Acambis related Press Releases

Acambis reports positive data from trials of universal influenza A vaccine

Maureen Martino — Thu, 10 Jan 2008 08:31:40 -0500

Acambis reports positive data from trials of universal influenza A vaccine

Cambridge, UK and Cambridge, Massachusetts – 3 January 2008 – Acambis plc (Acambis) (LSE: ACM), a leading vaccine development company, announces preliminary results from a Phase 1 clinical trial and a pre-clinical challenge study of its ACAM-FLU-A™ vaccine.

ACAM-FLU-A™ is a recombinant vaccine linked to a Hepatitis B core protein. It targets M2e, a conserved region of all influenza ‘A' strains. This approach could overcome the need for annual vaccine reformulations and, since all pandemic influenza strains are type ‘A', it could also be a potential vaccine against pandemics.

The Phase 1 trial of ACAM-FLU-A™ evaluated the vaccine's safety and ability to generate an immune response. The randomised, double-blind, placebo-controlled trial was conducted at multiple centres in the US and involved 79 subjects. The study consisted of four arms – ACAM-FLU-A™ alone, ACAM-FLU-A™ plus aluminium hydroxide adjuvant, ACAM-FLU-A™ plus QS-21 adjuvant and placebo – and the subjects received two doses. QS-21 Stimulon® adjuvant is an investigational adjuvant (immune stimulant) provided under an option agreement with Antigenics Inc., which has recently been converted to a non-exclusive licence and supply agreement.

The trial results demonstrate that ACAM-FLU-A™ is well tolerated and immunogenic. Whilst immune responses were seen in all vaccinated groups, the highest immune responses occurred in the group vaccinated with ACAM-FLU-A™ plus QS-21. In this group, 90% of subjects seroconverted.

In parallel with the Phase 1 trial, Acambis has conducted a pre-clinical study to test whether an M2e-based vaccine could protect against the Vietnam 2004 strain(1) of H5N1 avian influenza (bird flu). The H5N1 virus was lethal in the placebo-treated group, whereas 70% of those in the group vaccinated with the M2e-based vaccine from the same influenza strain were protected.

Acambis plans to submit these results for publication in due course.

Ian Garland, Chief Executive Officer of Acambis, said:

“We are very excited about these new data and believe that this highly innovative vaccine could be very attractive in such a competitive field. We will explore partnering in parallel with continued development of ACAM-FLU-A™.'

Michael Watson, Acambis' Executive Vice President, Research & Development, added:

“M2e is one of the most discussed new approaches for influenza vaccination. These are exciting data as they show that our ACAM-FLU-A™ vaccine can generate a robust M2e antibody response and that M2e-based vaccines can protect against H5N1 avian influenza. We believe that these results confirm we have an approach worthy of further development.'

Influenza is a major global threat, which the WHO estimates causes between 250,000 and 500,000 deaths every year around the world(2). Currently, influenza vaccines are reformulated each year to address virus mutations.

Acambis' vaccine candidate, which is protected by extensive intellectual property, was developed using technology licensed from VIB that was invented by Walter Fiers, Emeritus Professor of the VIB Department for Molecular Biomedical Research at the University of Ghent, Belgium.

-ends-

Enquiries:

Acambis plc
Ian Garland, Chief Executive Officer
Elizabeth Jones, Chief Financial Officer
Lyndsay Wright, VP, Communications and IR
Tel: +44 (0) 1223 275 300

Brunswick
Jon Coles / Justine McIlroy / Annabel Entress
Tel: +44 (0) 20 7404 5959

Editor's notes

About the influenza virus and influenza vaccines

Today, seasonal influenza represents the single largest vaccine market in the world, worth an estimated $2.2bn and projected to grow to $4bn by 2010(3). It is still a major global threat, which the WHO estimates causes between 250,000 and 500,000 deaths every year around the world(2).. Immunity against influenza viruses, whether acquired by natural infection or immunisation, is typically transient due to the virus's ability to mutate and evade pre-existing immunity. Accordingly, current licensed vaccines are updated on an annual basis to target most effectively the presently circulating strains.

Pandemic influenza viruses are sufficiently distinct from seasonal epidemic viruses that new vaccines must be developed to address them. Pandemic influenza vaccines, primarily targeting avian H5N1 viruses, are being stockpiled for emergency use. However, the efficacy of these vaccines may be negatively impacted by continual mutations in circulating H5N1 strains. Experts believe the next pandemic could cause disease in two billion people. Based on best-case scenarios modelled on the mild pandemic of 1968, this could result in two to seven million deaths. However, if the death toll associated with the 1918 influenza virus were applied to today's world population, there could be 180 million to 360 million deaths globally(4).

