Fuad El-Hibri

...now browsing by category

 

Emergent Announces Initiation of a Phase 1b/2 Study of TRU-016 in Combination with Rituximab and Bendamustine in Subjects with Relapsed – Indolent Lymphoma

Wednesday, August 24th, 2011

ROCKVILLE, Md., Aug 17, 2011 –
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 atwww.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.

ROCKVILLE, Md., Aug 17, 2011 –

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.

Posted in Chief Medical Officer, Chief executive officer, Clinical Research, Clinical trial, Emergent BioSolutions Inc, Fuad El-Hibri | No Responses »
Tags: , , ,

Fuad El-Hibri and the Heifetz International Music Institute

Saturday, July 30th, 2011

The Heifetz International Music Institute was established by Daniel Heifetz and is based in Ellicott City, Maryland. The institute also holds a six-week long summer festival program to train young musicians,  held at Brewster Academy in New Hampshire.

The founder, violinist Daniel Heifetz, has played with many world-renowned orchestras and has taught master classes as well as university courses. As a young musician, Heifetz was mentored by legendary names such as Henryk Szyerng, Efrem Zimbalist, Jascha Brodsky, and Ivan Galamian.In 1996, Heifetz started the Heifetz Music Institute in an effort to draw in talented young musicians of violin, viola, and cello from all over the world.

The Institute is 501(c)(3) non-profit organization and can be supported through various giving opportunities.  Its daily operations are led by Daniel Heifetz, but it is also guided by an advisory board whose members include local Maryland businessman Fuad el-Hibri.

Information can be found online about the institute, including reviews of past experiences. Violinist.com featured an article about the summer festival held by the Heifetz Institute from the perspective of a talented high school musician.More information about the institute can be found on its Facebook page.

Posted in Chief executive officer, Emergent BioSolutions Inc, Fuad El-Hibri, Music | No Responses »
Tags: , , , ,

Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax

Thursday, July 7th, 2011

ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June 23rdthat the Singapore Health Sciences Authority (HSA) has approved Emergent’s product license application for the marketing and sale of BioThrax(R) (Anthrax Vaccine Adsorbed) in Singapore. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

“Emergent is pleased with this development as it continues to grow its presence in the Pacific Rim,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “With HSA approval of BioThrax, we look forward to initiating discussions with the government of Singapore, as well as other allied governments that recognize HSA registered products such as Brunei, to help protect their constituents against the threat of anthrax as a biological weapon.”

HSA is the statutory board of the Singapore Ministry of Health that administers the country’s regulatory framework for pharmaceuticals, complementary medicines, medical devices and other health products. Its vision is to be the leading innovative authority that protects and advances national health and safety in Singapore.

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 http://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 http://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.

Enhanced by Zemanta

Posted in BioThrax, Chief executive officer, Emergent BioSolutions Inc, Fuad El-Hibri, Health Care, U.S. Food and Drug Administration | No Responses »
Tags: , , , ,

Emergent BioSolutions Chairman and CEO Fuad El-Hibri Appointed to U.S. Chamber of Commerce Board of Directors

Monday, June 20th, 2011

ROCKVILLE, Md., Jun 13, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that its Chairman and Chief Executive Officer, Fuad El-Hibri, has been appointed to serve on the Board of Directors of the U.S. Chamber of Commerce. The U.S. Chamber of Commerce is the world’s largest business federation representing the interests of more than 3 million businesses of all sizes, sectors, and regions, as well as state and local chambers and industry associations.

“I am pleased with the opportunity to serve on the Board of an organization whose mission is to advance human progress through initiative and responsibility,” said Mr. El-Hibri. “I look forward to helping move the Chamber’s agenda forward and contributing to its success.”

“Throughout his career, Fuad El-Hibri has successfully identified and expanded on business opportunities that contribute to creating jobs and growing the economy,” said Thomas J. Donohue, President and CEO of the U.S. Chamber of Commerce. “Fuad is an accomplished entrepreneur and the Chamber will benefit from his vast experience in international business and partnering with the U.S. government.”

Mr. El-Hibri has been at the helm of Emergent BioSolutions since its inception in 1998. Prior to Emergent, he worked extensively in the telecommunications, banking, and consulting industries. Mr. El-Hibri is chairman of the El-Hibri Charitable Foundation and serves on several boards, including that of the International Biomedical Research Alliance and the National Health Museum.

