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pharmafile | April 30, 2008 | News story | Research and Development, Sales and Marketing |
Acambis awarded smallpox vaccine contract by US government
Acambis has received a $425 million, ten-year contract from the US Government agency, the Centers for Disease Control and Prevention, to provide it with a warm-base manufacturing capability for Acambis's ACAM2000 smallpox vaccine.
Under the terms of the contract, Acambis will establish a US-based manufacturing capability for ACAM2000, deliver against Centers for Disease Control and Prevention (CDC) orders for a minimum of nine million doses per annum for the eight years from year three to year ten of the contract and undertake activities to maintain its product license.
Acambis will establish a US-based manufacturing capability by transferring the ACAM2000 production process to Acambis's facilities in Canton, Massachusetts and Rockville, Maryland.
The CDC will procure at least nine million doses of ACAM2000 a year in contract years three to ten. The structure of the contract allows the CDC to purchase up to 39 million doses in contract years five to ten, should the need arise. This would increase the headline value of the contract to around $660 million. For the dose-delivery activities, Acambis will receive payment on a fixed-price basis.
In addition, Acambis will undertake license maintenance activities throughout the life of the contract on a cost-plus-fixed-fee basis. In the initial years, this includes conducting a Phase IV study in US military personnel, establishing an enhanced surveillance program and myocarditis registry to monitor the safety profile of the vaccine, and undertaking a bridging trial to support a license amendment for transfer of bulk production to its Canton, Massachusetts facility.
Of the $425 million revenues, approximately two-thirds relates to the delivery of doses in contract years three to ten, and one-third to license maintenance activities.
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Biovail granted approval for depression drug
Biovail has received approval from the FDA for its new drug application for Aplenzin, a once-daily formulation of bupropion hydrobromide, developed for the treatment of depression in adults.
Aplenzin is an alcohol-resistant formulation of a new bupropion salt and has been approved in 174mg, 348mg, and 522mg extended-release tablets. The 522mg dosage strength provides patients requiring the maximum allowable dose of bupropion the only single tablet, once-daily option.
Biovail remains in active partnership discussions for the commercialization rights for Aplenzin in the US.
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Agennix initiates Phase II study of sepsis drug
Agennix has initiated a randomized, double-blind, placebo-controlled Phase II study of oral talactoferrin alfa in patients with severe sepsis.
The study is being supported by a Small Business Innovative Research grant awarded from the National Institutes of Health. The total amount of the grant, $3 million, will provide the financial resources necessary to conduct the 190-patient study, which is designed to evaluate the safety and activity of talactoferrin in patients with severe sepsis. Results from the trial are anticipated in mid-2009.
This is the first clinical trial of talactoferrin in sepsis and is based on both the mechanism of action of talactoferrin, and promising preclinical data demonstrating a significant reduction in mortality by talactoferrin in a variety of animal models of sepsis, including some that cause 100% mortality in untreated animals.
The Phase II trial, which has started enrollment, will be conducted at approximately 25 US centers with investigators who are said to be very experienced in conducting trials in severe sepsis.
Kalpalatha Guntupalli, principal investigator for the Phase II study, said: "Talactoferrin is a very promising compound with broad immunomodulatory and anti-inflammatory properties. We hope that the preclinical results translate to the drug showing activity in the Phase II study by reducing the number of deaths in patients with severe sepsis.
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