Emergent BioSolutions Completes Deliveries of BioThrax to Allied Foreign Governments

ROCKVILLE, MD, June 24, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) led by CEO Fuad El-Hibri,announced today that it has completed separate international sales and deliveries of BioThrax® (Anthrax Vaccine Adsorbed) to governments of several allied nations.  The company’s international sales efforts have resulted in these sales of an undisclosed number of BioThrax doses for aggregate revenue of approximately $2.3 million in the second quarter.

“Emergent recognizes that governments play a key role in protecting citizens against the growing threat of bioterrorism,” said Allen Shofe, senior vice president public affairs of Emergent BioSolutions.  “As the maker of the only U.S. FDA-licensed anthrax vaccine, and in line with our corporate mission to protect life, we are honored to support such biopreparedness efforts of allied international governments.”

About BioThrax

BioThrax is the only U.S. FDA-licensed vaccine for the prevention of anthrax infection.  It is indicated for the active immunization of adults who are at high risk of exposure to anthrax.  BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured over 42 million doses of BioThrax.  During that time period, more than 9.5 million doses have been administered to nearly 2.4 million military personnel.  For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

Important Safety Information for BioThrax®

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache. Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax.

Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If BioThrax is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to the fetus. This product should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.

Vaccination with BioThrax should be avoided by individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.

About Emergent BioSolutions Inc.

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

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

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Marvin White joins Fuad El-Hibri at Emergent BioSolutions, Inc.

Emergent BioSolutions, Inc., officials have announced the appointment of Marvin White to the board of directors.

“Mr. White’s expertise in financial management, gained in a patient-focused health care system and service-oriented environment, will prove an invaluable asset in guiding Emergent’s management team towards further growth and in increasing value for shareholders,” Fuad El-Hibri, Emergent BioSolutions, Inc.’s chairman and CEO, said. “We are delighted to welcome him to Emergent’s Board of Directors, composed of seasoned experts with diverse skill sets.”

White, who currently serves as system vice president and chief financial officer of St. Vincent Health, one of the largest health care systems in Indiana, said he is excited about the appointment to Emergent BioSolutions, Inc.’s board of directors.

“It is an honor to serve on the board of a company whose mission is to protect life by providing and developing life-saving vaccines and treatments that benefit public health,” White said. “Through this opportunity, I look forward to contributing to Emergent’s success by drawing from my experience in health care systems and pharmaceuticals as well as my efforts in philanthropy.”

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Emergent BioSolutions to Participate in June 2010 Investor Conferences

Fuad El-Hibri, CEO of Emergent BioSolutions Inc., announces that the company will be participating in the following investor conferences during June 2010:

  • The Jefferies & Company 2010 Global Life Sciences Conference
    New York, NY.
    June 8, 2010
    Corporate Overview Presentation
    11:00 AM Eastern
    There will be a full webcast with slides that will include discussion of the Company’s business activities, financial outlook and current news.
  • The Needham & Company 9th Annual Healthcare Conference
    New York, NY.
    June 10, 2010
    Corporate Overview Presentation
    3:20 PM Eastern
    There will be a full webcast with slides that will include discussion of the Company’s business activities, financial outlook and current news.

Both webcasts will be accessible from the Emergent website www.emergentbiosolutions.com under “Investors”.

 

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Nomination Deadline Approaching for 2010 El-Hibri Peace Education Prize

The El-Hibri Peace Education Prize is awarded yearly to an individual or organization  who is making valuable contributions to peace education and social justice in the Middle East.  The purpose of the $10,000 prize is to recognize outstanding peace educators, to provide financial support to continue peace education and study, and to promote the importance of peace education globally by affirming efforts to integrate peacemaking into curricula at all levels of education.

The nomination period  for the 2010 prize ends June 6th.   This year’s winner will be announced  July 11, 2010 and the award will be presented on September 21, 2010, the International Day of Peace. Nominees can be individuals or organizations, but they must be based in the United States and be making valuable contributions to the theory, practice, and teaching of peace and social justice in the Middle East.  More information about the nomination process and the prize itself can be found at http://www.elhibriprize.org .

