Fuad El-Hibri Network

ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that eight lots of BioThrax^(R) (Anthrax Vaccine Adsorbed) have received regulatory release for delivery to the U.S. government under the company’s contract (200-2009-30162) originally written to supply 14.5 million doses of BioThrax to the Strategic National Stockpile. This marks the largest single-week regulatory release of product for delivery in the company’s history. The company expects to complete delivery of the 14.5 million doses as early as June, approximately three months ahead of the schedule originally set forth in the contract. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

“Emergent is pleased with its progress towards early completion of its original procurement contract to supply 14.5 million doses of BioThrax,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “Upon completion of this delivery, anticipated to occur as early as June, the company will focus on delivering the additional 3.42 million doses under the modified procurement contract. With the recent request for proposal issued by the U.S. government, Emergent is also advancing discussions to supply 44.75 million doses of BioThrax over the next five years.”

About Emergent BioSolutions Inc.

Emergent BioSolutions.led by Chairman and CEO Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating 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.

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. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 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 2011, 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 or modifications to existing 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 of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 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.

ROCKVILLE, Md., May 25, 2011 — Emergent BioSolutions Inc. (NYSE: EBS) announced today that the company will be webcasting its presentation at the Jefferies 2011 Global Healthcare Conference in New York on Tuesday, June 7, 2011 at 1:15 PM Eastern. During the presentation, a member of the company’s senior management team will provide a corporate overview, which may include a discussion of the company’s business activities and financial performance.

A webcast of this presentation will be available both live and by replay, accessible from the Emergent website www.emergentbiosolutions.com under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating 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.

SOURCE: Emergent BioSolutions Inc.

ROCKVILLE, Md., May 05, 2011 (BUSINESS WIRE) — Emergent BioSolutionsInc. (NYSE: EBS) announced  its financial results for the first quarter ended March 31, 2011.

For 1Q 2011, total revenues were $18.5 million as compared to $46.8 million in 2010. In addition, for 1Q 2011 the company recorded a net loss of $21.4 million, or $0.61 per basic share, as compared to net income of $2.5 million, or $0.08 per basic share, in 2010.

R. Don Elsey, chief financial officer of Emergent BioSolutions, stated, “While our first quarter revenues were slightly lower than expected, we remain on track to achieve our full year guidance of total revenues of $320 to $340 million and net income of $35 to $45 million.”

1Q 2011 Key Financial Results

Product Sales

For 1Q 2011, product sales were $5.6 million, a decrease of $33.3 million, or 86 percent, from $38.9 million for 1Q 2010. This decrease was primarily due to an 88 percent decrease in the number of doses of BioThrax delivered. During the first quarter, the company redeployed its potency testing capacity from BioThrax release testing to qualification of replacement reference standards and other development testing. This process, which is required to enable continued future release of BioThrax doses, has now been substantially completed. Product sales revenues for 1Q 2011 consisted of BioThrax sales to CDC of $5.0 million and aggregate international and other sales of $0.6 million.

Contracts and Grants Revenues

For 1Q 2011, contracts and grants revenues were $12.9 million, an increase of $5.0 million, or 63 percent, from $7.9 million for 1Q 2010. The increase was primarily due to revenues from the recently awarded contract from BARDA for large-scale manufacturing for BioThrax, collaborations with Abbott and Pfizer, along with increased activity and associated revenue from development contracts with BARDA and NIAID.

Cost of Product Sales

For 1Q 2011, cost of product sales was $1.1 million, a decrease of $6.4 million, or 86 percent, from $7.5 million for 1Q 2010. This decrease was primarily attributable to the 88 percent decrease in the number of BioThrax doses sold.

Research and Development

For 1Q 2011, research and development expenses were $34.8 million, an increase of $14.8 million, or 74 percent, from $19.9 million for 1Q 2010. This increase primarily reflects higher contract service and personnel costs, and includes increased expenses of $13.9 million on product candidates and technology platform development activities associated with the BioSciences segment and increased expenses of $0.9 million on product candidates associated with the BioDefense segment. Net of development contracts and grants reimbursement revenue along with the net loss attributable to noncontrolling interests, research and development expenses were $20.0 million for 1Q 2011.

Selling, General and Administrative

For 1Q 2011, selling, general and administrative expenses were $18.2 million, an increase of $2.0 million, or 12 percent, from $16.2 million for 1Q 2010. This increase is primarily due to increased personnel-related expenses and professional services to support the business. Selling, general and administrative expenses for 1Q 2011 consisted of $14.0 million associated with the BioDefense segment and $4.2 million associated with the BioSciences segment.

Financial Condition and Liquidity

Cash and cash equivalents combined with investments at March 31, 2011 was $143.3 million compared to $171.0 million at December 31, 2010. Additionally, at March 31, 2011, the accounts receivable balance was $12.0 million, which is comprised primarily of unpaid amounts under our NIAID and BARDA development contracts.

2Q 2011 Revenue Forecast

For the second quarter of 2011, the company anticipates total revenues of $80 to $90 million.

