Posts Tagged ‘Anthrax vaccines’

Emergent BioSolutions Hosts Symposium for Biomedical Research Scholars

ROCKVILLE, Md., Aug 24, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today hosted “Looking Beyond the Bench,” a symposium organized for doctoral students enrolled in the NIH-Oxford-Cambridge Scholars Program. The symposium featured Emergent executives, who, based on their extensive experience in the biopharmaceutical industry, provided insight on potential career paths awaiting biomedical researchers. The speakers highlighted examples of how a scientific background would interrelate with such disciplines as Grants and Contracts, Clinical Development, Intellectual Property, and Product Development.

The NIH-Oxford-Cambridge Scholars Program (Scholars Program) was created in 2001 to revolutionize the way in which the most talented biomedical PhD and MD/PhD students are trained. Every pedagogical and logistical element of the Scholars Program was designed to produce scientists who will generate high-impact, breakthrough results at the speed at which science, government and industry must move to meet the demanding healthcare needs of a global population. The Scholars Program trains more “prestige” scholars (Rhodes, Marshall, Churchill, Gates, Howard Hughes Medical, Fulbright, and Goldwater) than any other program in the world. To date, the Scholars Program has produced 45 doctoral graduates and currently has 113 scholars enrolled.

“Emergent is pleased to welcome the future leaders in scientific research and discovery, who are already engaged in and contributing to public health improvement by exhibiting academic excellence,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions and member of the Alliance Board of Trustees. “We congratulate them for their exceptional talent, which brought them to the scholars program and which will guide them to its completion.”

“The Alliance is most grateful for Mr. El-Hibri’s private sector perspectives which have helped to shape the values, culture, goals and metrics of success of the Scholars Program,” said Ann Marie Drucker, Alliance President.

Over 35 scholars participated in the symposium and laboratory tour that was held at Emergent’s product development facility in Gaithersburg, Maryland.

About Emergent BioSolutions Inc.

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

About the International Biomedical Research Alliance

The International Biomedical Research Alliance (Alliance) was created in 2005 as a private, not-for-profit (501(c)(3) providing expertise and resources to assure the NIH-Oxford-Cambridge Scholars Program’s financial viability and unwavering adherence to absolute standards of excellence, continuous innovation and dedication to accelerated discovery for generations to come. In pursuit of its mission, the Alliance provides philanthropic, scientific and industry resources dedicated to developing the NIH-Oxford-Cambridge Scholars Program into the pre-eminent biomedical training pathway for leaders in the life sciences.

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Emergent Revises Upward 2010 Financial Forecast

Company anticipates total revenues of $275 to $300 million and net income of $40 to $50 million

ROCKVILLE, MD, July 20, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it is revising upwards its 2010 annual guidance to now reflect anticipated total revenues of $275 to $300 million and net income of $40 to $50 million.  Of the anticipated total revenues of $275 to $300 million, $165 to $190 million is expected to be recognized in the second half of 2010.  This revised forecast does not reflect or incorporate any revenue impact from a possible development contract for the company’s rPA vaccine candidate.

The revision to the 2010 financial forecast is supported primarily by the recent modification to the company’s current BioThrax® procurement contract with the US Centers for Disease Control and Prevention (CDC).  This contract modification increased the number of doses of BioThrax that the company can deliver into the Strategic National Stockpile (SNS) during calendar 2010.  This increased volume of available doses of BioThrax is due to consistently high production yields throughout 2010.

“This modification by the CDC to our existing BioThrax procurement contract reinforces, yet again, the US government’s commitment to BioThrax as a critical component of the Strategic National Stockpile and to our nation’s defense against bioterrorism,” said Fuad El-Hibri, chairman and chief executive officer of Emergent.  “This is another example of how we continue to work with our US government partners in establishing BioThrax as the backbone of our readiness against the threat of anthrax and to building a stockpile as rapidly as possible.”

Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, also commented, “The production yields we have been experiencing are a direct result of our commitment to driving innovation in our manufacturing process and to a multi-year initiative focused on process optimization of the existing Building 12 production facility.  We are extremely pleased with the results of our continuous process improvement program for BioThrax and expect this program to drive the maintenance of positive production metrics going forward.”

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease.  Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.  Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia.  Additional information 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.  Since 1998, the U.S. government has procured over 45 million doses of BioThrax.  During that time period, more than 9.6 million doses have been administered to nearly 2.4 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 2010, 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; 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 and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; 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 other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our manufacturing success rates; 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 March 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.

 

Emergent BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax

ROCKVILLE, Md., Jul 14, 2010

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax(R) (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company’s large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.

