Archive

Archive for the ‘Anthrax Vaccine’ Category

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

July 15th, 2010 admin No comments

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

July 13th, 2010 admin No comments

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

July 7th, 2010 admin No comments

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 on Answers.com

August 18th, 2009 admin No comments

Type: Public
On the web: http://www.emergentbiosolutions.com
Employees: 587
Employee growth: 4.8%

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.

Key numbers for fiscal year ending December, 2008:
Sales: $178.6M
One year growth: (2.4%)
Net income: $20.7M
Income growth: (9.8%)

Officers:
Chairman and CEO: Fuad El-Hibri
President, COO, and Director: Daniel J. Abdun-Nabi
SVP Finance and Administration, CFO, and Treasurer: R. Don Elsey

Reblog this post [with Zemanta]

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

August 14th, 2009 admin No comments

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.

Reblog this post [with Zemanta]

Board expands with Election of Fuad El-Hibri

June 22nd, 2009 admin No comments

NHM Chairman Louis Sullivan, MD, has announced the election of biotechnology executive Fuad El-Hibri, physician and public health expert Margaret A. Hamburg, MD, and technology entrepreneur James M. Philips to the NHM Board of Trustees for three-year terms of service. Fuad El-Hibri on National Health Museum, WASHINGTON— September 3, 2007.

one two three

Fuad
El-Hibri

Margaret Hamburg

James
Philips

“As we continue working toward our goal of an institution that will serve as a global information platform, we celebrate the election of three new board members who have each made key contributions to the creation of a healthier and safer world,” said Sullivan.

“Through his leadership in the field of biotechnology, Fuad El-Hibri is helping develop strategies to address serious threats to global health security.  Throughout a distinguished career in public service, Peggy Hamburg has focused her considerable intellect and medical training on similar concerns as well as a range of other pressing health policy issues.  And from his position at the vanguard of the information technology revolution, Jim Phillips has helped successfully launch companies and institutions that are improving our ability to connect, communicate and heal.

“We are proud to have earned the active interest and support of Fuad, Peggy and Jim and look forward to drawing extensively upon their experience and expertise as our efforts to develop NHM proceed,” said Sullivan.

Fuad El-Hibri, CEO and Chairman, Emergent Biosolutions

Fuad El-Hibri leads Emergent Biosolutions, a Maryland-based biotechnology company focused on the development, manufacture and commercialization of immunobiotics.  The company operates in two business segments: biodefense and commercial. In its biodefense business, Emergent develops and commercializes immunobiotics for use against biological agents that are potential weapons of bioterrorism. In its commercial business, the company develops immunobiotics for use against infectious diseases with significant unmet or underserved medical needs.

El-Hibri served as chief executive officer and chairman of the board of directors of BioPort Corporation from 1998 until 2004, when BioPort became a subsidiary of Emergent.  He also served as chairman of Digicel Holdings, Ltd., a privately held cellular telecommunications firm, from August 2000 to October 2006.  Since 1990, he has also served as chairman of East West Resources Corporation, a venture capital and financial consulting firm.

He is a member of the board of trustees of American University and a member of the board of directors of the International Biomedical Research Alliance, an academic joint venture among NIH, Oxford University and Cambridge University. He also serves as chairman and treasurer of El-Hibri Charitable Foundation which has contributed to a variety of international development projects, including a children’s orphanage in Lebanon.  He holds a master’s degree in public and private management from Yale University and a B.A. in economics from Stanford University.

Margaret A. Hamburg, MD, Senior Scientist, Global Health and Security Initiative, NTI

One of the youngest people ever elected to the Institute of Medicine of the National Academy of Sciences, Dr. Margaret “Peggy” Hamburg is a highly regarded expert in community health and bio-defense, including preparedness for nuclear, biological, and chemical threats.  She currently serves as Senior Scientist for the Global Health and Security Initiative of the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons.  A graduate of Radcliffe College, she earned her M.D. from Harvard Medical School, and completed her training at the New York Hospital/Cornell University Medical Center.

