Fuad El-Hibri

The Office of the Biomedical Advanced Research and Development Authority has advised Emergent BioSolutions that while BARDA’s Request for Proposal has been canceled, Emergent is encouraged to submit a proposal for the office’s Broad Agency Announcement.

BARDA canceled the RFP for the procurement for rPA vaccines after a technical evaluation panel determined that no proposals submitted by vaccine developers could meet the ProjectBioShield statutory requirement of having the product ready for licensure within eight years.

An amendment issued by BARDA to BAA 09-34 at the same time, however, enable companies to submit proposals to obtain development funding for rPA vaccine candidates, which Emergent has been strongly encouraged to do by BARDA.

Emergent plans to submit its proposal to the BAA by the end of this year, in front of the due date of February 1, 2010 for the proposals.

This announcement also does not impact Emergent’s $400 million procurement with the Centers for Disease Control and Prevention to manufacture and deliver 14.5 million doses of BioThrax for the Strategic National Stockpile.

“With this action, BioThrax remains a critical and long-term countermeasure for the US government,” Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, said. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA.  Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”

BioThrax is currently being delivered under this contract with an expected completion of deliveries by September 2011. BioThrax is the only FDA licensed vaccine for the prevention of anthrax diseases.

“We believe that BioThrax will remain a premier product based on its recent enhancements, such as four-year dating, a reduced vaccination schedule and intramuscular route of administration, together with the potential for a further reduction in the vaccination schedule to a 3-dose primary series with a 3-year boost,” Daniel J.Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, said. “BioThrax continues to be the product of choice for the USG and other customers seeking to address the anthrax threat.”

BARDA and Emergent are also in separate talks for a contract that would see BARDAA fund scale-up and related activities to obtain FDA licensure for large-scale production of BioThrax at Emergent’s new 50,000-square-foot Lansing, Mich., manufacturing facility.

“I am proud that Lansing remains home to America’s first line of defense against what experts say is the single biggest bioterror threat, anthrax,” U.S. Rep. Mike Rogers, MI-08, said. “The good news about the cancellation of this particular proposal is HHS recommitted itself to the Lansing-made anthrax vaccine and has opened a new proposal for a next-generation anthrax vaccine for which Emergent has indicated it will compete.

“Rest assured, I will continue working to strengthen our nation’s existing bioterror preparedness measures and protect national security jobs in Lansing.”

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Key news developments will affect shares of these two companies who help meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons.

The two companies which waited until late after hours on Monday to announce that the Biomedical Research and Development Authority had informed them of some negative news.

After hours on Monday, PharmAthene, Inc. (NYSE Amex: PIP) a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced that the Department of Health and Human Services Biomedical Research and Development Authority (BARDA) has canceled its request for proposal (RFP) for Recombinant Protective Antigen Anthrax Vaccine for the Strategic National Stockpile (RFP BARDA 08-15).

PharmAthene was informed of BARDA’s decision during a meeting late Monday afternoon with BARDA representatives.  BARDA issued a press release after the close of the securities markets announcing that it will cancel RFP BARDA 08-15 because it did not believe vaccine developers submitting proposals in response to the request for proposal (RFP) could have product ready for FDA licensure within 8 years.

In similar news…

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been advised by the Office of the Biomedical Advanced Research and Development Authority (BARDA) that the Request for Proposal (RFP) for the procurement of rPA vaccines has been cancelled in favor of a Broad Agency Announcement (BAA) for rPA vaccine development. According to BARDA officials, BARDA took this action after a technical evaluation panel determined that none of the vaccine developers submitting proposals could meet the Project BioShield statutory requirement of having a product ready for licensure within 8 years.

Simultaneously, BARDA issued an amendment to BAA 09-34 to enable companies to submit proposals to obtain development funding for rPA vaccine candidates. The due date for all proposals is February 1, 2010. During a meeting with company officials today, BARDA strongly encouraged Emergent to submit a proposal to this BAA. Emergent intends to submit its proposal by the end of this year.

While the decision by BARDA has no impact on the company’s $400 million procurement contract with the Centers for Disease Control and Prevention (CDC) for the manufacture and delivery of 14.5 million doses of BioThrax® into the Strategic National Stockpile (SNS). Investors are still likely to react negatively to the news.

After selling dies down, there may be a bounce trade opportunity for EBS followers since the company feels that “BioThrax remains a critical and long-term countermeasure for the US government,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA. Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”

Source :: http://biomedreports.com/articles/most-popular/20870-bad-news-clouds-move-in-on-these-stocks.html

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ROCKVILLE, MD, October 10, 2007— Emergent BioSolutions Inc. (NYSE: EBS) announced today that preliminary results from a recently completed, randomized, placebo-controlled Phase II clinical study demonstrated that its single-dose, drinkable typhoid vaccine candidate achieved the study endpoints for safety and immunogenicity.  In this clinical study, which recruited children between 5 and 14 years of age, a total of 101 children received the vaccine candidate and 50 children received placebo.  The vaccine candidate and placebo were allocated in a blinded manner.  This clinical study, which was conducted in Viet Nam, is the first study of this product candidate in a pediatric population in a region in which typhoid is endemic and was performed in collaboration with Oxford University and the Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam, and financially supported by the Wellcome Trust.

