Wednesday, December 15, 2010

Emergent BioSolutions Presents Positive Data from Its TRU-016 Program at American Society of Hematology Meeting

ROCKVILLE, Md., Dec 06, 2010 (BUSINESS WIRE) –

Emergent BioSolutions Inc. (NYSE: EBS) today announced the presentation of positive data from a Phase I dose escalation study of TRU-016 (Protocol 16007) at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida. In an oral presentation given yesterday, results from the study show that TRU-016 demonstrates favorable response rates and is generally well-tolerated in patients with chronic lymphocytic leukemia (CLL). TRU-016 is Emergent’s humanized anti-CD37 small modular immunopharmaceutical (SMIP(TM)) candidate in development with Abbott for the treatment of B-cell malignancies such as CLL and non-Hodgkin’s lymphoma (NHL). Data were presented during an oral presentation by Richard R. Furman, M.D., Director of the CLL Research Center at Weill Medical College of Cornell University. A copy of the presentation is available at www.truemergent.com/tru-016.

“Despite the many different therapies available for patients with CLL, almost all patients will relapse and die of their disease,” said Dr. Furman. “Novel agents that are more effective and better tolerated are needed to help transform CLL into a truly chronic condition. Of the therapeutics currently in development, targeting CD37 with TRU-016 appears to be among the most promising. TRU-016 is a potent inducer of apoptosis and Fc dependent cellular cytotoxicity of CLL cells. TRU-016’s favorable toxicity profile and preliminary evidence of efficacy in patients warrants further evaluation in combination with other agents.”

The objective of the ongoing open label Phase I study was to establish the maximum tolerated dose, overall safety and clinical activity of TRU-016 in patients with advanced CLL and small lymphocytic leukemia (SLL). Data were presented on 57 patients who had a median of four previous therapies and a median of two prior anti-CD20 therapies. Of the 57 patients, 46% received their last treatment for CLL less than 6 months before entering the study. Genomic data were available for 53 patients, the majority of which (n=35) had high-risk genomic features for CLL, including del(17p) and/or del(11q).

Patients received one of nine intravenous doses ranging from 0.03 mg/kg to 20 mg/kg of TRU-016 once a week for a total of 4 to 12 doses (weekly cohort). A second dosing schedule evaluated treatment with 3 mg, 6 mg or 10 mg on days 1, 3 and 5 during the first week of therapy, followed by 3 to 11 weekly doses (TIW cohort). Dose escalation and de-escalation was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) toxicity grades.

Pharmacokinetic data demonstrate rapid clearance of TRU-016 in the lower dose cohorts. Accumulation was seen in the 3mg/kg TIW and 6mg/kg weekly and higher cohorts. Patients in the 3 mg/kg TIW cohort (n=8) generally maintained serum concentrations of 10 g/ml during treatment. Partial response was observed in seven patients, including two patients with the del(17p) genomic risk factor. The median reduction in absolute lymphocyte count was 73% in those patients with lymphocytosis at baseline. The responses, all partial responses, were observed in patients who had received 1 – 2 prior therapies (n=16) for an overall response rate of 44% (n=7) with a median reduction in lymphocytes of 80% in this population. No responses were observed in patients who had received prior treatment with three or more therapies (n=41), although a median reduction in lymphocytes of 54% was observed in these patients. The median reduction in lymphocytes regardless of baseline lymphocyte count or the number of prior therapies was 60%.

The most commonly reported adverse events were nausea, fatigue, diarrhea, chills, pyrexia, and neutropenia. Serious adverse events occurring in more than one patient were pneumonia, febrile neutropenia, infusion reaction, pyrexia and dyspnea. A maximum tolerated dose has not yet been reached.

Additional data on Emergent’s TRU-016 and TRU-ADhanCe(TM) programs were presented at ASH:

#3931 TRU-016, An Anti-CD37 SMIPTM Biologic, In Combination with Other Therapeutic Drugs In Models of NHL;

#3098 CD37 Is a Potential Therapeutic Target for B-Cell Non-Hodgkin Lymphoma; and

#1847 GlycoVariant Anti-CD37 Small Modular Immuno-Pharmaceutical Exhibits Superior Natural Killer Cell Mediated Cytotoxicity Against Chronic Lymphocytic Leukemia Cells at Low Concentrations and Low Antigen Density.

“Based on favorable results observed to date, Emergent and our development partner Abbott are in the process of initiating additional combination studies of TRU-016 in CLL and NHL,” said Dr. W. James Jackson, chief scientific officer at Emergent BioSolutions. “We remain hopeful that TRU-016 could play a meaningful role in improving disease outcomes and quality of life, either on its own or in combination with other therapies.”

About the Clinical Trial (Protocol 16007)

The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia (CLL), and to obtain an estimate of clinical activity in patients with CLL and non-Hodgkin’s lymphoma (NHL).

This Phase I/Ib open-label study consists of two parts. The initial portion is a Phase I dose-escalation study evaluating the safety and tolerability of TRU-016 administered over a 4-week period to patients with relapsed CLL. It will identify the maximum tolerated dose and evaluate the pharmacokinetics and immunogenicity of TRU-016. Upon demonstrating satisfactory safety and tolerability in the Phase I portion, a Phase Ib expansion cohort will be enrolled to further characterize the safety of the selected dose from the first stage of the study and to estimate the clinical activity of TRU-016 in patients with treatment-naive CLL, relapsed CLL and NHL.

About CLL

According to the Leukemia & Lymphoma Society (LLS), there are approximately 85,710 people in the U.S. living with CLL, and more than 15,000 new cases are diagnosed each year. Existing treatments for CLL have shown significant efficacy in treating indolent B-cell cancers. However, research suggests that many patients do not achieve an initial response and most eventually relapse, which suggests an acute need for differentiated treatments.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a global 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 and investigational products target infectious diseases, oncology, and autoimmune disorders. Additional information about the company 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 the success of our ongoing and planned preclinical studies and clinical trials; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; 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, 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.

