Fuad El-Hibri Wire

“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.

Emergent BioSolutions Inc. today announced the appointment of Allen Shofe to the position of Vice President of Government Affairs. Fuad El-Hibri appoints Allen Shofe Vice President of Government Affairs

Emergent BioSolutions Appoints Allen Shofe Vice President of Government Affairs

GAITHERSBURG, Md., Sept. 15 /PRNewswire/ — Emergent BioSolutions Inc. today announced the appointment of Allen Shofe to the position of Vice President of Government Affairs.  In this position, Mr. Shofe will be responsible for designing, implementing and overseeing all aspects of the company’s domestic and international government affairs initiatives.

“Allen is a versatile and highly astute government relations and public affairs executive,” said Fuad El-Hibri, CEO of Emergent BioSolutions.  “His government affairs expertise and extensive network of professional contacts throughout the United States and Europe will prove invaluable as we continue our efforts to become a global leader in our field.”

Mr. Shofe has more than 15 years experience in government relations and government affairs at the Federal and state levels, as well as in the international arena.  Mr. Shofe previously held the position of Director of Federal Government Relations at Eli Lilly and Company, where he managed a series of government initiatives, including those that focused on intellectual property, patent law and tort reform.  Mr. Shofe received his BA in International Relations/Diplomacy at the University of Minnesota and an LL.M, Master of Laws from the University of Leicester in the United Kingdom. “I look forward to the opportunity to help advance Emergent BioSolutions into a world class biopharmaceutical company,” said Mr. Shofe.  “This company has such a promising future, and to be a part of its growth and success is something I am extremely proud of.”

About Emergent BioSolutions
Emergent BioSolutions Inc., formed in 2004, is dedicated to the research, development and manufacture of novel products which harness the immune system to treat and prevent disease.  These include vaccines and related products for prophylactic and therapeutic use against common infectious diseases and biological weapons of mass destruction.  The company currently employs more than 450 people with facilities in Gaithersburg and Frederick, Maryland, Lansing, Michigan, Berkshire, U.K. and Munich Germany.  More information about Emergent BioSolutions and its subsidiaries can be found at http://www.ebsi.com

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.

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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
Tags: Bacillus anthracis, BioThrax, Emergent BioSolutions, Government of India, India, United States, US Food and Drug Administration, Vaccine

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