“In line with Emergent’s mission of protecting life, we are proud to be working with HHS to scale-up manufacturing of BioThrax, the only vaccine licensed by the Food and Drug Administration (FDA) for the prevention of anthrax infection,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We applaud HHS for its unwavering commitment to strengthen the country’s biodefense infrastructure and to protect our military and civilian populations.”

This cost plus fixed fee development contract has a total value of $107 million and consists of a two-year base period of performance valued at $54.6 million and three option years that, if exercised by BARDA, would increase the contract value to up to $107 million. Under the contract, the company anticipates recognizing revenues of up to $10 million and pretax earnings of up to $5 million during the second half of 2010. A substantial majority of the value of the $107 million contract will be realized in the first three years of performance (July 2010 to July 2013), assuming exercise of the first option year.

The contract award is based on a technical proposal provided to BARDA that projects an annual large-scale manufacturing capacity of 26 million doses in Building 55. This is a significant increase from the company’s current capacity of approximately 7-8 million doses per annum.

The company has developed a comprehensive plan to demonstrate comparability between the current manufacturing process and the large-scale manufacturing process for BioThrax. The contract will fund activities related to process validation, assay validation, fill/finish, and if required, non-clinical and clinical studies. The plan also includes regulatory activities in support of the submission to FDA of a supplemental Biologics License Application (sBLA) for BioThrax at the expanded scale. The company expects to begin manufacturing consistency lots as early as the fourth quarter of 2011.

Emergent has invested significant resources in Building 55, which has been designed to manufacture up to 25 to 30 million doses of BioThrax as currently configured, and is expandable by adding a second manufacturing train that would double annual capacity, based on demand. This is aligned with the company’s core strategy to enhance its manufacturing capabilities to meet the increasing government demand for anthrax vaccines for inclusion in the SNS.

The company also continues to enhance the attractiveness of BioThrax as a significant component of the SNS, most recently through FDA approval of extended shelf life to four years. In addition, based on data from a seven-year study by the Centers for Disease Control and Prevention, the company has submitted to FDA an sBLA to further reduce the BioThrax vaccination schedule to three doses within six months with triennial booster vaccinations. To date, Emergent has supplied over 42 million doses of BioThrax to the U.S. government with additional deliveries scheduled through the third quarter of 2011 pursuant to the current procurement contract with HHS.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information 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. Since 1998, the U.S. government has procured over 42 million doses of BioThrax. During that time period, more than 9.6 million doses have been administered to nearly 2.4 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 2010, 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(R) procurement; our ability to obtain new BioThrax(R) sales contracts; our plans to pursue label expansions and improvements for BioThrax(R); our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; 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 other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; 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 March 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.

 

Emergent BioSolutions Hosts Biopreparedness Roundtable for NATO Parliamentarians

ROCKVILLE, Md., Jul 12, 2010 (BUSINESS WIRE) –

Emergent BioSolutions Inc. (NYSE:EBS) is hosting “Bioterrorism Prevention, Preparedness and Response,” a forum organized for members of the North Atlantic Treaty Organization (NATO) Parliamentary Assembly (PA) to raise global awareness of the importance of biopreparedness. The visiting delegation is composed of parliamentarians from Canada, Estonia, France, Finland, Germany, Greece, Italy, Hungary, Lithuania, the Netherlands, Norway, Romania, Poland, Portugal, Turkey, Sweden, Slovenia, Spain, and the United Kingdom.

“Emergent commends NATO parliamentarians for advancing the international dialogue on biopreparedness,” said Allen Shofe, senior vice president public affairs, Emergent BioSolutions. “We are pleased to share our knowledge based on Emergent’s extensive experience in the development, manufacture, and delivery of medical countermeasures that are critical to the U.S. government’s biodefense infrastructure.”

The forum features biodefense expert Dr. Robert Kadlec, Director of PRTM Biodefense and Public Health Practice, who will discuss the United States’ approach to bioterrorism prevention, including best practices and strategies such as funding, development, and manufacture of biodefense medical countermeasures, creation of strategic stockpiles, and cooperation within the international community.

Emergent BioSolutions’ senior management team, headed by Daniel J. Abdun-Nabi, President and Chief Operating Officer, Dr. Tevi Troy, Senior Visiting Fellow at the Hudson Institute and former Deputy Director of the U.S. Department of Health and Human Services, and Dr. Barry Kellman, President of the International Security and Biopolicy Institute (ISBI) are among the attendees. The forum is taking place in Washington, D.C.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

About the NATO Parliamentary Assembly

The NATO Parliamentary Assembly is the inter-parliamentary organization of legislators from the member countries of the North Atlantic Alliance as well as 14 associate members. The Assembly provides a critical forum for international parliamentary dialogue on an array of security, political and economic matters. For more information, visit www.nato-pa.int.

