Posts Tagged ‘Anthrax’

Emergent BioSolutions to Release Third Quarter 2010 Financial Results and Conduct a Conference Call on November 4, 2010Emergent BioSolutions to Release Third Quarter 2010 Financial Results and Conduct a Conference Call on November 4, 2010

Saturday, October 23rd, 2010

ROCKVILLE, Md., Oct 13, 2010 — Emergent BioSolutions Inc. (NYSE: EBS) announced today it will report financial results for third quarter 2010 on Thursday November 4, 2010, after market close.  Company management will host a conference call at 5:00 pm Eastern on November 4, 2010 to discuss the financial results for the third quarter and first nine months of 2010, recent business developments and the forecast for 2010. The conference call will be accessible by dialing 888/713-4211 or 617/213-4864 (international) and providing passcode 50859780. A webcast of the conference call will be accessible from the Company’s website at www.emergentbiosolutions.com, under “Investors”.

Emergent BioSolutions is offering call participants a pre-registration option that expedites access to the call and minimizes hold times. Pre-registrants will be issued a pin number to be used when dialing into the live call which will provide quick access to the conference call by bypassing the operator upon connection. Pre-registration, while not mandatory, can be accessed using the following website: https://www.theconferencingservice.com/prereg/key.process?key=PNP49E4W7.

A replay of the conference call will be accessible, approximately one hour following the conclusion of the call, by dialing 888/286-8010 or 617/801-6888 and using the passcode 97521313. The replay will be available through November 18. The webcast will be archived on the company’s website, www.emergentbiosolutions.com, under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO, Fuad El-Hibri, 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 disease. 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.

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

Friday, August 14th, 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.

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U.S. Government To Purchase Additional 14.5 Million Doses Of Biothrax® Under New Contract Valued At Up To $404 Million

Monday, July 13th, 2009

New contract extends USG’s commitment to purchase BioThrax through 3Q 2011 and is a follow-on to the existing 2007, $448 million contract

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has signed a new, multi-year, firm fixed price contract with the U.S. Department of Health and Human Services (HHS) to supply an additional 14.5 million doses of BioThrax® (Anthrax Vaccine Adsorbed), its FDA licensed anthrax vaccine, for inclusion in the Strategic National Stockpile (SNS).

The total value of this follow-on contract is between $364 million and $404 million, with the higher amount tied to the delivery of product having four-year expiry dating. First deliveries of BioThrax under this new contract are scheduled to begin in 3Q 2009, immediately following the scheduled completion of deliveries under the company’s current $448 million contract to supply 18.75 million doses of BioThrax to the SNS. Final product deliveries under this new contract are anticipated in 3Q 2011.

“This follow-on contract with HHS is continuing evidence of the government’s steadfast commitment to procure critical countermeasures to protect against the threat of bioterrorism in our country,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We are encouraged that we were able to secure this new procurement for an additional 14.5 million doses with HHS, because it represents a seamless transition from our current contract for the shipment of 18.75 million doses of BioThrax into the SNS. This clearly demonstrates the U.S. government’s commitment to maintaining a strong, domestic industrial base for biodefense medical countermeasures.”

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 Baccillus anthracis and contains no dead or live bacteria. BioThrax is administered by subcutaneous injection in three initial doses followed by three additional doses, with an annual booster dose recommended thereafter. Since 1998, the U.S. government has procured nearly 32 million doses of BioThrax. During that time period, nearly 7.9 million doses have been administered to more than two million military personnel. BioThrax cannot cause anthrax infection.

About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading, fully integrated biopharmaceutical company dedicated to one simple mission—to protect life. Emergent develops, manufactures and commercializes immune-related vaccines and biotherapeutics that assist the body’s immune system to prevent or treat infectious and other life threatening diseases. 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 infection. Emergent’s clinical pipeline includes franchises focused on anthrax and botulism, as well as individual program candidates targeting typhoid, tuberculosis, hepatitis B and chlamydia. 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, 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 procurement under the new SNS contract; appropriations for BioThrax procurement for the SNS under future contracts; our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; future appropriations for the procurement of BioThrax for the SNS; future appropriations for the funding of development contracts related to our other anthrax-related programs; 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; 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 current report on Form 10-Q for the quarter ended June 30, 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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Emergent Biosolutions Acquires Monoclonal Anthrax Product Candidate

Monday, July 13th, 2009

Acquisition represents important addition to company’s portfolio of anthrax countermeasures
Emergent BioSolutions Inc. (NYSE: EBS) announced that today it completed the acquisition of a group of anthrax monoclonal antibodies from AVANIR Pharmaceuticals (NASDAQ:AVNR), including Avanir’s lead product candidate, AVP-21D9.

AVP-21D9 is a human monoclonal antibody product candidate that is being developed as an intravenous treatment for patients who present with symptoms of anthrax disease following exposure to Bacillus anthracis. In non-clinical studies, this candidate demonstrated an ability to protect animals challenged with a lethal dose of inhaled anthrax spores. AVP-21D9 is being developed with funding support from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIAID), including a grant to establish a cGMP manufacturing process and to test efficacy in additional inhalation studies.

“The acquisition of Avanir’s monoclonal anthrax antibodies rounds out our anthrax countermeasure program nicely. In addition to our FDA-approved product, BioThrax? (Anthrax Vaccine Adsorbed), which is indicated for pre-exposure prevention of anthrax in individuals at high risk of exposure to anthrax spores, we are developing a polyclonal anthrax immune globulin therapeutic, which is a human plasma-derived product candidate. Now, as a result of this acquisition, we have another anthrax therapeutic in our product portfolio – a new monoclonal anthrax antibody product candidate that has performed well in proof-of-concept studies,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This transaction reflects our ongoing commitment to develop a full portfolio of countermeasures to strengthen our country’s preparedness in the event of future anthrax attacks.”

The U.S. government is funding the development of, and seeking to procure, two types of treatments for inhalational anthrax disease: polyclonal antibody products, also known as immune globulins, and monoclonal antibody products. Emergent BioSolutions currently is developing a polyclonal anthrax immune globulin (AIG) product, which is being manufactured by Talecris Biotherapeutics, Inc., at its FDA-approved production facilities. Two full-scale lots of this product candidate have been manufactured under current good manufacturing practices at Talecris, and we plan to conduct pivotal human and animal studies in 2008 and 2009, which could position us for a procurement contract as early as next year. NIAID has provided us grant funding of up to $13.4 million for a combination of initiatives relating to our AIG product candidate, including non-clinical efficacy studies and a human safety and pharmacokinetics study.

We intend to pursue additional NIAID development funding for both of our anthrax therapeutic product candidates, and we believe that both therapeutics would be eligible to be procured by the U.S. Department of Health and Human Service for inclusion in the SNS prior to receiving marketing approval, provided that they are deemed to be licensable under Project BioShield.

About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a profitable, multinational 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 products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. 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. 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; 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 September 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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