Archive for the ‘TB Vaccine’ Category
Originally posted on Gazette.net
Fuad El-Hibri has started a financial consulting business. He’s started telecommunications businesses.
But his most challenging venture has been the Rockville biotech he helped launch 14 years ago.
Still, El-Hibri — CEO and board chairman of Emergent BioSolutions — says the challenges are worth it, because the rewards are so great from protecting and saving lives.
Unlike products in many other sectors, vaccines and other bioscience products can take 10 to 15 years to develop. The regulatory climate can drive up costs. The probability of commercial success is relatively low, in the neighborhood of 20 percent.
“You need to have a strong and focused will,” said El-Hibri, 54, who is retiring as CEO as of Sunday, but remaining as executive chairman. “It takes a lot of patience and persistence.”
El-Hibri co-founded Emergent — then called BioPort Corp. — in 1998, and the company has seen annual revenues more than triple in the past eight years to almost $300 million, with a decade-long track record of financial profits. The biotech focuses on several prominent disease areas, with numerous clinical stage product development programs. Its biggest money-maker is its anthrax vaccine.
Brian Lewis/The Gazette “For us, our central mission is to protect life,” says Fuad El-Hibri, CEO of Emergent BioSolutions. “It’s been a great honor to serve the military and protect our active military.”
Emergent’s success can be attributed to El-Hibri’s vision, his ability to anticipate and overcome challenges, and his unwavering commitment that has motivated others in the company, said Daniel J. Abdun-Nabi, who is taking over as CEO after holding the president and COO posts since 2008.
“Over the years, we have come to appreciate his business acumen, drive to address global unmet medical needs and dedication to creating a workplace environment and culture that is both challenging and rewarding,” Abdun-Nabi said.
El-Hibri’s contributions extend beyond Emergent to the biotech and business communities throughout the state, said Henry Bernstein, a board member of the Tech Council of Maryland and senior vice president of Rockville real estate development and management firm Scheer Partners.
“Under his leadership, Emergent BioSolutions became a growth company that has contributed to the business community, attracted top talent to the region and invested heavily into the community overall,” said Bernstein, a former COO of the Montgomery County Department of Economic Development.
Emergent did what relatively few biotechs do — turn a profit for an entire year within four years of forming. Gaithersburg biotech giant MedImmune was founded in 1988 and took a decade to see an annual profit. After launching in 1992, Rockville life sciences company Human Genome Sciences saw net income in 1993 and 1994, but has seen only one profitable year since, in 2009.
Even during the Great Recession, Emergent continued to show a profit. A key factor was acquiring a product — BioThrax, the only federally licensed anthrax vaccine — that could generate revenue almost immediately, El-Hibri said. The federal government buys the vaccine to innoculate military personnel.
“It’s been quite a ride,” he said.
Early exposure to other countries
Born in Germany the son of a Lebanese father and German mother, El-Hibri split boyhood time in both nations. Being immersed in different nations gave him an early appreciation for various cultures, he said.
“I learned how you have to get along and respect other cultures,” El-Hibri said. “That’s an important factor to having peace and having a successful business.”
At Emergent, he carried that philosophy into defining five core corporate values: respect, empowerment, commitment, communication and innovation. Having such values is key to building a top-notch company, he said.
“For us, our central mission is to protect life,” El-Hibri said. “It’s been a great honor to serve the military and protect our active military.”
His entrepreneurial career started soon after earning a master’s in public and private management from Yale University and a bachelor’s in economics from Stanford University.
Following stints in banking with Citigroup and management consulting with Booz Allen Hamilton, the latter in southeast Asia, El-Hibri started a financial consulting business, East West Resources. Then came three mobile telecommunications companies: Mobile TeleSystems, Digitel and Digicel.
Mobile Telesystems, which he formed in 1993 and later sold, has grown to be a leading telecommunications company in Russia, with $12 billion in sales last year. The other two companies, which he also sold, are good-sized players in South America and Central America, respectively.
During the 1990s, El-Hibri got his first taste of biotechnology when he organized a management buyout of British life sciences company Porton and formed Speywood Holdings, a recapitalized biopharmaceutical company.