SOURCE: Emergent BioSolutions Inc.

Friday, December 10, 2010

Fuad El-Hibri Recognized by Vilcek Foundation

The Vilcek Foundation was established in 2000 by Jan and Marica Vilcek, immigrants from the former Czechoslovakia. The Foundation was established with the aim of raising public awareness around immigrants’ contributions to the sciences, arts, and culture in the United States. The Foundation’s mission was inspired by the couple’s careers in science and art, as well as their personal experiences and appreciation for the opportunities given to them as newcomers to the United States. The Foundation showcases immigrant artists and performers in their New York gallery, awards the annual Vilcek Prizes, and sponsors numerous events such as the Santa Fe Opera and Hawaii International Film Festival.

In the 2010 Spring newsletter, the Vilcek Foundation recognized Fuad El-Hibri, Chairman and CEO of Emergent BioSolutions, Inc. This is a summary of their report. The original can be found here:

http://www.vilcek.org/news_articles/newsletters/2010/spring/newsletter_spring2010.html

In addition to his accomplishments in the business world, El-Hibri founded the El-Hibri Charitable Foundation in 2001 in honor of his father, Ibrahim El-Hibri. The Foundation annually awards the El-Hibri Peace Education Prize to peace educators. It also funds other programs aligned with its four part mission statement promoting Peace Education, Interfaith Dialogue, Humanitarian Aid, and Social Justice.

El-Hibri credits much of his success in the business and philanthropic world to his immigrant background. He was raised in Europe, North Africa, and the Middle East but always knew he wanted to attend college in the United States. After being accepted to Stanford that dream became a reality. After completing his undergraduate degree at Stanford he received his Master’s degree from Yale. This international background instilled in El-Hibri the desire to encourage dialogue between different cultures which in 2007 lead to the annual El-Hibri Prize for Peace Education.

“We are trying to get to the crucial goal of establishing a more evident culture of peace,” said Zen Hunter-Ishikawa, Vice President of Operations at El-Hibri Charitable Foundation. The Prize for Peace Educators awards individuals who have made major contributions to the field of peace education. Past winners of the prize include Scott Kennedy, former Mayor of Santa Cruz, California, and Abdul Aziz Said, professor at American University in Washington D.C.

“It’s taken some time to get organized,” said El-Hibri, “So it’s only been the last few years we’ve been able to focus on our programs. We hope to grow significantly over the years.”

Saturday, November 13, 2010

Fuad El-Hibri and the International Biomedical Research Alliance

The International Biomedical Research Alliance (IBRA) is a philanthropic organization that is dedicated to the support of the NIH-Oxford-Cambridge Scholars Program, which strives to establish the highest standards of excellence in training biomedical researchers, advance groundbreaking biomedical research, enrich the pool of leaders in the field, and eliminate barriers which frustrate the transfer of a broad spectrum of knowledge to the next generation of researchers.

Along with colleagues from industry, education, and government, Fuad El-Hibri is a member of the IBRA Board of Directors. The Alliance helps provide opportunities for students to build and develop important elements of scientific leadership, giving students the opportunity to grow into exceptional biomedical research leaders. IBRA firmly believes in the ability of outstanding researchers to transform today’s promise of cures and treatments into available therapies, drugs and prevention measures that enhance the world’s health.

Since its inception in 2000, the Scholars program has recruited gifted, inquiring, creative and dedicated minds for a uniquely designed doctoral program of training and investigative, exploration to challenges some of the worlds greatest minds to achieve IBRA’s main goal to create the premier PhD and MD/PhD program.

Thursday, November 4, 2010

Emergent BioSolutions Completes Acquisition of Trubion Pharmaceuticals

ROCKVILLE, Md., Oct 28, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has completed the acquisition of Trubion Pharmaceuticals, Inc., following a majority vote to approve the merger by Trubion stockholders at a special meeting conducted at Trubion’s Seattle headquarters on October 28, 2010. The acquisition provides Emergent with multiple, advanced stage candidates in the key disease areas of oncology and autoimmunity as well as access to novel and versatile protein therapeutic platforms. Trubion’s platforms have been designed to address the limitations of monoclonal antibodies and complement Emergent’s existing antibody therapeutic capabilities.

“Emergent’s acquisition of Trubion helps achieve our goal of diversifying beyond infectious diseases and marks an important step towards being a fully integrated biopharmaceutical company,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We look forward to growing our presence in the state’s vibrant biotech community building on the strengths of the Emergent Seattle team in the field of biotherapeutics.”

Emergent will maintain research facilities in Seattle, Washington and the location will become a therapeutics-focused product development site.

Saturday, October 23, 2010

Emergent BioSolutions to Release Third Quarter 2010 Financial Results and Conduct a Conference Call on November 4, 2010

ROCKVILLE, Md., Oct 13, 2010 — Emergent BioSolutions Inc. (NYSE: EBS) announced today it will report financial results for third quarter 2010 on Thursday November 4, 2010, after market close. Company management will host a conference call at 5:00 pm Eastern on November 4, 2010 to discuss the financial results for the third quarter and first nine months of 2010, recent business developments and the forecast for 2010. The conference call will be accessible by dialing 888/713-4211 or 617/213-4864 (international) and providing passcode 50859780. A webcast of the conference call will be accessible from the Company’s website at www.emergentbiosolutions.com, under “Investors”.

Emergent BioSolutions is offering call participants a pre-registration option that expedites access to the call and minimizes hold times. Pre-registrants will be issued a pin number to be used when dialing into the live call which will provide quick access to the conference call by bypassing the operator upon connection. Pre-registration, while not mandatory, can be accessed using the following website: https://www.theconferencingservice.com/prereg/key.process?key=PNP49E4W7.

