protection. Importantly, the VLP vaccine induced antibodies with preferential binding of HA trimers (similar to those present on virions), and this binding correlated with virus neutralization titers. Serum samples with strong titers against the vaccine strain (A/Indonesia clade 2.1) also had high levels (70-90%) of cross-reactive neutralizing antibodies to clade 2.2 and 2.3 H5N1 viruses.

Dr. Greg Glenn, Chief Medical Officer of Novavax, stated: "We are excited about these results and insights into the quality of neutralizing and cross-protective antibody responses produced in the study volunteers by our H5N1 VLP vaccine candidate. Transmission of the highly pathogenic avian H5N1 flu virus in domestic poultry and humans is continuing in many countries 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. The antibodies induced by this vaccine candidate without the use of an adjuvant indicate that the VLP is immunogenic relative to egg-based or cell-culture-derived H5N1 vaccines. These data suggest that VLPs can induce robust and functional responses and warrant further development as a pandemic vaccine. This is an important avenue of research which we are now actively pursuing under our advanced development vaccine contract with the U.S. Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority."

About Novavax

Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company's proprietary VLP technology and single-use bioprocessing system enables rapid vaccine development and production where and when it's needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.

[dothedd]

NOVAVAX NEW WEBSITE:

www.novavax.com/

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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

ROCKVILLE, Md., Sept. 26, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that it will report top-line results from a Phase I clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in a presentation at the 5th Vaccine and ISV Annual Global Conference in Seattle on October 3, 2011. The presentation is titled, "Recombinant micellar RSV F vaccine for respiratory disease: Antigen characterization, preclinical efficacy and clinical evaluation" and will be made by Gregory M. Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax.

The blinded, placebo-controlled, dose-escalating Phase I trial was launched in January 2011 to assess the safety, immunogenicity and tolerability of Novavax's vaccine candidate against RSV. The study enrolled 150 healthy adults 18 to 49 years old who were allocated to six cohorts and randomized to receive vaccine treatment or saline placebo in a 4:1 ratio.

About Respiratory Syncytial Virus

RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 75,000 to 125,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.

It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high-risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV.

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 potent 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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2011 NOVAVAX PRESS RELEASES


NOVAVAX Launches Phase I Clinical Trial to Evaluate its Novel Vaccine Against Respiratory Syncytial Virus (RSV)
01/03/11

NOVAVAX to Present H1N1 VLP Influenza Vaccine Clinical Data at 7th World Health Organization (WHO) Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials
02/09/11

NOVAVAX Presents Final Results from H1N1 Influenza Vaccine Trial at World Health Organization Meeting
02/18/11

Novavax Licenses Recombinant VLP Influenza Vaccine to LG Life Sciences for South Korea and Other Countries
02/28/11

NOVAVAX Awarded HHS-BARDA Contract Valued at up to $179 Million to Develop Pandemic and Seasonal Influenza Vaccines for U.S. Government Using Recombinant VLP Technology
03/01/11

Novavax’s VLP Influenza Vaccine Named One of Top 100 Drugs in Development Today
04/05/11

Novavax Named Biotechnology Firm of the Year by Tech Council of Maryland
05/11/11

NOVAVAX and the Mexican Social Security Institute Publish Results from H1N1 Influenza Vaccine Trial in Mexico
08/04/11

NOVAVAX Announces Publication of Results from H5N1 Influenza Virus-Like Particle Vaccine Phase I/IIa Clinical Trial
09/08/11

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

NOVAVAX Reports Positive Results from Phase I Trial of Respiratory Syncytial Virus Vaccine Candidate
10/03/11

NOVAVAX Reports Positive Results from Phase I Trial of Respiratory Syncytial Virus Vaccine Candidate
- Well-tolerated with no systemic side-effect trends
- Highly immunogenic with an increase in anti-RSV antibodies in 100% of subjects in the highest-dose group
- Oral and poster presentations to be made at 5th Vaccine and ISV Annual Global Conference in Seattle

Rockville, MD (October 3, 2011)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced positive top-line results from a Phase I clinical study of its respiratory syncytial virus (RSV) fusion (F) recombinant nanoparticle vaccine candidate. In a paper titled “Recombinant RSV F nanoparticle vaccine for respiratory disease: antigen characterization, preclinical efficacy and clinical evaluation,” Gregory M. Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax, is presenting safety, immunogenicity and tolerability findings from this study in a poster and oral presentation today and tomorrow, respectively, at the 5th Vaccine and ISV Annual Global Conference in Seattle. In the United States, RSV is the most common cause of bronchiolitis and pneumonia in children under 1 year of age resulting in 90,000 to 147,000 hospitalizations in this age group. Additionally, 900,000 adult and elderly patients are hospitalized annually due to RSV infection in the United States and Europe.