About Emergent BioSolutions Inc.

Emergent BioSolutions 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.

SOURCE: Emergent BioSolutions Inc.

Posted in Chief executive officer, Emergent BioSolutions Inc, Fuad El-Hibri, entrepreneur | No Responses »

Emergent BioSolutions’ Investigational Anthrax Vaccine, NuThrax, Granted Fast Track Designation

Friday, June 10th, 2011

ROCKVILLE, Md., Jun 09, 2011 — Emergent BioSolutions Inc. (NYSE:EBS) announced today that its investigational anthrax vaccine, NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The vaccine candidate, also known as AV7909, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatoryoligodeoxynucleotide compound, CPG 7909, and is currently being evaluated in a Phase 1b clinical trial for safety, tolerability, and immunogenicity. The FDA’s Fast Track Development Program provides for expedited regulatory review of drugs and biologics that treat serious or life threatening diseases and that demonstrate the potential to address unmet medical needs.

“Emergent is pleased to receive Fast Track Designation for NuThrax,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “Expedited regulatory review could mean more frequent communications with FDA, priority review of Biologics License Applications (BLA) for our vaccine, and a rolling BLA submission, which allows FDA to review sections of the BLA in advance of receiving the complete submission.”

The Phase 1b trial for NuThrax 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, 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”, “may”, “would”, “will”, 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 preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the rate and degree of market acceptance 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 plans to pursue label expansions and improvements for BioThrax; 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, 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.

Posted in Chief executive officer, Emergent BioSolutions Inc, Fuad El-Hibri, NuThrax, U.S. Food and Drug Administration | No Responses »
Tags: , , , ,

Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule

Tuesday, June 7th, 2011

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.

Enhanced by Zemanta

Posted in BioThrax, Chief executive officer, Emergent BioSolutions Inc, Food and Drug Administration, Fuad El-Hibri, U.S. Food and Drug Administration | No Responses »
Tags: , , , , ,

Emergent BioSolutions to Present at Jefferies 2011 Global Healthcare Conference

Wednesday, June 1st, 2011

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.

Posted in Business, El-Hibri, Financial Performance, Fuad El-Hibri, Healthcare Conference, Investors | No Responses »
Tags: , , , , ,

Oxford-Emergent Tuberculosis Consortium Vaccinates Last Infant in Phase IIb Clinical Trial

Monday, May 2nd, 2011
  • 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.

Posted in Chief executive officer, Emergent BioSolutions Inc, Fuad El-Hibri, South Africa | No Responses »
Tags: , ,

Emergent BioSolutions Chairman and CEO Fuad El-Hibri Named Biotech CEO of the Year at the World Vaccine Congress

Friday, April 15th, 2011

ROCKVILLE, Md., Apr 12, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that Fuad El-Hibri, its chairman and chief executive officer, has been recognized as Biotech CEO of the Year during the Vaccine Industry Excellence (ViE) Awards at the World Vaccine Congress. The ViE awards showcase excellence and honor accomplishments of both individuals and companies in the global vaccine industry.

“This award is a testament to the collective efforts of the Emergent BioSolutions team, who on a daily basis and all over the world, lives out the corporate mission – to protect life,” said Mr. El-Hibri. “Our team shares a passion and commitment to make vital contributions to address unmet and underserved medical needs. It is an honor to be recognized for the work that we do.”

In selecting the winner for this category, the distinguished panel of judges evaluated the finalists based on their commitment to disease prevention and treatment, leadership, contribution to company performance, communication, and vision, industry influence, and achievements in company positioning and status.

About Emergent BioSolutions Inc.

Emergent BioSolutions 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.

Posted in Biotech, Biotechnology, Business, Chief executive officer, Emergent BioSolutions Inc, Fuad El-Hibri | No Responses »
Tags: , , , ,

Emergent BioSolutions Reports Financial Results for Full Year 2010

Wednesday, April 13th, 2011
  • 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.

Posted in Board of Directors, Business, Chief executive officer, Emergent BioSolutions Inc, Financial Results, Fuad El-Hibri | No Responses »
Tags: , , , , ,

« Older Entries
Newer Entries »