El-Hibri Fuad Blog

Posts Tagged ‘Tuberculosis

ROCKVILLE, Md.–(BUSINESS WIRE)–Mar. 22, 2012– Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has received a multi-year grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to advance the development of MVA85A, a candidate vaccine against tuberculosis (TB). The vaccine is being developed through a partnership between Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC), a joint venture between Emergent and the University of Oxford, where the vaccine was originally developed and investigated.

MVA85A is now completing a Phase 2b clinical trial sponsored by Aeras to evaluate the safety and efficacy of the vaccine in over 2,700 infants in South Africa. Results from this trial, which has received continued funding from Aeras and the Wellcome Trust, are anticipated later this year. MVA85A is also currently being studied in a second Phase 2b clinical trial, with primary funding and support from the European and Developing Countries Clinical Trials Partnership and Aeras, which will enroll approximately 1,400 adults living with the human immunodeficiency virus (HIV) in Senegal and South Africa.

“Emergent is honored to gain NIAID support, expanding the current government and non-government partners that are joining forces to advance this vaccine candidate. We all share a vision to declare victory in the global fight against tuberculosis and Emergent is proud to be at the forefront with such distinguished organizations,” said Daniel J. Abdun-Nabi, President and Chief Operating Officer of Emergent BioSolutions. “With efficacy data expected in the coming months, we are hopeful that MVA85A will have a significant impact on the global burden of this highly contagious and lethal disease.”

According to the World Health Organization, approximately 1.5 million people die from tuberculosis annually, and more than two billion people are infected with TB – an estimated one out of every three people on the planet. It is the second leading cause of death from infectious disease worldwide. The limited efficacy against pulmonary TB of the only available licensed TB vaccine, BacilleCalmette-Guerin (BCG), and the rise of multi-drug and extensively-drug resistant TB cases, demonstrate the need for improved control measures against TB.

“We join the rest of the world in observing World TB Day on March 24, commemorating the discovery of the cause of the disease, the TB bacillus, that paved the way for the development of TB treatments, diagnostics, and vaccines,” said Dr. Jacqui Shea, General Manager of OETC. “Through much appreciated and essential grant funding, product development partnerships are making significant steps forward to stop TB. With continued support and collaboration, we hope to achieve our shared goal of a world free of TB within our lifetime.”

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 MVA85A

The MVA85A vaccine candidate is intended to boost the response of T-cells already stimulated by the BCG vaccine. The vaccine candidate was originally developed at the University of Oxford by Professor Helen McShane, a professor of vaccinology and Wellcome Trust Senior Fellow, working with Dr. Sarah Gilbert, a Reader in Vaccinology, and Professor Adrian Hill, a Wellcome Trust Principal Research Fellow. It was licensed to theOxford-Emergent Tuberculosis Consortium by Isis Innovation, the University’s technology transfer company, inJuly 2008. Previous clinical trials of the vaccine in adults – supported by the Wellcome Trust – in the United Kingdom, the Gambia, Senegal and South Africa have demonstrated consistently high cellular immune responses in those who received the MVA85A vaccine candidate following vaccination with BCG. To date, the vaccine has been shown to have an acceptable safety profile. The vaccine has been awarded orphan drug status by theEuropean Medicines Agency (EMA) and is the most clinically advanced of a new generation of tuberculosis vaccine candidates.

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, 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 additional 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 on Form 10-K for the year ended December 31, 2011 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.

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Published Date : March 22, 2012

ROCKVILLE, Md., Mar 24, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today released the following statement in observance of  World TB Day.

The World TB Day 2011 campaign, “On the move against TB: Transforming the fight towards elimination,” challenges us to undertake the fight against TB with the end goal of eliminating this highly infectious and lethal disease. Two billion people or one-third of the world’s population is infected with TB bacilli, the microbes that cause TB. The World Health Organization estimates that there are over 9 million new TB cases and 1.7 million deaths from TB annually.

“One of the barriers identified towards eliminating TB is the lack of a fully effective vaccine in the market,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “As a collaborator in the  Oxford-Emergent Tuberculosis Consortium (OETC), Emergent’s joint venture with the University of Oxford, to develop what could be the first new TB vaccine in 90 years, we are pleased to be working toward a solution to address this global health emergency.”

A Phase IIb clinical trial involving 2,784 infants is currently underway in Worcester, South Africa to evaluate the efficacy of  MVA85A, the world’s most clinically advanced tuberculosis vaccine in development. The trial entails administering MVA85A as a booster to the BCG vaccine and is being conducted by the University of Cape Town’s South African Tuberculosis Vaccine Initiative, in partnership with OETC and  Aeras Global TB Foundation.

On World TB Day and beyond, Emergent hopes to raise public awareness of TB and the importance of new vaccines to help curtail the global health problem of tuberculosis. For more information, visit www.emergentbiosolutions.com/tbvaccine and view “OETC: Endeavor to End Tuberculosis,” a video that focuses on the efforts of OETC to further develop MVA85A.

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.

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, 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 additional 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.

Comments expressed during tour of South African clinical trial site where Emergent’s TB vaccine candidate is expected to complete enrollment in April for its Phase IIb efficacy study

ROCKVILLE, Md., Feb 25, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced that a joint delegation of Members of the European Parliament (MEPs) and representatives from the Oxford-Emergent Tuberculosis Consortium (OETC) today visited the trial site where MVA85A, the world’s most clinically advanced tuberculosis (TB) vaccine candidate in development, is being studied in a Phase IIb infant efficacy clinical trial. 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 OETC and Aeras.

“I am very anxious to see a new TB vaccine licensed and I am delighted that this trial of this promising new vaccine candidate is taking place,” said MEP Michael Cashman, Chairman of the South Africa Delegation of the European Parliament. “It is vital for South Africa that a new vaccine is developed as soon as possible, especially for infants and those with HIV. If this trial is successful, South Africa will benefit and so will the rest of the world. Too many lives are lost to tuberculosis and I am pleased to see so many public and private bodies coming together to deliver what could be the first new TB vaccine in 90 years.”

Emergent BioSolutions is proud to be part of OETC, a joint venture established with the University of Oxford in 2008, to further develop the most clinically advanced investigational TB vaccine,” said Allen Shofe, OETC Board Member and Senior Vice President Corporate Affairs of Emergent BioSolutions. “This collaboration is an integral part of a multi-pronged approach to alleviating the global burden of tuberculosis. Through our involvement in OETC, Emergent is given an opportunity to touch the lives of many in fulfillment of our company mission – to protect life.”

The MEPs learned firsthand about the TB vaccine candidate and progress of the clinical trial from lead scientist and developer Dr. Helen McShane from the University of Oxford. “We are extremely pleased with the progress of the trial,” said Dr. McShane. “We anticipate that the trial, which involves administering MVA85A as a booster to the BCG vaccine, will reach the enrollment target of 2,784 infants by the end of April 2011. The follow-up period and study results are expected to be completed in 2012.”

The delegation also observed the vaccination of infants as part of the trial and visited the hospital facilities with Dr. Hassan Mahomed, SATVI’s Principal Investigator on the study.

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, 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 additional 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 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.