The Office of the Biomedical Advanced Research and Development Authority has advised Emergent BioSolutions that while BARDA's Request for Proposal has been canceled, Emergent is encouraged to submit a proposal for the office's Broad Agency Announcement.
BARDA canceled the RFP for the procurement for rPA vaccines after a technical evaluation panel determined that no proposals submitted by vaccine developers could meet the ProjectBioShield statutory requirement of having the product ready for licensure within eight years.
An amendment issued by BARDA to BAA 09-34 at the same time, however, enable companies to submit proposals to obtain development funding for rPA vaccine candidates, which Emergent has been strongly encouraged to do by BARDA.
Emergent plans to submit its proposal to the BAA by the end of this year, in front of the due date of February 1, 2010 for the proposals.
This announcement also does not impact Emergent's $400 million procurement with the Centers for Disease Control and Prevention to manufacture and deliver 14.5 million doses of BioThrax for the Strategic National Stockpile.
“With this action, BioThrax remains a critical and long-term countermeasure for the US government,” Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, said. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA. Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”
BioThrax is currently being delivered under this contract with an expected completion of deliveries by September 2011. BioThrax is the only FDA licensed vaccine for the prevention of anthrax diseases.
“We believe that BioThrax will remain a premier product based on its recent enhancements, such as four-year dating, a reduced vaccination schedule and intramuscular route of administration, together with the potential for a further reduction in the vaccination schedule to a 3-dose primary series with a 3-year boost," Daniel J.Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, said. "BioThrax continues to be the product of choice for the USG and other customers seeking to address the anthrax threat.”
BARDA and Emergent are also in separate talks for a contract that would see BARDAA fund scale-up and related activities to obtain FDA licensure for large-scale production of BioThrax at Emergent's new 50,000-square-foot Lansing, Mich., manufacturing facility.
"I am proud that Lansing remains home to America's first line of defense against what experts say is the single biggest bioterror threat, anthrax," U.S. Rep. Mike Rogers, MI-08, said. "The good news about the cancellation of this particular proposal is HHS recommitted itself to the Lansing-made anthrax vaccine and has opened a new proposal for a next-generation anthrax vaccine for which Emergent has indicated it will compete.
"Rest assured, I will continue working to strengthen our nation's existing bioterror preparedness measures and protect national security jobs in Lansing."
Upon Urging of HHS, Emergent Plans to Submit Response to BAA by the End of This Year
BioThrax® Remains Sole Anthrax Vaccine Available for USG Procurement for at Least the Next 8 Years
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been advised by the Office of the Biomedical Advanced Research and Development Authority (BARDA) that the Request for Proposal (RFP) for the procurement of rPA vaccines has been cancelled in favor of a Broad Agency Announcement (BAA) for rPA vaccine development. According to BARDA officials, BARDA took this action after a technical evaluation panel determined that none of the vaccine developers submitting proposals could meet the Project BioShield statutory requirement of having a product ready for licensure within 8 years.
Simultaneously, BARDA issued an amendment to BAA 09-34 to enable companies to submit proposals to obtain development funding for rPA vaccine candidates. The due date for all proposals is February 1, 2010. During a meeting with company officials today, BARDA strongly encouraged Emergent to submit a proposal to this BAA. Emergent intends to submit its proposal by the end of this year.
This decision by BARDA has no impact on the company’s $400 million procurement contract with the Centers for Disease Control and Prevention (CDC) for the manufacture and delivery of 14.5 million doses of BioThrax® into the Strategic National Stockpile (SNS). The company is currently delivering BioThrax under this contract and expects to complete deliveries by September 2011. BioThrax is the only vaccine licensed by the FDA for the prevention of anthrax disease.
“With this action, BioThrax remains a critical and long-term countermeasure for the US government,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA. Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”
Emergent has recently resumed BioThrax scale-up activities within its new 50,000 sq. ft. state-of-the-art manufacturing facility in Lansing. In addition, BARDA and Emergent are in discussions for a separate contract under which BARDA would fund scale-up and related activities to obtain FDA licensure for large-scale production of BioThrax in this new facility. This new facility is designed as a campaignable, multi-product facility capable of producing up to 30 million doses of BioThrax per annum. With the addition of a second train, the capacity of the facility could be doubled to up to 60 million doses per annum.
“This is an exciting development because it positions BioThrax as the sole anthrax vaccine for USG procurement for at least the next eight years,” said Daniel J. Abdun-Nabi, president and chief operating officer, Emergent BioSolutions. “We believe that BioThrax will remain a premier product based on its recent enhancements, such as four-year dating, a reduced vaccination schedule and intramuscular route of administration, together with the potential for a further reduction in the vaccination schedule to a 3-dose primary series with a 3-year boost. BioThrax continues to be the product of choice for the USG and other customers seeking to address the anthrax threat.”