A replay of the conference call will be accessible, approximately one hour following the conclusion of the call, by dialing 888/286-8010 or 617/801-6888 and using the passcode 97521313. The replay will be available through November 18. The webcast will be archived on the company’s website, www.emergentbiosolutions.com, under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO, Fuad El-Hibri, 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(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease. 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.

Tuesday, October 5, 2010

Fuad El-Hibri and The National Health Museum

The National Health Museum (NHM) is a science-based institution devoted to educating and inspiring Americans to live healthier lives. With an on site museum planned in Atlanta, and a web-based cyber museum, NHM is committed to bringing health science to life with exhibits, programs, and teaching strategies for educators. The web-based cyber museum is a global online network and digital information hub, consisting of an interactive online exhibit of cutting-edge science. Its global conference center and forum will stimulate dialogue between scientists, policy makers, and consumers concerning medical breakthroughs. Along with other leaders in business, science, public service, and medicine, Fuad El-Hibri serves on the NHM Board of Trustees.

NHM’s on-site museum, called The Experience Museum, is expected to be located at Atlanta Centennial Olympic Park. The facility will consist of self-guided multi-dimensional immersive presentations of life, health, and the human body, designed by BRC Imagination Arts. Renowned architect Moshe Safdie is designing the facility.

Monday, September 20, 2010

Emergent BioSolutions Awarded HHS Contract Valued at up to $186.6 Million to Develop rPA Anthrax Vaccine

ROCKVILLE, MD, September 17, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract, valued at up to $186.6 million, with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), for the development of a recombinant protective antigen (rPA) anthrax vaccine. This five year cost plus fixed fee development contract consists of a two-year base period of performance valued at approximately $51 million, three successive one-year option periods valued at approximately $126 million and funding for optional non-clinical studies valued at approximately $9 million.

“We applaud the U.S. Government’s commitment to the biodefense industry and to the development of additional medical countermeasures using multiple technologies and additional sites to address the acknowledged anthrax threat,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This award solidifies Emergent’s anthrax franchise and reaffirms our position as a leading supplier to, and developer for, the U.S. government of anthrax biomedical countermeasures. We are enthusiastic about the role we serve in addressing this need and in creating jobs and expanding economies within the local communities where we operate.”

Under the contract, the base value will fund activities related to process characterization and assay validation, as well as formulation and stability studies. Milestone-based options include completion of a Phase II clinical study and non-clinical efficacy studies, process validation, as well as consistency lot manufacture. Emergent has developed this comprehensive plan as a foundation to advance its rPA anthrax vaccine candidate in preparation for pivotal studies that would potentially lead to licensure application with the U.S. Food and Drug Administration.

The company anticipates recognizing revenues from this award in the fourth quarter of 2010 of approximately $2 million with no major impact on pretax earnings.

Emergent’s rPA anthrax vaccine candidate is a purified recombinant protective antigen protein formulated with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins. It is based on the pioneering work of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and has been the subject of two research and development grants totaling approximately $100 million by the National Institute of Allergy and Infectious Diseases (NIAID).

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 our ability to win a procurement contract with the U.S. government for our recombinant protective antigen anthrax vaccine candidate; 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; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; 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, 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.

Friday, September 10, 2010

Emergent BioSolutions Awarded NIAID Contract That Increases Potential Funding to Over $58 Million for Advanced Development of Third Generation Anthrax

New Contract Valued at up to $28.7 Million for Phase II Clinical Trial

ROCKVILLE, Md., Sep 01, 2010 –Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $28.7 million with the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH), for advanced development of the company’s third generation anthrax vaccine candidate. The award of this contract increases to over $58 million the total potential development funding from NIAID for this product. This product candidate, one of two third generation vaccines being developed as part of Emergent’s anthrax franchise, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909 (VaxImmuneTM).

“Emergent applauds the U.S. government’s commitment to protecting the nation against biological threats by supporting critical development of advanced vaccine and therapeutic candidates,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe our vaccine candidate addresses key criteria established by the government for a third generation anthrax vaccine. If successfully developed, we believe this product would strengthen the government’s portfolio of biodefense medical countermeasures.”

This four-year development contract consists of a two-year base, valued at $9.1 million, and milestone-based options that if exercised, would increase the total contract value to up to $28.7 million. The base contract will fund activities related to manufacturing and stability studies of Phase II clinical trial lots, process characterization and assay validation, and clinical trial preparation. The milestone-based options include continued stability testing of Phase II clinical trial lots and a clinical study to evaluate safety and immunogenicity of the product candidate. The Phase II clinical trial is anticipated to begin in the first quarter of 2012, with preliminary data expected to be available in the second half of 2012.

This new contract was awarded to expand the development efforts being conducted under a Biomedical Advanced Research and Development Authority (BARDA)/NIAID contract awarded in September 2008, which provides for funding of up to $29.7 million. Thus, with this new contract, the potential funding from the U.S. government for this third generation anthrax vaccine candidate increases to over $58 million.

About Emergent BioSolutions Inc.
Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, 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(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 .

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 the success of our ongoing and planned preclinical studies and clinical trials; our plans to pursue label expansions and improvements for BioThrax(R); the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; 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 June 30, 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.

Monday, August 30, 2010

Emergent BioSolutions Hosts Symposium for Biomedical Research Scholars

ROCKVILLE, Md., Aug 24, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today hosted “Looking Beyond the Bench,” a symposium organized for doctoral students enrolled in the NIH-Oxford-Cambridge Scholars Program. The symposium featured Emergent executives, who, based on their extensive experience in the biopharmaceutical industry, provided insight on potential career paths awaiting biomedical researchers. The speakers highlighted examples of how a scientific background would interrelate with such disciplines as Grants and Contracts, Clinical Development, Intellectual Property, and Product Development.

