Posts Tagged Infectious disease
Emergent BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax
Posted by admin in Anthrax, Biothrax, Chief executive officer, Emergent BioSolutions, U.S. Food and Drug Administration, fuad el-hibri on July 15th, 2010
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 Completes Deliveries of BioThrax to Allied Foreign Governments
Posted by admin in Anthrax, Biothrax, Chief executive officer, Emergent BioSolutions, U.S. Food and Drug Administration, fuad el-hibri on July 7th, 2010
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
Posted by admin in Chairman, Chief executive officer, Emergent BioSolutions, Infectious disease, Profile, U.S. Food and Drug Administration, Vice President, fuad, fuad el-hibri on August 13th, 2009
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 SIGNS $448 MILLION THREE YEAR CONTRACT WITH DEPARTMENT OF HEALTH AND HUMAN SERVICES
Posted by admin in Uncategorized on July 14th, 2009
ROCKVILLE, MD, September 26, 2007—Emergent BioSolutions Inc. (NYSE: EBS), announced today that it has signed a three year contract with the U.S. Department of Health and Human Services (HHS), with a total value of up to $448 million. Components of the contract include:
(i) $400 million firm fixed-price for delivery of 18.75 million doses of BioThrax® (Anthrax Vaccine Adsorbed) for inclusion in the strategic national stockpile (SNS);
(ii) $34 million for receipt of regulatory approval of 4-year expiry dating for BioThrax payable through a combination of a lump-sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the per dose price to be paid for doses delivered following approval;
(iii) up to $11.5 million in milestone payments in connection with advancement towards a post-exposure prophylaxis (PEP) indication for BioThrax; and,
(iv) $2.2 million for logistics services and other related support.
The Company anticipates making deliveries for approximately 6 million doses under this contract by year-end 2007. As a result, the company reaffirms its expectation for full year total revenue growth of 10 to 15 percent, with a bias toward the upper end of the range, and full year positive net earnings.
Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, stated, “We are honored to continue our longstanding relationship with HHS to provide BioThrax as a critical component of our nation’s biodefense stockpile. I applaud the dedication and professionalism of the senior leadership within HHS and Biomedical Advanced Research and Development Authority in completing this important step towards enhancing our domestic biodefense infrastructure. Emergent BioSolutions remains dedicated to working with various government agencies in their commitment to procure medical countermeasures as a primary element of establishing the highest possible levels of biopreparedness.”
Under terms of the contract, HHS will purchase from the company an aggregate of 18.75 million doses of BioThrax through September 2010, for a firm, fixed-price of $400 million. In the event the company receives U.S. Food and Drug Administration (FDA) approval of the company’s pending supplement to its biologics license application (BLA) to extend the shelf life of BioThrax from three years to four years, the company will receive a lump sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the price per dose to be paid for doses delivered following the date of approval, with a total value of approximately $34 million. If FDA approval of 4-year expiry dating is not received during the term of the contract, the company will not be entitled to receive any of the $34 million. The company submitted its supplement for 4-year expiry dating to the FDA in December 2006 and has been providing additional information to the agency in support of its application.
Under the contract, HHS will also provide up to $11.5 million in connection with advancing the company’s program to obtain a PEP indication for BioThrax. The PEP indication, which would expand the use of BioThrax beyond the current pre-exposure prophylaxis indication, is designed to permit the administration of BioThrax in combination with antibiotics following exposure to anthrax. These funds are payable upon the company’s achievement of specific program milestones. The company anticipates that it will receive $8.8 million of this amount in the fourth quarter of 2007.
In addition, under the contract the company has agreed to provide all shipping services related to delivery of doses into the SNS over the contract term, and will receive payment of an additional $2.2 million.
The contract has been funded with Federal funding through the Project BioShield Special Reserve Fund, which was created by an act of Congress in May 2004.
Previously, Emergent BioSolutions has provided 10 million doses of BioThrax to HHS for inclusion in the SNS under a May 2005 supply agreement for 5 million doses valued at $123 million and a May 2006 contract modification for an additional 5 million doses valued at $120 million.
Conference Call & Webcast
Company management will host a conference call at 9:00 am Eastern today, September 26, 2007 to discuss this announcement. Interested parties may participate in the live teleconference by dialing 866/383-8008 or 617/597-5341 or via a webcast accessible at www.emergentbiosolutions.com, under “Investors”. A replay of the teleconference will be available on the company website or by dialing 888/286-8010 or 617/801-6888 and using the passcode 61817264, approximately one hour after the teleconference concludes. The replay will be available through October 10, 2007.
About BioThrax® (Anthrax Vaccine Adsorbed)
BioThrax is the only FDA-approved vaccine for the prevention of anthrax infection. It is approved 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 Baccillus anthracis and contains no dead or live bacteria. BioThrax is administered by subcutaneous injection in three initial doses followed by three additional doses, with an annual booster dose recommended thereafter. Since 1998, approximately 20 million doses of BioThrax have been procured by the U.S. government. During that time period, over 6.5 million doses have been administered to over 1.6 million military personnel. BioThrax cannot cause anthrax 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 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.
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EMERGENT BIOSOLUTIONS RECEIVES DEVELOPMENT CONTRACT FROM NIAID/BARDA TO FUND CONTINUED DEVELOPMENT OF ANTHRAX THERAPEUTIC
Posted by admin in Uncategorized on July 14th, 2009
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.
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EMERGENT BIOSOLUTIONS’ TYPHOID VACCINE CANDIDATE ACHIEVES ENDPOINTS IN PHASE II CLINICAL STUDY
Posted by admin in Uncategorized on July 14th, 2009
Vaccine well tolerated and immunogenic in double-blind, placebo-controlled study in pediatric population
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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EMERGENT BIOSOLUTIONS ANNOUNCES RESULTS FROM ANNUAL MEETING OF STOCKHOLDERS
Posted by admin in Uncategorized on July 14th, 2009
ROCKVILLE, MD, June 14, 2007—Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today the results of the company’s 2007 annual meeting of stockholders, which took place today at the Hyatt Regency Bethesda at 10:00 am Eastern.
There were present, in person or represented by proxy, the holders of more than a majority of the shares of the outstanding common stock of the company, thus constituting a quorum.
Proposal 1—Election of Directors
The following individuals were elected Class I directors of the company to serve for a three-year term expiring 2010: Fuad El-Hibri, Jerome M. Hauer and Ronald B. Richard.
Proposal 2—Ratify Selection of Ernst & Young LLP as the Company’s Independent Registered Public Accounting Firm
The proposal to select Ernst & Young LLP as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2007 successfully passed.
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.
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Emergent BioSolutions buys flu vaccine maker
Posted by admin in Uncategorized on July 14th, 2009
Emergent BioSolutions has inked a deal to acquire the Protein Sciences Corporation assets for up to $75 million. The move is part of Emergent’s strategy to expand its product portfolio with a drug candidate focused on infectious disease. Currently, most of Emergent’s business comes from government contracts for biodefense. Emergent will acquire PSC’s ongoing operations, including FluBlok, a Phase III recombinant influenza vaccine candidate, and certain other assets. “The acquisition of FluBlok is consistent with Emergent’s strategy of expanding its product portfolio with a vaccine candidate focused on a major infectious disease,” said Fuad El-Hibri, Emergent’s CEO. The company recently bought rival VaxGen’s anthrax vaccine business.
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