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 disease. 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 and www.biothrax.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, our expected revenue growth and net earnings for 2009, 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 success of 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 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, 2009 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.
Contacts
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
Globally, upstarts led by OLX move to edge Craigslist out of fast-growing local classified advertising markets and to crack its dominance in the U.S. By Douglas MacMillan
http://www.businessweek.com/print/technology/content/dec2009/tc2009126_680884.htm
Fabrice Grinda is bullish on Brazil and betting big on Internet classified ads in South America's largest country. This year, Grinda's New York-based company OLX opened an office in São Paulo, hired locals to translate the OLX site into Portuguese, asked top real estate brokers and auto dealers to offer low-priced listings, and recruited an executive from eBay (EBAY) in Latin America.
That approach has worked well for OLX in Mexico, Spain, Portugal, Russia, and a handful of other countries. And in September, OLX became the leading classifieds site in Brazil, surpassing local rival QueBerato in visitors, according to researcher comScore (SCOR). Craigslist, which has come to dominate the U.S. and other markets by charging no fees for most ads, is a distant No. 42 in Brazil, according to comScore. "I would like to think we have a chance to become the Craigslist of the rest of the world," Grinda says.
Craigslist is a worthy target. Founded in 1995, the popular site for free online listings has almost singlehandedly replaced the classifieds business of print newspapers and now dominates the U.S. online market. Yet critics say Craigslist has done little to innovate, ignoring opportunities to expand through search, social networking, and wireless communication. It's also been slow to penetrate some developing overseas markets. Internationally.Craigslist is "asleep at the wheel," says Grinda.
New players are raring to overhaul online classifieds. "Classifieds have gone through two chapters," says Craig Donato, co-founder and CEO of classifieds startup Oodle. First came newspapers, then Craigslist, he says. "We are focused on the third chapter." Craigslist declined to make an executive available to comment for this story.
Most of the innovation in classifieds has happened in specific areas such as job postings on Monster (MWW) and real estate listings on Trulia. "Those sites all have a lot of traffic and they co-exist with Craigslist," says Greg Sterling, founding principal of researcher Sterling Market Intelligence. Jobs are one of the few areas where Craigslist charges a fee for postings. It also charges for New York real estate listings.
No. 2 OLX tries harder with locals
Newcomers find it tough to challenge Craigslist's array of listings, which range from used Apple (AAPL) iPods, to beachfront properties in Miami, to solicitations for "casual encounters," often a euphemism for consensual sex.
Still, upstarts are making headway. In 2009, its fourth year, OLX became the world's second-most-visited online classifieds property, leapfrogging eBay's Kijiji sites and approaching Craigslist. Co-founder and CEO Grinda says the site encompasses 90 countries and 40 languages, compared with Craigslist's 70 countries and 6 languages. Unlike the more established site, OLX works hands-on with locals in all its major markets to translate its services and to relate to merchants in the community, Grinda says. Hands-off Craigslist relies mainly on local sellers to post listings. It does next-to-no marketing.
OLX makes money by promoting ads to the top of listings, charging $2 to $10 a week. The company saw its first profit in June and expects more than $10 million in sales this year. "OLX is the leading classifieds site in a bunch of markets that are small today but have the opportunity to be the same size as Craigslist," says Jeremy Levin, partner in Bessemer Partner Ventures, which contributed to OLX's $29 million in funding. "When you add them all up you get something that's substantially larger than the U.S. market and a business that generates—if it is successful—hundreds of millions of dollars in revenue." This year, Craigslist is expected to bring in $100 million in sales, according to the AIM Group. The closely held company doesn't report financial figures.
Craigslist's dated technology also gives rivals a lever, even in the U.S. Oodle, which started in San Mateo, Calif., in 2005, is pursuing what it considers a missed opportunity in connecting classifieds to social relationships on sites such as Facebook. Classifieds are "not about inviting some anonymous person over to my house to test-drive my car," says Oodle co-founder Donato. "We're trying to create a different experience, based on trust and reputation."
Craigslist ads search poorly
Oodle's approach is best demonstrated on Facebook Marketplace, a classifieds site on the social network. There, Oodle lets users buy and sell items in an environment where people and merchants use real names; users can quickly share good deals with Facebook friends. The company earns revenue by taking bids for prominently placed ads, similar to OLX, and through a subscription service that helps real estate brokers and other professionals find customers. Besides Facebook, Oodle has partnered with Wal-Mart (WMT), AOL, and News Corp.'s (NWS) MySpace. Oodle has raised more than $20 million in funding, including some from Greylock Partners.