The NIH-Oxford-Cambridge Scholars Program (Scholars Program) was created in 2001 to revolutionize the way in which the most talented biomedical PhD and MD/PhD students are trained. Every pedagogical and logistical element of the Scholars Program was designed to produce scientists who will generate high-impact, breakthrough results at the speed at which science, government and industry must move to meet the demanding healthcare needs of a global population. The Scholars Program trains more “prestige” scholars (Rhodes, Marshall, Churchill, Gates, Howard Hughes Medical, Fulbright, and Goldwater) than any other program in the world. To date, the Scholars Program has produced 45 doctoral graduates and currently has 113 scholars enrolled.

“Emergent is pleased to welcome the future leaders in scientific research and discovery, who are already engaged in and contributing to public health improvement by exhibiting academic excellence,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions and member of the Alliance Board of Trustees. “We congratulate them for their exceptional talent, which brought them to the scholars program and which will guide them to its completion.”

“The Alliance is most grateful for Mr. El-Hibri’s private sector perspectives which have helped to shape the values, culture, goals and metrics of success of the Scholars Program,” said Ann Marie Drucker, Alliance President.

Over 35 scholars participated in the symposium and laboratory tour that was held at Emergent’s product development facility in Gaithersburg, Maryland.

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(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.

About the International Biomedical Research Alliance

The International Biomedical Research Alliance (Alliance) was created in 2005 as a private, not-for-profit (501(c)(3) providing expertise and resources to assure the NIH-Oxford-Cambridge Scholars Program’s financial viability and unwavering adherence to absolute standards of excellence, continuous innovation and dedication to accelerated discovery for generations to come. In pursuit of its mission, the Alliance provides philanthropic, scientific and industry resources dedicated to developing the NIH-Oxford-Cambridge Scholars Program into the pre-eminent biomedical training pathway for leaders in the life sciences

Monday, August 23, 2010

Colman McCarthy to Receive 2010 EL-HIBRI Peace Education Prize

August 17, 2010 — The El-Hibri Charitable Foundation announced today that prominent peace educator, nationally renowned columnist and accomplished author Colman McCarthy has been selected as the recipient of the 2010 El-Hibri Peace Education Prize. The Prize, which carries a monetary award of $15,000, is given annually by the foundation to honor an individual or organization that has made a significant contribution to the field of peace education. McCarthy’s selection was made by a committee of peace education experts chaired by Dr. Mubarak Awad, President of Nonviolence International.

“Colman McCarthy has dedicated his life to teaching young people the principles of peaceful conflict resolution,” noted Robert Buchanan, president of the El-Hibri Charitable Foundation. “His personal commitment and example, combined with his access to national media, have inspired countless individuals to incorporate the values of peace and nonviolence in their personal and professional lives. The El-Hibri Charitable Foundation is pleased to recognize Colman McCarthy for his tireless efforts on behalf of peace education.”

McCarthy was a columnist with The Washington Post from 1969 to 1997. He also wrote for The New Yorker, The Nation, and The Atlantic, among other publications, and has been a frequent guest on C-SPAN. In addition to his career in journalism, McCarthy has been teaching courses on nonviolence and peace studies for nearly thirty years at Washington, D.C. area schools, universities, and student leadership programs. In 1985, he founded and continues to lead the Center for Teaching Peace, a non-profit organization that works with schools and individuals around the world to initiate and expand academic programs in peace education.

McCarthy’s publications include “I’d Rather Teach Peace”, “All of One Peace” and “At Rest with the Animals”.He is also the editor of two anthologies of peace essays that are used as course texts in high schools and colleges: “Solutions to Violence” and “Strength Through Peace”.

The 2010 El-Hibri Peace Education Prize will be awarded to Colman McCarthy at a ceremony to be held at 6:30 p.m. on September 25th at the El-Hibri Charitable Foundation’s Washington, D.C. headquarters.

The El-Hibri Charitable Foundation is a 501(c)(3) non-profit private foundation founded in 2001 and led by Fuad El-Hibri, Chairman of the Board of Trustees.. The foundation seeks to build a better world by encouraging peace education, interfaith dialogue, humanitarian aid and social justice.The El-Hibri Peace Education Prize was initiated in 2007. Past Laureates include Abdul Aziz Said, founder of the Center for Global Peace at American University; Scott Kennedy, peace activist and co-founder of the Resource Center for Nonviolence; and Mary E. King,international educator,author and policy advisor.

For further information, visit http://www.elhibriprize.org

Thursday, August 19, 2010

Emergent BioSolutions to Acquire Trubion Pharmaceuticals

  • Trubion provides promising clinical-stage therapeutic candidates in the targeted disease areas of oncology and autoimmunity
  • Trubion offers novel, protein therapeutic platforms and scientific expertise for developing innovative therapeutic candidates
  • Transaction leverages large pharma partnerships to provide sales and marketing infrastructureidates
  • Emergent reaffirms 2010 guidance for revenues and net income

ROCKVILLE, Md., Aug 12, 2010 (BUSINESS WIRE) –

Emergent BioSolutions Inc. (NYSE: EBS) announced today it has entered into a definitive agreement to acquire Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) for upfront consideration of $96.8 million of value and up to $38.7 million of success-based milestones, resulting in a total consideration of up to $135.5 million. The acquisition will diversify Emergent’s product development pipeline with the addition of Trubion’s two clinical-stage product candidates focused on the targeted disease areas of oncology and autoimmunity. The acquisition also offers novel platforms, consisting of proprietary Small Modular Immunopharmaceutic (SMIPTM) and SCORPIONTM technologies, for developing additional innovative therapeutic candidates.
The acquisition of Trubion is expected to further Emergent’s position as a leading, fully integrated biopharmaceutical company focused on the manufacture, development and commercialization of vaccines and antibody therapeutics. Trubion’s clinical and preclinical stage programs, as well as its leading edge science, will expand Emergent’s product development pipeline and significantly broaden its antibody-based capabilities. Upon closing, the transaction is expected to provide approximately $20 million in cash, net of customary closing costs, and $70 million of net operating losses (NOLs) that are expected to be used over the next ten years.
Trubion’s development pipeline is comprised of two clinical-stage therapeutic candidates and multiple preclinical programs, including:

  • a clinical-stage CD20 directed SMIP candidate (SBI-087) for the treatment of Rheumatoid Arthritis (Phase 2) and Systemic Lupus Erythematosus (Phase 1/2) in partnership with Pfizer;
  • a clinical-stage CD37 targeted SMIP candidate (TRU-016) for the treatment of Chronic Lymphocytic Leukemia (Phase 1/2), Non-Hodgkin’s Lymphoma (Preclinical/Phase 1) in partnership with Abbott; and
  • promising preclinical candidates based on the novel, proprietary SMIP and SCORPION platforms for the treatment of selected oncology and autoimmune diseases.

