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Posts Tagged ‘U.S. Food and Drug Administration’

Emergent Biosolutions on Answers.com

August 18th, 2009 admin No comments

Type: Public
On the web: http://www.emergentbiosolutions.com
Employees: 587
Employee growth: 4.8%

Emergent BioSolutions protects your thorax against anthrax. Emergent BioSolutions develops and produces, for government and commercial markets, drugs that treat or protect against infectious diseases and bio-agents. The company supplies BioThrax (the US’s only FDA-approved anthrax vaccine) primarily to the departments of Defense and Health and Human Services (HHS). Its biodefense unit is also developing a post-exposure treatment for anthrax and a preventive vaccine for botulinum toxin. For commercial markets, Emergent is working on therapies and vaccines for typhoid, Group B strep, and hepatitis B, among other things. Chairman and CEO Fuad El-Hibri controls more than half of the company.

Key numbers for fiscal year ending December, 2008:
Sales: $178.6M
One year growth: (2.4%)
Net income: $20.7M
Income growth: (9.8%)

Officers:
Chairman and CEO: Fuad El-Hibri
President, COO, and Director: Daniel J. Abdun-Nabi
SVP Finance and Administration, CFO, and Treasurer: R. Don Elsey

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Fuad El-Hibri’s Linkedin Profile

August 18th, 2009 admin No comments
Fuad El-Hibri

Chairman and Chief Executive Officer at Emergent BioSolutions Inc.

Greater Seattle Area

Fuad El-Hibri is currently Chairman and Chief Executive Officer at Emergent BioSolutions Inc.

Emergent BioSolutions Inc. (EBS) CEO & Chairman, 10% Owner Fuad El-hibri sells 15,000 Shares

August 14th, 2009 admin No comments

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.

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Fuad El-Hibri Ernst & Young Entrepreneur of the Year

June 22nd, 2009 admin No comments

Emergent BioSolutions chairman and CEO, Mr. Fuad El-Hibri, named Ernst & Young Entrepreneur of the Year 2009 award finalist in greater Washington. Emergent BioSolutions chairman Fuad El-Hibri:

Mr. Fuad El-Hibri named Ernst & Young Entrepreneur of the Year 2009 award finalist in greater Washington

ROCKVILLE, Md. – (BUSINESS WIRE) – Emergent BioSolutions Inc. (NYSE:EBS) announced today that its chairman and chief executive officer, Mr. Fuad El-Hibri, is a finalist for the Ernst & Young Entrepreneur of the Year 2009 Award in the Greater Washington region. According to Ernst & Young LLP, the awards program recognizes entrepreneurs who demonstrate extraordinary success in the areas of innovation, financial performance and personal commitment to their businesses and communities. Mr. El-Hibri was selected as a finalist from nearly 100 nominations by a panel of independent judges. Award winners will be announced at a special gala event on June 18 at the Ritz-Carlton, Tysons Corner in Virginia.

“It is an honor to be chosen as a finalist for the Ernst & Young Entrepreneur of the Year Award,” said Mr. Fuad El-Hibri. “I am proud of the entrepreneurial spirit, commitment, and collaboration that prevail at Emergent, which are key factors to our company’s success. This recognition represents the contributions of each and every member of the Emergent Team as we work together in pursuit of our company mission – to protect life.”

Mr. El-Hibri was also a finalist for the Greater Washington region in 2007. The Ernst & Young Entrepreneur of the Year awards program celebrates its 23rd anniversary this year. The program has expanded to recognize business leaders in over 135 cities in 50 countries throughout the world.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

About Ernst & Young’s Entrepreneur of the Year Awards Program

Ernst & Young’s Entrepreneur of the Year Award is the world’s most prestigious business award for entrepreneurs. The award makes a difference through the way it encourages entrepreneurial activity among those with potential and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, the Ernst & Young Entrepreneur of the Year award celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 135 cities in 50 countries.

Sponsors
Founded and produced by Ernst & Young LLP, the Entrepreneur of the Year awards are pleased to have the Ewing Marion Kauffman Foundation and SAP America as national sponsors.