Novavax initiated the blinded, placebo-controlled, dose-escalating Phase I trial in December 2010 to assess the safety and tolerability of aluminum phosphate-adjuvanted (adjuvant) and unadjuvanted formulations of its RSV vaccine candidate. 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 4 dose levels of vaccine. The two highest dose levels were formulated with and without the adjuvant. Subjects were randomized to receive injections of vaccine or saline placebo in a 4:1 ratio on days 0 and 30. Immune responses were evaluated in blood samples taken on days 0, 30, and 60.
“The results from our first RSV in-human study are very encouraging and support expanded testing of this vaccine candidate to those most affected by RSV infection, infants and children, and adults age 65 and older,” Dr. Glenn said. “Our findings from this Phase I trial are consistent with our preclinical results in relevant animal models, which indicated that our vaccine candidate was generally well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV. In the same preclinical studies, the vaccine was fully protective against live-virus challenge, indicating that such measures of immunity are associated with protection. RSV disease is a major unmet medical need and a priority target for vaccine developers, and the results from this trial represent an important step towards reaching the ultimate goal of a safe and effective vaccine.”

In his presentations, Dr. Glenn is reporting that Novavax’s RSV vaccine candidate was well-tolerated and highly immunogenic, inducing levels of functional immunity that could potentially correlate with protective immunity in future trials. The fusion (F) antigen used in the Novavax RSV vaccine candidate is common to all RSV strains. Antibodies against the F antigen are known to prevent RSV disease in premature infants using the injected monoclonal antibody Synagis® (palivizumab), the current standard of care for RSV prophylaxis in premature infants. The data seen in this trial indicate that the Novavax RSV vaccine candidate induces immunity similar to natural protective immunity, as well as induces responses against the specific molecular target of Synagis on the F protein. Together, these data suggest that the vaccine may hold promise for prevention of RSV illness.
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. 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. Plaque reduction neutralizing titers (PRNT) were also measured and were significantly higher (p<0.01) in all the vaccine groups containing adjuvant. Exploratory measures of the vaccine-generated immunity specific to the Synagis epitope on the RSV F protein indicated that the vaccine induced significant increases (p<0.0001) compared to placebo in all groups.
Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: “I congratulate my colleagues and our clinical investigators on these impressive results which will allow us to continue to pursue the development of a vaccine to prevent RSV infection. There remains an urgent public health need for such a vaccine, as none exist today and current treatments for RSV are expensive, difficult to administer and of limited benefit. We believe our vaccine candidate shows great promise as a potential prophylactic against RSV lower respiratory tract illness. The clinical data from this trial now provides a pathway for us to aggressively move forward in studying this vaccine candidate in infants, young children and older adults who represent the populations most affected by RSV.”

About Respiratory Syncytial Virus

RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis
(inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 90,000 to 147,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.

It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high-risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV.

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 potent 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.


NOVAVAX Announces Contract Award from U.S. Department of Homeland Security to Develop Foot-and-Mouth Disease Vaccine
10/05/11

NOVAVAX Announces Contract Award from U.S. Department of Homeland Security to Develop Foot-and-Mouth Disease Vaccine
Rockville, MD (October 5, 2011)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced that it has been awarded a $1.3 million contract from the U.S. Department of Homeland Security to develop a virus-like particle (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 Novavax recombinant VLP-based vaccine which, unlike current FMD vaccines, would not require the use of infectious FMD virus to be manufactured. This would address the potential risk of releasing infectious virus during vaccine production and stockpiling in the U.S. or other FMD-free countries.

“We welcome this opportunity to apply our recombinant vaccine technology to address a major threat to U.S. livestock producers,” said Stanley C. Erck, Novavax’s President and Chief Executive Officer. “Although the United States remains free of FMD, an effective vaccine will help prevent the spread of disease if an outbreak should occur and may abolish the risk of infection if used through a national vaccination program of all susceptible livestock.”

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 potent 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 Announces Conference Call to Discuss Results From Phase I Trial of Respiratory Syncytial Virus Vaccine Candidate

ROCKVILLE, Md., Oct. 10, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that it will conduct a conference call for invited analysts and institutional investors on October 13, 2011 at 10:30 am ET to review the recent top-line results from a Phase I clinical trial of its respiratory syncytial virus (RSV) fusion (F) recombinant nanoparticle vaccine candidate. Participating on the call will be Gregory M. Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax, and Pedro A. Piedra, M.D., Professor at Baylor College of Medicine in the Department of Molecular Virology and Microbiology. They will review recent safety, immunogenicity and tolerability findings from the study which were presented at the 5th Vaccine and ISV Annual Global Conference in Seattle earlier this week.