Fuad El-Hibri, chairman of the board of directors and chief executive officer of Emergent BioSolutions, stated, “This acquisition strengthens Emergent’s biologics capabilities in two key aspects. First, it diversifies our product pipeline beyond infectious diseases into the two high growth areas of oncology and autoimmunity. And, second, it broadens our monoclonal antibody therapeutic capabilities. Emergent’s stable vaccine franchise, substantial capital resources, and expertise in manufacturing and product development combined with Trubion’s world-class therapeutic platform technologies and clinical-stage development programs should translate into significant value over the near and long term.”
Steven Gillis, Ph.D., executive chairman of the board of directors and acting president of Trubion, stated, “The acquisition of Trubion by Emergent should accelerate the continued development of our leading products and technologies. We believe the combination of Emergent’s strong financial position and expertise in development of biologics with Trubion’s innovative SMIP and SCORPION protein therapeutic product candidates and technologies will provide an efficient and effective development path for these promising products and technologies.”
Emergent will maintain research facilities in Seattle, Washington upon completion of the acquisition, and the location will become a therapeutics-focused product development site for the combined company. Taking this transaction into account, Emergent is reaffirming its annual 2010 forecast of $275 to $300 million in total revenues and $40 to $50 million in net income.

Terms of the Agreement

The transaction has been approved by the Boards of Directors of both companies and is subject to customary closing conditions, including the approval of the acquisition by stockholders of Trubion Pharmaceuticals and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Under the terms of the agreement, each share of Trubion Pharmaceuticals common stock will be converted into the right to receive an upfront payment of $1.365 per share in cash and 0.1641 shares of Emergent BioSolutions common stock. The upfront payment represents a value of $4.55 per share, or approximately $96.8 million, based on Trubion’s total common shares outstanding, the net value of dilutive stock options, and the trading average of Emergent BioSolutions common stock for the five days prior to the signing of the definitive agreement. In the aggregate, Emergent will issue approximately 3,350,000 shares of its common stock as part of the upfront consideration, which after the closing of the merger will represent approximately 9.2% of Emergent’s total shares outstanding. Certain of these shares will be subject to lockup provisions. Trubion Pharmaceuticals stockholders will also receive one Contingent Value Right (CVR) per share, which will entitle the holders to receive cash payments based upon achievement of five predefined Phase 2 and Phase 3 clinical study initiation milestones and one manufacturing-related milestone. The total potential aggregate value of the CVRs is $38.7 million over a 36-month period following the closing of the merger.

Details regarding the predefined milestones are as follows:

Milestone Events Applicable Payments
Initiation of the first Phase 2 clinical study for TRU-016 $1.75 million
Release of TRU-016 manufactured for use in clinical studies $10.0 million
Initiation of dosing in the first Phase 2 clinical study for a non-CD20 target $0.75 million
Initiation of the first Phase 3 clinical study in oncology indication for TRU-016 $15.0 million
Initiation of dosing in the first Phase 3 clinical study for the first major indication for CD20 candidate $6.25 million
Initiation of dosing in the first Phase 3 clinical study for the second major indication for CD20 candidate $5.0 million

The acquisition of Trubion is expected to close in the fourth quarter of 2010.

Conference Call and Webcast

Emergent hosted a conference call to discuss the acquisition of Trubion Pharmaceuticals on August 12, 2010 at 5:00 pm Eastern. A replay of the conference call is accessible by dialing 888/286-8010 or 617/801-6888 and using the passcode 48453582. The replay will be archived for an indefinite period on the company’s website, www.emergentbiosolutions.com, under “Investors”.

Advisors

Wedbush PacGrow Life Sciences is acting as financial advisor and Bingham McCutchen LLP is acting as legal advisor to Emergent BioSolutions for this transaction. MTS Health Partners, L.P. is acting as financial advisor and Fenwick & West LLP is acting as legal advisor to Trubion Pharmaceuticals.

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(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease. 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.

Additional Information and Where to Find It

This communication is being made in connection with the proposed merger (the “Merger”) among Emergent BioSolutions Inc. (”Emergent”), Trubion Pharmaceuticals, Inc. (”Trubion”) and certain of Emergent’s direct and indirect wholly-owned subsidiaries. Emergent intends to file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, which will contain a prospectus relating to the securities Emergent intends to issue in the proposed Merger. Trubion intends to file a preliminary proxy statement in connection with the proposed Merger and to mail a definitive proxy statement and other relevant documents to Trubion’s stockholders. Stockholders of Emergent and Trubion and other interested persons are advised to read, when available, the registration statement and Trubion’s preliminary proxy statement, and amendments thereto, and definitive proxy statement in connection with Trubion’s solicitation of proxies for the special meeting to be held to approve the Merger because these documents will contain important information about Trubion, Emergent and the proposed Merger. The definitive proxy statement will be mailed to stockholders as of a record date to be established for voting on the Merger. Stockholders will also be able to obtain a copy of the documents filed with the SEC, without charge, once available, at the SEC’s website at http://www.sec.gov or by directing a request to: Emergent BioSolutions Inc., Attn: Investor Relations, 2273 Research Boulevard, Suite 400, Rockville, Maryland 20850, or Trubion Pharmaceuticals, Inc., Attention: Investor Relations, 2401 4th Avenue, Suite 1050, Seattle, Washington, 98121.

