EMERGENT BIOSOLUTIONS ANTICIPATES 2ND QUARTER BIOTHRAX REVENUES OF APPROXIMATELY $20 MILLION BASED ON ACCELERATED DELIVERY TO DEPARTMENT OF DEFENSE
Jul/090
ROCKVILLE, MD, June 27, 2007—Emergent 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 reliability—an 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.
EMERGENT BIOSOLUTIONS ANNOUNCES THE APPOINTMENT OF DENISE LANDRY AS SENIOR VICE PRESIDENT, QUALITY
Jul/090
ROCKVILLE, MD, October 9, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that Ms. Denise Landry has joined the company as Senior Vice President, Quality with responsibility for managing and overseeing all Quality activities company-wide. Ms. Landry has broad-based quality experience for pharmaceutical and biologics operations, including activities relating to all phases of product development, regulatory submissions, and compliance programs. In addition, Mrs. Landry has extensive experience interacting with regulatory authorities including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the Medicines and Healthcare Product Regulatory Agency (MHRA) in the United Kingdom.
Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions stated “I am pleased to welcome Ms. Denise Landry to Emergent BioSolutions as Senior Vice-President, Quality. Her two decades of experience in the Quality programs will be a critical asset to our team. Denise’s first-hand experience and breadth of knowledge make her uniquely qualified for such an important role in our company.”
Ms. Landry joins the company from MGI Pharma Inc. and its predecessor Guilford Pharmaceuticals, where she served as Vice President, Corporate Quality. Prior to her 13 year tenure there, Ms. Landry was the Director Quality Assurance for Pharmaceutical Systems, Inc. and Quality Assurance Director for Smith & Nephew Solopak. She began her career in the quality control field as a Service Quality Manager for Baxter Healthcare Corporation.
“I am very pleased to be joining the management team at Emergent BioSolutions, and I share their commitment to maintaining the highest quality standards in manufacturing and product development,” said Ms. Denise Landry. “I have dedicated my career to this industry and look forward to leading and promoting continuous quality improvement throughout the company as it develops and manufactures products to protect life.”
Mrs. Landry holds a BA in Biology from Fisk University in Tennessee. She is a member of the American Society of Quality Control and the Parenteral Drug Association.
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, 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.
STATEMENT BY FUAD EL-HIBRI, EMERGENT BIOSOLUTIONS CHAIRMAN AND CHIEF EXECUTIVE OFFICER, ON THE PASSING OF ADMIRAL WILLIAM CROWE, JR., FORMER BOARD MEMBER.
Jul/090
ROCKVILLE, MD, October 19, 2007— Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, issued the following statement on the passing of Admiral William Crowe, Jr., who served on the company’s Board of Directors from 1998-2005.
“I was deeply saddened to learn of the passing of my dear friend and former colleague, the honorable Admiral William J. Crowe Jr. My thoughts are with his family during this difficult time,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.
“A benevolent and courageous public servant, Admiral Crowe committed his life to serving the nation. He was a candid man who led with nobility and grace, and never wavered in his commitment to the protection of our country. His compassion and boundless love for his family and friends were matched only by his steadfast integrity and tenacious commitment to the United States military and the field of education. Admiral Crowe’s countless contributions to the American people will not be forgotten, and our nation is fortunate to have known such a dignitary. The Admiral was an invaluable asset to our company, and I will always remember the great strategic insight and disarming humor he brought to every situation. Emergent BioSolutions is a stronger company as a result of his vision and leadership, and I am particularly grateful for his many years of friendship,” he concluded.
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.
EMERGENT BIOSOLUTIONS ANNOUNCES MANAGEMENT CHANGES
Jul/090
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.