Conference Call Information

The conference call will be accessible on Novavax's website at www.novavax.com under the "Investor Info/Events" tab 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 following the call. To access the replay of the conference call, dial 1 [phone] (domestic) or 1 [phone] (international) and enter pass code 17801248.

About Respiratory Syncytial Virus

RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 90,000 to 147,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.

It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high-risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV.

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 potent 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.

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

Source: Novavax, Inc.

[dothedd]

Novavax CEO Testifies on BIO's Behalf on the Importance of IP Rights Internationally for Small Businesses


October 27, 2011

By electronic submission

Saurabh Vishnubhakat

Attorney Advisor,

Office of Chief Economist

United States Patent and Trademark Office

Washington, D.C.


Name of Person Testifying:

Stanley C. Erck, President and CEO, Novavax


Representing:

Novavax

Biotechnology Industry Organization


Testimony:

My name is Stanley C. Erck, President and CEO of Novavax, Inc. and I am testifying today on behalf of the Biotechnology Industry Organization (BIO). Novavaxis a clinical-stage biopharmaceutical company focused on developing highly potent recombinant vaccines. We have a novel and innovative technology platform based on our proprietary, genetically-engineered three-dimensional nanostructures that we call virus-like particles or VLPs. Importantly, our VLPS, and in some cases, smaller portions of the virus called micelles, have the capability of being genetically adapted to a variety of infectious dieseases. Right now, Novavax is focused on our lead vaccine product candidates in seasonal and pandemic influenza (H5N1), however we recently announced the results from our first Phase 1 clinical trial in our vaccine against Respiratory Syncytial Virus, known as RSV. In addition, we have a portfolio of additional vaccine candidates against a number of important health concerns that are in various stages of preclinical study. As you might expect given our robust portfolio of vaccine candidates, we have a similarly robust portfolio of patents and patent applications. In an industry that traditionally utilizes chicken egg-based vaccine technology, well-known for half a century or more, protecting our proprietary, cutting-edge, recombinant vaccine technology is a paramount. As a result we have structured a portfolio of international patents and applications that we believe is both diverse and healthy.

The Biotechnology Industry Organization (BIO) is a non-profit organization with a membership of more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations in all 50 States and a number of foreign countries. BIO’s members are involved in the research and development of health care, agricultural, industrial, and environmental biotechnology products. The U.S. life sciences industry, fueled by the strength of the U.S. patent system, supports more than 7.5 million jobs in the United States, and has generated hundreds of drug products, medical diagnostic tests, biotech crops, and other environmentally-beneficial products such as renewable fuels and bio-based plastics.

The majority of BIO’s members are small companies that currently do not have products on the market. As such, BIO’s members rely heavily on the strength and scope of their patents, both domestically and internationally to generate the investment necessary to sustain their long product development cycle. On average, it takes more than 10 years to develop a biotechnology invention from its inception to regulatory approval and market launch. The average, fully capitalized cost of developing a biologic medicine has been estimated at USD 1.2 billion.

For BIO’s small companies, pursuing international patent protection generally occurs early in the company’s life cycle. All biotechnology companies understand that the products they hope to develop require robust patent protection abroad. This is because when small biotechnology companies seek access to capital to sustain their existence, a central factor for valuation is the strength of their IP portfolio, which must include, in almost every instance, patents or patent applications in at least the markets of the United States’ major foreign trading partners.

In fact, empirically we know that U.S. biotechnology companies are a large exporter of IP. The United States is, by a wide margin, the largest originator of international biotechnology patents in all major markets. [1]Small biotechnology companies, which together hold approximately 80% of the development pipeline for new medicines, diagnostics and other bio-based products, play a significant part in this patenting activity.

As products advance through development, small biotech companies often need larger partners in the United States and abroad to develop their experimental products to a market-ready, approvable stage. And even for market-ready products, U.S.-based biotech companies often find it easier to partner with a foreign affiliate who will secure foreign regulatory approval and market the invention in a foreign market, rather than establishing their own overseas sales force. In each case, such partnering depends on robust patent rights that will secure all partners a return on investment.