From 1997 to 2001, Hamburg held the position of Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services (HHS), serving as principal policy advisor to Secretary of Health and Human Services Donna Shalala.  From 1991 to 1997, she served as New York City Health Commissioner, a position in which she designed and implemented an internationally recognized tuberculosis control program that produced dramatic declines in tuberculosis cases, and created the first public health bio-terrorism preparedness program in the nation.  Between 1986 and 1990, she held a variety of positions within HHS, including Special Assistant to the Director, Office of Disease Prevention and Health Promotion; and Special Assistant to the Director, and later Assistant Director, of the National Institute of Allergy & Infectious Diseases at the National Institutes of Health.

A member of the Harvard College Board of Overseers and the Boards of Trustees of Rockefeller University and the Rockefeller Foundation, Hamburg is also a distinguished senior fellow with the Center for Strategic and International Studies, and a fellow of the American Association of the Advancement of Science.  She holds membership in the New York Academy of Medicine, and the Council on Foreign Relations and serves on the board of Henry Schein Company.  She has served on the boards of other organizations, including the New York City Health and Hospitals Corporation, the Nathan Cummings Foundation, the Primary Care Development Corporation, and the Board of Scientific Counselors for the National Center for Infectious Diseases of the Centers for Disease Control and Prevention.

James M. Phillips, Vice Chairman, Luminetx

James “Jim” Phillips’s career has been marked by success at starting and guiding companies through successful initial public offerings and pioneering new technologies into major industry-leading positions – including the PDA, digital cell phone, fixed cellular and internet multimedia.  A classic entrepreneur, Phillips’ began his career with Telecommunications System of America, which was sold to Northern Telecom (Nortel), where Phillips eventually became vice president.  He held subsequent executive positions at SkyTel, which became the nation’s largest messaging company; Telular Corporation, the world’s largest fixed wireless cellular company; and Motorola, where he participated in launching digital cellular and multimedia, bringing cable modem to the market.

Phillips then became Chairman and CEO of IPIX, which produced digital photographs with 360° navigable images that are today widely used on major Web sites.  After taking the company public, he was asked to become involved with the effort to build the FedEx Institute of Technology (FIT), a partnership between Federal Express Corp. and The University of Memphis.  Phillips resigned from IPIX, moved to Memphis and raised $100 million to make FIT a reality.  Information Week has called FIT the technology industry’s “newest center for innovation” and WIRED has compared it to the famous Media Lab at MIT.

After successfully launching FIT, Phillips served as CEO in residence at Morgan Keegan, a Memphis-based investment firm, before raising the capital to launch Luminetx Corporation.  Luminetx produces the VeinViewer, which was named in 2004 by Time as “one of the coolest medical inventions of the year.”  Phillips is Vice Chairman of Luminetx, having previously served as the company’s CEO, president and chairman.  A holder of patents in cell phone, PDA and data modem design, he also serves on a number of boards including the American Museum of Science and Energy, Visio Technologies Corporation, EmergeMemphis, Memphis Biotech Foundation, University of Memphis Fogelman School of Business and Economics, and the Memphis Area Chamber of Commerce.


Reblog this post [with Zemanta]

Fuad El-Hibri on Anthrax Vaccine Contract

June 21st, 2009 admin No comments

“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.

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.

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.


Reblog this post [with Zemanta]

Anthrax Vaccine by Fuad El-Hibri

June 21st, 2009 admin No comments

An anthrax vaccine discovered and initially developed by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has been acquired by a Maryland-based firm for advanced development that could lead to eventual licensure of the product by the Food and Drug Administration.

Fuad El-Hibri Next Generation Anthrax Vaccine

Jun 15
Comments

Fuad El-Hibri next generation anthrax vaccine

FOR IMMEDIATE RELEASE CONTACT: Caree Vander Linden
May 12, 2008 (301) 619-2285
Caree.Vander-Linden@amedd.army.mil

USAMRIID’s Next Generation Anthrax Vaccine Acquired for Advanced Development

According to company officials, Emergent BioSolutions Inc. has acquired the next generation anthrax vaccine, as well as the technology on which it is based. This vaccine candidate was patented by USAMRIID and previously licensed to a company called VaxGen, which had pursued advanced development since 2002 under a contract from the U.S. Department of Health and Human Services.The vaccine uses recombinant protective antigen, or rPA, a protein secreted by the anthrax bacterium, Bacillus anthracis. This protein induces the body’s immune system to produce antibodies against the bacteria’s toxins. In several nonhuman primate studies conducted at USAMRIID, rPA has demonstrated the ability to induce a high level of protection against inhalational anthrax—the type most likely to occur following a bioterrorist event.