EMERGENT BIOSOLUTIONS ANNOUNCES THAT DEPARTMENT OF HEALTH AND HUMAN SERVICES AND DEPARTMENT OF DEFENSE ISSUED NOTICES OF INTENT TO PROCURE UP TO A COMBINED 22.75 MILLION DOSES OF BIOTHRAX®(ANTHRAX VACCINE ADSORBED)
Jul/090
ROCKVILLE, MD, April 18, 2007—Emergent BioSolutions Inc. (NYSE: EBS) (EBS) today announced that the U.S. Department of Health and Human Services (HHS) and the U.S. 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, such as 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 developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on developing immunobiotics for use against infectious diseases which pose 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, our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management 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 existing 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.
Emergent BioSolutions Chairman and CEO, Mr. Fuad El-Hibri, Named Ernst & Young Entrepreneur of the Year 2009 Award Finalist in Greater Washington
Jul/090
Emergent BioSolutions Inc. (EBS) announced today that its chairman and chief executive officer, Mr. Fuad El-Hibri, is a finalist for the Ernst & Young Entrepreneur of the Year® 2009 Award in the Greater Washington region. According to Ernst & Young LLP, the awards program recognizes entrepreneurs who demonstrate extraordinary success in the areas of innovation, financial performance and personal commitment to their businesses and communities. Mr. El-Hibri was selected as a finalist from nearly 100 nominations by a panel of independent judges. Award winners will be announced at a special gala event on June 18 at the Ritz-Carlton, Tysons Corner in Virginia.
“It is an honor to be chosen as a finalist for the Ernst & Young Entrepreneur of the Year Award,” said Mr. Fuad El-Hibri. “I am proud of the entrepreneurial spirit, commitment, and collaboration that prevail at Emergent, which are key factors to our company’s success. This recognition represents the contributions of each and every member of the Emergent Team as we work together in pursuit of our company mission – to protect life.”
Mr. El-Hibri was also a finalist for the Greater Washington region in 2007. The Ernst & Young Entrepreneur of the Year awards program celebrates its 23rd anniversary this year. The program has expanded to recognize business leaders in over 135 cities in 50 countries throughout the world.
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 www.emergentbiosolutions.com.
About Ernst & Young’s Entrepreneur of the Year® Awards Program
Ernst & Young’s Entrepreneur of the Year® Award is the world’s most prestigious business award for entrepreneurs. The award makes a difference through the way it encourages entrepreneurial activity among those with potential and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, the Ernst & Young Entrepreneur of the Year® award celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 135 cities in 50 countries.
Sponsors
Founded and produced by Ernst & Young LLP, the Entrepreneur of the Year awards are pleased to have the Ewing Marion Kauffman Foundation and SAP America as national sponsors.
In Greater Washington, sponsors include HSBC Bank, Pillsbury Law, Reznick Group, Lockton Companies and the Washington Business Journal.
EMERGENT BIOSOLUTIONS INC Profile on AOL
Jul/090
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.
Fuad El-Hibri Profiles
Jul/090
- Fuad El-Hibri on backtype
- Fuad El-Hibri on BigContact
