Archive for the ‘Health Care’ 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 July 7, 2011on:
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.
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.
The Vilcek Foundation was established in 2000 by Jan and Marica Vilcek, immigrants from the former Czechoslovakia. The Foundation was established with the aim of raising public awareness around immigrants’ contributions to the sciences, arts, and culture in the United States. The Foundation’s mission was inspired by the couple’s careers in science and art, as well as their personal experiences and appreciation for the opportunities given to them as newcomers to the United States. The Foundation showcases immigrant artists and performers in their New York gallery, awards the annual Vilcek Prizes, and sponsors numerous events such as the Santa Fe Opera and Hawaii International Film Festival.
In the 2010 Spring newsletter, the Vilcek Foundation recognized Fuad El-Hibri, Chairman and CEO of Emergent BioSolutions, Inc. This is a summary of their report. The original can be found here:
In addition to his accomplishments in the business world, El-Hibri founded the El-Hibri Charitable Foundation in 2001 in honor of his father, Ibrahim El-Hibri. The Foundation annually awards the El-Hibri Peace Education Prize to peace educators. It also funds other programs aligned with its four part mission statement promoting Peace Education, Interfaith Dialogue, Humanitarian Aid, and Social Justice.
El-Hibri credits much of his success in the business and philanthropic world to his immigrant background. He was raised in Europe, North Africa, and the Middle East but always knew he wanted to attend college in the United States. After being accepted to Stanford that dream became a reality. After completing his undergraduate degree at Stanford he received his Master’s degree from Yale. This international background instilled in El-Hibri the desire to encourage dialogue between different cultures which in 2007 lead to the annual El-Hibri Prize for Peace Education.
“We are trying to get to the crucial goal of establishing a more evident culture of peace,” said Zen Hunter-Ishikawa, Vice President of Operations at El-Hibri Charitable Foundation. The Prize for Peace Educators awards individuals who have made major contributions to the field of peace education. Past winners of the prize include Scott Kennedy, former Mayor of Santa Cruz, California, and Abdul Aziz Said, professor at American University in Washington D.C.
“It’s taken some time to get organized,” said El-Hibri, “So it’s only been the last few years we’ve been able to focus on our programs. We hope to grow significantly over the years.”
Emergent BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax
Posted July 15, 2010on:
ROCKVILLE, Md., Jul 14, 2010
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax(R) (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company’s large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.
“In line with Emergent’s mission of protecting life, we are proud to be working with HHS to scale-up manufacturing of BioThrax, the only vaccine licensed by the Food and Drug Administration (FDA) for the prevention of anthrax infection,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We applaud HHS for its unwavering commitment to strengthen the country’s biodefense infrastructure and to protect our military and civilian populations.”
This cost plus fixed fee development contract has a total value of $107 million and consists of a two-year base period of performance valued at $54.6 million and three option years that, if exercised by BARDA, would increase the contract value to up to $107 million. Under the contract, the company anticipates recognizing revenues of up to $10 million and pretax earnings of up to $5 million during the second half of 2010. A substantial majority of the value of the $107 million contract will be realized in the first three years of performance (July 2010 to July 2013), assuming exercise of the first option year.
The contract award is based on a technical proposal provided to BARDA that projects an annual large-scale manufacturing capacity of 26 million doses in Building 55. This is a significant increase from the company’s current capacity of approximately 7-8 million doses per annum.
The company has developed a comprehensive plan to demonstrate comparability between the current manufacturing process and the large-scale manufacturing process for BioThrax. The contract will fund activities related to process validation, assay validation, fill/finish, and if required, non-clinical and clinical studies. The plan also includes regulatory activities in support of the submission to FDA of a supplemental Biologics License Application (sBLA) for BioThrax at the expanded scale. The company expects to begin manufacturing consistency lots as early as the fourth quarter of 2011.
Emergent has invested significant resources in Building 55, which has been designed to manufacture up to 25 to 30 million doses of BioThrax as currently configured, and is expandable by adding a second manufacturing train that would double annual capacity, based on demand. This is aligned with the company’s core strategy to enhance its manufacturing capabilities to meet the increasing government demand for anthrax vaccines for inclusion in the SNS.
The company also continues to enhance the attractiveness of BioThrax as a significant component of the SNS, most recently through FDA approval of extended shelf life to four years. In addition, based on data from a seven-year study by the Centers for Disease Control and Prevention, the company has submitted to FDA an sBLA to further reduce the BioThrax vaccination schedule to three doses within six months with triennial booster vaccinations. To date, Emergent has supplied over 42 million doses of BioThrax to the U.S. government with additional deliveries scheduled through the third quarter of 2011 pursuant to the current procurement contract with HHS.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a 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 product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.
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. Since 1998, the U.S. government has procured over 42 million doses of BioThrax. During that time period, more than 9.6 million doses have been administered to nearly 2.4 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 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 appropriations for BioThrax(R) procurement; our ability to obtain new BioThrax(R) sales 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 and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; 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 March 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.
The El-Hibri Foundation is a nonprofit organization with the goal of fostering dialogue between various religions and encouraging nonviolent solutions to global challenges affecting humankind. The Foundation has a new website at www.elhibrifoundation.org.
The Foundation, lead by Chairman of the Board of Trustees Fuad El-HIbri, is divided into four different initiatives: The Peace Education Initiative, The Interfaith Dialogue Initiative, The Humanitarian Aid Initiative, and The Social Justice Initiative.
The Peace Education Initiative focuses on conflict resolution, embracing cultural diversity, and supporting cross-cultural approaches to peace-building. The Interfaith Dialogue Initiative focuses on supporting understanding between the three Abrahamic faiths: Islam, Judaism and Christianity. The Humanitarian Aid Initiative provides grants to organizations that aim at delivering education and medical care to the disadvantaged. The last of the four initiatives is the Social Justice Initiative. The Social Justice Initiative addresses issues of equality, justice and human rights, especially for women and children.
The El-Hibri Foundation promotes these four initiatives through the provision of grants. Since its creation in 2001, the Foundation has given away 36 grants totaling over 8.2 million dollars.
For more information on the El-Hibri Foundation visit their website: www.elhibrifoundation.org
Fuad El-Hibri serves on the Advisory Board for the Yale Healthcare Conference, a joint effort between the Yale School of Management and the Health Professional Schools at Yale University. The 6th annual healthcare conference was held on April 9, 2010 in New Haven, CT. The conference topic was “Re-Forming Healthcare: Excellence in a Transforming System” and brought together professionals, academics, and students to engage in an instructive conversation about current healthcare issues. The conference addressed the challenges key stakeholders will face in a changing healthcare system and offered information on how to foster continued excellence. Emergent Biosolutions, LLC, led by CEO and Yale School of Management alumnus, Fuad El-Hibri, co-sponsored the conference. For more information, please see http://www.yalehealthcare.com/advisory.php