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FDA Advisory Committee Unanimously Votes in Favor of Acambis' Smallpox Vaccine

Smallpox Vaccine Supplied to US Government for Strategic National Stockpile Receives Positive Vote From Panel of Infectious Disease and Vaccine Experts

CAMBRIDGE, England and CAMBRIDGE, Massachusetts, May 17, 2007 /PRNewswire-FirstCall/ -- Acambis plc (Acambis) , a leading biotechnology company targeting infectious diseases with novel vaccines, announces that the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration (FDA) today voted unanimously that Acambis' smallpox vaccine, ACAM2000, is both safe and efficacious.

The Advisory Committee was asked to review whether the efficacy and safety data were sufficient to support the use of ACAM2000 in situations where it is determined that there is high risk of exposure to smallpox virus. At a meeting held in Gaithersburg, Maryland, the panel voted 11-0 in favor on both the safety and efficacy of ACAM2000.

The Advisory Committee provides the FDA with independent, non-binding advice from outside experts on issues related to vaccines and biological products. While the Committee provides recommendations to the Agency, the FDA makes all final decisions regarding licensure.

To date, Acambis has supplied 192.5 million doses of ACAM2000 to the US Centers for Disease Control and Prevention (CDC) for the Strategic National Stockpile (SNS) under an FDA Investigational New Drug applicaton. The CDC procured ACAM2000 as part of the Government's policy, adopted after the events of 9/11, to establish a smallpox vaccine stockpile large enough to provide a dose for every man, woman and child in the US.

Acambis developed ACAM2000 under contracts with the CDC and conducted clinical development of the vaccine in parallel with the manufacturing program. ACAM2000 was derived from the smallpox vaccine used during the global eradication programme and is manufactured using modern cell-culture techniques. It is intended to be used for protection of persons determined to be at high risk for smallpox infection, including vaccination of military personnel being deployed to certain regions.

Ian Garland, Acambis' Chief Executive Officer, said:

"We welcome the Advisory Committee's recommendation and look forward to the FDA's decision on ACAM2000's license application. Our ACAM2000 smallpox vaccine is already an important component of the US Government's emergency preparedness strategy and SNS stockpile, and we hope to provide the US with long-term protection against this bioterrorist threat."

Acambis is in discussions with the CDC for a contract to provide the US Government with long-term manufacturing capability of ACAM2000 located entirely in the US and license maintenance activities. Licensure of ACAM2000 is a prerequisite for awarding this contract.

The FDA has identified August 31, 2007 as the target date for the FDA's license application response for ACAM2000 under the Prescription Drug User Fee Act.

About smallpox

Smallpox is a contagious and sometimes fatal disease marked by fever and a progressive skin rash. The majority of patients with smallpox recover, but death may occur in up to 30% of cases. Many smallpox survivors have permanent scars over large areas of their body (1).

In 1980, smallpox was declared eradicated following worldwide vaccination programmes and commercial manufacture of licensed smallpox vaccines ceased. However, following the events of September and October 2001, the CDC has identified smallpox as a high-priority agent posing the highest risk to the public and national security (2).

About ACAM2000

Acambis' investigational smallpox vaccine, ACAM2000, is derived from Dryvax(R), a first-generation vaccine used during the global smallpox eradication programme. Unlike previously licensed smallpox vaccines, ACAM2000 is manufactured using modern cell-culture techniques designed to comply with current Good Manufacturing Practice standards.

ACAM2000 has been tested in just under 3,000 subjects and its clinical safety has been shown to be the same or better than that of Dryvax. Acambis submitted a Biologics License Application for licensure of ACAM2000 in 2006.

About Acambis

Acambis is a leading biotechnology company targeting infectious diseases with novel vaccines. Acambis' development-stage pipeline includes vaccines that could either offer improvements over existing products or target unmet medical needs. ChimeriVax-JE, Acambis' most advanced product in the non-biodefence pipeline, has to date shown an excellent safety and efficacy profile following pivotal Phase 3 trials. It is currently undergoing paediatric trials in India and is partnered with sanofi pasteur and Bharat Biotech. Acambis' proprietary ChimeriVax technology, developed in association with St Louis University, has also been used to develop ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing, making it the most advanced investigational vaccine against the West Nile virus. Acambis also has the only vaccine in development against Clostridium difficile bacteria, a leading cause of hospital-acquired infections. Recognized internationally as the leading producer of smallpox vaccines, Acambis is developing an investigational smallpox vaccine, ACAM2000, and is manufacturing emergency-use stockpiles of this investigational vaccine for the US Government and other governments around the world.

Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is listed on the London Stock Exchange (ACM).

"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 relevant risk sections in the Company's latest Annual Report and Form 20-F, in addition to those detailed on the Company's website and 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.

(1) CDC Web site

(2) CDC Web site

CONTACT: Enquiries: Acambis: Lyndsay Wright, VP, Communications and IR:tel +44-(0)-1223-275-300; Tracy Paczkowski, Communications Specialist: tel:+1-617-761-4200

Ticker Symbol: (:ACAMF)

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Posted: May 2007

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