Participants in Solicitation

Emergent, Trubion and their respective directors and officers may be deemed participants in the solicitation of proxies from Trubion’s stockholders. Information regarding Emergent’s directors and officers is available in Emergent’s proxy statement for its 2010 annual meeting of stockholders and its 2009 annual report on Form 10-K, which were filed with the SEC and are available at the SEC’s website at http://www.sec.gov. Information regarding Trubion’s directors and officers is available in Trubion’s proxy statement for its 2010 annual meeting of stockholders and its 2009 annual report on Form 10-K, which were filed with the SEC and are available at the SEC’s website at http://www.sec.gov. Information regarding Trubion’s directors and officers will also be contained in Trubion’s proxy statement in connection with the Merger when it becomes available. Emergent’s and Trubion’s stockholders may obtain additional information about the interests of Trubion’s directors and officers in the Merger by reading Trubion’s proxy statement when it becomes available.

Emergent BioSolutions Forward-Looking 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 and how the acquisition of Trubion will impact that strategy, the financial impact of the merger on Emergent’s 2010 forecast, the provision of expected cash and NOLs, the anticipated timing for the transaction and anticipated future operations, 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 parties’ ability to consummate the transaction; the conditions to the completion of the transaction, including the effectiveness of Emergent’s registration statement on Form S-4 or the regulatory approvals required for the transaction may not be obtained on the terms expected or on the anticipated schedule; and the parties’ ability to meet expectations regarding the timing, completion and financial and tax treatments of the merger; the possibility that the parties may be unable to achieve expected synergies and operating efficiencies in the merger within the expected time-frames or at all and to successfully integrate Trubion’s operations into those of Emergent; such integration may be more difficult, time-consuming or costly than expected; operating costs, partner loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, partners, licensors and others) may be greater than expected following the transaction; the retention of certain key employees of Trubion may be difficult; the parties are subject to intense competition and increased competition is expected in the future; the failure to protect either party’s intellectual property rights may weaken its competitive position; third parties may claim that either party’s products infringe their intellectual property rights; the rate and degree of market acceptance and clinical utility of the parties’ products; the success of ongoing and planned development programs, preclinical studies and clinical trials; the ability to identify and acquire or in license products and product candidates that satisfy Emergent’s selection criteria; the potential benefits of the parties existing collaboration agreements and the ability to enter into selective additional collaboration arrangements; the timing of and ability to obtain and maintain regulatory approvals for other product candidates; commercialization, marketing and manufacturing capabilities and strategy; and other factors identified in Emergent’s Quarterly Report on Form 10-Q for the quarter ended June 30, 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.

SOURCE: Emergent BioSolutions Inc.

Tuesday, August 3, 2010

Emergent Revises Upward 2010 Financial Forecast

Company anticipates total revenues of $275 to $300 million and net income of $40 to $50 million

ROCKVILLE, MD, July 20, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it is revising upwards its 2010 annual guidance to now reflect anticipated total revenues of $275 to $300 million and net income of $40 to $50 million. Of the anticipated total revenues of $275 to $300 million, $165 to $190 million is expected to be recognized in the second half of 2010. This revised forecast does not reflect or incorporate any revenue impact from a possible development contract for the company’s rPA vaccine candidate.

The revision to the 2010 financial forecast is supported primarily by the recent modification to the company’s current BioThrax® procurement contract with the US Centers for Disease Control and Prevention (CDC). This contract modification increased the number of doses of BioThrax that the company can deliver into the Strategic National Stockpile (SNS) during calendar 2010. This increased volume of available doses of BioThrax is due to consistently high production yields throughout 2010.

“This modification by the CDC to our existing BioThrax procurement contract reinforces, yet again, the US government’s commitment to BioThrax as a critical component of the Strategic National Stockpile and to our nation’s defense against bioterrorism,” said Fuad El-Hibri, chairman and chief executive officer of Emergent. “This is another example of how we continue to work with our US government partners in establishing BioThrax as the backbone of our readiness against the threat of anthrax and to building a stockpile as rapidly as possible.”

Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, also commented, “The production yields we have been experiencing are a direct result of our commitment to driving innovation in our manufacturing process and to a multi-year initiative focused on process optimization of the existing Building 12 production facility. We are extremely pleased with the results of our continuous process improvement program for BioThrax and expect this program to drive the maintenance of positive production metrics going forward.”

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.

About BioThrax®

BioThrax is the only 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 45 million doses of BioThrax. During that time period, more than 9.6 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.

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; 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 other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our manufacturing success rates; 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, 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.

Tuesday, July 27, 2010

Maryland Governor Martin O’Malley Leads Ribbon Cutting Ceremony at Emergent’s Baltimore Manufacturing Facility

ROCKVILLE, MD, July 16, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) today held a ribbon cutting ceremony, led by Governor Martin O’Malley and Fuad El-Hibri, Emergent’s chairman and chief executive officer, to mark the formal opening of Emergent Manufacturing Operations Baltimore. Emergent’s new facility consists of 56,000 square feet of manufacturing and office space, and includes multiple manufacturing suites designed to support clinical and commercial manufacture of the company’s rPA, anthrax monoclonal, and tuberculosis product candidates, among others.

“The Baltimore facility symbolizes Emergent’s continued investment in manufacturing as one of its core competencies and competitive advantages,” said Mr. El-Hibri. “It is also a testament to Emergent’s commitment to the State of Maryland, where we are proud to be a key contributor to economic development and job growth.”

“Maryland has a reputation of being a haven for thriving life sciences and biotechnology companies, thanks to industry leaders like Emergent BioSolutions,” said Governor O’Malley. “Emergent’s expansion into Baltimore, through the purchase and re-commissioning of this facility, enables significant investment in the biotech infrastructure already in place and ensures that high-paying, highly-skilled jobs are created and remain in Maryland.”