In Greater Washington, sponsors include HSBC Bank, Pillsbury Law, Reznick Group, Lockton Companies and the Washington Business Journal.

Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Vice President, Corporate Communications
301-795-1800
SchmittT@ebsi.com

Comment on this story, by email comment@newsblaze.com

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Ernst & Young’s Entrepreneur of the Year Fuad El-Hibri

June 22nd, 2009 admin No comments

chairman and chief executive officer, Mr. Fuad El-Hibri, is a finalist for the Ernst & Young Entrepreneur of the Year® 2009 Award in the Greater Washington region.  Yahoo! Finance and Mr. Fuad El-Hibri:

Emergent BioSolutions Inc. (NYSE:EBSNews) announced today that its.  According to Ernst & Young LLP, the awards program recognizes entrepreneurs who demonstrate extraordinary success in the areas of innovation, financial performance and personal commitment to their businesses and communities. Mr. El-Hibri was selected as a finalist from nearly 100 nominations by a panel of independent judges. Award winners will be announced at a special gala event on June 18 at the Ritz-Carlton, Tysons Corner in Virginia.

“It is an honor to be chosen as a finalist for the Ernst & Young Entrepreneur of the Year Award,” said Mr. Fuad El-Hibri. “I am proud of the entrepreneurial spirit, commitment, and collaboration that prevail at Emergent, which are key factors to our company’s success. This recognition represents the contributions of each and every member of the Emergent Team as we work together in pursuit of our company mission – to protect life.”

Mr. El-Hibri was also a finalist for the Greater Washington region in 2007. The Ernst & Young Entrepreneur of the Year awards program celebrates its 23rd anniversary this year. The program has expanded to recognize business leaders in over 135 cities in 50 countries throughout the world.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

About Ernst & Young’s Entrepreneur of the Year® Awards Program

Ernst & Young’s Entrepreneur of the Year® Award is the world’s most prestigious business award for entrepreneurs. The award makes a difference through the way it encourages entrepreneurial activity among those with potential and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, the Ernst & Young Entrepreneur of the Year® award celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 135 cities in 50 countries.

Sponsors
Founded and produced by Ernst & Young LLP, the Entrepreneur of the Year awards are pleased to have the Ewing Marion Kauffman Foundation and SAP America as national sponsors.

In Greater Washington, sponsors include HSBC Bank, Pillsbury Law, Reznick Group, Lockton Companies and the Washington Business Journal.

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Fuad El-Hibri on Anthrax Vaccine Contract

June 21st, 2009 admin No comments

“We strongly support this step by HHS, which potentially reduces development risk for our rPA vaccine candidate. We remain confident that we are well-positioned and competitive to receive any award granted by HHS for the development and procurement of the rPA vaccine. We look forward to continuing our long-standing relationship with the US Government as the proven and preeminent supplier of medical countermeasures to protect our nation,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

Emergent BioSolutions Inc. (NYSE:EBS) announced that late on April 15th, HHS requested that each bidder in the competitive range for the rPA contract submit its product development plans to FDA for review in advance of an award. Emergent had already requested and is presently scheduling a meeting with the FDA as part of its pre-award activity. The Company intends to incorporate any FDA comments into its rPA development plan. Emergent will continue to move its rPA program forward to position the company to execute on the anticipated contract, once awarded.

As with any government solicitation of this size and scope, there are no assurances that HHS will not impose additional requirements, which may further extend contract negotiations.

This action has no impact on the company’s existing contracts with HHS to supply BioThrax®, the only FDA licensed anthrax vaccine, for the Strategic National Stockpile (SNS). This year Emergent is completing the delivery of 18.75 million doses of BioThrax for inclusion in the SNS. Also this year, following the completion of that delivery, Emergent will begin to supply HHS with an additional 14.5 million doses of BioThrax under a follow-on contract. The total value of these two procurement contracts with HHS for BioThrax exceeds $800 million.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at http://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, 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 clinical programs; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; 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 annual report on Form 10-K for the year ended December 31, 2008 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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Fuad El-Hibri and Emergent gets boost from FDA

June 21st, 2009 admin No comments
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“We are pleased that the FDA has approved the 4-year expiry dating of BioThrax as this extends the ability of the U.S. government to store our product in the nation’s Strategic National Stockpile,” said Fuad El-Hibri, chairman and CEO.