 

Fuad El-Hibri, Founder of the El-Hibri Peace Education Prize and Dr. Abdul Aziz Said, First Laureate of the El-Hibri Peace Education Prize

The prize was founded in 2007 by businessman and philanthropist Fuad El-Hibri and his wife Nancy El-Hibri in order to highlight the importance of peace education and to support people who are working for a just, peaceful and healthy planet.  El-Hibri is the CEO of Emergent BioSolutions, as well Chairman of the El-Hibri Charitable Foundation.  Past winners include Professor Abdul Aziz Said (2007); Scott Kennedy (2008) ; and Dr. Mary Elizabeth King (2009).

For more information, contact: nonviolence@igc.org

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October 9, 2008 – Farr Honors Former Santa Cruz Mayor

WASHINGTON, D.C. – R. Scott Kennedy, former mayor of Santa Cruz and co-founder of the city’s Resource Center for Nonviolence, was presented with the 2008 El-Hibri Peace Education Prize. This prize, including a check for $10,000, is a joint effort between Nonviolence International, American University and the El-Hibri family.

Nancy El-Hibri presented Kennedy the prize honoring his service as a “peace educator and activist of extraordinary impact.” The award presentation ceremony highlighted his central role in “establishing and promoting the now cottage industry of educational delegations for peace to Central America and the Middle East.”

Congressman Sam Farr (D-Carmel), entered a congratulatory statement in the Congressional Record paying tribute to Kennedy.

“It is with great pleasure that I call attention to Dr. Scott Kennedy’s work to bring peace to the world over the course of his lifetime,” Rep. Farr wrote. “He has been a Peace Educator for 40 years and was instrumental in pioneering educational delegations to conflict zones, now a widely practiced form of peace education.”

During the October 4 award ceremony, Kennedy remarked, “Peace education in the classroom is valuable, yet needs to be complemented with pragmatic, hands-on efforts in our communities to make peace and justice a living reality.” He expressed deep appreciation for the many colleagues at the Resource Center for Nonviolence as well as the citizens of Santa Cruz for their tremendous support and inspiration.

Mr. Fuad El-Hibri, who established the El-Hibri Peace Education Prize, noted that he and the El-Hibri Charitable Foundation will continue to support the prize and its growth each year in an effort to highlight the importance of peace education, and to support people who are working for a just, peaceful and healthy planet.

Kennedy is co-founder of Witness for Peace, the Resource Center for Nonviolence and Interfaith Peacebuilders, which has sent educational around the world to countries whose people suffer from conflict, lack of educational opportunities and social injustice.

Source : : http://www.farr.house.gov/index.php?option=com_content&task=view&id=442

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Bad News Clouds Two Bio Defense Stocks

Written by Staff and Wire Reports
Tuesday, 08 December 2009 01:28

Key news developments will affect shares of these two companies who help meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons.

The two companies which waited until late after hours on Monday to announce that the Biomedical Research and Development Authority had informed them of some negative news.

After hours on Monday, PharmAthene, Inc. (NYSE Amex: PIP) a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced that the Department of Health and Human Services Biomedical Research and Development Authority (BARDA) has canceled its request for proposal (RFP) for Recombinant Protective Antigen Anthrax Vaccine for the Strategic National Stockpile (RFP BARDA 08-15).

PharmAthene was informed of BARDA’s decision during a meeting late Monday afternoon with BARDA representatives. BARDA issued a press release after the close of the securities markets announcing that it will cancel RFP BARDA 08-15 because it did not believe vaccine developers submitting proposals in response to the request for proposal (RFP) could have product ready for FDA licensure within 8 years.

In similar news…

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been advised by the Office of the Biomedical Advanced Research and Development Authority (BARDA) that the Request for Proposal (RFP) for the procurement of rPA vaccines has been cancelled in favor of a Broad Agency Announcement (BAA) for rPA vaccine development. According to BARDA officials, BARDA took this action after a technical evaluation panel determined that none of the vaccine developers submitting proposals could meet the Project BioShield statutory requirement of having a product ready for licensure within 8 years.