2011 Forecast

For full year 2011, the company is reaffirming its financial forecast of total revenues of $320 to $340 million and net income of $35 to $45 million.

2011 total revenue is expected to be driven by, among other things:

• the continuation of deliveries of BioThrax under the current multi-year procurement contract with CDC, which was recently modified to increase the total contracted doses to 17.9 million;
• additional deliveries of BioThrax under a follow-on, multi-year procurement contract with CDC, anticipated to begin in 4Q 2011;
• a significant increase in contracts and grants revenue based primarily on development contracts related to product development programs in the company’s BioDefense segment; and
• collaboration and milestone revenues associated with achievement of clinical development milestones related to the company’s oncology product candidate, which is under an existing co-development agreement with Abbott, and the company’s autoimmune product candidate, which is being developed by Pfizer under a license agreement from the company.

Conference Call and Webcast

Company management hosted a conference call at 5:00 pm Eastern on May 5, 2011 to discuss the financial results for the first quarter of 2011, recent business developments, revenue guidance for the second quarter of 2011 and revenue and net income guidance for the full year 2011.

A replay of the conference call will be accessible by dialing 888/286-8010 or 617/801-6888 and using the passcode 12159691. The replay will be available through May 19, 2011. The webcast will be archived on the company’s website, www.emergentbiosolutions.com, under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO, Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. 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 estimates of preliminary results for 2010, and our expected revenue growth and net earnings for 2011, 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 or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax^(R); our ability to perform under our current development contracts with the U.S. government; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products and product candidates; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the potential benefits of our existing collaborations and our ability to selectively enter into additional collaborative arrangements; ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company’s Annual Report on Form 10-K for the year ended December 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.

• Total of 2,784 infants vaccinated in TB efficacy trial evaluating MVA85A
• Study results expected to be available as early as mid-2012

ROCKVILLE, Md., Apr 28, 2011

Emergent BioSolutions Inc. (NYSE:EBS) announced today that its joint venture with the University of Oxford (Oxford), the Oxford-Emergent Tuberculosis Consortium (OETC), has vaccinated the last of the 2,784 infants in its Phase IIb efficacy trial evaluating MVA85A, the world’s most clinically advanced tuberculosis (TB) vaccine in development. This clinical trial in Worcester, South Africa, is being conducted by the University of Cape Town’s South African Tuberculosis Vaccine Initiative (SATVI), in partnership with Aeras, the clinical sponsor of the study, and the Wellcome Trust.

“Emergent BioSolutions joined the fight against TB when it formed OETC with Oxford to further develop MVA85A,” said Daniel J. Abdun-Nabi, Chairman of the Board, OETC and President and Chief Operating Officer, Emergent BioSolutions. “We are pleased to complete the vaccination of our targeted 2,784 infants, which is the largest number of infants enrolled in any TB vaccine clinical trial. Our quest to fulfill Emergent’s corporate mission – to protect life – will come to fruition when we can bring this vaccine candidate to market and ultimately make an impact in patients’ lives.”

“We are extremely proud of this achievement and are eager to see the study results, which are expected to be available as early as mid-2012,” said Dr. Helen McShane, lead scientist and developer of MVA85A from the University of Oxford. “This milestone brings us a step closer to potentially having a new TB vaccine, from which millions of people around the world would benefit.”

This Phase IIb clinical trial was initiated in July 2009 and involves a two-year follow up on the infants vaccinated as part of the trial to evaluate whether the vaccine candidate has conferred protection against TB.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman &CEO, Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating 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 strategy, future operations, future financial position, future revenues, projected costs, future product development, prospects, plans and objectives of management, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the actual results of the Consortium or Emergent to differ materially from those indicated by such forward-looking statements, including the timing of, and the potential for successful outcomes resulting from, future product development efforts; the ability of the Consortium or Emergent to obtain funding for product development efforts; plans of the Consortium and Emergent to expand manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of products; and other factors identified in Emergent’s Annual Report for the year ended December 31, 2010 and subsequent reports filed with the SEC. The Consortium and Emergent disclaim 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.

• 2010 revenues of $286.2 million
• 2010 net income of $51.7 million, or $1.63 per share, representing ninth consecutive year of profitability
• 2010 cash, investments and accounts receivable balance of $210.4 million
• 2011 forecast reaffirmed: total revenues of $320 to $340 million and net income of $35 to $45 million

Emergent BioSolutions Inc. (NYSE: EBS) announced on 10 March its financial results for the full year ending December 31, 2010.

Total revenues for 2010 were $286.2 million as compared to $234.8 million in 2009, and net income was $51.7 million, or $1.63 per basic share, as compared to $31.1 million, or $1.02 per basic share, in 2009.

For the fourth quarter 2010, total revenues were $103.2 million as compared to $53.8 million in 2009, and net income was $26.2 million, or $0.78 per basic share, as compared to $4.2 million, or $0.14 per basic share, in 2009.

