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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
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Accumuli | LSE:ACM | London | Ordinary Share | GB00B0YMTT32 | ORD 0.25P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 31.25 | 0.00 | 00:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
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0 | 0 | N/A | 0 |
Acambis files US licence application for ARILVAX yellow fever vaccine Cambridge, UK and Cambridge, Massachusetts - 12 December 2003 - Acambis plc ("Acambis") (LSE: ACM, NASDAQ: ACAM) announces that it has filed a Biologics License Application ("BLA") with the CBER vaccine division of the US Food and Drug Administration ("FDA") to seek registration in the US of its ARILVAXTM vaccine to prevent yellow fever. Acambis recently completed a Phase III paediatric trial of ARILVAXTM, which provided additional data to supplement that generated from two previous Phase III adult trials. ARILVAXTM is a live, attenuated vaccine to prevent yellow fever. It is already registered in 10 countries, including the UK, and Acambis has the rights to market the vaccine in the US. Rights outside of the US are owned by the vaccine's manufacturer, Chiron Vaccines, part of California-based Chiron Corporation. Dr John Brown, Chief Executive Officer of Acambis, commented: "This submission marks a major achievement for Acambis, not only because this is our first ever BLA but also because it is the first time a BLA has been submitted electronically to the CBER vaccine division of the FDA. It is another significant milestone in our plan to establish a travel vaccines franchise in North America." -ends- Enquiries: Acambis plc Dr John Brown, Chief Executive Officer Tel: +44 (0) 1223 275 300 Lyndsay Wright, Director of Communications Gordon Cameron, Chief Financial Officer Tel: +1 (617) 761 4200 Financial Dynamics David Yates/ Charlie Armitstead Tel: +44 (0) 20 7831 3113 About Acambis Acambis is a leading developer of vaccines to prevent and treat infectious diseases. Recognised internationally as the leading producer of smallpox vaccines, Acambis is developing a second-generation smallpox vaccine which is currently undergoing clinical trials and, under a unique arrangement given the threat of smallpox being used as a bioterrorist weapon, is manufacturing emergency-use stockpiles of this investigational vaccine for the US Government and other governments around the world. Acambis is establishing a travel vaccines franchise through its US-based subsidiary Berna Products Corporation, which markets Vivotif®, the world's only oral typhoid vaccine, in North America. Acambis has a number of other potential travel vaccines in development and is conducting clinical trials of vaccines against yellow fever, Japanese encephalitis and dengue fever. Acambis recently became the first company to start human clinical trials of a vaccine targeting the West Nile virus, which has spread to 45 US States in the last four years. Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US. Its primary listing is on the London Stock Exchange (ACM) and its shares are listed in the form of American Depositary Receipts on Nasdaq (ACAM). More information is available at www.acambis.com. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: The statements in this news release that are not historical facts are forward-looking statements that involve risks and uncertainties, including the timing and results of clinical trials, product development, manufacturing and commercialisation risks, the risks of satisfying the regulatory approval process in a timely manner, the need for and the availability of additional capital. For a discussion of these and other risks and uncertainties see "Risk factors" in the Company's Annual Report and Form 20-F for the most recently ended fiscal year, in addition to those detailed in the Company's filings made with the Securities and Exchange Commission from time to time. These forward-looking statements are based on estimates and assumptions made by the management of Acambis and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements. END
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