 

Emergent BioSolutions Completes Deliveries of BioThrax to Allied Foreign Governments

ROCKVILLE, MD, June 24, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) led by CEO Fuad El-Hibri,announced today that it has completed separate international sales and deliveries of BioThrax® (Anthrax Vaccine Adsorbed) to governments of several allied nations.  The company’s international sales efforts have resulted in these sales of an undisclosed number of BioThrax doses for aggregate revenue of approximately $2.3 million in the second quarter.

“Emergent recognizes that governments play a key role in protecting citizens against the growing threat of bioterrorism,” said Allen Shofe, senior vice president public affairs of Emergent BioSolutions.  “As the maker of the only U.S. FDA-licensed anthrax vaccine, and in line with our corporate mission to protect life, we are honored to support such biopreparedness efforts of allied international governments.”

About BioThrax

BioThrax is the only U.S. 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. Since 1998, the U.S. government has procured over 42 million doses of BioThrax.  During that time period, more than 9.5 million doses have been administered to nearly 2.4 million military personnel.  For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

Important Safety Information for BioThrax®

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache. Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax.

Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If BioThrax is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to the fetus. This product should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.

Vaccination with BioThrax should be avoided by individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease.  Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.  Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia.  Additional information may be found 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, 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 2010, 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; 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 and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 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.

 

Emergent BioSolutions Inc. (EBS) CEO & Chairman, 10% Owner Fuad El-hibri sells 15,000 Shares

CEO & Chairman, 10% Owner of Emergent BioSolutions Inc. (EBS) Fuad El-hibri sells 15,000 shares of EBS on 08/11/2009 at an average price of $16.78 a share.

EMERGENT BIOSULUTIONS INC. is a leading biopharmaceutical company dedicated to one simple mission – to protect life. EBS develops manufactures and commercializes vaccines and therapeutics that assist the body\’s immune system to prevent or treat disease. Their products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Their marketed product BioThrax? (Anthrax Vaccine Adsorbed) is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent BioSolutions Inc. has a market cap of $511.8 million; its shares were traded at around $16.91 with a P/E ratio of 13.1 and P/S ratio of 2.8.

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Emergent BioSolutions Inc. Company Profile

Emergent BioSolutions protects your thorax against anthrax. Emergent BioSolutions develops and produces, for government and commercial markets, drugs that treat or protect against infectious diseases and bio-agents. The company supplies BioThrax (the US’s only FDA-approved anthrax vaccine) primarily to the departments of Defense and Health and Human Services (HHS). Its biodefense unit is also developing a post-exposure treatment for anthrax and a preventive vaccine for botulinum toxin. For commercial markets, Emergent is working on therapies and vaccines for typhoid, Group B strep, and hepatitis B, among other things. Chairman and CEO Fuad El-Hibri controls more than half of the company.

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HHS Requires Bidders In Competitive Range For Recombinant Anthrax Vaccine (rPA) Contract To Submit Development Plan To FDA For Review

Emergent BioSolutions Inc. (NYSE:EBS) announced that late on April 15th, HHS requested that each bidder in the competitive range for the rPA contract submit its product development plans to FDA for review in advance of an award. Emergent had already requested and is presently scheduling a meeting with the FDA as part of its pre-award activity. The Company intends to incorporate any FDA comments into its rPA development plan. Emergent will continue to move its rPA program forward to position the company to execute on the anticipated contract, once awarded.

“We strongly support this step by HHS, which potentially reduces development risk for our rPA vaccine candidate. We remain confident that we are well-positioned and competitive to receive any award granted by HHS for the development and procurement of the rPA vaccine. We look forward to continuing our long-standing relationship with the US Government as the proven and preeminent supplier of medical countermeasures to protect our nation,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

As with any government solicitation of this size and scope, there are no assurances that HHS will not impose additional requirements, which may further extend contract negotiations.

This action has no impact on the company’s existing contracts with HHS to supply BioThrax®, the only FDA licensed anthrax vaccine, for the Strategic National Stockpile (SNS). This year Emergent is completing the delivery of 18.75 million doses of BioThrax for inclusion in the SNS. Also this year, following the completion of that delivery, Emergent will begin to supply HHS with an additional 14.5 million doses of BioThrax under a follow-on contract. The total value of these two procurement contracts with HHS for BioThrax exceeds $800 million.

About Emergent BioSolutions Inc.