Small biotechs often bear the initial burden of procuring international patent protection, since patent rights must typically be sought early, and near-simultaneously in the U.S. and in foreign jurisdictions. Early international filing enables these small companies to partner with larger companies later in their product life cycle to export their products internationally. It is generally not an option for small biotech companies to wait to secure foreign patent protection until after such partnerships, as possible forfeiture of patent rights is too great a risk in foreign “absolute novelty” jurisdictions. It is imperative that small biotechnology companies plan ahead, even at their inception, to ensure that over the ensuing 10 to 15 years they have the opportunity to partner with larger companies to export their products internationally.

What then are the challenges small biotechnology companies face when filing for patents internationally? First and foremost, international patent procurement is expensive. Small biotechnology companies face unique challenges as foreign biotechnology patent prosecution can be complicated and are subject to greater non-uniformity of the law than in many other technologies. Patent claim scope and what is permitted can differ significantly from country to country, which complicates and increases the cost of international patent filing for biotech inventions. Without procedural or substantive harmonization, these problems are likely to increase costs for small biotechnology companies.

In addition to filing and prosecution costs, uncertainty limits the ability of small biotechnology companies to limit patenting costs. Small biotechnology companies must patent early in their development life while simultaneously trying to predict which patents will be valuable in 10 years and which patents will not. As such, biotechnology companies deal with slowly-developing technology that does not allow them to decide to abandon or maintain a family of applications before the real prosecution costs kick in. For example, a biotech company that files a U.S. patent application today (and a PCT application one year from now) has only 30 months to decide whether to abandon the application if it wants to avoid the cost of entering the national stage in a number of foreign countries. Thirty months may be enough in some other industries, but in biotech that’s too soon for an informed decision. Including translation costs, the aggregate expense of entering the national stage in Japan, Korea, Europe, Australia, and the NAFTA countries can easily exceed $100,000; if the BRIC countries are added, costs can double. Likewise, even if the company defers foreign examination where that’s an option, annuities can accumulate to more than negligible amounts. Foreign attorney fees, once prosecution begins, add another layer of cost. Many such costs must be incurred before a biotech company is able to decide whether to maintain or abandon the application. We have small member companies with 30 or 40 employees who are many years from the market, who must every year reserve for patent prosecution several hundred thousand of their sorely-needed dollars.

All of these challenges for small biotechnology companies result in patent filing and prosecution costs that are often far from negligible relative to their R&D budgets. Uniformly, such companies would prefer to spend their money to advance their science. This USPTO study, and other initiatives like it, has the opportunity to provide solutions that would save small biotechnology companies significant money - money that could be spent on researching life-saving products, hiring technicians, engineers and scientists, and accelerating the pace of biotechnology innovation.

We are aware of grant or loan programs in various foreign countries aimed at helping small businesses defray costs for both domestic and international applications. China is one such example where the Ministry of Finance in 2009 started subsidizing patent filings for foreign patent applications made by small and medium-sized domestic enterprises, and public and scientific research institutions.[2] WIPO’s Small and Medium Sized Enterprises program white paper on “Managing Patent Costs: An Overview”[3], reports that “in an increasing number of countries, worldwide, governments and other funding agencies that provide grants or subsidies for R & D/Innovation activities to research institutes, universities, and enterprises have begun to allow a portion of the funds to be utilized for meeting patenting costs. In a few of such support schemes, the costs also cover enforcement costs and international filing costs.” Munari and Xu, in a recent white paper on the effectiveness of patent subsidies on small and mid-sized enterprises, provide a number of examples of foreign financial assistance programs aimed at facilitating international patent procurement by small businesses.[4]

For our small businesses, securing IP protection is as important as obtaining laboratory equipment, leasing space, or hiring creative, dedicated employees. And because IP business assets are at least as important as other, more tangible business assets, there is no reason to exempt patent rights from publicly-funded small business assistance programs that are available for more tangible assets such as capital equipment, hiring, or leasing space. Extending the range of public assistance programs to patent rights for small businesses would help small biotechs spend money normally allocated to patent filing and prosecution elsewhere.[5]

The particular mechanism for helping small businesses file patent applications internationally requires additional thought, and BIO’s members have no final view on the matter. Generally, it would seem important that any programs, in order to be effective, would have to be adequately funded so as to result in awards that make a meaningful difference to beneficiary businesses. Implementing policies should also place an emphasis on coordination and transparency to avoid fragmentation across grantor government agencies. Financial assistance could be in the form of a grant, refundable tax credit, or matching program. Recognizing that most small biotech companies do not have tax liability, such mechanisms would have to be structured in a way to make them just as usable as for tax-paying companies A matching program, where, for example, every two dollars of the company’s money would be matched by eight dollars of grant funding, has the advantage of providing assistance while keeping the small biotech’s ‘skin in the game,’ thereby ensuring that the company would still have to make a careful business decision where they file internationally. Further thought on these mechanisms, and how they would affect small biotechnology companies, is necessary.

