Posts Tagged U.S. Food and Drug Administration
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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Maker of anthrax vaccine discusses challenges of marketing overseas
Posted by admin in Anthrax, U.S. Food and Drug Administration on August 5th, 2009
BioPort is the only FDA-licensed producer of the anthrax vaccine.
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| Fuad El-Hibri, chairman and CEO of Emergent BioSolutions Inc., speaks March 9 in Sage Hall. Kevin Stearns/University Photography |
On March 9, MBA students taking International Political Risk Management, a course taught by Elena Iankova, a lecturer at the S.C. Johnson Graduate School of Management, heard Fuad El-Hibri, chairman and CEO of Bioport’s parent company, Emergent BioSolutions Inc., discuss the hurdles his firm faces in making and marketing its products abroad.
His guest lecture was titled “Managing International Risk in the Bio-Defense and Telecommunications Industries.”
Using his own company as an example, El-Hibri outlined six areas of risk in international business, among them export/import regulations, politics at home and abroad and financial issues. Much of his talk focused on political issues ranging from export regulations to how to deal with foreign governments. Read More
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EMERGENT BIOSOLUTIONS ANNOUNCES MANAGEMENT CHANGES
Posted by admin in Uncategorized on July 14th, 2009
ROCKVILLE, MD, May 16, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today the consolidation of the president and chief operating officer position. With this change, Daniel J. Abdun-Nabi, the company’s president, will also take on the role of chief operating officer. In this combined role, Mr. Abdun-Nabi will oversee all of the company’s product development, manufacturing and corporate affairs activities. Mr. Abdun-Nabi will continue to report to Fuad El-Hibri, chairman and chief executive officer of the company.
Specifics of other management changes, which are also effective immediately, include:
- R. Don Elsey is being promoted to the position of senior vice president finance and administration. Mr. Elsey was formerly vice president finance and administration. Mr. Elsey will continue to retain his responsibilities as chief financial officer for the company and will now assume additional responsibility for investor relations and human resource activities. Mr. Elsey will continue to report to Mr. El-Hibri, chairman and chief executive officer.
- Kyle W. Keese is being appointed to the position of senior vice president corporate affairs with responsibility for public affairs, marketing and sales and corporate development. Mr. Keese was formerly senior vice president marketing and communications.
- Thomas K. Zink, M.D. is assuming the responsibility for clinical development in addition to medical affairs. Dr. Zink, formerly senior vice president medical affairs, is now senior vice president medical and clinical development. Dr. Zink will continue to retain his responsibilities as chief medical officer for the company and, in that capacity, will continue to report to Mr. El-Hibri, chairman and chief executive officer.
- Edward J. Arcuri, Ph.D., is resigning his position as chief operating officer. The resignation is effective immediately.
“Today’s senior management consolidation and associated changes within our corporate organization are designed to strengthen the integration of our development and manufacturing organizations and to enhance the company’s positioning and capabilities in both the biodefense and commercial immunobiotic markets,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc.
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 or 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 expected revenue growth and net earnings for 2007, 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 performance under BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; 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; 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 Annual Report on Form 10-K for the year ended December 31, 2006 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 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 ANNOUNCES DR. STEPHEN LOCKHART JOINS COMPANY TO LEAD COMMERCIAL PRODUCT DEVELOPMENT SUBSIDIARY
Posted by admin in Uncategorized on July 14th, 2009
Dr. Lockhart Brings Top-Tier Pharma Leadership to Development of Company’s Commercial Product Portfolio
ROCKVILLE, MD, October 18, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that Dr. Stephen Lockhart has been appointed President, Emergent Product Development UK. Dr. Lockhart will be based at the company’s office located in Wokingham, England, and his responsibilities will include providing oversight, leadership, direction and execution of development programs in both the United Kingdom and Germany. These programs include, among others, the following product candidates: a single-dose oral typhoid vaccine that recently completed a Phase II clinical trial; a drinkable Hepatitis B therapeutic vaccine in a Phase II clinical trial; and a group B streptococcal vaccine candidate that completed a Phase I clinical study and for which further clinical studies are being planned in collaboration with the National Institute of Allergy and Infectious Diseases.