Simultaneously, BARDA issued an amendment to BAA 09-34 to enable companies to submit proposals to obtain development funding for rPA vaccine candidates. The due date for all proposals is February 1, 2010. During a meeting with company officials today, BARDA strongly encouraged Emergent to submit a proposal to this BAA. Emergent intends to submit its proposal by the end of this year.

While the decision by BARDA has no impact on the company’s $400 million procurement contract with the Centers for Disease Control and Prevention (CDC) for the manufacture and delivery of 14.5 million doses of BioThrax® into the Strategic National Stockpile (SNS). Investors are still likely to react negatively to the news.

After selling dies down, there may be a bounce trade opportunity for EBS followers since the company feels that “BioThrax remains a critical and long-term countermeasure for the US government,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “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.”

Source :: http://biomedreports.com/articles/most-popular/20870-bad-news-clouds-move-in-...

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Emergent BioSolutions reacts to BARDA’s Request for Proposal cancellation

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.”

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Nominations Being Accepted Now for 2010 El-Hibri Peace Education Prize

The El-Hibri Peace Education Prize is awarded yearly to an individual who is making valuable contributions to peace education and social justice in the Middle East.  The purpose of the $10,000 prize is to recognize outstanding peace educators, to provide financial support to continue peace education and study, and to promote the importance of peace education globally by affirming efforts to integrate peacemaking into curricula at all levels of education.

The prize was founded in 2007 by businessman and philanthropist Fuad El-Hibri and his wife Nancy El-Hibri in order to highlight the importance of peace education and to support people who are working for a just, peaceful and healthy planet.  El-Hibri is the CEO of Emergent BioSolutions, as well Chairman of the El-Hibri Charitable Foundation.  Past winners include Professor Abdul Aziz Said, the Mohammed Said Farsi Chair of Islamic Peace at American University; Scott Kennedy, an influential Peace Educator for 40 years; and Dr. Mary Elizabeth King a professor of peace and conflict studies at the United Nations-affiliated University for Peace.

Nominations for the 2010 prize will be accepted until June 6, 2010, with the winner announced on July 11, 2010.  The award will be presented on September 21, 2010, which is the International Day of Peace. Nominees can be individuals or organizations based in the United States making valuable contributions to the theory, practice, and teaching of peace and social justice in the Middle East.  More information about the nomination process and the prize itself can be found at http://www.elhibriprize.org .

Nominations, questions, and financial contributions may be sent to: nonviolence@igc.org

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Emergent BioSolutions Chairman and CEO Fuad El-Hibri Recognized as Outstanding International Business Leader

ROCKVILLE, Md., Mar 11, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (EBS 15.96, -0.03, -0.19%) announced today that Fuad El-Hibri, its chairman and chief executive officer, has been named by the World Trade Center Institute (WTCI) as one of Maryland’s outstanding international business leaders. Celebrating the spirit of global ambition and excellence in international leadership, WTCI presents the Maryland International Leadership Awards annually to leaders within the state who exemplify entrepreneurial spirit, innovation, and global reach.

Mr. El-Hibri stated, “Across the globe and on a daily basis, the Emergent team lives out the company mission of protecting life – a commitment to make meaningful contributions to address unmet medical needs especially in underserved markets. It is an honor to be recognized for the work that we do and to receive this award on behalf of the team.”

“Mr. El-Hibri recognizes the importance of global markets as key to future growth. WTCI is pleased to showcase Mr. El-Hibri and Emergent BioSolutions’ many achievements and is honored to name him as one of Maryland’s 2010 International Business Leadership Award winners,” said Deborah M. Kielty, president and executive director of the World Trade Center Institute.

WTCI was established in Baltimore in 1989 as a non-profit membership organization to help connect Maryland to the globe. It is the region’s premier private sector international business partner and a member of the World Trade Center Association, a family of 300 centers located in vibrant business communities around 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(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

SOURCE: Emergent BioSolutions Inc.

 

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