On behalf of BIO, I would like to thank the United States Patent Office for the opportunity to testify. BIO hopes that the USPTO finds a way to defray the hundreds of thousands of dollars it costs small biotechnology companies to file and prosecute patents internationally so that our small companies can spend more money on research, job creation, and product commercialization for the benefit of American workers, patients, farmers and consumers.
------------------------------------------------------------------------------

[1]It appears that U.S. dominance as an originator of international patent applications is nowhere as pronounced as in the biomedical arts. For example, for the 2001-2005 timeframe, the 2008 WIPO World Patent Report lists the following numbers of foreign-filed patent families, by country of origin (top 2 countries):


Technology / Originating country

United States

Japan


Biotechnology

32,139

7,094


Pharmaceuticals

43,317

7,738


Instruments – Medical Technology

57,902


17,611



Telecommunications

34,627


39,479


Semiconductors

20,431


48,369




Instruments - Optics

8,012

54,278


Machine tools

9,207

11,257



[2]http://english.peopledaily.com.cn/90001/90778/90862/6782417.html


[3]http://www.wipo.int/sme/en/documents/managing_patent_costs.htm#sub(providing examples)


[4]http://www.epip.eu/conferences/epip06/papers/Parallel%20Session%20Papers/MUNARI%20Federico.pdf


[5]Of course, small biotechnology businesses face cost-related challenges with respect to their international patenting efforts that go beyond patent procurement. The enforcement of foreign patents and the defense of patents in opposition proceedings, for example, can add additional unanticipated layers of costs that small businesses are ill-equipped to bear. For purposes of these comments, however, BIO confines itself to issues of international patent procurement.

[dothedd]

With VLP, these types of costly mistakes can be avoided...

www.novavax.com/


Faulty vaccine caused foot and mouth outbread 11 1 11
Faulty vaccine caused foot-and-mouth outbreak: Paraguay
AGENCE FRANCE-PRESSENOVEMBER 1, 2011
One of the most contagious animal diseases known to scientists, foot-and-mouth (also known as hoof-and-mouth) disease infects mainly cattle and swine but also sheep and goats.

ASUNCION, PARAGUAY - A botched vaccine intended to protect Paraguay’s livestock against foot-and-mouth disease was responsible for transmitting the ailment to hundreds of animals that later had to be destroyed, the government said Tuesday.

After extensive laboratory tests, Paraguayan and international scientists concluded that "human error" and "negligence" in the production of the vaccine caused the outbreak last September, a top veterinary official here said.

"After the most recent laboratory analysis, we have confirmed that the outbreak of foot and mouth disease... came about as a result of problems with the vaccination of animals," said Daniel Rojas, head of Paraguay’s National Service for Animal Health and Quality.
"There now is no doubt that it was human error that led to the outbreak of foot-and-mouth," he said.

The affected animals were at the Santa Helena ranch, a hacienda some 400 kilometers (250 miles) northeast of Asuncion, in the department of San Pedro.

Authorities said all told, more than a thousand cattle had to be sacrificed during the outbreak, which sent tremors through a region that prizes its meat industry.

Officials said they have not yet determined who would be held accountable for the costly mistake..
"We still have to identify at what stage in the process the problem occurred, determine who was responsible for the mistake and punish them," Rojas said, adding that the outbreak "led to significant economic losses for the country."

The outbreak prompted neighboring countries to ban the import of Paraguayan meat, livestock, and meat by-products to prevent the spread of the disease across international boundaries.

The export ban was a major blow to tiny, mostly rural Paraguay, where beef is the number two export, totaling $650 million last year.
Officials estimate that the ban costs the economy some $70 million each month.

One of the most contagious animal diseases known to scientists, foot-and-mouth (also known as hoof-and-mouth) disease infects mainly cattle and swine but also sheep and goats.

The disease can be spread with dust, animal-to-animal in herds, through consumption of contaminated animal products and even with farm implements and vehicles.