Emergent employs over 680 employees across the globe, with 180 employees located in Maryland, where, aside from the Baltimore manufacturing facility, its corporate headquarters and one of its product development sites are located. The opening of this new facility could create an additional 120 jobs in the next five years.

“The opening of this new biopharmaceutical facility is good news for three reasons: jobs, jobs and more jobs for Maryland,” said Senator Barbara Mikulski (MD-D). “To keep our state competitive in the global economy, we have to create and support Maryland’s jobs of the future, like the innovative life sciences jobs at Emergent BioSolutions. I’m proud that East Baltimore has been selected to house a facility dedicated to research that will keep Americans healthy and safe.”

Maryland Governor Martin O'Malley and Fuad El-Hibri

“I’m pleased to welcome Emergent BioSolutions to Baltimore,” said Congressman John Sarbanes (MD-D). “This manufacturing facility helps Maryland maintain its status as a leader in the bioscience industry and brings more than 100 high paid, high skilled jobs for Marylanders.”

“Baltimore City is excited about Emergent BioSolutions’ decision to invest here, which will create many jobs and contribute a great deal to the Baltimore biotech industry,” Baltimore Mayor Stephanie Rawlings-Blake said. “I welcome Emergent BioSolutions to Baltimore City and look forward to the company’s growth in one of Baltimore’s key industries.”

The company is currently working on modifying and re-commissioning the facility. Planned facility modifications will allow for the utilization of disposable manufacturing technology to potentially result in lower capital investments, lower operating costs, and accelerated process development timelines. The facility previously operated as a Food and Drug Administration (FDA) licensed facility used by an experienced contract manufacturing organization to produce a number of products approved by the FDA and the European Medicines Agency.

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; 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 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 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.

Thursday, July 15, 2010

Emergent BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax

ROCKVILLE, Md., Jul 14, 2010

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax(R) (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company’s large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.

“In line with Emergent’s mission of protecting life, we are proud to be working with HHS to scale-up manufacturing of BioThrax, the only vaccine licensed by the Food and Drug Administration (FDA) for the prevention of anthrax infection,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We applaud HHS for its unwavering commitment to strengthen the country’s biodefense infrastructure and to protect our military and civilian populations.”

This cost plus fixed fee development contract has a total value of $107 million and consists of a two-year base period of performance valued at $54.6 million and three option years that, if exercised by BARDA, would increase the contract value to up to $107 million. Under the contract, the company anticipates recognizing revenues of up to $10 million and pretax earnings of up to $5 million during the second half of 2010. A substantial majority of the value of the $107 million contract will be realized in the first three years of performance (July 2010 to July 2013), assuming exercise of the first option year.

The contract award is based on a technical proposal provided to BARDA that projects an annual large-scale manufacturing capacity of 26 million doses in Building 55. This is a significant increase from the company’s current capacity of approximately 7-8 million doses per annum.

The company has developed a comprehensive plan to demonstrate comparability between the current manufacturing process and the large-scale manufacturing process for BioThrax. The contract will fund activities related to process validation, assay validation, fill/finish, and if required, non-clinical and clinical studies. The plan also includes regulatory activities in support of the submission to FDA of a supplemental Biologics License Application (sBLA) for BioThrax at the expanded scale. The company expects to begin manufacturing consistency lots as early as the fourth quarter of 2011.

Emergent has invested significant resources in Building 55, which has been designed to manufacture up to 25 to 30 million doses of BioThrax as currently configured, and is expandable by adding a second manufacturing train that would double annual capacity, based on demand. This is aligned with the company’s core strategy to enhance its manufacturing capabilities to meet the increasing government demand for anthrax vaccines for inclusion in the SNS.

The company also continues to enhance the attractiveness of BioThrax as a significant component of the SNS, most recently through FDA approval of extended shelf life to four years. In addition, based on data from a seven-year study by the Centers for Disease Control and Prevention, the company has submitted to FDA an sBLA to further reduce the BioThrax vaccination schedule to three doses within six months with triennial booster vaccinations. To date, Emergent has supplied over 42 million doses of BioThrax to the U.S. government with additional deliveries scheduled through the third quarter of 2011 pursuant to the current procurement contract with HHS.

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(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.

About BioThrax

BioThrax is the only 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 9.6 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.

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(R) procurement; our ability to obtain new BioThrax(R) sales contracts; our plans to pursue label expansions and improvements for BioThrax(R); 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; 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 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 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.

Wednesday, July 14, 2010

The El-Hibri Foundation Launches Website

Fuad El-Hibri awards the 2009 Peace Education award


The El-Hibri Foundation is a nonprofit organization with the goal of fostering dialogue between various religions and encouraging nonviolent solutions to global challenges affecting humankind. The Foundation has a new website at www.elhibrifoundation.org.

The Foundation, lead by Chairman of the Board of Trustees Fuad El-HIbri, is divided into four different initiatives: The Peace Education Initiative, The Interfaith Dialogue Initiative, The Humanitarian Aid Initiative, and The Social Justice Initiative.

The Peace Education Initiative focuses on conflict resolution, embracing cultural diversity, and supporting cross-cultural approaches to peace-building. The Interfaith Dialogue Initiative focuses on supporting understanding between the three Abrahamic faiths: Islam, Judaism and Christianity. The Humanitarian Aid Initiative provides grants to organizations that aim at delivering education and medical care to the disadvantaged. The last of the four initiatives is the Social Justice Initiative. The Social Justice Initiative addresses issues of equality, justice and human rights, especially for women and children.

The El-Hibri Foundation promotes these four initiatives through the provision of grants. Since its creation in 2001, the Foundation has given away 36 grants totaling over 8.2 million dollars.