- Fuad El-Hibri on BlogCatalog
- Fuad El-Hibri on Blogger
- Fuad El-Hibri on BloggersUnite
- Fuad El-Hibri on Carbonmade
- Fuad El-Hibri on Disqus
- Fuad El-Hibri on FriendFeed
- Fuad El-Hibri on HelloTxt
- Fuad El-Hibri on Identica
- Fuad El-Hibri on isfingawesome
- Fuad El-Hibri on koornk
- Fuad El-Hibri on kwippy
- Fuad El-Hibri on LiveJournal
- Fuad El-Hibri on posterous
- Fuad El-Hibri on Soup
- Fuad El-Hibri on Sphinn
- Fuad El-Hibri on Tribe
- Fuad El-Hibri on Ttiqq
- Fuad El-Hibri on Tumblr
- Fuad El-Hibri on vox
- Fuad El-Hibri on Wists
- Fuad El-Hibri on Wordpress
- Fuad El-Hibri on yotify
- Fuad El-Hibri on zooomr
- Fuad El-Hibri on Backflip
- Fuad El-Hibri on BlinkList
- Fuad El-Hibri on Bonzo
- Fuad El-Hibri on Clipmarks
- Fuad El-Hibri on Cocomment
- Fuad El-Hibri on Connotea
- Fuad El-Hibri on Delicious
- Fuad El-Hibri on Diigo
- Fuad El-Hibri on Faves
- Fuad El-Hibri on Folkd
- Fuad El-Hibri on FortyThreeMarks
- Fuad El-Hibri on IndianPad
- Fuad El-Hibri on Kirtsy
- Fuad El-Hibri on Mixx
- Fuad El-Hibri on Muti
- Fuad El-Hibri on Mylinkvault
- Fuad El-Hibri on NewsCloud
- Fuad El-Hibri on Rollyo
- Fuad El-Hibri on Searchles
- Fuad El-Hibri on Squidoo
- Fuad El-Hibri on StumbleUpon
- Fuad El-Hibri on Stumpedia
- Fuad El-Hibri on visualizeus
- Fuad El-Hibri on Getsatisfaction
- Fuad El-Hibri on LinkedIn
- Fuad El-Hibri on Slideserve
- Fuad El-Hibri on slidesix
- Fuad El-Hibri on Asoboo
- Fuad El-Hibri on BrightKite
- Fuad El-Hibri on eHow
- Fuad El-Hibri on eventful
- Fuad El-Hibri on Gather
- Fuad El-Hibri on Groups
- Fuad El-Hibri on Hubpages
- Fuad El-Hibri on jaiku
- Fuad El-Hibri on KnowEm
- Fuad El-Hibri on Multiply
- Fuad El-Hibri on MySpace
- Fuad El-Hibri on Netlog
- Fuad El-Hibri on Platial
- Fuad El-Hibri on Plugim
- Fuad El-Hibri on Skyrock
- Fuad El-Hibri on SlideShare
- Fuad El-Hibri on Socialight
- Fuad El-Hibri on Tipd
- Fuad El-Hibri on Trendrr
- Fuad El-Hibri on Twine
- Fuad El-Hibri on virb
- Fuad El-Hibri on Xanga
- Fuad El-Hibri on Aviary
- Fuad El-Hibri on WeHeartGossip
- Fuad El-Hibri on Kiva
- Fuad El-Hibri on tipjoy
- Fuad El-Hibri on Claimid
- Fuad El-Hibri on CliqSet
- Fuad El-Hibri on Myopenid
- Fuad El-Hibri on Peoplepond
- Fuad El-Hibri on Adocu
- Fuad El-Hibri on Dipity
- Fuad El-Hibri on Plurk
- Fuad El-Hibri on Tweetphoto
- Fuad El-Hibri on Twitter
- Fuad El-Hibri on Youare
- Fuad El-Hibri on Zcapes
- Fuad El-Hibri on soundcloud
- Fuad El-Hibri on BuzzFlash
- Fuad El-Hibri on Dropjack
- Fuad El-Hibri on fark
- Fuad El-Hibri on HuffingtonPost
- Fuad El-Hibri on reddit
- Fuad El-Hibri on wakoopa
- Fuad El-Hibri on DailyMotion
- Fuad El-Hibri on FunnyOrDie
- Fuad El-Hibri on odeo
- Fuad El-Hibri on Seesmic
Emergent Biosolutions Submits Proposal In Response To Hhs’ Rfp For Development And Procurement Of A Recombinant Protective Antigen Anthrax Vaccine
Jul/090
The company’s submission provides the U.S. Government with the critical option to select a domestic source to meet planned procurement of 25 million doses of rPA vaccine.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has submitted a proposal in response to a request for proposal (RFP) issued by the U.S. Department of Health and Human Services (HHS) for a recombinant protective antigen anthrax vaccine (rPA). Emergent’s rPA vaccine candidate, which has completed one Phase II clinical trial, is a reformulated and more stable form of the rPA 102 vaccine originally developed at USAMRIID and is well positioned to be a leading candidate for an award under this RFP.
