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Bio Contracts (2012)

BIOTERRORBIBLE.COM: The following news and events are in respect to the field of bio-terror and pandemic related contracts which occurred within the calendar year of 2012. The American government, more than any other nation, has been systematically preparing its population for an upcoming bio-terror related pandemic by funding draconian bio-terror contracts in the wake of the 9/11 attacks.

Title: Court Denies SIGA’s Motion For Re-Argument
Date:
January 3, 2012
Source:
Bio Prep Watch

Abstract:
The Delaware Court of Chancery denied SIGA Technologies' motion for re-argument that was filed on October 4, upholding the court's original September 22 decision regarding compensation for PharmAthene, Inc.
 
The decision awarded PharmAthene 50 percent of the net profits over 10 years from all sales of SIGA's smallpox antiviral therapeutic, ST-246, and related products after SIGA receives the initial net profits of $40 million. The court also awarded PharmAthene one-third of its reasonable expert witness costs and attorney's fees.
 
"We are pleased by the Court's decision to uphold its original ruling in favor of PharmAthene," Eric I. Richman, the president and chief executive officer of PharmAthene, said. "The court's decision to award 50 percent of the net profits of ST-246 to PharmAthene represents a tremendous victory for our company. The significant economic interest and near-term revenue we expect to recognize following this decision will enable us to accelerate our path to profitability and generate immediate value for investors. Coupled with potential future revenue from our current programs, which continue to make exciting progress, PharmAthene is positioned to become one of the nation's premier biodefense innovators."
 
In the motion filed on October 4, SIGA requested that the court vacate the "equitable lien relief" or "equitable payment stream" it awarded to PharmAthene.
 
"SIGA…denied PharmAthene the benefit of its bargain by conducting those negotiations in bad faith and, thus, is liable for breach of contract and under the doctrine of promissory estoppel….[T]he underlying purposes of a constructive trust and equitable lien [are] applicable to the circumstances of this case…PharmAthene would have accepted the use of a 50/50 profit split…[and] SIGA wrongfully deprived PharmAthene of its expectation of a major role in controlling the pace of the ST-246 development and expenditures," the court said in its opinion.
 
SIGA was awarded a base contract for the initial procurement of 1.7 million treatment courses of ST-246 from the Biomedical Advanced Research and Development Authority. The award is valued at $433 million, $412.6 million of which is for the purchase of the product. PharmAthene was formed to meet the needs of the U.S. and its allies by developing and commercializing medical countermeasures against chemical and biological weapons (Bio Prep Watch, 2012).

Title:
Soligenix Receives Funding For Anthrax Vaccine
Date: January 4, 2012
Source: Bio Prep Watch

Abstract:
Soligenix, Inc., was recently granted $9.4 million in funding to develop an anthrax vaccine in cooperation with Harvard University.

The biopharmaceutical company, based in West Windsor, New Jersey, received the grant money from the U.S. National Institute of Allergy and Infectious Disease, according to NJ.com.

The current standard anthrax vaccine, known as anthrax vaccine absorbed, requires a series of multiple injections and annual booster shots. Soligenix officials believe that their new anthrax vaccine development program is capable of making a vaccine that would require only a single dose and remain effective for a long period.

“If long-term stability were achieved, the vaccine would have the potential to be stockpiled for general use and for post-exposure prophylaxis,” Soligenix CEO and President Christopher Schaber said, NJ.com reports.

Schaber said that the U.S. government has already spent close to $4 billion in efforts to develop a vaccine more effective for pre- and post-anthrax exposure.

Mercer County, the home of Soligenix, housed the facility that processed four anthrax-laced letters during the 2001 anthrax mail attacks. During those attacks a handful of postal employees were exposed to the agent through inhalation or contact with the skin. The facility was forced to close and more than 1,000 people were treated for potential exposure (Bio Prep Watch, 2012).

Title: HHS Enters Contract For Novel Biowarfare Antibiotic
Date:
January 24, 2012
Source:
Bio Prep Watch

Abstract:
The U.S. Department of Health and Human Services recently entered a contract with CUBRC, Inc., to aid in the development of a novel antibiotic to be used to treat the effects of biological warfare agents such as anthrax and plague.