For more information on the El-Hibri Foundation visit their website: www.elhibrifoundation.org

Tuesday, July 13, 2010

Emergent BioSolutions Hosts Biopreparedness Roundtable for NATO Parliamentarians

ROCKVILLE, Md., Jul 12, 2010 (BUSINESS WIRE) –

Emergent BioSolutions Inc. (NYSE:EBS) is hosting “Bioterrorism Prevention, Preparedness and Response,” a forum organized for members of the North Atlantic Treaty Organization (NATO) Parliamentary Assembly (PA) to raise global awareness of the importance of biopreparedness. The visiting delegation is composed of parliamentarians from Canada, Estonia, France, Finland, Germany, Greece, Italy, Hungary, Lithuania, the Netherlands, Norway, Romania, Poland, Portugal, Turkey, Sweden, Slovenia, Spain, and the United Kingdom.

“Emergent commends NATO parliamentarians for advancing the international dialogue on biopreparedness,” said Allen Shofe, senior vice president public affairs, Emergent BioSolutions. “We are pleased to share our knowledge based on Emergent’s extensive experience in the development, manufacture, and delivery of medical countermeasures that are critical to the U.S. government’s biodefense infrastructure.”

The forum features biodefense expert Dr. Robert Kadlec, Director of PRTM Biodefense and Public Health Practice, who will discuss the United States’ approach to bioterrorism prevention, including best practices and strategies such as funding, development, and manufacture of biodefense medical countermeasures, creation of strategic stockpiles, and cooperation within the international community.

Emergent BioSolutions’ senior management team, headed by Daniel J. Abdun-Nabi, President and Chief Operating Officer, Dr. Tevi Troy, Senior Visiting Fellow at the Hudson Institute and former Deputy Director of the U.S. Department of Health and Human Services, and Dr. Barry Kellman, President of the International Security and Biopolicy Institute (ISBI) are among the attendees. The forum is taking place in Washington, D.C.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, 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(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.

About the NATO Parliamentary Assembly

The NATO Parliamentary Assembly is the inter-parliamentary organization of legislators from the member countries of the North Atlantic Alliance as well as 14 associate members. The Assembly provides a critical forum for international parliamentary dialogue on an array of security, political and economic matters. For more information, visit www.nato-pa.int.

Wednesday, July 7, 2010

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.

Monday, June 7, 2010

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”.

Thursday, June 3, 2010

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

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

Tuesday, May 18, 2010

Emergent BioSolutions Recognized as Biotechnology Firm of the Year by Tech Council of Maryland

ROCKVILLE, MD, May 13, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been named Biotechnology Firm of the Year at the Tech Council of Maryland’s (TCM) Annual Tech Awards. This award acknowledges the company that best exemplifies the spirit of Maryland’s biotechnology community as well as its presence and leadership within the state.

“It is an honor to represent Emergent BioSolutions, a company composed of talented and hardworking individuals committed to the corporate mission of protecting life,” said Fuad El-Hibri, chairman and chief executive officer, who received the award on behalf of the company.

For 22 years, TCM has recognized companies that have helped establish Maryland’s thriving technology community. This year’s theme “Building Something Great Together” focuses on the tremendous growth and future outlook for the technology community.

“The theme, ‘Building Something Great Together,’ is meaningful because Emergent’s success is built on teamwork and collaboration,” Mr. El-Hibri continued. “It also acknowledges the role that businesses play in contributing to the State’s economic and job growth. Emergent is proud to be amongst the technology and life sciences companies that have chosen Maryland as its home.”


Fuad El-Hibri Accepts the 2010 Tech Council of Maryland Biotechnology Firm of the Year Award

The criteria for the Biotechnology Firm of the Year Award include: achieving significant and measurable success, contributing to the advancement of biosciences through cutting-edge research and development, crisply executing a growth strategy, and helping foster a vibrant biotech community.

TCM is the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. TCM’s mission is to advocate for the interests of the technology community, further the role of technology in the Maryland economy, and nurture an environment where technology companies can collaborate, grow and succeed.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody 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 disease. 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

Tuesday, May 11, 2010

Emergent BioSolutions Hosts Biopreparedness Forum for Members of the NATO Parliamentary Assembly

Emergent BioSolutions' senior management team, headed by Fuad El-Hibri, chairman and chief executive officer and Daniel J. Abdun-Nabi, president and chief operating officer, are hosting "Bioterrorism Prevention, Preparedness and Response," a forum uniquely organized for members of the North Atlantic Treaty Organization (NATO) Parliamentary Assembly (PA). The one-day event is an interactive discussion related to biopreparedness strategies and best practices such as funding, development, and manufacture of biodefense medical countermeasures, creation of strategic stockpiles, and cooperation within the international community.


"Strengthening the Biological Weapons Convention and international cooperation in biodefense are of paramount importance. This forum organized by Emergent is extremely valuable in helping us, as national legislators, to obtain more information on biopreparedness and to promote the idea of strengthening national biodefense capabilities using the best practices and expertise developed by our Allies," said Canadian Senator Pierre Claude Nolin, NATO PA Treasurer and Vice Chairman of the NATO PA Science and Technology Committee. "We are firm believers in international mechanisms to address bioterrorism challenges."


The forum is to provide an overview of the United States' approach to bioterrorism prevention, the role of the Department of Defense and the importance of coordination of international efforts. Featured speakers include: Congressman Mike Rogers (R-MI), Dr. Robert P. Kadlec, Director of PRTM Biodefense and Public Health Practice, Jim Saxton, former Member of the U.S. House of Representatives, and Dr. Tevi Troy, Senior Visiting Fellow at the Hudson Institute and former Deputy Director of the U.S. Department of Health and Human Services. The visiting delegation, led by NATO Officers of the Science and Technology Committee, is composed of parliamentarians from representative NATO nations including Canada, the Czech Republic, France, and Portugal. The forum is taking place in Washington, D.C.