Although adult animals normally do not die from the disease, they must be destroyed once infected to keep it from spreading.

www.montrealgazette.com/story_print.html?id=5637999&sponsor=



NOVAVAX Announces Contract Award from U.S. Department of Homeland Security to Develop Foot-and-Mouth Disease Vaccine
10/05/11

NOVAVAX Announces Contract Award from U.S. Department of Homeland Security to Develop Foot-and-Mouth Disease Vaccine
Rockville, MD (October 5, 2011)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced that it has been awarded a $1.3 million contract from the U.S. Department of Homeland Security to develop a virus-like particle (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 Novavax recombinant VLP-based vaccine which, unlike current FMD vaccines, would not require the use of infectious FMD virus to be manufactured. This would address the potential risk of releasing infectious virus during vaccine production and stockpiling in the U.S. or other FMD-free countries.

“We welcome this opportunity to apply our recombinant vaccine technology to address a major threat to U.S. livestock producers,” said Stanley C. Erck, Novavax’s President and Chief Executive Officer. “Although the United States remains free of FMD, an effective vaccine will help prevent the spread of disease if an outbreak should occur and may abolish the risk of infection if used through a national vaccination program of all susceptible livestock.”

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 potent 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]

Source: Novavax, Inc.
Date: November 03, 2011 16:28 ET
NOVAVAX Appoints Erica S. Shane, Ph.D., Vice President, Process Development
ROCKVILLE, Md., Nov. 3, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced today the appointment of Erica Shane, Ph.D., to the position of Vice President, Process Development. In this role, Dr. Shane will have responsibility for all process development activities for Novavax. In addition she will provide oversight of process validation and technical support for manufacturing.


Prior to joining Novavax, Dr. Shane was Senior Director of BioProcess Engineering at MedImmune.

In this position, she was responsible for technology transfer to clinical and commercial sites as well as scale-up of cell culture and purification processes. Dr. Shane joined the purification department in 1994 and spent 12 years developing clinical and commercial purification processes. Her contributions were critical to the successful launch of Synagis®, a monoclonal antibody medication to help protect high-risk babies from severe RSV disease. In 2005, she assumed leadership of clinical manufacturing rising to the position of Senior Director in 2008. During the course of her tenure, Dr. Shane contributed to over 20 pipeline product programs. Prior to joining MedImmune, she held positions at DNX Corporation and American Cyanamid.

"We are very pleased to have someone of Erica's caliber and capabilities join Novavax at this time when process development is so important to the success of our current influenza vaccine program and our emerging vaccine programs, including our RSV vaccine," said Timothy J. Hahn, SVP, Manufacturing and Process Development.

Dr. Shane received her doctorate degree from Carnegie Mellon University, and her bachelor's degree from the Massachusetts Institute of Technology, both in chemical engineering.

About Novavax

Novavax, Inc. (Nasdaq

[dothedd]

Source: Novavax, Inc.
Date: October 28, 2011 08:00 ET

NOVAVAX to Report Third Quarter 2011 Financial Results on November 4, 2011

ROCKVILLE, Md., Oct. 28, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) will report financial results for the third fiscal quarter of 2011 on Friday, November 4, 2011, before the U.S. financial markets open. The announcement will be followed by a webcast and conference call hosted by Stanley C. Erck, President and Chief Executive Officer, and other members of senior management at 10:00 a.m. Eastern time. The webcast and conference call will be available at www.novavax.com under Investors/Events. The dial-in number for the conference call is 1-877-212-6076 (domestic) or 1-707-287-9331 (international). Webcast and telephone replays of the conference call will be available shortly after the completion of the call. To access the replay, dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and use passcode 23074432.

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

[dothedd]

NOVAVAX Reports Third Quarter 2011 Financial Results

ROCKVILLE, Md., Nov. 4, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced financial results for the third quarter ended September 30, 2011.

Novavax reported a net loss of $3.2 million, or $0.03 per share, for the third quarter of 2011 compared to a net loss of $10.2 million, or $0.10 per share, for the third quarter of 2010. For the nine months ended September 30, 2011, the net loss was $15.7 million, or $0.14 per share, compared to a net loss of $29.4 million, or $0.29 per share, for the same period in 2010. The primary reason for the decreased loss for the third quarter of 2011 as compared to the same period in 2010 was due to revenue recognized under the contract with the Office of Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS), awarded in February 2011, as well as lower research and development spending to support the company's clinical trials related to its vaccine candidates.

Research and development (R&D) expenses for the third quarter of 2011 were $6.2 million as compared to $7.9 million in the same period in 2010. The decrease in R&D expenses was due primarily to lower outside-testing costs, partially offset by higher employee-related costs. General and administrative expenses were $2.7 million for the third quarter of 2011 as compared to $2.8 million in the same period in 2010.

As of September 30, 2011, the company had $19.6 million in cash, cash equivalents and short-term investments compared to $31.7 million as of December 31, 2010.