The data from this Phase II clinical study, which is still being analyzed, support the following key findings:

• The vaccine was immunogenic and met the predefined criterion of an overall immune response rate of greater than 50%, with 95% confidence.
• The vaccine induced significantly higher antibody concentrations, indicative of systemic responses, in children in the vaccine group compared to the placebo control group.
• The vaccine was well tolerated with no serious adverse events or deaths reported, and no subjects withdrew due to adverse events.
• Overall, there were no statistical differences in the incidence of adverse events between the vaccinated and placebo treated groups.

“We are very pleased to have met the objectives of this Phase II study of our typhoid vaccine candidate.  This data is encouraging and indicates great promise for what would be the first single-dose, drinkable typhoid vaccine. We are particularly grateful to the Wellcome Trust for their partnership and generous support of this important project,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Typhoid is endemic in many developing countries, putting countless international travelers and families who visit these nations at risk.  With typhoid claiming 200,000 lives each year, continued progress in the development of this vaccine is an important milestone in our company’s efforts to protect life.  Emergent BioSolutions remains committed to addressing significant underserved health needs,” he continued.

About the Typhoid Vaccine Candidate

The company’s typhoid vaccine candidate is a live, attenuated strain of the Salmonella typhi bacterium designed to eliminate virulence by deletion of two specific genes.  The vaccine is intended to be administered in a single, drinkable dose prior to travel to countries where typhoid is endemic.  If approved, this method of administration could provide a competitive advantage compared to currently approved typhoid vaccines.

Previously published studies have shown the vaccine candidate to be immunogenic and well-tolerated.  In addition to this Phase II clinical study, the following clinical trials have been completed:

• An open-label, non-placebo controlled, pilot study conducted in the United Kingdom in healthy adults in which the vaccine candidate was well tolerated and immunogenic, eliciting both cell mediated and humoral immunogenicity.
• A double-blind, placebo controlled, single dose, dose escalating clinical trial conducted in the United States in which 100% of the trial participants in the highest dose group and 56% of the participants in the lowest dose group had an immune response on the scheduled testing days.
• An open-label, controlled, single dose clinical trial conducted in the United States in healthy adults to evaluate the safety and immunogenicity of two different presentations of the vaccine.  The vaccine candidate was similarly immunogenic in both presentations and both were well tolerated.
• A single-blind, placebo controlled clinical trial in Viet Nam in healthy adults.  The Wellcome Trust provided funding for the trial.  The vaccine met the criterion for immunogenicity and was well tolerated, with no serious adverse events reported.

About Typhoid

Typhoid, also known as typhoid fever, is caused by infection with the bacterium Salmonella typhi. Typhoid is characterized by fever, headache, constipation, malaise, stomach pains, anorexia and myalgia. Severe cases of typhoid can result in confusion, delirium, intestinal perforation and death.  Typhoid is transmitted by consuming contaminated food or drinks. Contamination usually results from poor hygiene and sanitation.  Typhoid is often endemic in developing countries in which there is limited access to treated water supplies and sanitation.

An estimated 22 million cases of typhoid occur per year worldwide.  The Centers for Disease Control (CDC) recommends that all persons from the United States traveling to developing countries consider receiving a typhoid vaccination, with travelers to Asia, Africa and Latin America deemed to be especially at risk. U.S. military personnel deployed in these areas are also at risk of infection.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission — to protect life.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease.  Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available at www.emergentbiosolutions.com.

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, prospects, plans and objectives of management, including clinical trial results and development plans, 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 the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials, including future clinical data for our typhoid vaccine candidate; our ability to identify and acquire or in-license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 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.

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Tuberculosis kills 1.8 million people per year and more than two billion people worldwide are infected with TB — approximately one out of every three people on the planet. New vaccines are urgently needed as part of the global response to TB. BCG is currently the only available vaccine against TB. BCG, which is administered to infants throughout the developing world and in certain countries in the developed world, provides some protection against pediatric TB. However, BCG provides only variable protection against pulmonary tuberculosis, which accounts for most of the worldwide disease burden.

“The world desperately needs new and better approaches to combat TB,” said Dr. Marcos Espinal, Executive Secretary of the Stop TB Partnership. “The advancement of a new TB vaccine candidate to this stage is an exciting development for all of us who seek to end this terrible epidemic.”

This new vaccine candidate is intended to augment the response of T-cells already stimulated by the BCG vaccine. Previous clinical trials of the vaccine in adults have demonstrated consistently high cellular immune responses in those who received the MVA85A/AERAS-485 vaccine candidate following vaccination with BCG.

“The search for a new TB vaccine is a complex and challenging process requiring a broad commitment, and we are pleased to be collaborating with so many dedicated and talented researchers on this important effort,” said Jerald C. Sadoff, MD, President & CEO of the Aeras Global TB Vaccine Foundation. “There is still a long road ahead, but this marks an important milestone toward the goal of a more effective TB vaccine.”