About ACAM-FLU-A™

ACAM-FLU-A™ is a recombinant vaccine that uses a hepatitis B core protein (HBc) to present M2e, the extracellular domain of the ion channel protein M2(5). M2 is one of the three proteins expressed on the surface of the ‘A' strain influenza virus and of infected cells alongside haemagglutinin (HA) and neuraminidase (NA). Unlike HA and NA, M2 is highly conserved, albeit under natural conditions not easily recognised by the immune system. M2e could elicit an immune response to all influenza ‘A' strains. As such, ACAM-FLU-A™ has the potential to be both a universal pandemic or pre-pandemic influenza vaccine and part of a universal seasonal vaccine. Historically, influenza pandemics have been caused by ‘A' strains of the virus while seasonal vaccines target both ‘A' and ‘B' strains of the virus.

References

(1) The Vietnam 2004 Clade 1 avian influenza virus has been used by manufacturers to develop and produce pre-pandemic vaccines. http://www.who.int/csr/disease/avian_influenza/guidelines/recommendationvaccine.pdf
(2) WHO: http://www.who.int/mediacentre/factsheets/fs211/en/
(3) Datamonitor
(4) Kamps-Hoffmann-Preiser, Influenza Report 2006
(5) Neirynck et al., Nature Medicine, 5, 1157, 1999

About Acambis

Acambis is a leading vaccine company developing novel vaccines that address significant unmet medical needs or substantially improve standards of care. ChimeriVax™-JE, Acambis' most advanced product in its development-stage 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 has established a global collaboration with Sanofi Pasteur for further development and commercialisation of the vaccine. ChimeriVax™ has also been applied to development of Sanofi Pasteur's tetravalent dengue vaccine, which has successfully demonstrated proof-of-concept in a Phase 2 trial by generating 100% seroconversion to all four dengue virus serotypes.

Acambis also has the only vaccine in development against Clostridium difficile bacteria, a leading cause of hospital-acquired infections. C. difficile is estimated to cause at least 360,000 cases of C. difficile-associated disease in the US alone with annual costs to the healthcare system of $3.2bn. Acambis' influenza programme aims to develop a universal vaccine against influenza, for which a universal ‘A' strain vaccine, ACAM-FLU-A™, has completed a Phase 1 trial. It also includes various further vaccine candidates in the research and pre-clinical stages.

Acambis is recognised internationally as the leading producer of smallpox vaccines. Acambis' ACAM2000™ (Smallpox (Vaccinia) Vaccine, Live) vaccine for active immunisation against smallpox disease for persons determined to be at high risk for smallpox infection was licensed by the US Food and Drug Administration in August 2007. Acambis has manufactured doses of ACAM2000™ for emergency-use stockpiles held by the US Government and several other governments around the world. For safety and prescribing information, please refer to www.acambis.com/ACAM2000.

Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is listed on the London Stock Exchange (ACM). More information is available at www.acambis.com.

“Safe Harbour' statement
Statements contained within this news release may contain forward-looking comments, which involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions and forward-looking references in this news release are subject to the satisfactory progress of research which is, by its very nature, unpredictable. Forward projections reflect management's best estimates based on information available at the time of issue.

PRESS RELEASE: Acambis Joins Forces With Sanofi Pasteur to Develop West Nile Virus Vaccine

Maureen Martino — Tue, 13 Nov 2007 12:17:42 -0500

Acambis Joins Forces With Sanofi Pasteur to Develop West Nile Virus Vaccine

CAMBRIDGE, England and CAMBRIDGE, Massachusetts, November 1 - No Human Vaccine Currently Exists Against the West Nile Virus, Which has Caused 3,265 Cases and 92 Deaths in the US so far in 2007; Collaboration Aims to Bring Leading West Nile Virus Vaccine Candidate to Market as Rapidly as Possible

Acambis plc (Acambis) , a leading vaccine development company, announced today that it has signed an exclusive global collaboration agreement with Sanofi Pasteur, the vaccines division of sanofi-aventis Group, for the development and marketing of Acambis' ChimeriVax(TM)-West Nile vaccine, which is the leading West Nile vaccine in development.
"Since 1999 when it was first detected in the US, the West Nile virus has spread across the entire continental United States, causing 27,240 cases and 1,054 deaths," commented Ian Garland, Chief Executive Officer of Acambis. "Vaccination is the ideal approach to tackling this disease and, through this unique collaboration, we aim to bring this vaccine to market as rapidly as possible."

"Providing a vaccine against West Nile disease may now be within reach. This vaccine candidate is the most promising in the industry and would help meet a growing public health need," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur.

Acambis started developing a West Nile vaccine in 1999, shortly after the virus was first identified in the US. Under the terms of the agreement, Acambis will continue to perform ChimeriVax(TM)-West Nile development activities, up to and including the filing of a license application in the US.

Acambis will receive an upfront payment of $10m in 2007 from Sanofi Pasteur, and would be eligible for pre- and post-marketing milestone payments of up to $70m based on product approval and sales in the US market. It would also be entitled to receive development funding and royalties on net sales of the vaccine. In addition, if the vaccine were registered in other countries, Acambis would be entitled to further post-marketing milestone payments and royalties.
There is currently no human vaccine for the prevention of West Nile virus-related disease and no specific treatment. As of 6 November 2007, 3,265 cases of disease and 92 deaths had been recorded in 42 US States by the US Centers for Disease Control and Prevention (CDC) this year. The CDC has identified those aged 50 and above as being most at risk of severe West Nile virus-related disease. In the US, this population totals more than 87 million people.

