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Bio Contracts (2011)

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 2011. 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: U.S. Government Expands BioThrax Procurement Contract To 17.92M Doses From 14.5M Increasing Contract Value By Up To $101 Million
Date: May 2, 2011
Source: Business Wire

Abstract: Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a modification to its current procurement contract (200-2009-30162) with the U.S. government to supply an additional 3.42 million doses of BioThrax® (Anthrax Vaccine Adsorbed). BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

This modification to the contract is valued at up to $101 million for the delivery and shipping of additional doses of BioThrax beginning 3Q 2011. Delivery of these doses will commence immediately following early completion of final delivery of the original 14.5 million doses of BioThrax under the contract prior to this modification. Emergent anticipates completing all deliveries of these additional 3.42 million doses of BioThrax during the remainder of 2011.

“Emergent proudly supports the U.S. government’s efforts and unwavering commitment to meet its stated need of 75 million doses of anthrax vaccines,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This contract is an indication that BioThrax remains a critical component of the government’s arsenal of biodefense medical countermeasures. In addition to this contract modification, we are continuing discussions with the U.S. government regarding a follow-on procurement contract, which we anticipate will cover a multi-year period.”

About Emergent BioSolutions Inc.

Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent's marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 million military personnel. For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2011, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Annual Report for the year ended December 31, 2010 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release (Business Wire, 2011).

Title: U.S. Increases Emergent BioSolutions' Anthrax Vax Contract
Date: May 4, 2011
Source: Fierce Vaccines

Abstract: Emergent BioSolutions is adding another 3.42 million doses to its 14.5 million-dose BioThrax contract with the U.S. government. The contract extension is worth an approximate $101 million; the company has made $1.2 billion through federal contracts since 2004. BioThrax is the only FDA-approved anthrax vaccine.

"Emergent proudly supports the U.S. government's efforts and unwavering commitment to meet its stated need of 75 million doses of anthrax vaccines," said CEO Fuad El-Hibri in a release. "This contract is an indication that BioThrax remains a critical component of the government's arsenal of biodefense medical countermeasures."

El-Hibri also stated that Emergent and the U.S. are in talks for another multi-year contract. The company will begin delivering the additional doses for the Strategic National Stockpile in the third quarter of this year after all previously contracted doses have been filled. Emergent also has secured a $186.6 million contract for a recombinant protein antigen to combat anthrax and a $28.7 million contract for a third-generation vaccine (Fierce Vaccines, 2011).

Title: Fighting Bio Terrorism With SIGA Technologies
Date:
June 28, 2011
Soure:
Beacon Equity Research 

Abstract: The United States has been on high alert for additional terrorist attacks since the attack on September11, 2001. Security has been ramped up everywhere in an effort to prevent another destructive event. One of the more insidious weapons used in warfare and potentially by stateless terrorists is biological. Biological weapons are among the most feared as they are silent and highly effective killers.

Fortunately, there are effective countermeasures against biological weapons.  In the United States, a division of the Office of the Assistant Secretary of Preparedness and Response known as the Biomedical Advanced Research and Development Authority or BARDA handles the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases. This governmental agency stockpiles pharmaceutical products to be used in widespread medical emergencies like biological attacks. As you can imagine obtaining a contract from BARDA is a highly lucrative score for a company.

Our focus stock today, SIGA Technologies (Nasdaq: SIGA) is one such pharmaceutical company with a contract from BARDA. The contract is for 1.7 million courses of SIGA’s groundbreaking drug, ST-246, an oral therapeutic agent active against orthopoxviruses including smallpox. It is the only drug from any source ever to have demonstrated efficacy in non-human primate models of orthopox virus disease, which was a requirement of the request for proposal that resulted in the current contract. ST-246 will be the first entirely new small-molecule drug delivered to the Strategic National Stockpile under Project Bioshield. Smallpox, even though no longer present naturally in the environment, is considered a formidable bioterrorism threat, and there is currently no FDA-approved treatment for symptomatic individuals.

The contract was modified to just 1.7 million courses from the original option of 12 million.  It does not preclude BARDA from purchasing additional courses, however. Being that SIGA is the only company that produces this drug, it’s possible that the modified contract could work in SIGA’s favor. Being that its no longer optioned in the contract, should BARDA need to purchase additional product, price increases may now be possible.  I am not an expert in Government Pharma purchases but it makes sense on the surface.

Technically, shares have fallen sharply off their recent highs and are basing around the $10.50 per share range. $12.40 is significant resistance as the 200 day moving average for any up moves. Price is jumping higher on the contract news. A close eye should be kept on the $12.40 area! (Beacon Equity Research, 2011).