Recent Business Highlights:

Reported positive top-line results from Phase 1 study of vaccine to prevent respiratory syncytial virus (RSV), the most important viral cause of lower respiratory tract infection in infants and children worldwide. Vaccine candidate was well-tolerated with no vaccine-related serious adverse events. A significant dose response pattern to the RSV-F antibody was observed and high rates of sero-conversion were seen in all doses, with 100% at the highest dose adjuvant group;
Received $1.3 million contract award from the U.S. Department of Homeland Security to develop a virus-like-particle (VLP) vaccine to prevent foot-and-mouth disease, a highly contagious viral disease of livestock and a potential threat to U.S. agriculture; and
Published positive safety and immunogenicity results from H1N1 influenza vaccine trial in Mexico, the first peer-reviewed publication of clinical data generated using Novavax's influenza VLPs.
Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: "With the recent impressive results from our Phase 1 RSV vaccine study, we now have three promising vaccine candidates in clinical testing to address urgent public health needs. We look forward to advancing our RSV vaccine candidate into later-stage testing and to initiating new clinical testing of our vaccine candidates to prevent seasonal and pandemic influenza under the HHS BARDA contract. In addition, our recent contract award to develop a vaccine to prevent foot-and-mouth disease in livestock opens up an important new avenue of vaccine research and development for our company."
Conference Call

Novavax's management will host its quarterly conference call today at 10:00 a.m. Eastern time today. The live conference call will be accessible on Novavax's website at www.novavax.com under "Investor/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. To access the replay of the conference call, dial 1 [phone] (domestic) or 1 [phone] (international) and enter pass code 23074432.

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 potent 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]

Centers for Innovation in Advanced Development and Manufacturing

Solicitation Number: 11-100-SOL-00011

Agency: Department of Health and Human Services
Office: Office of the Secretary
Location: Acquisitions Management, Contracts, & Grants (AMCG


Solicitation Number:

11-100-SOL-00011

www.fbo.gov/index?s=opportunity&mode=form&id=633c2fe5d2ed2712fd6e0067bc734b6c&tab=core&_cview=1


Notice Type:

Solicitation



Synopsis:


Added: Mar 02, 2011 10:25 am
TITLE: Centers for Innovation in Advanced Development and Manufacturing

SOLICITATION NO: 11-100-SOL-00011


NAICS Code: 236210


Description:
THIS IS A FORMAL SYNOPSIS OF A PROPOSED CONTRACT ACTION NOTICE IN ACCORDANCE WITH FAR 5.2. THIS COMPETITIVE ACTION IS BEING PROCURED UNDER FULL AND OPEN COMPETITION.

The Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) and the Office of Acquisitions Management, Contracts & Grants (AMCG) seek to establish U.S.-based Centers for Innovation in Advanced Development and Manufacturing (the ‘Centers') as public-private partnerships that share facility construction costs, facilitate development and manufacture of medical countermeasure (MCM) product candidates, ensure domestic vaccine and other biopharmaceutical manufacturing surge capacity in an emergency, and provide workforce development training programs. These U.S.-based Centers are expected primarily to provide, on a routine basis, core services that include advanced development and manufacturing capabilities of USG-supported developers of medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) MCMs to address national preparedness and response priorities and needs. Additionally, HHS/BARDA requires Contractor(s) to provide new or renovated domestic facilities that utilize state-of-the art flexible and innovative manufacturing processes and platform technologies to produce CBRN biopharmaceutical MCMs under routine conditions or vaccines or other biopharmaceuticals in an emergency for outbreaks of emerging infectious pathogens including pandemic influenza or other threats. Further, HHS/BARDA requires Contractor(s) to provide a workforce development training program to enhance and maintain the nation's ability to produce these MCMs. The work performed at these Centers will be coordinated and integrated by HHS/BARDA with programs from other USG agencies to provide long-term solutions that address the medical consequences of currently known or unknown threats. The Contractor and/or subcontractors or other affiliates must be experienced in vaccine and biopharmaceutical advanced development, manufacturing, quality systems, and regulatory affairs for FDA-approved products, in addition to maintaining a facility with adequate manufacturing surge capacity in a state of readiness for an extended period of time under the contract.