The $11.4 million contract will be managed by the HHS Biomedical Advanced Research and Development Authority. CURBC will work in partnership with Tetraphase Pharmaceuticals, according to YadkinRipple.com.

The contract is scheduled for one year, but can be extended to a total of five years with a potential value of $67.2 million.

The drug, known as TP-434, is a member of the tetracycline class of antibiotics, which is currently used primarily to treat intra-abdominal infections. Early indications are that TP-434 can be effective against bacteria resistant to an increasing number of antibiotics, including other tetracyclines already approved by the U.S. Food and Drug Administration.

The funding will support the testing of TP-434 in both clinical and animal studies and in the development of an efficient manufacturing process. Both oral and intravenous forms of the drug are being explored.

“Protecting the nation against biological threats requires a wide variety of countermeasures, and we’ve found that an efficient way to develop such countermeasures is to focus on products that have both commercial and biodefense uses,” BARDA Director Robin Robinson said, YadkinRipple.com reports. “This approach was recommended by the Public Health Emergency Medical Countermeasure Enterprise Review which the Secretary released in 2010, and supporting the development of TP-434 reflects our ongoing commitment to multi-purpose products and the expansion of our antimicrobial portfolio for national preparedness” (Bio Prep Watch, 2012).

Title: Idaho Technology, Inc. Delivers Biothreat Detection Kits To U.S. Military
Date: January 26, 2012
Source: Bio Prep Watch

Abstract: Idaho Technology, Inc., a privately held Salt Lake City-based biotechnology company, announced on Wednesday that it has delivered the first shipment of a biothreat detection kit to the Critical Reagents Program.

The RAZOR CRP BioThreat-X Kits will be supplied to the U.S. military. The kit is the first Department of Defense system that is able to test for 10 biothreat agents at one time in the field. The results of the test are available in 30 minutes.

“Idaho Technology is fully committed to collaborating with the US military to enhance its biological threat detection capabilities in support of the warfighter, and this project is a good example of the many joint efforts between Idaho Technology and the US government,” Kirk Ririe, the CEO of Idaho Technology, said.

The kit contains polymerase chain reaction assays that are developed in DoD laboratories. The assays are then packaged and freeze-dried in a patented pouch system designed to run on the kit’s platform. The RAZOR CRP BioThreat-X Kit also includes a PCR inhibition control and amplification control to confirm proper operation of the system. The kit was developed at the direction of the CRP as part of an 18 month joint effort. The kit will be available for purchase by agencies cleared through the CRP catalogue (Bio Prep Watch, 2012).

Title: BARDA Extends Contract With Pfenex For Development Of Anthrax Vaccine
Date: May 2, 2012
Source: Bio Prep Watch


Abstract: Pfenex, Inc., a protein production company, announced on Tuesday that the Biomedical Advanced Research and Development Authority has exercised an option to extend its contract with Pfenex to develop a recombinant protective antigen from anthrax.

BARDA is a division of the U.S. Department of Health and Human Services. The authority began the contractual relationship with Pfenex in July 2010. The contract supports the development of a robust Pfenex Expression Technology based production strain and process for producing the rPA from anthrax in bulk.

Under the terms of the contract, Pfenex will continue developing the rPA-based anthrax vaccine from rPA produced in Pseudomonas fluorescens. During the base period of the contract, Pfenex showed that a stable, immunogenic and protective type of rPA could be recovered and expressed from the very efficient fermentation process of a P. fluorescens strain that had been engineered to produce the antigen.

“We are pleased with the results and progress provided by Pfenex’s recombinant platform technology to the production of a next generation anthrax vaccine,” Bertrand C. Liang, the chief executive officer of Pfenex, said. “The exercise of this option by BARDA enables Pfenex and BARDA to continue our successful partnership sharing a common objective to develop an anthrax vaccine with a process capable of achieving the goals of the Strategic National Stockpile for the U.S. government, including production, shelf life, and administration improvements.”