Another complaint about Craigslist is that it lacks sophisticated search. Shoppers can't search within a limited geographic area—say, a tri-state area. Its listings typically don't get picked up by search engines such as Google (GOOG). San Francisco-based Vast is trying to help online classifieds become more searchable by working with publishers to help users quickly retrieve listings tailored to them. For example, Vast powers the search for cars on the Web site of Kelley Blue Book.
Such online niche sectors as travel, autos, and real estate are already worth at least $1 billion apiece, says Vast CEO Kevin Law. His company collects most of its money from fees paid by advertisers each time the search engine refers a customer. Some real estate brokers end up sharing a significant percentage—sometimes more than $1,000—upon completion of a sale.
Craigslist's new competitors may not soon edge out the classifieds king, says Kelsey Group analyst Peter Krasilovsky. Craigslist has the critical mass of millions of users that many upstarts struggle to achieve, he says. In the U.S., the service had 44.1 million unique users in October 2009, up 20% from a year earlier, according to comScore. "There's no evidence that Craigslist has been cannibalized," says Krasilovsky, who nevertheless contends there's room for new players to grow. "There's more participation in classifieds than there's ever been before."
Douglas MacMillan is a staff writer for BusinessWeek in New York.
http://www.businessweek.com/print/technology/content/dec2009/tc2009126_680884.htm
Emergent acquires manufacturing facility from MdBio and land from City of Baltimore for $8.2 million
ROCKVILLE, MD, November 13, 2009 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has completed the acquisition of a 55,000 square foot manufacturing facility from MdBio Foundation and the land on which the facility stands from the City of Baltimore for a total purchase price of $8.2 million. The facility, located within the City of Baltimore, Maryland, previously operated as a Food and Drug Administration (FDA) licensed facility used by an experienced contract manufacturing organization (CMO) to produce a number of FDA approved products.
“Emergent is excited about this new facility in Baltimore because it houses several suites capable of manufacturing multiple products at the same time,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Accordingly, this facility will provide the flexibility to conduct large-scale manufacturing of rPA while also producing other products in our pipeline.”
Emergent worked closely with the Maryland Department of Business and Economic Development (DBED), MdBio, the City of Baltimore, Baltimore Development Corporation, and other related governmental agencies to complete this transaction.
“Maryland is continuing to strengthen its biotechnology prowess by helping to grow industry leaders like Emergent BioSolutions,” said Governor Martin O’Malley. “The transaction between MdBio and Emergent will maximize the value of the BioProcessing Center by maintaining a bio-manufacturing infrastructure for Maryland’s bioscience community, enabling additional investment to be made in the Center and ensuring that those high paying, highly skilled jobs are created and remain in Maryland.”
Emergent BioSolutions employs over 600 employees across the globe, with over 150 employees located in its corporate headquarters in Rockville and one of its product development sites in Gaithersburg.
“This acquisition reflects our commitment to both continually creating jobs and investing additional capital in the State of Maryland,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We extend our sincere appreciation to the state and local governments for their ongoing support of our efforts to develop our local manufacturing capabilities and look forward to growing Emergent’s presence in the state.”
Mayor Sheila Dixon, commenting on the announcement, said, “The City of Baltimore is excited about welcoming Emergent BioSolutions to the Baltimore biotech community. With great research institutions such as Johns Hopkins and the University of Maryland as potential partners in the area, we know that Emergent will be a wonderful contributor in the future.”
“Emergent’s decision to expand in Maryland underscores not only our rich research and development environment, but also our mission to support the complete product development life cycle that includes bio manufacturing,” said Maryland Department of Business and Economic Development Secretary Christian S. Johansson. “The Department was pleased to work with MdBio Foundation and the Baltimore Development Corp. to bring this project to fruition.”
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 and www.biothrax.com.
About MdBio Foundation, Inc.
The MdBio Foundation, Inc. is a charitable and educational organization whose mission is to provide and support the State of Maryland’s bioscience community through bioscience awareness, education and workforce development programs including scholarships, post-doctoral conference and career expos, BioGENEius science competition and summer science camps. Since 2003, MdBio has operated the MdBioLab, an educational and well-known mobile bioscience laboratory that visits high schools throughout Maryland to educate youth on biosciences. Over the past six years, MdBioLab has held more than 2,800 classes with 55,000 students and 1,500 teachers. MdBio Foundation became an affiliate of the Tech Council of Maryland in 2006.
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, our expected revenue growth and net earnings for 2009, 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 our ability to obtain FDA approval to manufacture products or product candidates in the newly acquired facility; 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 success of 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 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 period ended September 30, 2009 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.
###
Chris Abraham, Rachel Sterne, and Chris Card at Scholastic in NYC http://tinyurl.com/yhc553y