Title: Five Metro [U.S. Postal] Areas To Receive Grants To Fight Anthrax
Date: August 3, 2011
Source:
Bio Prep Watch

Abstract: Five metropolitan areas that have demonstrated the ability to deliver anthrax antibiotics through the National Postal Model will receive a total of $400,000 in grants from the U.S. Department of Health and Human Services.

The grants fund planning and exercises incorporating U.S. Postal Service workers into community plans to deliver medication after an anthrax bioterrorism attack, the News Eagle reports.

The Boston Public Health Commission, the Philadelphia Department of Health, the Louisville/Jefferson County Metropolitan Board in Kentucky and the San Diego Health and Human Services Agency will each receive $50,000 grants for initial planning and exercises. The Minneapolis Department of Health, will receive a $200,000 grant to conduct a full-scale exercise simulating an anthrax attack in the metropolitan area.

If a full-scale anthrax attack were to occur, everyone potentially exposed to anthrax would need to receive an initial supply of antibiotics within 48 hours. Under the NPM, volunteers from the USPS would pick up antibiotic packages at an established location and, protected by law enforcement officers, would deliver the antibiotics to homes in predetermined ZIP codes.

“The fatality rate for people whose lungs are infected with anthrax is extremely high if they do not receive antibiotic treatment, which means the quicker health professionals can get antibiotics into people’s hands, the quicker we can protect health and save lives,” Dr. Nicole Lurie, the assistant secretary for Preparedness and Response, said, according to the News Eagle. “The postal model offers an additional tool for local health departments to begin treating people potentially exposed to anthrax.”

This method would augment existing dispensing plans that ask residents and visitors to go to special medication dispensing sites (Bio Prep Watch, 2011).

Title: A-T Solutions To Train Navy On Biological, Chemical Weapon Operations
Date: August 26, 2011
Source:
Bio Prep Watch

Abstract: A-T Solutions, Inc., a U.S. counterterrorism company, has received a $21.9 million contract from the U.S. Navy to provide logistical and instructor support for explosive ordnance disposal.

Under the contract, A-T Solutions will provide experts experienced in explosive ordnance disposal operations, improvised explosive device and unexploded ordnance, chemical, biological and nuclear operations, exercise planning, operations and maintenance of tactical vehicles, small boats and EOD robots, and advanced expeditionary combat shooting skills.

A-T Solutions, which has headquarters in Virginia, received the four year award from the Naval Explosive Ordnance Disposal Training and Evaluation Unit One. A-T Solutions will train approximately 3,000 explosive ordnance disposal technicians and other Department of Defense Personnel as part of the contract.

“We are excited to continue our work training and supporting our EOD forces,” Dennis Kelly, the president and CEO of A-T Solutions, said. “Navy EOD and Naval Expeditionary Support forces continue to play an extremely important role in the global war on terrorism. EODTEU ONE provides the requisite advanced training to EOD and NECC personnel prior to combat deployments to Iraq, Afghanistan and other global theaters. In addition, our support to COMEODGRU ONE in training and readiness, coupled with our operations and maintenance support at ESU ONE, enables A-T Solutions to provide ‘full scope’ support to these critical missions”
(Bio Prep Watch, 2011).

Title: GlaxoSmithKline Receives Federal Contract To Develop Anthrax Antibiotic
Date: September 7, 2011
Source:
Bio Prep Watch

Abstract: GlaxoSmithKline has been awarded a federal contract worth up to $94.5 million to develop a new antibiotic to combat threats like plague and anthrax.

GSK will initially receive $38.5 million from the Biomedical Advanced Research and Development Authority over two years, which will be directed to the research and development of experimental antibiotic known as GSK2251052.

GSK2250152, also known as GSK'052, is a boron-based antibacterial from Anacor Pharmaceuticals' boron chemistry platform. GSK entered a research and development collaboration with Anacor in 2007. GSK'052 was the first compound that came from the collaboration that GSK licensed.

“We welcome this agreement with BARDA, which will support the development of GSK2251052 and important research into medical countermeasures for bioterrorism,” David Payne, the head of antibacterial drug discovery at GSK, said. “Such innovative public-private collaborations provide an additional stimulus for anti-bacterial research and development.”

GSK'052 targets the bacterial enzyme leucyl tRNA synthetase. Additional financing could be available if BARDA exercises options for future funding, which could bring the total value of the award to $94.5 million.

BARDA is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services that supports the advanced development of countermeasures that address emerging disease threats to public health
(Bio Prep Watch, 2011).