“It is with great pleasure that I welcome Dr. Lockhart to the company,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We are very fortunate to have someone at the helm of our commercial product development efforts with such broad and varied expertise in vaccinology, as well as an intimate understanding of the critical elements involved in the biopharmaceutical industry. His experience in bringing vaccines through clinical development and regulatory approval makes him ideally suited to lead our commercial product development programs.”
Dr. Lockhart has over fifteen years of experience in vaccine development and most recently was Assistant Vice President and Global Head of Bacterial Vaccine Clinical R&D at Wyeth. Prior to joining Wyeth in 1990, Dr. Lockhart served as a Medical Adviser with Janssen Pharmaceutical from 1986-1989.
“I am pleased to be joining Emergent BioSolutions and am particularly excited about leading product development for such a diverse portfolio,” said Dr. Lockhart. “The success of our efforts will potentially help millions of people and I am eager to apply my years of experience towards this exciting portfolio and the mission of the company,” he continued.
Dr. Lockhart is an internationally recognized leader in vaccine-related product development and has been the recipient of multiple awards. He accepted the Prix Galien, a renowned award given for excellence in pharmaceutical innovation, on behalf of Wyeth in both 2000 and 2005 and received the Wyeth Research President’s Award in 2000 for leading the development of Meningitec, a meningitis C vaccine.
Dr. Lockhart has an MA from Cambridge University and received his advanced medical and research degrees from Oxford University. In 1983 he became a Member of the Royal College of Physicians and in 1988 received his Diploma in Pharmaceutical Medicine. After becoming a Member for the Faculty of Pharmaceutical Medicine in 1991, Dr. Lockhart was inducted as a Fellow of the Faculty of Pharmaceutical Medicine in 2003.
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 any 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 execution of our strategy by our executive team; 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; 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 EXPANSION OF BOARD OF DIRECTORS AND APPOINTMENT OF DR. SUE BAILEY TO THE COMPANY’S BOARD OF DIRECTORS
Posted by admin in Uncategorized on July 14th, 2009
ROCKVILLE, MD, June 15, 2007—Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today that at a regularly scheduled meeting of its board of directors the board passed a resolution authorizing the expansion of the total number of members of the board to eight. The board also unanimously appointed Sue Bailey, M.D., as a Class III director, for a two-year term that will expire at the 2009 annual meeting of stockholders.
“I am delighted to welcome Dr. Bailey to the Emergent BioSolutions Board of Directors. Her extensive experience in managing complex organizations and healthcare-related issues for both the federal government and private corporations and her expertise in media relations will contribute greatly to our ability to meet our nation’s need for bioterrorism countermeasures and to create shareholder value,” said Fuad El-Hibri, Emergent BioSolutions’ chairman and chief executive officer.
Dr. Bailey served as a news analyst for NBC Universal from 2001 to 2006, focused on national security, bioterrorism, environmental safety and public health issues. Dr. Bailey also served as Administrator for the National Highway Traffic Safety Administration from 2000 to 2001, as Assistant Secretary Of Defense (Health Affairs) from 1998 to 2000, and as Deputy Assistant Secretary Of Defense (Clinical Services) from 1994 to 1995. During her tenure with DoD Health Affairs, Dr. Bailey headed the $17 billion military medical system, with responsibility for protecting American military forces from combat causalities, disease, environmental hazards, and biochemical warfare.
“Protecting America’s military men and women against acts of bioterrorism and safeguarding citizens against infectious diseases has been the focus of my career,” said Dr. Bailey. “I am pleased to be joining the Board of Emergent BioSolutions where I can help guide the company’s development of medical countermeasures that can protect the lives of those most at risk.”
Dr. Bailey is a board certified physician whose clinical and academic background included a faculty position at Georgetown University Medical School. In addition, she was formerly a Navy officer, having achieved the rank of Lt. Commander, U.S. Navy Reserve. Dr. Bailey also serves as an advisor or member of the board of directors for a variety of industry, academic and trade healthcare and safety-oriented organizations.
Dr. Bailey holds a degree from the University of Maryland and her medical degree from the Philadelphia College of Osteopathic Medicine. She completed her internship and residency at George Washington University and completed a medical post-graduate fellowship at Johns Hopkins University.
