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Emergent BioSolutions reacts to BARDA’s Request for Proposal cancellation

Friday, December 11th, 2009

by Nick Rees on December 8, 2009

El-hibri_fuad

The Office of the Biomedical Advanced Research and Development Authority has advised Emergent BioSolutions that while BARDA’s Request for Proposal has been canceled, Emergent is encouraged to submit a proposal for the office’s Broad Agency Announcement.

BARDA canceled the RFP for the procurement for rPA vaccines after a technical evaluation panel determined that no proposals submitted by vaccine developers could meet the ProjectBioShield statutory requirement of having the product ready for licensure within eight years.

An amendment issued by BARDA to BAA 09-34 at the same time, however, enable companies to submit proposals to obtain development funding for rPA vaccine candidates, which Emergent has been strongly encouraged to do by BARDA.

Emergent plans to submit its proposal to the BAA by the end of this year, in front of the due date of February 1, 2010 for the proposals.

This announcement also does not impact Emergent’s $400 million procurement with the Centers for Disease Control and Prevention to manufacture and deliver 14.5 million doses of BioThrax for the Strategic National Stockpile.

“With this action, BioThrax remains a critical and long-term countermeasure for the US government,” Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, said. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA.  Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”

BioThrax is currently being delivered under this contract with an expected completion of deliveries by September 2011. BioThrax is the only FDA licensed vaccine for the prevention of anthrax diseases.

“We believe that BioThrax will remain a premier product based on its recent enhancements, such as four-year dating, a reduced vaccination schedule and intramuscular route of administration, together with the potential for a further reduction in the vaccination schedule to a 3-dose primary series with a 3-year boost,” Daniel J.Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, said. “BioThrax continues to be the product of choice for the USG and other customers seeking to address the anthrax threat.”

BARDA and Emergent are also in separate talks for a contract that would see BARDAA fund scale-up and related activities to obtain FDA licensure for large-scale production of BioThrax at Emergent’s new 50,000-square-foot Lansing, Mich., manufacturing facility.

“I am proud that Lansing remains home to America’s first line of defense against what experts say is the single biggest bioterror threat, anthrax,” U.S. Rep. Mike Rogers, MI-08, said. “The good news about the cancellation of this particular proposal is HHS recommitted itself to the Lansing-made anthrax vaccine and has opened a new proposal for a next-generation anthrax vaccine for which Emergent has indicated it will compete.

“Rest assured, I will continue working to strengthen our nation’s existing bioterror preparedness measures and protect national security jobs in Lansing.”

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

Friday, August 14th, 2009

CEO & Chairman, 10% Owner of Emergent BioSolutions Inc. (EBS) Fuad El-hibri sells 15,000 shares of EBS on 08/11/2009 at an average price of $16.78 a share.

EMERGENT BIOSULUTIONS INC. is a leading biopharmaceutical company dedicated to one simple mission – to protect life. EBS develops manufactures and commercializes vaccines and therapeutics that assist the body\’s immune system to prevent or treat disease. Their products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Their marketed product BioThrax? (Anthrax Vaccine Adsorbed) is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent BioSolutions Inc. has a market cap of $511.8 million; its shares were traded at around $16.91 with a P/E ratio of 13.1 and P/S ratio of 2.8.

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Emergent BioSolutions Inc., Q2 2009 Earnings Call Transcript

Friday, August 14th, 2009

Emergent BioSolutions Inc., (EBS)

Q2 2009 Earnings Call

August 6, 2009 5:00 pm ET

Executives

Robert G. Burrows – Vice President, Investor Relations

Fuad El-HibriChairman of the Board, Chief Executive Officer

R. Don Elsey – Chief Financial Officer

Daniel J. Abdun-Nabi – President, Chief Operating Officer

W. James Jackson, Ph.D. – Senior Vice President and Chief Scientific Officer

Analysts

Eric Schmidt – Cowen & Company

David Moskowitz – Caris & Company

Mona Ashiya – J.P. Morgan

Sean Long – Kennedy Capital Management

Presentation

Operator

Welcome to the Emergent BioSolutions Incorporated second quarter 2009 financial results conference call. (Operator Instructions) I would now like to turn the call over to Mr. Robert Burrows.

Robert Burrows

Good afternoon ladies and gentlemen. My name is Robert Burrows, Vice President of Investor Relations for Emergent. Thank you for joining us today as we discuss Emergent BioSolutions financial results for the second quarter and first six months of 2009. As is customary, our call today is open to all participants. In addition, the call is being recorded and is copyrighted by Emergent BioSolutions.

Joining me on the call this afternoon will be Fuad El-Hibri, Chairman and Chief Executive Officer, and Don Elsey, Chief Financial Officer. Additional members of our senior management team will be present on the call for purposes of the Q&A session.

Before we begin, however, I am compelled to remind everyone that during the all management may make projections and other forward-looking statements regarding future events and the company’s prospects or future performance. These forward-looking statements reflect Emergent’s current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve substantial risks and uncertainties. Actual results may differ materially from those projected in any forward-looking statements.

