Archive for July, 2009

Emergent BioSolutions Inc. Company Profile

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

Reblog this post [with Zemanta]
 

Emergent Biosolutions Announces That Biothrax (Anthrax Vaccine Adsorbed) Receives Market Authorization In India

Biological E. of Hyderabad, India to serve as marketing agent for BioThrax in India

ROCKVILLE, MD., February 12, 2009 — Emergent BioSolutions Inc. (NYSE: EBS) announced today that the Drugs Controller General of India (DCGI) has issued a registration certificate for BioThrax® (Anthrax Vaccine Adsorbed), which enables the marketing and sale of the vaccine in India to help prevent anthrax infection. Emergent BioSolutions has signed a marketing agreement with Biological E. Limited for the marketing of BioThrax in India. BioThrax is the only vaccine for the prevention of anthrax infection licensed by the U.S. Food and Drug Administration (FDA).

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

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

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

About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immune-related biologic products, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. 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 development pipeline includes programs focused on anthrax, botulism, typhoid, tuberculosis, hepatitis B 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, 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 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 September 30, 2008 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Reblog this post [with Zemanta]
 

EMERGENT BIOSOLUTIONS ANNOUNCES DR. STEPHEN LOCKHART JOINS COMPANY TO LEAD COMMERCIAL PRODUCT DEVELOPMENT SUBSIDIARY


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.

Reblog this post [with Zemanta]
 

Fuad El-Hibri on CorridorInC

May 8, 2009

ImageFuad El-Hibri, chairman and chief executive officer at Emergent BioSolutions Inc., is a finalist for the Ernst & Young Entrepreneur of the Year® 2009 Award in the Greater Washington region. The awards program recognizes extraordinary innovation, financial performance and personal commitment to a businesses and its community. Emergent BioSolutions, based in Rockville, is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics.

Reblog this post [with Zemanta]
 

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

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

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

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

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

About Emergent BioSolutions Inc.

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

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, and any other statements containing the words “believes,” “expects,” “anticipates,” “plans,” “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of our clinical programs; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s annual report on Form 10-K for the year ended December 31, 2008 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Reblog this post [with Zemanta]
 

EMERGENT BIOSOLUTIONS RECEIVES DEVELOPMENT CONTRACT FROM NIAID/BARDA TO FUND CONTINUED DEVELOPMENT OF ANTHRAX THERAPEUTIC

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

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

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

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

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

About Anthrax Immune Globulin (AIG)

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

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

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

About Emergent BioSolutions Inc.

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

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our performance under our contract with HHS and future payments from HHS to us under the contract, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

 

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

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

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

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

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

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

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

Reblog this post [with Zemanta]
 

EMERGENT BIOSOLUTIONS RECEIVES DEVELOPMENT CONTRACT FROM NIAID/BARDA TO FUND CONTINUED DEVELOPMENT OF ANTHRAX THERAPEUTIC



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

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

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

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

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

About Anthrax Immune Globulin (AIG)

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

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

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

About Emergent BioSolutions Inc.

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

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our performance under our contract with HHS and future payments from HHS to us under the contract, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Reblog this post [with Zemanta]
 

Fuad El-Hibri Profiles

 

EMERGENT BIOSOLUTIONS ANTICIPATES 2ND QUARTER BIOTHRAX REVENUES OF APPROXIMATELY $20 MILLION BASED ON ACCELERATED DELIVERY TO DEPARTMENT OF DEFENSE


Company preparing response to DoD request for proposal for delivery of up to 14 million additional doses of BioThrax

ROCKVILLE, MD, June 27, 2007Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today that, pursuant to the terms of an amended contract with the U.S. Department of Defense (DoD), it anticipates completing delivery of 900,000 doses of BioThrax® (Anthrax Vaccine Adsorbed) during the quarter ending June 30, 2007 or shortly thereafter. The company anticipates that, with these deliveries, second quarter revenues would be approximately $20 million. The terms of the amended contract with the DoD authorize delivery of BioThrax ahead of schedule.

The company is also preparing its response to a May 7, 2007 request for proposal from the DoD for a follow-on contract for the supply of up to 14 million doses of BioThrax to the military for its active immunization program. The request for proposal contemplates a contract term of one base year and three option years.

“Emergent BioSolutions and the DoD have a longstanding relationship and we are pleased to continue to provide doses of BioThrax for the military’s ongoing active immunization program,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “By repeatedly fulfilling our commitments to the U.S. Government, we continue to strengthen our reputation for reliabilityan essential element of a successful partnership with the government. I am proud of our role in helping to protect our nation’s troops against biological threats.”

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 for the second quarter of 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 contract with the U.S. Department of Defense, including the timing of deliveries under that contract; 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 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, 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.

Reblog this post [with Zemanta]