HHS orders 18 million doses of anthrax vaccine

first_img Besides the shelf-life bonus, the contract also provides for bonuses if the company makes progress toward winning regulatory approval for using the vaccine to help protect people after possible exposure to anthrax (postexposure prophylaxis, or PEP). The vaccine is currently approved only for preexposure use. Sep 26 Emergent BioSolutions news releasehttp://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-newsArticle&ID=1055689 The contract also includes $2.2 million to cover shipping costs for delivering doses to the national stockpile, the company said. HHS has a goal of acquiring a next-generation anthrax vaccine that would require fewer doses and cause fewer side effects. In 2004 the agency awarded an $877 million contract to VaxGen Inc., based in Brisbane, Calif., for 75 million doses of a vaccine based on a recombinant form of an anthrax protein called protective antigen. But last December HHS canceled the contract after problems with the vaccine’s stability caused VaxGen to miss a deadline for starting a phase 2 clinical trial. Under the contract, HHS also promises to pay Emergent up to $11.5 million for achieving certain steps toward winning a PEP indication for the vaccine, the company said. Officials said they expect to receive $8.8 million of that by the end of this year. Sep 26, 2007 (CIDRAP News) – The federal government has awarded a $400 million contract to Emergent BioSolutions for another 18.75 million doses of anthrax vaccine, with a bonus to be paid if the company wins approval for extending the vaccine’s shelf life. Funds for the anthrax vaccine come from Project BioShield, a $5.6 billion program that Congress established in 2004 to promote development of medical countermeasures for chemical, biological, radiological, and nuclear weapons by guaranteeing that the government would buy promising products. Sep 26 HHS news releasehttp://www.hhs.gov/news/press/2007pres/09/20070926a.html “HHS expects to issue a new rPA anthrax Vaccine Request for Proposals within the next month or so,” Wolfson added. HHS officials said in a statement today, “Today’s acquisition, in addition to the current stockpile of anthrax vaccine, will allow HHS to maintain a stockpile of at least 10 million doses of anthrax vaccine through 2011. In addition, HHS has two current contracts for the acquisition of anthrax antitoxins, to treat individuals with advanced anthrax disease.” See also: center_img Emergent BioSolutions, based in Gaithersburg, Md., previously sold a total of 10 million doses of AVA to HHS under contracts awarded in May 2005 and May 2006, according to a company news release. The 3-year contract for BioThrax vaccine, also known as Anthrax Vaccine Adsorbed (AVA), is worth up to $448 million, according to the US Department of Health and Human Services (HHS). The vaccine will go into the Strategic National Stockpile of drugs and medical supplies for civilian use. HHS still aims to acquire 75 million doses of a new anthrax vaccine, or enough to immunize 25 million people, Wolfson told CIDRAP News by e-mail. He said the agency published a request for information from industry on a recombinant protective antigen (rPA) vaccine in May. The vaccine has an official 3-year shelf life, but the company applied to the Food and Drug Administration (FDA) last year to extend the shelf life to 4 years, the company said. If the FDA approves the application before the new contract expires in September 2010, the company will receive about $34 million to reflect an increase in the vaccine price. The company won’t get any of the money if the FDA doesn’t approve the change before the contract expires. The stockpile contains enough antibiotics to treat 40 million people for anthrax, according to Marc Wolfson, a spokesman for the Office of the Assistant Secretary for Preparedness and Response. AVA, developed in the 1950s, is the only anthrax vaccine licensed in the United States. It requires six doses, with an annual booster recommended thereafter. More than 1.6 US military personnel have received the vaccine since 1998, but some have protested or refused the vaccine because of concern about side effects. In announcing the purchase, Rear Adm. Craig Vanderwagen, MD, HHS assistant secretary for preparedness and response, said, “Together with the already substantial supply of antibiotics, our nation’s first line of defense against an anthrax attack, this additional AVA anthrax vaccine will further broaden the stockpile’s medical countermeasures.” But major biotechnology companies showed little interest in the program. As a result, last December Congress passed a bill designed to strengthen the program. The bill established the Biomedical Advanced Research and Development Authority within HHS, which can pay contractors when they achieve development milestones, instead of requiring them deliver finished products before they can get paid. Dec 20, 2006, CIDRAP News story “HHS cancels VaxGen anthrax vaccine contract”http://www.cidrap.umn.edu/cidrap/content/bt/anthrax/news/dec2006vaxgen.htmllast_img read more

​LD Pensions picks Acadian for first active quant mandate

first_img“In order to assess where the results come from, it has been important for us to choose a partner with transparent and understandable procedures”Kristoffer Birch, head of equities at LD Pensions“So in order to assess where the results come from, it has been important for us to choose a partner with transparent and understandable procedures,” he said.In February, LD Pensions said the mandate being tendered was for an initial amount of around DKK1bn (€134m), to be invested actively in both developed and emerging markets, adding that the product offered had to have at least €500m of available capacity at the time of signing the deal.LD Pensions has been unable to say in advance how much its mandates will be for because of the unpredictability of the eventual size of LD Feriemidler. That fund was first set to amount to around DKK100bn, though much was expected to be in the form of debt owed by employers rather than investible assets.In June, however, Danish politicians opted give workers early access to three of their five weeks of holiday allowances that had been due to be managed by LD Funds, in order to boost the COVID-hit domestic economy.This means LD Feriemidler is now to have total assets of around DKK40bn.Asked by IPE how much Acadian would now be managing, Birch said: “Any amount we are going to invest in the coming year is very uncertain due to the uncertainty around the holiday allowance fund.”LD Pensions would assess the funding after the summer, he said.Looking for IPE’s latest magazine? Read the digital edition here. Denmark’s LD Pensions has chosen US firm Acadian Asset Management from 10 firms competing to run the global active quantitative equities it put out to tender in February, citing the firm’s “transparent and comprehensible” process as a plus.But the already uncertain amount of pensions money the winning manager will have to invest has now become even less predictable, after a political decision last month more than halved the size of the holiday allowance fund LD Pensions manages.Kristoffer Birch, head of equities at the Frederiksberg-based pensions manager, said: “Acadian has developed a very interesting tool to predict stock returns, based on proprietary signals.”This differed from the method used by both LD Pensions’ smart beta managers and its more traditional active managers, so would be a “really exciting addition” to the equity portfolio. “On top of this, the fact that Acadian bases its processes on solid research made the choice even easier,” Birch said.The mandate Acadian has won is the first active quant contract for LD Pensions, and will be used to invest assets of both of the two pension funds LD Pensions runs.These are LD Dyrtidsmidler, a declining fund based on cost-of-living allowances granted to workers in 1980, and LD Feriemidler, the new fund consisting of vacation entitlements Danish employees are being granted as a result of a change in the law.In the original tender, the Danish firm said the quant investment product had to be provided as a segregated mandate, and be tailored LD Pensions’ needs by incorporating its exclusion list, tracking error as well as other restrictions.Announcing the mandate award, LD Pensions said that while traditional equity managers often ignored short-term stock movements to focus on the long-term growth potential of companies, Acadian tried to predict short-term movements.The US manager did this both by using high-frequency traditional data such as price per share relative to earnings, the Danish firm said, as well as more alternative methods including quantitative text analysis of company announcements.Birch said predicting stock returns was difficult, and quantitative stock selection with new techniques such as machine-learning could quickly become a black-box.last_img read more