CAMBRIDGE, England, and CAMBRIDGE, Mass., Feb. 25 /PRNewswire-FirstCall/ -- Acambis plc ("Acambis") (Nasdaq: ACAM; LSE: ACM) announces that its US subsidiary, Acambis Inc., has been awarded a $9.2m contract by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, to develop a new Modified Vaccinia Ankara ("MVA") vaccine.
MVA is a weakened form of the current generation of smallpox vaccines and, as such, should allow the safe inoculation of "at risk" people with weakened immune systems, who would otherwise be unable to be vaccinated against smallpox.
The contract requires Acambis to develop a new MVA vaccine, deliver several thousand doses of the vaccine to NIAID and conduct a Phase I clinical trial in healthy adults. The contract is structured on a "cost plus fixed fee" basis. For this contract, Acambis has partnered with Baxter Healthcare Corporation, its major shareholder and strategic partner. Acambis is acting as the prime contractor and Baxter as sub-contractor, leveraging each other's strengths and capabilities. Acambis expects to hold the exclusive commercial rights to the MVA vaccine.
The NIAID can award additional funds under the contract for expanded Phase II clinical trials in healthy adults and Phase I and Phase II studies in "at risk" populations. The estimated value of Acambis undertaking the work required by this additional element is $26.5m.
In addition, the US Government has declared its intention to stockpile MVA vaccine. The NIAID plans to issue a Request for Proposals for the production of up to 30 million doses of MVA vaccine constituting the US Government's stockpile for emergency use.
Under contracts dating from September 2000 and November 2001, Acambis is also producing smallpox vaccine for the US Government as part of programme to produce a stockpile sufficient to provide a dose for every man, woman and child in the US.
Dr John Brown, Chief Executive Officer, said: "We recognise the importance of MVA as a product that complements our existing smallpox vaccine. With the addition of MVA to our ACAM2000 vaccine, we have established a vaccine franchise that enables us to offer governments the package of products they need to protect all their people against smallpox.
"Winning this first contract puts us in a great position to tender for the second contract to supply the US Government's MVA stockpile," Dr Brown commented.
Acambis
Acambis is a biopharmaceutical company discovering, developing and manufacturing vaccines to prevent and treat infectious diseases. It has operations in Cambridge, UK, and in Cambridge, Massachusetts, US. It has a broad portfolio of vaccine product candidates undergoing clinical trials and technology platforms that provide the basis for further vaccine product candidates.
Smallpox virus
Smallpox -- caused by the variola virus -- has killed more people than any other infectious disease. In 1980, following a programme of mass vaccination, the World Health Organization declared the global eradication of smallpox.
Smallpox vaccines
Smallpox vaccine is made from a live virus related to smallpox called vaccinia. The vaccine stimulates the immune system to react against the vaccinia virus and develop immunity to it. Immunity to vaccinia also provides immunity to smallpox. Although adverse reactions are rare in healthy recipients of the conventional vaccine, there is a proportion of the population that is more at risk as these people's immune systems have been compromised by disorders such as HIV or who suffer from eczema. They may benefit from the use of MVA.
MVA
MVA is a weakened form of vaccinia. It has a substantial clinical history due to its extensive use as a vaccine to immunize over 120,000 people in Germany in the 1970s. It has a very limited ability to replicate.
Acambis' US Government smallpox vaccine contracts
Concerns about the potential use of smallpox as a bioterrorist weapon led the US Government to award Acambis a contract in September 2000 to develop a new second-generation smallpox vaccine (ACAM1000) and establish a 40 million-dose stockpile. That contract was accelerated in October 2001 to require the manufacture of 54 million doses. In November 2001, Acambis was awarded a second US Government contract requiring it to manufacture a further 155 million doses of smallpox vaccine (known as ACAM2000) as part of the US Government's plan to produce an emergency stockpile large enough to provide a dose of vaccine for every man, woman and child in the US. Acambis is currently conducting clinical trials of the vaccine with a view to applying to the regulatory authorities around the end of 2003 for licensure.
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