The Aeras Global TB Vaccine Foundation is working with the Consortium to develop MVA85A/AERAS-485 with additional funding from the Wellcome Trust. The vaccine candidate was originally developed at the University of Oxford by Dr. Helen McShane, a Wellcome Trust Senior Clinical Research Fellow, working with Dr. Sarah Gilbert, a Reader in Vaccinology and Professor Adrian Hill, a Wellcome Trust Principal Research Fellow. It was licensed by Isis Innovation, the University’s technology transfer company to the Oxford- Emergent TB Consortium in July 2008. The vaccine has been awarded orphan drug status by the European Medicines Agency (EMEA) and is the most clinically advanced of a new generation of tuberculosis vaccine candidates.

“We believe this is the most exciting advance in the field of TB vaccines for over 80 years,” said Dr Helen McShane of the Jenner Institute, University of Oxford, “and is a testament to the commitment shown by the partners and funders involved. We have shown that this vaccine is safe and stimulates strong immune responses. This trial will hopefully show that the vaccine can protect people from getting TB and enable the global community to begin to control this devastating disease.”

Professor Gregory Hussey, Director of SATVI, says that the announcement of this study brings a message of hope: “We are testing the vaccine in an area burdened by one of the highest incidence rates of TB in the world, in a community most likely to benefit from its success. The study strengthens our commitment to stop TB.”

“This marks an important milestone in what we believe is an extraordinary opportunity to prevent tuberculosis, which is a major global health crisis. Emergent is proud to join such distinguished partners as we make progress in the fight against one of the world’s deadliest diseases,” said Fuad El-Hibri, Chairman and Chief Executive Officer at Emergent BioSolutions.

The Aeras Global TB Vaccine Foundation is a non-profit organization working as a Product Development Partnership to develop new tuberculosis vaccines and ensure that they are distributed to all who need them around the world. Aeras collaborates with academia, industry, foundations and governments to develop new TB vaccine candidates and delivery systems, manufacture vaccines at low cost and establish intellectual property rights to assure their future availability and affordability. Aeras’ major funders are the Bill & Melinda Gates Foundation, the Netherlands Ministry of Foreign Affairs, the Danish International Development Agency, the Research Council of Norway and the U.S. Centers for Disease Control and Prevention. Aeras operates a state-of-the-art manufacturing and laboratory facility in Rockville, Maryland, USA and has an office in Cape Town, South Africa. www.aeras.org

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

Isis Innovation Ltd is the University of Oxford’s technology company and manages the University’s intellectual property portfolio, working with University researchers on identifying, protecting and marketing technologies through licensing, spin-out company formation and material sales. Isis files on average one new patent application each week, has concluded over 400 technology licensing agreements, and established 62 new spin-out companies from Oxford. Isis also manages Oxford University Consulting (OUC), which arranges consulting services providing clients access to the world-class expertise of the University’s academics to enhance innovative capability. Last year OUC arranged over 100 consulting deals. Isis has established a separate business division, Isis Enterprise, offering consulting expertise and advice in technology transfer and open innovation to university, government and industrial clients around the world. Isis was founded in 1987 and is today one of the world’s leading technology transfer and innovation management companies.

The Oxford-Emergent Tuberculosis Consortium Ltd “OETC” is a joint venture between the University of Oxford and Emergent Product Development UK Ltd. OETC was formed with the aim of developing the MVA85A TB vaccine to meet both developed and developing country health needs.

The South African Tuberculosis Vaccine Initiative is located in the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (UCT). Since 1999, with funding largely from the Aeras Global TB Vaccine Foundation, SATVI has developed the capacity to conduct registration standard vaccine trials at a site in Worcester, where rates of tuberculosis are amongst the highest in the world. SATVI has a state of the art immunology laboratory where it conducts cutting edge basic science research aimed at better understanding the human immune response to tuberculosis and to tuberculosis vaccines. SATVI has also conducted a number of very large field trials and epidemiological cohort studies, which are necessary to test the efficacy of new tuberculosis vaccines. www.satvi.uct.za

The University of Oxford’s Medical Sciences Division is one of the largest biomedical research centers in Europe. It represents almost one-third of Oxford University’s income and expenditure, and two-thirds of its external research income. Oxford’s world-renowned global health program is a leader in the fight against infectious diseases (such as malaria, HIV/AIDS, tuberculosis and avian flu) and other prevalent diseases (such as cancer, stroke, heart disease and diabetes).

Key to its success is a long-standing network of dedicated Wellcome Trust-funded research units in Asia (Thailand, Laos and Vietnam) and Kenya, and work at the MRC Unit in The Gambia. Long-term studies of patients around the world are supported by basic science at Oxford and have led to many exciting developments, including potential vaccines for tuberculosis, malaria and HIV, which are in clinical trials. www.medsci.ox.ac.uk

Wellcome Trust is the largest charity in the UK. Its mission is to fund innovative biomedical research in the UK and internationally, spending around £600 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing. www.wellcome.ac.uk

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