The solicitation will include a Statement of Objectives, not a Statement of Work. The Offerors however will be required to submit a detailed Statement of Work to address these Objectives as part of their submission. There are five (5) Minimum Mandatory Eligibility Criteria for this solicitation. [1] FDA Licensure of a Biopharmaceutical Product within the Last Ten (10) Years: The Offeror or it's subcontractor thereof shall have proficiency in biopharmaceutical product licensure and/or the manufacture of licensed biopharmaceuticals (i.e. vaccines, monoclonal antibodies, well-characterized biological products). This shall be demonstrated by the Offeror or a subcontract thereof having successfully sponsored a Biologics License Agreement (BLA) or New Drug Application (NDA) leading to production of a licensed biopharmaceutical product in the United States in the past ten (10) years. [2] U.S. Biopharmaceutical Manufacturing: The Offeror shall provide in the proposal written evidence of a firm commitment that the Offeror shall establish and maintain the necessary facilities in the U.S. or its territories for core advanced development and multi-purpose manufacturing services throughout the amortized lifetime of the facility(s). [3] Cost Sharing: The Offeror shall be required to propose cost sharing for this requirement. At a minimum, the Offeror shall commit to fund fifty-one percent (51%) of the total cost of the project for the new construction of biopharmaceutical facility(s), or twenty-five percent (25%) of the total cost for the retrofit of existing pharmaceutical facility(s). [4] Surge Manufacturing Capacity of Vaccines for Pandemic Influenza & Other Threats: Efforts funded as a result of this solicitation shall lead to U.S.-based manufacturing facility(s) that can be used, in an emergency, to produce, next- generation cell-, recombinant-, or molecular-based pandemic influenza vaccine to protect the U.S. population. These facilities may also be used, in an emergency, to produce vaccine or bother biopharmaceutical products against emerging infectious diseases and others threats of known and unknown origin. Therefore, the Offeror shall provide written evidence of a firm commitment to supply regulatory, quality, and production plans that will achieve a minimum of 50 million finished pandemic influenza vaccine doses within four (4) months of receipt of a Delivery Order for pandemic influenza vaccine. An Offeror that cannot identify a specific pandemic influenza vaccine candidate at the time of proposal submission shall be paired by HHS/BARDA with an appropriate vaccine candidate at the time of contract award or afterwards. [5] Training: The Offeror shall provide written evidence of a firm commitment to supply biopharmaceutical-oriented workforce development program that is aligned with current regulatory guidelines with U.S.-based, accredited academic institutions or other USG-recognized U.S.-based organizations that specialize in this area. Additional technical evaluation criteria will be identified in the RFP.
It is anticipated that two (2) pre-proposal conferences will be held during the solicitation period. Potential Offerors and any subcontractors are encouraged to attend. Teaming or partnering agreements (inclusive of small businesses) are highly encouraged. Small Businesses interested in subcontracting opportunites can contact the Contracting Officer or Offerors identified on www.FedBizOpps.gov. Multiple contract awards may be awarded as a result of this solicitation. Contract(s) awarded under this solicitation will have a base period between 2 to 8 years and option periods between 17 to 23 years depending on the successful Offeror(s) best overall approach. Option periods will not be further synopsized. Therefore, base and all option periods (if exercised) shall not exceed a maximum of 25 years. Please note that a draft RFP of this requirement was previous posted in FEDBIZOPPS under reference number DRAFT-RFP-AMCG-10-39 with subsequent questions and answers posted. Potential Offerors may review the previous posted information. However, this previous draft RFP does not represent the Government's official requirement and is no longer applicable. This final RFP, when released, is the official Request for Proposal for HHS's requirements. Information regarding the Centers for Innovation in Advanced Development and Manufacturing can be found online at www.medicalcountermeasures.gov. HHS/BARDA will be hosting a web-based session during the term of this Synopsis to provide an overview of HHS's requirements and provide additional responses to previous comments and questions; details regarding this meeting, pre-proposal conferences dates and other public information will be posted on www.medicalcountermeasures.gov.


The RFP Number 11-100-SOL-00011, Centers for Innovation in Advanced Development and Manufacturing solicitation will be issued for this requirement on or about 15 to 30 days after the release of this synopsis. The solicitation, all related documents and amendments, if any, will only be released and available electronically through the FedBizOpps. As such, no written, telephonic, facsimile or email requests for the solicitation package will be honored. Interested parties can register at the aforementioned site to receive procurement announcements by email. Since this solicitation will only be available electronically, it is solely the responsibility of interested parties to monitor www.FedBizOpps.gov for any solicitation amendments. Any responsive and responsible Offeror may submit a proposal to be considered by the USG. This notice does not commit the USG to the award of a contract. No collect calls or facsimile transmissions will be accepted. All responses should be identified with the respective solicitation number 11-100-SOL00011, name of company, business size, name of requestor, mailing address, telephone number, fax number, and email address of Point of Contact (POC), should be submitted to the Contracting Officer address identified in this notice.