Posts Tagged Vaccine
Washington Launched Me, But I am Proud to be a Lebanese Dreaming of New Technology – Al Anwar
Posted by admin in Entrepreneur on October 13th, 2009
By Nihad Tobalian
Lebanese businessman Fuad El-Hibri is the “Entrepreneur of the Year for 2009” for the Washington, DC area, and earned this award from Ernst & Young’s Global Technology Group, which is given to honor businessmen who lead nascent companies to growth in their specialized area of work. He earned this award for leading his American company, “Emergent BioSolutions,” which he transformed from a stumbling company into a pioneer company in the field of development of medical vaccines. What are the details of this award, and the types of vaccines that the 51-year-old El-Hibri has developed?
During a meeting with Anwar, businessman Fuad El-Hibri, who spends his annual vacation in Lebanon, said:
From this award, “Ernst & Young” is seeking major companies that apply quality standards of work and production and the ability to develop new products, against the contribution of these companies in the development and preservation of the community. What helped us as “Emergent BioSolutions” to win this award, specifically for the category of technology in the Washington metropolitan area, is our adherence to the requirement of the award, especially after the recent acquisition of the company, which was for sale for approximately $25 million, and which has 170 employees. Through expansion and development strategy, the price of the company rose to between 400 and 500 million dollars, according to the New York Stock Exchange, as the price per share has risen from six dollars ten years ago to 26 dollars, in addition to increasing the number of employees to 600 employees, which helped us to increase the volume of our business, especially since our approved strategy was also based on a policy of expansion through the acquisition of three money losing companies in the United States, Britain and Germany.
Overseeing Companies
“Ernst & Young,” explains businessman Fuad El-Hibri, “is a global financial company that exercises financial control over companies, and honors those who achieve their aspirations and consequently, their achievements in the creative and innovative areas in the field of technology. After that, a panel of judges selects a ‘Leading Businessman.’ Ernst &Young selected me as the pioneer businessman for 2009 in the field of technology, in my capacity as owner of the company ‘Emergent BioSolutions.’ And while I am proud of the award, I am also proud of every employee in the company, because they all, in addition to being loyal to the company, believe in what we do, and devote themselves to work, especially since the scope of our work requires protecting human life. It is true that the company has a business face, but the primary nature of our work is to protect human life through the development of vaccines that will provide them with immunity against disease. The motto with which we operate the commercial side does not negate the human aspect.”
Oxford University
● You spoke about the specialized vaccines that the company you own develop. What are these vaccines? And against which diseases do they work?
- We are currently working on the development of several new vaccines, including a vaccine for tuberculosis. We, in this regard, are working to develop a special vaccine for this disease, and I can say we are in the advanced stages of testing which we have conducted in South Africa, as we are in the second stage, Phase b, results of which have been encouraging. After two years of testing this vaccine on a sample of children to determine its potency, we have reached the stage of measuring the potency and immunity of the vaccine. If the tests are successful tests, then we will move on to Phase III of the trials to expand the tests to include the category of adults who provide material support for the companies developing the typhoid vaccine. We also receive support from the “Wellcome Trust,” while our partner in these trials is the University of Oxford in the United Kingdom.
The second vaccine—according to El-Hibri—is related to hepatitis B, which would, if successfully tested, provide immunity for patients with this disease. It would also provide a treatment for the chronic diseases resulting from hepatitis B. Businessman Fuad El-Hibri explains, “Patients who suffer from this disease often experience hepatitis B turning into a chronic disease, which may lead, in advanced stages, to liver cancer or liver failure for good. The vaccine, which we are currently developing, helps the patient’s body to protect itself against the disease in terms of reducing and limiting the progress of the disease and limiting its spread in the body. If I were to be optimistic, I would say that this vaccine could eliminate the disease completely, but today, I would say that if we were able to alleviate the pressure of this disease on the patient’s body, then we would have achieved a great result in this area, namely the prevention of the deterioration of the patient’s health. With respect to this vaccine, we have reached the second phase of testing which was conducted on a sample of citizens in China.
A New Medical Development
● What about the work on a vaccine for cancer, for which effective medical treatments have not been found?
- We are working on a number of vaccines for multiple diseases, including for example, work on the development of a vaccine to increase the effectiveness of an old vaccine. For example, there is an effective vaccine for typhoid, but we are working to develop a single dose vaccine, to be administered orally, not with a needle. As for internal diseases, such as internal inflammations for example, we have two technical working groups at the company studying the possibility of trying to find volunteers to receive these vaccines. However, I think it is premature to talk about this vaccine, because we are still in the early stages of the work, and specifically, we are still at the exploration stage. However, in this connection, if we were to look at this issue from a scientific point of view, vaccines are the most advanced in the pharmaceutical industry. Biological studies have shown that vaccines, and immunity enhancement and vaccination are more mature in biological research than they are in the pharmaceutical industry.
● Those who are familiar with your curriculum vitae will find that you specialize in economics. What led you to work in the medical treatment field?
- By nature, I love to work on the development of medical treatments. True, I specialized in economics, where I got a diploma from Stanford University and then an advanced degree in business from Yale University, then worked as head of the Operations Department at Citibank Group and then in Hamilton, and both were of consulting nature that encompass different industries, from the financial industry to beverages to research management. After that, I moved to work for consulting firm Booz Allen Hamilton, but above all I love to work on the development of medical treatments, even though I do not have any scientific background in the field of medicine. However, the nature of my work in these institutions and companies helped me to get into this area. In addition, I was lucky to have a wonderful team that helped me and taught me, because the working group has a scientific background and its members are dreamers like me. They have taught me and helped me to penetrate this field.