The company’s Pfenex Expression Technology is based on the P. fluorescens microorganism that produces reagent proteins, research proteins, innovator biopharmaceuticals and biosimilars (Bio Prep Watch, 2012).

Title: FLUMIST Vaccine, First To Protect Against Four Flu Strains, Gets FDA Approval
Date: March 1, 2012
Source:
Examiner

Abstract: To date, all currently available, licensed influenza vaccines on the market are trivalent, or contain three strains of the influenza virus.

That is until now. In a press release Wednesday, Maryland biological products manufacturer, MedImmune, announced the US Food and Drug Administration (FDA) approval of the first quadrivalent vaccine to protect against seasonal influenza.

The vaccine, FLUMIST Quadrivalent, intranasal, offers broader coverage against the seasonal flu by incorporating a second influenza B strain.

The US Centers for Disease Control and Prevention (CDC) said in the past decade, two different strains of influenza B have circulated (B/Yamagata and B/Victoria) with half the years the flu vaccine did not contain the predominant strain.

This comes a day after the FDA's Vaccines and Related Biological Products advisory committee voted on which strains to include in the trivalent flu vaccines for the 2012-2013 season.

They voted nearly unanimously to replace the current Brisbane/Victoria strain with the Wisconsin/Yamagata strain.

The World Health Organization (WHO) recommended including the California and Victoria influenza A strains and the Wisconsin/Yamagata influenza B strain in vaccines for the Northern Hemisphere for the 2012-2013 season.

However, as MedImmune’s executive vice president of Research and Development, Bahija Jallal said, “This is the first quadrivalent influenza vaccine approved and MedImmune is pleased to be able to take the next steps in making this product available to the public. We believe that the inclusion of an additional B strain in an annual influenza vaccine could provide a direct health benefit to individual vaccine recipients in the event that the correct B lineage either is not selected for inclusion in a trivalent vaccine, or if both lineages co-circulate” (Examiner, 2012)

Title: Japan Orders NBC Detection Systems From Lockheed Martin
Date: May 4, 2012
Source: Bio Prep Watch


Abstract: The Japan Ministry of Defense has ordered 19 AbleSentry systems from the Bethesda, Maryland-based Lockheed Martin to provide early warning and detection of potential nuclear, biological or chemical attacks.

The AbleSentry is a system designed for tactical battlefields that can be simply deployed, operated and maintained. It uses a detection algorithm and a network of remote sensors to detect threats and minimize the possibility of false alarms. The networking of the sensors prevents the possibility of a system-wide alarm being caused by one sensor.

“The system’s ability to provide information on where the threat is coming from and how fast it’s moving gives battlefield commanders the advanced warning they need to make the decisions necessary to keep their troops out of harm’s way,” Daniel Heller, the vice president of new ventures for Lockheed Martin’s Mission Systems & Sensors business, said.

The AbleSentry system is the next evolutionary step after the company’s Biological Aerosol Warning System and its Enhanced Biological Aerosol Warning System platforms. The new system adds radiological and chemical detection capabilities. Lockheed Martin has delivered 24 BAWS and EBAWS systems to Japan’s Ground Self Defense Forces since 2005.

The AbleSentry also monitors temperature, wind direction and speed, humidity and location data, and collects air samples for the identification and confirmation of biological agents.

Japan will use the devices for counter-terrorism efforts (Bio Prep Watch, 2012).

Title: Anthrax Alert System At Risk As Cost Estimate Hits $5.7 billion
Date: June 18, 2012
Source:
Washington Post

Abstract: Funding for BioWatch, an early warning system to detect deadly pathogens in 30 U.S. cities, may be in jeopardy after cost estimates surged to $5.7 billion, six times the initial assessment.

The Department of Homeland Security wants to open bidding before October on the next phase of the program, which monitors the air for pathogens such as anthrax and smallpox.

 The five-year contract for as much as $3.1 billion would upgrade the system to automatically transmit collected data to laboratories, eliminating the present manual handling.