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Cornerstone Ceremony Welcomes New Vaccine Production Facility To Michigan

Monday, August 3rd, 2009

Emergent BioSolutions’ $75 Million Investment and Commitment to Michigan Applauded by Governor Granholm.

LANSING, MI, July 21, 2006 – Emergent BioSolutions, a biopharmaceutical company, announced today the dedication of a new large-scale vaccine production facility for its BioDefense Operations in a gala ceremony on itsLansing, Michigan campus. This $75 million dollar project represents a significant investment in the company’s future and adds biotechnology diversity to Michigan’s economy.

Governor Jennifer Granholm and other dignitaries and visitors, including Lansing Mayor Virgil Bernero and Major General Stephen Reeves (Executive Officer, Department of Defense Joint Program for Chemical and Biological Defense), were on hand for the cornerstone ceremony.
“This building represents a major investment in our biodefense business, and significantly expands our core manufacturing capabilities,” said Fuad El-Hibri, Chairman and Chief Executive Officer of Emergent BioSolutions. “When we purchased this facility from the state in 1998, we could only dream of being where we are today. With the support of our employees, our customers, the city of Lansing, and the state of Michigan, that dream is now a reality.”

The new 50,000-square-foot facility is designed to enable the company to expand production of its current product, BioThrax (Anthrax Vaccine Adsorbed), and will provide the potential opportunity for production of other products in the company’s pipeline. Construction of this facility began in February 2006 and is scheduled for completion in 2007. The company expects to initiate manufacturing in this new facility in 2008. BioThrax is the only FDA-approved anthrax vaccine. Present customers include the U.S. Department of Health and Human Services, the U.S. Department of Defense, and certain foreign governments.

“This historic Lansing site has seen a number of milestone events in its long history, and we’re proud to call Michigan home,” said Robert G. Kramer, President of BioDefense Operations for Emergent Solutions. “This project signifies our unwavering commitment to protecting life. This facility is designed to provide new and expanded capabilities to produce immunobiotics to defend against biological agents and other public health threats.”

About Emergent BioSolutions
Emergent BioSolutions is a biopharmaceutical company dedicated to protecting life through the development, manufacture, and commercialization of immunobioticsTM, which are novel products that direct the immune system to prevent and treat life-threatening diseases. These include products for prophylactic and therapeutic use against serious diseases where there exists significant unmet or underserved medical needs and against biological agents which may potentially be used as weapons of bioterrorism. The company currently employs more than 450 people with sites in Maryland, Michigan, the United Kingdom, Germany, and the Republic ofSingapore. More information about Emergent BioSolutions is available at www.emergentbiosolutions.com.

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Emergent BioSolutions Chairman and CEO, Mr. Fuad El-Hibri, Named Ernst & Young Entrepreneur of the Year 2009 Award Winner in Greater Washington

Monday, August 3rd, 2009

ROCKVILLE, Md.–(BUSINESS WIRE)–Emergent BioSolutions Inc. (NYSE:EBSNews) announced today that Fuad El-Hibri, its chairman and chief executive officer, received the Ernst & Young Entrepreneur of the Year® 2009 Award in the Technology category in Greater Washington. According to Ernst & Young LLP, the award recognizes outstanding entrepreneurs who are building and leading dynamic, growing businesses. Mr. El-Hibri was selected by an independent panel of judges and the award was presented at a special gala event on June 18 at the Ritz-Carlton, Tysons Corner in Virginia.

“It is a tremendous honor to receive this award considering the many biopharmaceutical and life sciences companies in the greater Washington region,” said Mr. El-Hibri. “I am proud of Emergent BioSolutions’ continuous growth and financial strength. These successes are firmly anchored on the entrepreneurial spirit and commitment of our employees. All their contributions, in pursuit of our company mission to protect life, have made this award possible.”

Under Mr. El-Hibri’s leadership, Emergent BioSolutions has expanded its capabilities in the development and manufacture of vaccines and immune-related therapeutics. By strengthening its core biodefense portfolio, which includes the only FDA-licensed vaccine against anthrax disease, Emergent has become the premier biodefense supplier of medical countermeasures to the U.S. government.

The Ernst & Young Entrepreneur of the Year awards program celebrates its 23rd anniversary this year and continues to honor entrepreneurs who have demonstrated excellence in such areas as innovation, financial performance, and personal commitment to their businesses and communities. The program has expanded to recognize business leaders in over 135 cities in 50 countries throughout the world.

As a Greater Washington award winner, Mr. El-Hibri is now eligible for consideration for the Ernst & Young Entrepreneur of the Year 2009 national program. Award winners in several national categories, as well as the overall national Ernst & Young Entrepreneur of the Year award winner, will be announced at the annual awards gala in Palm Springs, California on November 14, 2009. The awards are the culminating event of the Ernst & Young Strategic Growth Forum, the nation’s most prestigious gathering of high-growth, market-leading companies.

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.

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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

Tuesday, June 30th, 2009

Dr. Bailey brings DoD and media relations expertise to the company’s Board

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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