Emergent BioSolutions Inc. (EBS) CEO & Chairman, 10% Owner Fuad El-hibri sells 15,000 Shares
Posted by admin in Chairman, Chief executive officer, Emergent BioSolutions, Infectious disease, Profile, U.S. Food and Drug Administration, Vice President, fuad, fuad el-hibri on August 13th, 2009
CEO & Chairman, 10% Owner of Emergent BioSolutions Inc. (EBS) Fuad El-hibri sells 15,000 shares of EBS on 08/11/2009 at an average price of $16.78 a share.
EMERGENT BIOSULUTIONS INC. is a leading biopharmaceutical company dedicated to one simple mission – to protect life. EBS develops manufactures and commercializes vaccines and therapeutics that assist the body\’s immune system to prevent or treat disease. Their products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Their marketed product BioThrax? (Anthrax Vaccine Adsorbed) is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent BioSolutions Inc. has a market cap of $511.8 million; its shares were traded at around $16.91 with a P/E ratio of 13.1 and P/S ratio of 2.8.
EMERGENT BIOSOLUTIONS’ TYPHOID VACCINE CANDIDATE ACHIEVES ENDPOINTS IN PHASE II CLINICAL STUDY
Posted by admin in Uncategorized on July 14th, 2009
Vaccine well tolerated and immunogenic in double-blind, placebo-controlled study in pediatric population
ROCKVILLE, MD, October 10, 2007— Emergent BioSolutions Inc. (NYSE: EBS) announced today that preliminary results from a recently completed, randomized, placebo-controlled Phase II clinical study demonstrated that its single-dose, drinkable typhoid vaccine candidate achieved the study endpoints for safety and immunogenicity. In this clinical study, which recruited children between 5 and 14 years of age, a total of 101 children received the vaccine candidate and 50 children received placebo. The vaccine candidate and placebo were allocated in a blinded manner. This clinical study, which was conducted in Viet Nam, is the first study of this product candidate in a pediatric population in a region in which typhoid is endemic and was performed in collaboration with Oxford University and the Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam, and financially supported by the Wellcome Trust.
The data from this Phase II clinical study, which is still being analyzed, support the following key findings:
- The vaccine was immunogenic and met the predefined criterion of an overall immune response rate of greater than 50%, with 95% confidence.
- The vaccine induced significantly higher antibody concentrations, indicative of systemic responses, in children in the vaccine group compared to the placebo control group.
- The vaccine was well tolerated with no serious adverse events or deaths reported, and no subjects withdrew due to adverse events.
- Overall, there were no statistical differences in the incidence of adverse events between the vaccinated and placebo treated groups.
“We are very pleased to have met the objectives of this Phase II study of our typhoid vaccine candidate. This data is encouraging and indicates great promise for what would be the first single-dose, drinkable typhoid vaccine. We are particularly grateful to the Wellcome Trust for their partnership and generous support of this important project,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Typhoid is endemic in many developing countries, putting countless international travelers and families who visit these nations at risk. With typhoid claiming 200,000 lives each year, continued progress in the development of this vaccine is an important milestone in our company’s efforts to protect life. Emergent BioSolutions remains committed to addressing significant underserved health needs,” he continued.
About the Typhoid Vaccine Candidate
The company’s typhoid vaccine candidate is a live, attenuated strain of the Salmonella typhi bacterium designed to eliminate virulence by deletion of two specific genes. The vaccine is intended to be administered in a single, drinkable dose prior to travel to countries where typhoid is endemic. If approved, this method of administration could provide a competitive advantage compared to currently approved typhoid vaccines.
Previously published studies have shown the vaccine candidate to be immunogenic and well-tolerated. In addition to this Phase II clinical study, the following clinical trials have been completed:
- An open-label, non-placebo controlled, pilot study conducted in the United Kingdom in healthy adults in which the vaccine candidate was well tolerated and immunogenic, eliciting both cell mediated and humoral immunogenicity.
- A double-blind, placebo controlled, single dose, dose escalating clinical trial conducted in the United States in which 100% of the trial participants in the highest dose group and 56% of the participants in the lowest dose group had an immune response on the scheduled testing days.
- An open-label, controlled, single dose clinical trial conducted in the United States in healthy adults to evaluate the safety and immunogenicity of two different presentations of the vaccine. The vaccine candidate was similarly immunogenic in both presentations and both were well tolerated.
- A single-blind, placebo controlled clinical trial in Viet Nam in healthy adults. The Wellcome Trust provided funding for the trial. The vaccine met the criterion for immunogenicity and was well tolerated, with no serious adverse events reported.
About Typhoid
Typhoid, also known as typhoid fever, is caused by infection with the bacterium Salmonella typhi. Typhoid is characterized by fever, headache, constipation, malaise, stomach pains, anorexia and myalgia. Severe cases of typhoid can result in confusion, delirium, intestinal perforation and death. Typhoid is transmitted by consuming contaminated food or drinks. Contamination usually results from poor hygiene and sanitation. Typhoid is often endemic in developing countries in which there is limited access to treated water supplies and sanitation.
An estimated 22 million cases of typhoid occur per year worldwide. The Centers for Disease Control (CDC) recommends that all persons from the United States traveling to developing countries consider receiving a typhoid vaccination, with travelers to Asia, Africa and Latin America deemed to be especially at risk. U.S. military personnel deployed in these areas are also at risk of infection.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission — to protect life. We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare. Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease. Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. More information on the company is available 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, prospects, plans and objectives of management, including clinical trial results and development plans, 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 rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials, including future clinical data for our typhoid vaccine candidate; 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 product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; 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, 2007 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.
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