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). This contract would be in addition to the $448 million three-year contract awarded to Emergent in 2007 that includes the supply of 18.75M doses of its FDA licensed anthrax vaccine BioThrax to the SNS. In the event that Emergent receives an award under the rPA RFP, doses of rPA procured by HHS would be in addition to the 18.75 million doses of BioThrax being procured by HHS pursuant to the three-year contract. HHS has indicated that any awards under the rPA RFP would be granted at the end of 2008, at the earliest.
“We are very pleased with our submission in response to this RFP and we are confident that our rPA 102 vaccine is a leading candidate to be selected as an advanced rPA anthrax vaccine. Our company is proud of our proven track record of delivering critical biodefense countermeasures to the U.S. government and we believe our reputation as the premiere domestic biodefense supplier, coupled with our development and manufacturing expertise, uniquely situates Emergent to meet HHS’s stated commitment to procure 25 million doses of a recombinant anthrax vaccine for the Strategic National Stockpile,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.
“Considerable effort and resource have been directed toward improving the stability of the rPA 102 vaccine. Analytical testing as well as animal immunogenicity and efficacy studies indicate the stability of our recombinant protective antigen vaccine candidate has been significantly improved. We are confident that the new, enhanced vaccine formulation will address any stability concerns HHS may have had in the past. The current formulation, we believe, will meet and most likely exceed BARDA stability requirements for an rPA vaccine,” said Dr. James Jackson, senior vice president and chief scientific officer of Emergent BioSolutions.
The company intends to manufacture this rPA anthrax vaccine, as well as BioThrax, in its recently constructed, large-scale manufacturing facility at its Lansing campus. The continued development of this rPA vaccine candidate further solidifies Emergent’s well established franchise of anthrax countermeasures, which now includes:
BioThrax® (Anthrax Vaccine Adsorbed) is 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 post-exposure treatment for patients who present symptoms of anthrax disease; and
AIG, a polyclonal anthrax immune globulin product candidate being developed as an intravenous post-exposure treatment for patients who present symptoms of anthrax disease, is derived from human plasma from individuals who have been vaccinated with BioThrax.
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).
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading, multinational biopharmaceutical company dedicated to one simple mission — to protect life. Emergent develops, manufactures and commercializes immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. The company’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. 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 sales contracts for BioThrax®, rPA 102, AVP-21D9 and AIG with the U.S. government; our plans for future sales of BioThrax, rPA 102, AVP-21D9 and AIG; 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; 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 March 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]](http://img.zemanta.com/reblog_e.png?x-id=c64a4f0f-ce69-4d69-9887-bebf53b34212)
![Reblog this post [with Zemanta]](http://img.zemanta.com/reblog_e.png?x-id=a5ae7005-9177-4cdb-80dd-65777ac04964)
![Reblog this post [with Zemanta]](http://img.zemanta.com/reblog_e.png?x-id=c6d77834-50f8-4079-abbe-37b2c157332f)
![Reblog this post [with Zemanta]](http://img.zemanta.com/reblog_e.png?x-id=d9a37653-e0ec-4ba0-bf0a-f7ac0d403a87)
![Reblog this post [with Zemanta]](http://img.zemanta.com/reblog_e.png?x-id=091dde03-0614-4199-a86a-95fafa8d996a)
![Reblog this post [with Zemanta]](http://img.zemanta.com/reblog_e.png?x-id=f8032cb1-8bd0-4c0e-b41e-8d77fd4fc69b)
![Reblog this post [with Zemanta]](http://img.zemanta.com/reblog_e.png?x-id=f5e32b44-e823-47af-8b8d-93ef47959768)
![Reblog this post [with Zemanta]](http://img.zemanta.com/reblog_e.png?x-id=7202286b-92ae-4db9-a418-3029b0eef6ea)
![Reblog this post [with Zemanta]](http://img.zemanta.com/reblog_e.png?x-id=adb58ce1-d269-48a5-b682-b7948f7014ae)