Emergent BioSolutions hit a jackpot of sorts when the Food and Drug Administration approved extending the shelf life of its anthrax vaccine from three to four years.

The milestone approval means that the vaccines that the Rockville biotech has already sold to the Department of Health and Human Services‘ Strategic National Stockpile are worth $30 million more than the original price. In a statement, Emergent said it plans to record that extra income in the current quarter.

Furthermore, the extended shelf life means that the value of the company’s contract for 14.5 million additional doses has increased to $405 million.

“This is a critically important product feature that we believe will increase the attractiveness of BioThrax to the U.S. government as it increases BioThrax’s life cycle value. We are continuing our efforts to further enhance the attributes of BioThrax, including research toward a further reduction in the vaccination schedule and an expanded label indication for post-exposure prophylaxis. We believe these enhancements, if approved, will advance the U.S. government’s preparedness efforts in response to anthrax as a potential weapon of bioterrorism.”

Emergent has supplied more than 33 million doses of BioThrax, the only FDA-approved anthrax vaccine, to the federal government, with more deliveries scheduled through the third quarter of 2011.

Also this week, Emergent sued privately held Protein Sciences Corp. of Meriden, Conn., which it planned to acquire last year, according to a filing with the Securities and Exchange Commission. In connection with the planned acquisition, Emergent made a $10 million loan to Protein Sciences, which used its assets as collateral. A May 31 deadline for repayment passed, prompting the suit, Emergent said.

Emergent also plans to proceed with its pending lawsuits against Protein Sciences and its management, including claims for breach of contract, fraud and unfair business practices.


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Fuad El-Hibri’s Emergent BioSolutions gets market authorization in India for BioThrax

June 21st, 2009 admin No comments

Emergent BioSolutions Inc. announced that the Drugs Controller General of India (DCGI) has issued a registration certificate for BioThrax (Anthrax Vaccine Adsorbed), which enables the marketing and sale of the vaccine in India to help prevent anthrax infection.

Fuad El-Hibri’s Emergent BioSolutions gets market authorization in India for BioThrax

According to a release, Emergent BioSolutions has signed a marketing agreement with Biological E. Limited for the marketing of BioThrax in India. BioThrax is the only vaccine for the prevention of anthrax infection licensed by the U.S. Food and Drug Administration (FDA).

The company noted that the BioThrax market authorization for India follows the publication in 2008 of the National Disaster Management Guidelines by the Indian National Disaster Management Authority (NDMA), which is the government body that oversees disaster management. In that document, the  government of India provided guidance with respect to the management of biological disasters and said that there is a need to have a supply of readily available anthrax vaccines to be administered rapidly in the event of an outbreak. The report goes on to state that all first responders will be vaccinated in an impending disaster situation.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, said, “The Government of India has been explicit in expressing its commitment to protect its population from the continuing threat of bioterrorism. We are certainly pleased that BioThrax will be a valuable countermeasure available to the Government of India to achieve that goal. Today marks a pivotal milestone in Emergent’s efforts to expand globally and further our mission of protecting life.”

About BioThrax (Anthrax Vaccine Adsorbed): BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is licensed by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis and contains no dead or live bacteria. Since 1998, the U.S. government has procured nearly 33.5 million doses of BioThrax. During that time period, nearly 8.4  million doses have been administered to more than 2.1 million military personnel. BioThrax cannot cause anthrax infection. Please visit emergentbiosolutions.com/pdf/emergent_biothrax_us.pdf for full prescribing information.

Emergent BioSolutions is a biopharmaceutical company focused on the development, manufacture and commercialization of immune-related biologic products, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.

((Comments on this story may be sent to health@closeupmedia.com))

For full details on Emergent BioSolutions Inc (EBS) click here. Emergent BioSolutions Inc (EBS) has Short Term PowerRatings of 1. Details on Emergent BioSolutions Inc (EBS) Short Term PowerRatings is available at This Link.

Posted in BioThrax, El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri
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