Showing posts with label U.S. Food and Drug Administration. Show all posts
Showing posts with label U.S. Food and Drug Administration. Show all posts

Thursday, August 20, 2009

Emergent biosolutions announces that department OF HEALTH AND HUMAN SERVICES AND DEPARTMENT OF DEFENSE ISSUED NOTICES OF INTENT TO PROCURE UP TO A COM


ROCKVILLE, MD, April 18, 2007—Emergent BioSolutions Inc. (NYSE: EBS) (EBS) today announced that the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DoD) issued two separate notices of intent to procure up to a combined total of 22.75 million doses of BioThrax® (Anthrax Vaccine Adsorbed).

In a Presolicitation Notice issued today, HHS stated its intent to procure 10.4 million doses of BioThrax for the Strategic National Stockpile (SNS) with options for up to an additional 8.35 million doses. HHS announced that it intends to enter sole source negotiations with the company to finalize the procurement and to make an award on or about July 24, 2007.

Separately, DoD issued a Special Notice signaling an anticipated sole source contract award to procure a minimum of 4 million doses of BioThrax, over a base period and 3 optional ordering periods.

“We were very pleased to learn of HHS and DoD’s intent to procure additional doses of BioThrax,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc. “These notices indicate a continued commitment by the U.S. Government to Emergent BioSolutions’ FDA-licensed anthrax vaccine for the protection of military personnel and civilians. We are committed to working with both HHS and DoD to promptly complete these intended procurements to ensure both federal agencies have continued access to and supply of this critical biodefense countermeasure.”

Friday, August 14, 2009

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

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.

Friday, August 7, 2009

Emergent Biosolutions Announces Results From Annual Meeting Of Stockholders

ROCKVILLE, MD, June 14, 2007—Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today the results of the company’s 2007 annual meeting of stockholders, which took place today at the Hyatt Regency Bethesda at 10:00 am Eastern.

There were present, in person or represented by proxy, the holders of more than a majority of the shares of the outstanding common stock of the company, thus constituting a quorum.

Proposal 1—Election of दिरेक्टोर्स

The following individuals were elected Class I directors of the company to serve for a three-year term expiring 2010: Fuad El-Hibri, Jerome M. Hauer and Ronald B. Richard.

Proposal 2—Ratify Selection of Ernst & Young LLP as the Company’s Independent Registered Public Accounting फिरम

The proposal to select Ernst & Young LLP as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2007 successfully passed.

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 infection. 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.

Thursday, August 6, 2009

Fuad El-Hibri On Muckety


Fuad El-Hibri on Muckety

Emergent BioSolutions Celebrates Initial Public Offering; CEO To Ring Opening Bell on the NYSE

21 November, 2006 GAITHERSBURG, Md.–(BUSINESS WIRE)–Nov. 21, 2006–Emergent BioSolutions Inc. (NYSE:EBS), a biopharmaceutical company that develops vaccines and therapeutics for biodefense and commercial applications and manufactures the only anthrax vaccine approved by the U.S. Food and Drug Administration (FDA), today announced it will be celebrating the Company’s recently completed initial public offering with the ringing of the opening bell of the New York Stock Exchange by Fuad El-Hibri, chairman and chief executive officer, on Wednesday November 22, 2006. “Throughout the Company’s history, our people, science and technology have contributed significantly to safeguarding millions of military personnel and the general population through the delivery of a safe and effective countermeasure against the threat of anthrax infection,” said Mr. El-Hibri. “Tomorrow’s ringing of the opening bell is an opportunity to celebrate our Company and our achievements thus far, while acknowledging the commitment and support of our employees, customers and, now, investors who continue to drive our success.” Emergent BioSolutions’ common stock began trading on November 15, 2006 under the symbol EBS. Emergent is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and immune globulins, that induce or assist the body’s immune system to prevent or treat disease. The Company operates in two business segments: biodefense and commercial. In its biodefense business, the Company develops and commercializes immunobiotics for use against biological agents that are potential weapons of bioterrorism. In its commercial business, the Company develops immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. The Company’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the FDA for the prevention of anthrax infection. For more information about BioThrax, please review the package insert located on the Company’s website www.emergentbiosolutions.com. In addition to BioThrax(R), the Company’s biodefense product portfolio includes three biodefense product candidates in preclinical development and a next generation anthrax vaccine program with product candidates in preclinical and Phase I clinical development. The Company’s commercial product portfolio includes a typhoid vaccine candidate and a hepatitis B therapeutic vaccine candidate, both of which are in Phase II clinical development, one vaccine candidate in Phase I clinical development and two vaccine candidates in preclinical development. 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 Emergent’s actual results to differ materially from those indicated by such forward-looking statements, including our plans for future sales of BioThrax; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; 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 product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the Company’s Registration Statement on Form S-1 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. www.emergentbiosolutions.com