BioWatch has suffered cost estimate increases and delays since then-President George W. Bush, prompted by the post-Sept. 11, 2001, anthrax attacks, started it in 2003. Rep. Gus Bilirakis (R-Fla.), chairman of the House subcommittee with jurisdiction over BioWatch, says he wants assurances that costs are under control and has asked the Government Accountability Office to analyze the proposed spending.

“The program could find itself in danger of being cut back or completely scrapped if law­makers determine that it’s becoming a major and costly acquisition failure,’’ Jessica Herrera-Flanigan, a partner with Monument Policy Group, a Washington-based consulting firm, said in a telephone interview. Herrera-Flanigan was staff director for the House Homeland Security Committee from 2005 through 2008.

Companies with investments at stake include Northrop Grumman, which has worked since at least 2009 to develop technology for BioWatch.

BioWatch was developed after it took more than two weeks to identify what was killing U.S. citizens during the anthrax attacks in 2001, said Leonard Cole, an adjunct professor at Rutgers University’s Newark branch, andauthor of the book, “The Anthrax Letters.’’

Letters laced with anthrax were sent through the mail and resulted in five deaths, including two postal workers and a newspaper photo editor. Another 17 people became ill. No one has been charged in the attacks, Chris Allen, a Federal Bureau of Investigation spokesman, said by telephone.

“Before BioWatch, we were all canaries in a coal mine,’’ Cole said in a phone interview. “Only after people dropped dead or became ill did we understand that a pathogen was floating around.’’

August Report
The federal government has spent about $800 million on BioWatch since 2003, Rep. Bennie Thompson (D-Miss.), ranking member of the subcommittee overseeing the program, said at a March 29 hearing.

He and Bilirakis both questioned the cost of upgrading BioWatch. Lawmakers are “increasingly concerned about the viability of this developing technology and also about the department’s ability to deploy it on time and within budget,’’ Bilirakis said at the hearing of the Homeland Security subcommittee on emergency preparedness, response and communications.

The GAO report, due in August, “will not be considered lightly, especially given our country’s current fiscal situation and the price tag for the BioWatch program,’’ he said in an e-mail message last week.

The estimated lifetime cost of the program rose from $921 million in 2010 to $2.1 billion the following year, according to a June 2010 report by the GAO, citing figures from the Office of Management and Budget.

The total price may reach $5.7 billion, according to a 2011 report by LMI, a McLean-based consulting firm hired by the Department of Homeland Security.

The $2.1 billion and $5.7 billion “cannot be validly compared,’’ Noah Bartolucci, a BioWatch spokesman, said in an e-mail.

The $5.7 billion figure covers a longer time period — 17 years, vs. 10 years — and program planners “assigned no confidence level’’ to the $2.1 billion estimate, he said.

BioWatch currently uses canisters that must be installed manually and taken to a lab for analysis. It can take 48 hours to get the results. That delay could mean lost lives in an emergency, Michael Walter, program manager for BioWatch, said in a phone interview.

Automated Labs
The upgraded system, called Gen-3, would use permanent boxes containing small, automated laboratories that would detect pathogens and then securely transmit the information to local health departments. Results would be available in as little as three hours, Walter said.

BioWatch is installed at undisclosed locations in cities that include Boston, Chicago and Houston. The system is set up to detect pathogens indoors and out, Walter said.

In one incident, after an antiwar protest in 2005, BioWatch filters in Washington picked up traces of a bacterium that causes a potentially deadly infection called tularemia, according to the Department of Homeland Security and city health department. No cases of illness were reported. Health officials later said the protesters may have kicked up soil contaminated with harmless quantities of the bacterium.

Northrop, based in Falls Church, tested its BioWatch technology in 2010 with an $8.4 million contract. In all,Northrop has received about $18 million for BioWatch from the federal government, Yolanda Murphy, a company spokeswoman, said in an e-mail.

The company has experience overseeing the U.S. Postal Service’s biodetection system, said Dave Tilles, Northrop’s director of chemical, biological, radiological, nuclear and enhanced conventional weapons defense systems.

“We understand what it takes to develop, manufacture and support automated biodetection systems,’’ he said in a telephone interview. “We think the technology for BioWatch Gen-3 is ready, and we hope that Congress moves ahead with this important mission.’’