In 1998, El-Hibri was among a team that bought the rights to BioThrax, which was being manufactured in Michigan, and its production facilities.
“They only marketed it on a relatively small scale,” he said. “After we acquired the product, we renovated the facilities and increased capacity.”
About 170 Michigan state employees agreed to transition to the privately held business that year, El-Hibri said. BioPort later became Emergent, which went public in 2006 and now has more than 800 employees in 10 locations. Some 250 employees are in Maryland, within the Rockville headquarters, a research and development facility in Gaithersburg and a manufacturing plant in Baltimore.
The company has branched out into combating tuberculosis, cancer and autoimmune disorders. Since 2003, the company has acquired three biotech companies and completed other acquisitions to broaden its product pipeline.
Some reports, including one by a researcher with the Center for American Progress, say that Emergent lobbied hard against a former California biotech, VaxGen, which received a major federal contract to develop a new anthrax vaccine in 2004. VaxGen had never produced a drug before, and the government canceled the contract two years later.
Emergent’s lobbyists did not criticize VaxGen but simply stated what their own company could do, El-Hibri said.
“We lobbied using a positive message,” he said. “We did not criticize their product. … The government decided to cancel the contract. It was not because of us.”
Emergent also purchased the VaxGen vaccine through a fair process and is working to develop that as a secondary vaccine, El-Hibri said.
Building a better world
El-Hibri has his own charitable foundation, which promotes peace and social justice. In 2007, he started the annual El-Hibri Peace Education Prize, which recognizes educators who teach about peace issues. The organization also has constructed orphanages in Lebanon.
“I have a strong belief in giving back,” he said. “There are so many worthwhile projects and organizations.”
As a member of the U.S. Chamber of Commerce’s board of directors, El-Hibri has the opportunity to discuss national issues with business leaders across the country.
“It’s very interesting to meet business leaders across the nation and get their perspective,” he said. “As you can guess, there is no full agreement on every issue, but there is hope that the economy will turn around soon.”
El-Hibri also serves on the board of trustees of the International Biomedical Research Alliance, an academic venture between the National Institutes of Health in Bethesda, Oxford University and Cambridge University in the U.K., and the National Health Museum, a science institution planned to open in Atlanta in the near future.
He is on the advisory board for the Yale Healthcare Conference, which brings together professionals, academics and students to discuss health care issues, and the Heifetz International Music Institute in Staunton, Va., founded by acclaimed violinist Daniel Heifetz to teach young musicians.
Among the awards El-Hibri has garnered are Biotech CEO of the Year during the 2011 World Vaccine Congress; the International Leadership Award from the World Trade Center Institute in 2010; the Ernst and Young Entrepreneur of the Year Award in Greater Washington in 2009; and the Rene Moawad Foundation Distinguished Community Service and Achievement Award in 2007 for philanthropic work in Lebanon.
In choosing El-Hibri for the honor at the World Vaccine Congress last year, judges cited his “leadership and entrepreneurial spirit” in guiding Emergent to another profitable year, securing some key development contracts, completing an acquisition and arranging collaborations with Pfizer and Abbott, according to business conference organizing company Terrapinn Holdings.
Sometimes hands-on, sometimes not
El-Hibri said he can vary his management style depending on the situation.
“Some managers are new, and I roll up my sleeves and get deep in the weeds,” he said. “Other people are seasoned and don’t need as much supervision.”
His primary residence is now in Naples, Fla., where Emergent has an office. But he also maintains a home in Potomac. He and his wife, Nancy, have three children and two grandchildren.
El-Hibri doesn’t engage in the stereotypical executive hobbies such as golf. He likes to fly single-engine airplanes, scuba dive and participate in equestrian sports. He flies a Diamond Aircraft plane, and has scuba dived in Indonesia, the Red Sea and the Caribbean.
“I seem to like being either very high above sea level or below sea level,” he said with a laugh.
Posted March 29, 2012on:
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.
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.
Emergent BioSolutions Inc.
Robert G. Burrows
Vice President, Investor Relations
Vice President, Corporate Communications
Published Date : March 22, 2012