Posts Tagged ‘Private Securities Litigation Reform Act’

Emergent Biosolutions Announces That Biothrax (Anthrax Vaccine Adsorbed) Receives Market Authorization In India

Monday, July 13th, 2009

Biological E. of Hyderabad, India to serve as marketing agent for BioThrax in India
Emergent BioSolutions Inc. (NYSE: EBS) announced today 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. 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 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 stated 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, stated, “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 www.emergentbiosolutions.com/pdf/emergent_biothrax_us.pdf for full prescribing information.

About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. 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. Emergent’s 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’s development pipeline includes programs focused on anthrax, botulism, typhoid, tuberculosis, hepatitis B and chlamydia. Additional information may be found 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, 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 appropriations for BioThrax procurement; our ability to obtain new BioThrax sales contracts; 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 quarterly report on Form 10-Q for the quarter ended September 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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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 And Ninebio Sdn. Bhd. Announce Joint Venture In Malaysia

Monday, July 13th, 2009

Newly formed company to focus on creating critical R&D and manufacturing infrastructure and supplying biodefense countermeasures within Asia and other territories.
January 24, 2008 – Emergent BioSolutions (NYSE: EBS) and Ninebio Sdn. Bhd. (“9Bio”) today announced the formation of a joint venture in Malaysia that will focus on creating critical biologics infrastructure and supplying biodefense countermeasures, including BioThrax® (Anthrax Vaccine Adsorbed), and other medical and complementary products and services to the Government of Malaysia. It is anticipated that the joint venture will also supply such products and services to certain member countries of the Organisation of the Islamic Conference (“OIC”) and other countries within Asia. 9Bio is a Malaysian Government owned company and one of the National Institutes of Health under the Ministry of Health. 9Bio is fully funded by the Government of Malaysia. The Government of Malaysia, through 9Bio, has selected Emergent BioSolutions as one of its principal partners to assist, as a contract service provider, in building vaccine development and manufacturing infrastructure. The joint venture will be majority owned by Emergent BioSolutions.

“This joint venture is a step towards our objective to obtain vaccine development and manufacturing capabilities as well as bio-terrorism preparedness. I am very proud that 9Bio has been entrusted to serve as an extension of the Malaysian Government’s implementation of these critical objectives. Emergent BioSolutions is the most appropriate partner for 9Bio for this venture and I am confident that the new company will exemplify both expertise and experience in this area,” said chief executive officer of 9Bio, Datuk Dr. Nor Shahidah Khairullah. “We are looking forward to working very closely with the Ministry of Health and other agencies in Malaysia in developing and implementing this plan.”

“We are honored to partner with 9Bio for this important joint venture and to have been selected by the Government of Malaysia to provide these important services. It is our belief that this joint venture will not only expand the use of our anthrax vaccine in this market, but will also serve as a platform for joint product development and manufacturing activities,” said Fuad El–Hibri, chairman and chief executive officer of Emergent BioSolutions. “Emergent BioSolutions applauds the Malaysian Government’s support of a public-private partnership approach to growing the Malaysia biotechnology sector and we welcome the opportunity to play a pivotal role in the implementation of its plan.”

Witnessing the signing ceremony, Director General of the Malaysian Ministry of Health, Tan Sri Datuk Dr Haji Ismail Merican affirmed that through 9Bio, one of the National Institutes of Health in Malaysia, the Ministry of Health would be able to focus on developing and manufacturing biologics, biosecurity and bioterrorism countermeasures for Malaysia.

About Ninebio
Ninebio Sdn. Bhd. is a Malaysian Government owned company, and as one of the National Institutes of Health, under the Ministry of Health, is focused on the research and development of vaccines, natural products and biologics. Its vision is to “drive innovation solutions for a healthier world.” One of the focus areas of development is in biosecurity and bioterrorism counter-measures. 9Bio is currently cementing strategic alliances with companies that meet its needs. 9Bio is constructing its research and development and secondary manufacturing facility in Bandar Enstek, Negeri Sembilan, Malaysia. It is expected to be completed by 2010. Pending the completion of its facilities, 9Bio intends to procure and distribute vaccines, natural products and biologicals to customers in the ASEAN region thereby building its brand name. 9Bio is primarily funded by the Government of Malaysia.

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 and other medical conditions that have resulted in significant unmet or under deserved public health needs. Our marketed product, BioThrax® (Anthrax Vaccine Absorbed), 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 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 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 products; ability to identify and acquire or in license products and product candidates that satisfy 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 Emergent’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and subsequent reports filed with the SEC. Emergent 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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