As the costs of BioWatch rise, they will need to be weighed against the system’s intended benefits, Walter said.

“From a public health standpoint we have to ask if this program is going to be useful in reducing casualties and will it be an improvement over the current system,’’ he said. “How do you deal with the value of human life and human suffering?’’ (Washington Post, 2012).

Title: Glaxo, Novartis To Get U.S. Contracts To Make Vaccines
Date: June 19, 2012
Source:
Reuters

Abstract: Pharmaceutical companies including GlaxoSmithKline PLC and Novartis AG will get federal money to help develop medicines against pandemics and bioterrorist threats, the U.S. government said on Monday.

The two drugmakers - among the world's largest vaccine makers - as well as U.S.-based Emergent Biosolutions Inc will work with U.S. universities and smaller biotechnology companies at one of three centers to develop and manufacture the medicines.

The U.S. Department of Health and Human Services (HHS) announced the partnership to ensure enough critical medicines - such as protection against pandemics like influenza or biological attacks like anthrax - are manufactured within U.S. borders.

"We anticipate that together, the centers will be able to produce a quarter of a nation's pandemic influenza vaccine within four months of the onset of a pandemic," said Dr. Nicole Lurie, the assistant secretary for preparedness and response at HHS.

In 2009, only one H1N1 vaccine maker had facilities that were located only in the United States, she said.

The contracts also aim to help smaller biotech companies to turn their ideas into successful products.

The bulk of the government's initial $400 million contract will go towards maintaining or expanding manufacturing facilities to make sure they can make several different medicines, and easily switch from one medicine to another in case of an emergency.

GlaxoSmithKline will be part of a $176 million five-year contract in Texas, Novartis will head a $60 million four-year contract in North Carolina, and Emergent will work on a $163 million eight-year contract in Maryland.

The contracts can be renewed for up to 25 years and will be overseen by the Biomedical Advanced Research and Development Authority within HHS (Reuters, 2012)

Title: Soligenix To Collaborate With IDRI On Biodefense Vaccines
Date: June 28, 2012
Source:
BioPrepWatch

Abstract: Soligenix, Inc., a development stage biopharmaceutical company, announced a collaboration on Wednesday with the Seattle-based Infectious Disease Research Institute to develop biodefense vaccines using IDRI’s synthetic adjuvants and Soligenix’s ThermoVax platform.

The vaccines, which will also use Soligenix’s proprietary subunit proteins, may result in vaccines with characteristics for the rapid onset of protective immunity and long-term stability that could be stockpiled for use in an emergency. The first objective of the collaboration will be the development of an anthrax vaccine.

“IDRI is enthusiastic about working with Soligenix to support their efforts in developing their anthrax and ricin vaccine candidates, and are highly confident that IDRI’s adjuvant technology can help build effective vaccines,” Darrick Carter, IDRI’s vice president of adjuvant technology, said. “These new candidate vaccines could be the critical solution in providing protection to people in the event there is a bioterror threat from the release of anthrax or ricin toxins.”

The anthrax vaccine will combine IDRI’s adjuvant compounds for generating high titer neutralizing antibodies to anthrax toxin with Soligenix’s second generation dominant negative inhibitor subunit protein anthrax vaccine candidate called VeloThrax. The companies will also collaborate on a ricin vaccine.

“We are very pleased to be able to enter into a partnership of this type with IDRI,” Christopher J. Schaber, the president and CEO of Soligenix, said. “IDRI possesses novel R&D, manufacturing and technical expertise in the field of adjuvants. We believe that with the addition of IDRI’s potent adjuvants to our hyperimmunogenic anthrax and ricin toxin vaccines, we will have the potential to develop highly competitive biodefense vaccines that can address the exact needs of the US government with regard to rapid onset immunity with just one or two doses. As with any biodefense program, our goal is to have VeloThrax and RiVax stockpiled by the U.S. government in its strategic national stockpile.”

The initial research of the collaboration will be conducted under Soligenix’s existing $9.4 million grant from the National Institute of Allergy and Infectious Disease (BioPrepWatch, 2012).