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 expected revenue growth and net earnings for 2007, 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 performance under BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; 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; 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 Annual Report on Form 10-K for the year ended December 31, 2006 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 Acquires Advanced Recombinant Protective Antigen Anthrax Vaccine Candidate And Technology
Posted by admin in Uncategorized on July 11th, 2009
Acquisition positions Emergent to offer the U.S. Government a domestic source for an advanced anthrax vaccine candidate to meet planned procurement of 25 million doses of rPA vaccine
Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has completed the acquisition of all assets and rights related to a recombinant protective antigen (rPA) anthrax vaccine product candidate and related technology from VaxGen, Inc. Recent improvements to the rPA vaccine, specifically related to stability, suggests that it is well positioned to be a leading candidate for an award under a request for proposal (RFP) recently issued by the U.S. Department of Health and Human Services (HHS). The vaccine candidate has completed one Phase 2 clinical study. This RFP is designed to meet the government’s stated goal to procure 25 million doses of an rPA anthrax vaccine for the Strategic National Stockpile (SNS). HHS has indicated that any awards under this RFP are scheduled to be granted in late 2008.
The acquisition of this rPA vaccine candidate, and the pending RFP, have no effect on Emergent’s $448 million contract with HHS for the delivery of 18.75 million doses of BioThrax® (Anthrax Vaccine Adsorbed), the only FDA approved vaccine for the prevention of anthrax disease, into the SNS. Emergent continues to manufacture and deliver doses of BioThrax in accordance with this multi-year agreement.
The company intends to manufacture this new rPA anthrax vaccine, as well as BioThrax, in its recently constructed, large-scale manufacturing facility at its Lansing campus. The acquisition of the rPA vaccine candidate further solidifies Emergent’s well established franchise of anthrax countermeasures, which now includes:
BioThrax®, the only FDA-approved vaccine to prevent the infection of anthrax. Nearly 2.0 million men and women of the United States military have received the vaccine, and HHS has procured more than 28 million doses of BioThrax for the SNS;
rPA 102, a recombinant anthrax vaccine candidate, which is composed of a purified protein with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins;
AVP-21D9, a human monoclonal antibody product candidate being developed as an intravenous treatment for patients who present symptoms of anthrax disease; and
AIG, a polyclonal anthrax immune globulin product candidate, which is derived from human plasma from individuals who have been vaccinated with BioThrax.
“As the manufacturer of the only FDA approved anthrax vaccine, Emergent BioSolutions has a proven track record of delivering critical biodefense countermeasures to the U.S. Government. Given HHS’s stated commitment to procure up to an additional 25 million doses of a recombinant anthrax vaccine for the Strategic National Stockpile, we felt this was the right opportunity for our company at the right time,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Additionally, we are pleased to provide the U.S. Government with the important option to select an advanced rPA anthrax vaccine candidate from a domestic manufacturer. As the premiere domestic biodefense supplier, this was a natural fit for us,” he continued.
Data reviewed to date relating to the rPA vaccine candidate suggests that the steps taken to address a prior stability issue affecting the vaccine position the product for continued development toward regulatory approval and to be a leading candidate for the HHS procurement contract of 25 million doses under the recently issued RFP.
Under the terms of the asset acquisition, Emergent BioSolutions paid VaxGen $2 million upon execution of the definitive agreement and may be obligated to pay up to an additional $8 million in milestone payments, plus specified percentages of future net sales.
About rPA 102
The vaccine candidate, rPA 102, is based on a recombinant form of the protective antigen protein. This vaccine contains a purified protein (rPA) formulated with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins. The vaccine candidate does not cause anthrax infection and is based on the pioneering work of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). rPA 102 has been the subject of two research and development grants totaling approximately $100 million from the National Institute for Allergy and Infectious Diseases (NIAID). In 2004, HHS awarded VaxGen an $877 million contract for delivery of 75 million doses of rPA 102. The contract was subsequently terminated by HHS, based on its determination that VaxGen failed to successfully cure the condition endangering performance and failed to meet a milestone imposed by HHS that required VaxGen to initiate a clinical trial of the vaccine candidate by December 18, 2006. This failure was primarily related to stability issues with the vaccine.
About USAMRIID
USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the DoD 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
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a profitable, multinational 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 products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Our 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. 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 expected revenue growth and net earnings for 2008, 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 ability to obtain new BioThrax® sales contracts with the U.S. government; our plans for future sales of BioThrax; 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; 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 Annual Report on Form 10-K for the year ended December 31, 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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