“We believe this acquisition will facilitate the continued development of this promising anthrax vaccine candidate,” said Colonel George W. Korch, Jr., commander of USAMRIID. “We are excited about the future prospects for rPA as an effective medical countermeasure for the nation’s biodefense.”

Anthrax is caused by spores and most commonly occurs in wild and domestic mammals, although it has the potential to be used as a biological threat agent. Symptoms vary depending on the route of exposure; however, sore throat, mild fever, and muscle aches usually begin within 7 days of exposure. Severe breathing difficulty, shock, and meningitis can follow, and as the bacteria multiply in the lymph nodes, toxemia progresses and the potential for widespread tissue destruction and organ failure increases. Up to 90 percent of untreated cases of inhalational anthrax result in death. Obtaining an alternative for the currently licensed anthrax vaccine would provide the Department of Defense—and the nation—with additional options in protecting against this threat.

USAMRIID’s proprietary technology also has a number of potential manufacturing advantages, including the ability to express full-length soluble anthrax PA in a non-toxic, non

spore-forming strain of the anthrax bacterium. When full-length rPA is expressed in anthrax bacteria, it is secreted into the culture fluid, from which it can be isolated in a highly purified form. This material also has the potential to provide broader protection against anthrax.

“By acquiring this particular vaccine candidate, Emergent will be able to leverage over a decade of development work conducted at USAMRIID and 5 years of experience and advanced development work conducted by VaxGen, in order to continue the development of this vaccine through to licensure,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc.

USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Department of Defense Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute conducts basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. While USAMRIID’s primary mission is focused on the military, its research often has applications that benefit society as a whole. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. For more information, visit www.usamriid.army.mil

###


Reblog this post [with Zemanta]

Fuad El-Hibri’s Emergent BioSolutions gets market authorization in India for BioThrax

June 21st, 2009 admin No comments

Emergent BioSolutions Inc. announced that the Drugs Controller General of India (DCGI) has issued a registration certificate for BioThrax (Anthrax Vaccine Adsorbed), which enables the marketing and sale of the vaccine in India to help prevent anthrax infection.

Fuad El-Hibri’s Emergent BioSolutions gets market authorization in India for BioThrax

According to a release, Emergent BioSolutions has signed a marketing agreement with Biological E. Limited for the marketing of BioThrax in India. BioThrax is the only vaccine for the prevention of anthrax infection licensed by the U.S. Food and Drug Administration (FDA).

The company noted that the BioThrax market authorization for India follows the publication in 2008 of the National Disaster Management Guidelines by the Indian National Disaster Management Authority (NDMA), which is the government body that oversees disaster management. In that document, the  government of India provided guidance with respect to the management of biological disasters and said that there is a need to have a supply of readily available anthrax vaccines to be administered rapidly in the event of an outbreak. The report goes on to state that all first responders will be vaccinated in an impending disaster situation.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, said, “The Government of India has been explicit in expressing its commitment to protect its population from the continuing threat of bioterrorism. We are certainly pleased that BioThrax will be a valuable countermeasure available to the Government of India to achieve that goal. Today marks a pivotal milestone in Emergent’s efforts to expand globally and further our mission of protecting life.”

About BioThrax (Anthrax Vaccine Adsorbed): BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is licensed by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis and contains no dead or live bacteria. Since 1998, the U.S. government has procured nearly 33.5 million doses of BioThrax. During that time period, nearly 8.4  million doses have been administered to more than 2.1 million military personnel. BioThrax cannot cause anthrax infection. Please visit emergentbiosolutions.com/pdf/emergent_biothrax_us.pdf for full prescribing information.

Emergent BioSolutions is a biopharmaceutical company focused on the development, manufacture and commercialization of immune-related biologic products, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.

((Comments on this story may be sent to health@closeupmedia.com))

For full details on Emergent BioSolutions Inc (EBS) click here. Emergent BioSolutions Inc (EBS) has Short Term PowerRatings of 1. Details on Emergent BioSolutions Inc (EBS) Short Term PowerRatings is available at This Link.

Posted in BioThrax, El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri
Tags: , , , , , , ,


Reblog this post [with Zemanta]