Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 1b/2 study (16011) of TRU-016 in combination with rituximab and bendamustine for patients with relapsed indolent non-Hodgkin’s B-cell lymphomas, including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma. TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical(TM) protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott.

“Although patients show a high rate of clinical response to first line therapies they often relapse and in many cases, develop a resistance to treatment,” said Dr. Scott Stromatt, Vice President of Clinical Research and Chief Medical Officer at Emergent BioSolutions. “Our preclinical studies show that when used together, TRU-016 and bendamustine resulted in increased anti-tumor activity beyond results achieved when either drug was administered alone. TRU-016 is also synergistic with rituximab in preclinical models. Based on these data, as well as data from our ongoing clinical studies of TRU-016 for chronic lymphocytic leukemia, we believe that TRU-016 in combination with bendamustine and rituximab could produce meaningful results in patients with indolent NHL.”

The Phase 1b portion is a dose escalation study to determine the Phase 2 dose of TRU-016 given in combination with rituximab and bendamustine. In this portion of the trial, up to 12 patients will receive two dose levels of TRU-016 in combination with rituximab and bendamustine administered intravenously. The primary safety endpoint for the Phase 1b portion of the study is the incidence of dose-limiting toxicities (DLTs).

The Phase 2 portion will be an expansion study of approximately 76 additional patients to examine the safety and efficacy of TRU-016 in combination with 375 mg/m² of rituximab and 90 mg/m² of bendamustine, versus bendamustine and rituximab. The primary efficacy endpoint for the Phase 2 portion of the study is complete response (CR) rate as determined by using the Revised Response Criteria for Malignant Lymphoma. The pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study.

The total expected enrollment for both phases of this study is expected to be 88 patients, all of whom have a confirmed diagnosis of relapsed indolent B-cell lymphoma, and who have failed prior treatments. Study enrollment is expected to be completed by the end of 2012. Additional information about this Phase 1b/2 clinical study can be found at www.clinicaltrials.gov (protocol 16011).

About non-Hodgkin’s Lymphoma (NHL)

According to the National Cancer Institute, there are approximately 65,980 cases of NHL diagnosed each year, with close to 30% of these cases resulting in death. NHL is a broad range of malignant lymphoid disorders that are categorized on the basis of aggressiveness and cell of origin. Indolent or slow-growing NHL causes few symptoms, particularly early in the natural history of the disease, making early detection difficult. The majority of patients with indolent NHL present with Stage III or IV disease. Most patients with NHL requiring treatment receive rituximab in combination with chemotherapy as initial treatment; however, many patients become refractory to both chemotherapy and rituximab.

About TRU-016

TRU-016 is a CD37-directed protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott. TRU-016 uses a different mechanism of action than currently marketed CD20-directed therapies. As a result, TRU-016 may provide patients with improved therapeutic options and enhance efficacy when used alone or in combination with chemotherapy and/or other immunotherapeutics. TRU-016 is currently in Phase 1b/2 development for chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.

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.

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 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 June 30, 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.

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.

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.

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.

“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

• 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 9^th 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”.

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 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 .

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

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