Title: DARPA's Blue Angel - Pentagon Prepares Millions Of Vaccines Against Future Global Flu
Date: July 28, 2012
Source:
RT

Abstract: The Pentagon’s DARPA lab has announced a milestone, but it doesn’t involve drones or death missiles. Scientists at the Defense Advanced Research Projects Agency say they’ve produced 10 million doses of an influenza vaccine in only one month’s time.

In a press release out of the agency’s office this week, scientists with DARPA say they’ve reach an important step in being able to combat a flu pandemic that might someday decimate the Earth’s population. By working with the Medicago Inc. vaccine company, the Pentagon’s cutting edge research lab says that they’ve used a massive harvest of tobacco plants to help produce a plethora of flu-fighting vaccines.

“Testing confirmed that a single dose of the H1N1 VLP influenza vaccine candidate induced protective levels of hemagglutinin antibodies in an animal model when combined with a standard aluminum adjuvant,” the agency writes, while still noting, though, that “The equivalent dose required to protect humans from natural disease can only be determined by future, prospective clinical trials.”

Researchers have before relied on using chicken eggs to harvest compounds to use in influenza vaccines. With a future outbreak requiring scientists to step up with a solution as soon as possible, though, they’ve turned to tobacco plants to help produce the vaccines.

“Vaccinating susceptible populations during the initial stage of a pandemic is critical to containment,” Dr. Alan Magill, DARPA program manager, says in an official statement. “We’re looking at plant-based solutions to vaccine production as a more rapid and efficient alternative to the standard egg-based technologies, and the research is very promising.”

The World Health Organization has gone on the record to say that as much as half of the people on the planet could be affected by a pandemic in the near future, and it could take as much as nine months for a vaccine for a pandemic virus strain to become made available. With the lives of billions of people across the world at stake, DARPA has been trying to determine new ways of churning out antidotes in as little time as possible. Now its researchers say, that in only a month, scientists “produced more than 10 million doses (as defined in an animal model) of an H1N1 influenza vaccine candidate based on virus-like particles (VLP).”

Through DARPA’s previously established Blue Angel program, researchers have spent several years searching for new ways to produce mass quantities of vaccine-grade protein that could be used to combat what they say are very real emerging and novel biological threats.

Andy Sheldon, Chief Executive Officer of Medicago , says in the company’s own press release that "The completion of the rapid fire test marks a substantial achievement in demonstrating our technology and the potential for Medicago to be the first responder in the event of a pandemic flu outbreak.”

Medicago’s research was conducted in a 97,000-square-foot vaccine facility in North Carolina that was funded through a $21 million Technology Investment Agreement with DARPA (RT, 2012)

Title: Elusys Awarded $50.2 Million For Anthrax Treatment
Date: August 3, 2012
Source:
BioPrepWatch

Abstract: Elusys Therapeutics, Inc., a biopharmaceutical company, announced on Thursday that it has received $50.2 million in additional funding from the U.S. government for the advanced development of an investigational agent for treating anthrax.

ETI-204, also known as Anthim, is an antibody that targets a protective antigen of anthrax-causing Bacillus anthracis, neutralizing its lethal effects. The agent is being developed for the potential treatment of inhalational anthrax after a biological attack.

The additional funding was awarded by the Biomedical Advanced Research and Development Authority. The Pine Brook, N.J.-based company previously received $57.5 million in funding as part of a five year, $143 million contract. The contract is meant to support Elusys in its attempt to gain licensure from the U.S. Food and Drug Administration for manufacturing, human safety trials and non-clinical effectiveness studies in animals.

“We are pleased that the U.S. government is continuing to support our efforts to advance ETI-204 through the final stages of our development program, including validation of our commercial manufacturing processes,” Elizabeth Posillico, the president and CEO of Elusys, said. “We recently completed a clinical dose-escalation study and look forward to reviewing those data.”

Inhalational anthrax is often fatal even if treated with antibiotics. ETI-204 may serve as a promising candidate to treat humans for inhalational anthrax (BioPrepWatch, 2012).