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 http://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, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, 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 success of our clinical programs; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s annual report on Form 10-K for the year ended December 31, 2008 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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EMERGENT BIOSOLUTIONS RECEIVES DEVELOPMENT CONTRACT FROM NIAID/BARDA TO FUND CONTINUED DEVELOPMENT OF ANTHRAX THERAPEUTIC

$9.5 million development contract to fund non-clinical and clinical studies of anthrax immune globulin (AIG) over next 24 months

ROCKVILLE, MD., September 27, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has received a development contract, valued at up to $9.5 million, in support of non-clinical and clinical studies of the company’s anthrax therapeutic, or AIG, product candidate. This product candidate is an immune globulin being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease following exposure to anthrax.

This development contract has been funded in whole or in part from Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS), under Contract No. HHSN272200700034C.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, stated, “We are very pleased to have continuing support for AIG from NIAID and BARDA and commend the leadership throughout HHS for their commitment to funding the development of effective medical countermeasures against this deadly biological agent. With the continued development funding of our AIG candidate, in conjunction with the $448 million contract with HHS announced yesterday regarding procurement of 18.75 million doses of our BioThrax anthrax vaccine for the strategic national stockpile, we are very encouraged by the government’s support of our anthrax franchise. We look forward to continuing to be a leading participant in the U.S. government’s effort to build a robust domestic biodefense industry.”

Under terms of the development award, the funds will be used to conduct various studies on AIG, including (i) non-clinical studies in support of efficacy; and (ii) a Phase I/II clinical study to evaluate pharmacokinetics and safety. Previously, in August 2006 the company received $3.9 million from NIAID in support of the company’s AIG program. When combined with the $9.5 million under this new development award, the total amount of government funding for AIG to date is over $13 million.

About Anthrax Immune Globulin (AIG)

Emergent BioSolutions’ anthrax immune globulin (AIG) is being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body and for whom the use of the vaccine is no longer an effective option. If successfully developed, AIG could be prescribed for administration in these circumstances either as a monotherapy or in conjunction with an antibiotic.

AIG is being developed using plasma collected from healthy donors who have been vaccinated with BioThrax® (Anthrax Vaccine Adsorbed), Emergent BioSolutions’ anthrax vaccine, which is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.

The company has collected a sufficient amount of plasma to initiate manufacturing of AIG under cGMP using a validated and approved process. This manufacturing process entails fractionating the plasma and purifying the immune globulin. The company has signed an exclusive license with Talecris Biotherapeutics, Inc., a North Carolina-based biopharmaceutical company and leading fractionation provider, to fractionate, purify and fill AIG at Talecris’ FDA-approved facilities. To date, the first full-scale lot of AIG has been manufactured under cGMP requirements at Talecris. The company has scheduled plans to complete a second full-scale lot of AIG.

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 infection. 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, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our performance under our contract with HHS and future payments from HHS to us under the contract, 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 our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; 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.

 

Emergent Biosolutions requested to provide Biothrax® (Anthrax vaccine) to US Departments for Health and for Defence

Emergent BioSolutions Inc announced that the US Department of Health and Human Services (HHS) and the US Department of Defense (DoD) issued two separate notices of intent to procure up to a combined total of 22.75 million doses of BioThrax® (Anthrax Vaccine Adsorbed).
In a Presolicitation Notice issued today, HHS stated its intent to procure 10.4 million doses of BioThrax for the Strategic National Stockpile (SNS) with options for up to an additional 8.35 million doses. HHS announced that it intends to enter sole source negotiations with the company to finalize the procurement and to make an award on or about July 24, 2007.

Separately, DoD issued a Special Notice signaling an anticipated sole source contract award to procure a minimum of 4 million doses of BioThrax, over a base period and 3 optional ordering periods.

“We were very pleased to learn of HHS and DoD’s intent to procure additional doses of BioThrax,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc. “These notices indicate a continued commitment by the U.S. Government to Emergent BioSolutions’ FDA-licensed anthrax vaccine for the protection of military personnel and civilians. We are committed to working with both HHS and DoD to promptly complete these intended procurements to ensure both federal agencies have continued access to and supply of this critical biodefense countermeasure.”

“We compliment the Government’s leadership in following a strategy of acquiring licensed available countermeasures for the highest threat agents, while pursuing next generation development utilizing new and emerging technologies,” continued Mr. El-Hibri. In support of this strategy the company has a next generation anthrax countermeasure development program which includes both BioThrax and rPA-based candidates. This program is designed to meet the next generation requirements of the Government, including: room temperature storage, extended shelf life, novel adjuvants and novel delivery systems.

Since 1998, the company has delivered 19 million doses of BioThrax under contracts with HHS and DoD.

About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, consisting of vaccines and therapeutics that induce or assist the body’s immune system to prevent or treat disease. The company’s biodefense business is focused on immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on development, manufacture and commercialization of immunobiotics for use against infectious diseases. These immunobiotics are designed to address significant unmet or underserved public health needs. More information on the company is available at www.emergentbiosolutions.com.

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