R. Don Elsey, chief financial officer of Emergent BioSolutions, stated, "Our 2010 financial performance reflects our continued success in growing revenue from the sale of BioThrax(R) and government development contracts, as well as from development collaborations with our large pharma partners. We achieved this revenue growth while closely managing our overall expenditures even as we continued to advance our pipeline of vaccines and therapeutics targeting key disease areas. We expect to continue our growth in 2011, as evidenced by our reaffirmed 2011 forecast of total revenues of $320 to $340 million and net income of $35 to $45 million."

2010 Key Operational Accomplishments

• Acquired Trubion Pharmaceuticals, Inc. for a total consideration of up to $131.6 million, including $92.9 million in upfront cash and stock and up to $38.7 million of success-based milestones, payable between October 2010 and October 2013;
• Secured a BARDA development contract, valued at up to $107.0 million, to fund qualification, validation and licensure of Building 55 in order to manufacture BioThrax(R) (Anthrax Vaccine Adsorbed) at large-scale;
• Secured a BARDA development contract, valued at up to $186.6 million, to fund development of our rPA vaccine candidate PreviThraxTM (Recombinant Protective Antigen Anthrax Vaccine, Purified);
• Secured a NIAID development contract, valued at up to $28.7 million, to fund further development of NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), the second contract award for this vaccine candidate;
• Launched Singapore operations and formed EPIC Bio, Pte. Ltd., a joint venture with Temasek Life Sciences Ventures Pte. Ltd., to develop, manufacture, and commercialize pre-pandemic influenza vaccines and therapeutics;
• Obtained Fast Track designation and Orphan Drug status from FDA for ThravixaTM (Fully Human Anthrax Monoclonal Antibody);
• Initiated a Phase 1 clinical study for Thravixa;
• Initiated a Phase 1 clinical study for NuThrax; and

Expanded the Board of Directors with the appointment of John E. Niederhuber, M.D., former Director, The National Cancer Institute (NCI), and Marvin White, Chief Financial Officer, St. Vincent Health and former Chief Financial Officer, LillyUSA.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEOFuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information may be found at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.emergentbiosolutions.com&esheet=6643305&lan=en-US&anchor=www.emergentbiosolutions.com&index=3&md5=974c9d419f86092b960b6d8622d54f18.

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 estimates of preliminary results for 2010, and our expected revenue growth and net earnings for 2011, 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 or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax(R); our ability to perform under our current development contracts with the U.S. government; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products and product candidates; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the potential benefits of our existing collaborations and our ability to selectively enter into additional collaborative arrangements; 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 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.

Emergent BioSolutions Inc. (NYSE: EBS) will be webcasting its presentation at the 10^th Annual Needham & Company Healthcare Conference in New York on Tuesday, April 5, 2011 at 8:00 AM Eastern. During the presentation, a member of the company’s senior management team will provide a corporate overview, which may include a discussion of recent business developments, 2010 financial results and financial guidance for 2011.

A webcast of this presentation will be available both live and by replay, accessible from the Emergent website www.emergentbiosolutions.com under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO, Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating 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.

ROCKVILLE, Md., Feb 24, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today it will report financial results for the fourth quarter and full year 2010 on Thursday, March 10, 2011, after market close.

Company management will host a conference call at 5:00 pm Eastern on March 10, 2011 to discuss the financial results for the fourth quarter and full twelve months of 2010, recent business developments and the forecast for 2011. The conference call will be accessible by dialing 888/713-4205 or 617/213-4862 (international) and providing passcode 91804244. 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: www.theconferencingservice.com/prereg/key.process?key=PWXFXF88Y.

A replay of the conference call will be accessible, approximately two hours following the conclusion of the call, by dialing 888/286-8010 or 617/801-6888 and using the passcode 77289976. The replay will be available through March 24, 2011. The webcast will be archived on the company’s website, www.emergentbiosolutions.com, under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating 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.

SOURCE: Emergent BioSolutions Inc.

ROCKVILLE, Md., Dec 27, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase I clinical trial for NuThrax^TM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. The product candidate, a third generation vaccine 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.

“Emergent is pleased to commence this clinical trial in support of the U.S. government’s multiple product strategy to strengthen the nation’s biodefense capabilities,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe this third generation anthrax vaccine has the potential to exhibit advanced characteristics such as requiring fewer doses, generating an enhanced immune response, and having a favorable shelf life. If successful, this could be an attractive candidate for the government’s growing arsenal of medical countermeasures.”

The Phase I clinical trial, a parallel arm dose-ranging study, is designed to evaluate the safety, tolerability, and immunogenicity of the vaccine candidate. The study is being conducted in multiple sites within the U.S. and involves 105 healthy volunteers. Preliminary data from this study is expected to be available in the third quarter of 2011.

This Phase I trial is being conducted with support from a development contract that is jointly administered under contract number HHSN272200800051C by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), and the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).

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; 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 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.

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 52^nd 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 SMIP^TM 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

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SOURCE: Emergent BioSolutions Inc.

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.