Acambis is currently conducting a Phase 2 safety, tolerability and immunogenicity trial of ChimeriVax-West Nile in the US in adults aged 41-64 years and 65 years and above. Preliminary data from a previous Phase 2 dose-ranging trial in healthy adults have shown that over 98% of subjects seroconverted 28 days after a single vaccination. The safety profile of the vaccine has been shown to be satisfactory. Acambis' West Nile vaccine candidate uses its proprietary ChimeriVax(TM) technology, which was developed in association with St Louis University.

About West Nile virus
West Nile virus is a potentially serious illness. Experts believe it is established as a seasonal epidemic in North America that flares up in the summer and continues into the fall. About one in 150 people infected with West Nile virus will develop severe illness. The severe symptoms can include high fever, headache, neck stiffness, stupor, disorientation, coma, tremors, convulsions, muscle weakness, vision loss, numbness and paralysis. These symptoms may last several weeks, and neurological effects may be permanent. Up to 20% of the people who become infected have symptoms such as fever, headache, body aches, nausea, vomiting, and sometimes swollen lymph glands or a skin rash on the chest, stomach and back. Symptoms can last for as short as a few days, though even healthy people have become sick for several weeks. Approximately 80% of people who are infected with West Nile virus will not show any symptoms at all.

About Acambis
Acambis is a leading vaccine company developing novel vaccines that address significant unmet medical needs or substantially improve standards of care. ChimeriVax(TM)-JE, Acambis' most advanced product in its 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(TM) technology, developed in association with St Louis University, has also been used to develop ChimeriVax(TM)-West Nile, which is undergoing Phase 2 clinical testing, making it the most advanced investigational vaccine against the West Nile virus. Acambis has established a global collaboration with Sanofi Pasteur for further development and commercialization of the vaccine. ChimeriVax(TM) has also been applied to development of Sanofi Pasteur's tetravalent dengue vaccine, which has successfully demonstrated proof-of-concept in a Phase 2 trial by generating 100% seroconversion to all four dengue virus serotypes.

Acambis also has the only vaccine in development against Clostridium difficile bacteria, a leading cause of hospital-acquired infections. C. difficile is estimated to cause at least 350,000 cases of C. difficile-associated disease in the US alone with annual costs to the healthcare system of $1.1bn. Acambis' influenza program aims to develop a universal vaccine against influenza, for which a universal 'A' strain vaccine, ACAM-FLU-A, is currently being tested in a Phase 1 trial, and also includes various further vaccine candidates in the research and pre-clinical stages.

Acambis is recognised internationally as the leading producer of smallpox vaccines. Acambis' ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) vaccine for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection was licensed by the US Food and Drug Administration in August 2007. Acambis has manufactured doses of ACAM2000 for emergency-use stockpiles held by the US Government and several other governments around the world. For safety and prescribing information, please refer to http://www.acambis.com/ACAM2000.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is listed on the London Stock Exchange (ACM). More information is available at http://www.acambis.com/.

"Safe Harbor" statement
Statements contained within this news release may contain forward-looking comments, which involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions and forward-looking references in this news release are subject to the satisfactory progress of research which is, by its very nature, unpredictable. Forward projections reflect management's best estimates based on information available at the time of issue.

PRESS RELEASE: FDA Approves ACAM2000 Vaccine for Protection Against Smallpox

Maureen Martino — Tue, 04 Sep 2007 11:02:09 -0400

FDA Approves ACAM2000 Vaccine for Protection Against Smallpox

CAMBRIDGE, England and CAMBRIDGE, Massachusetts, September 3 /PRNewswire-FirstCall/ -- Acambis plc (Acambis) , a leading vaccine company, announced today that the US Food and Drug Administration (FDA) has approved its ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) vaccine for protection against smallpox. The vaccine is intended for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 is the first biodefense vaccine to be approved as part of the US response to the 2001 bioterrorism attacks.

Acambis developed ACAM2000 under contracts with the US Centers for Disease Control and Prevention (CDC). To date, Acambis has supplied 192.5 million doses of ACAM2000 to the CDC for the US Strategic National Stockpile (SNS), which was established to provide medicines to the American public in the event of a public health emergency, such as a terrorist attack.

Having produced a stockpile of ACAM2000 doses for the SNS, Acambis and the CDC are now in advanced discussions on a "warm-base manufacturing" contract for Acambis to provide ACAM2000 production and license maintenance activities for the long term.

Ian Garland, Acambis Chief Executive Officer, said: "The licensure of ACAM2000 is a significant milestone not only for Acambis but also for the US Government in its efforts to ensure a state of preparedness against the threat of smallpox. This has been a highly successful collaboration between Acambis and the CDC, and Acambis is very proud to have played a role in providing this countermeasure against a significant bioterrorism threat. We look forward to finalizing an agreement with the CDC that will ensure that a US-based capability to manufacture ACAM2000 remains at the ready."

ACAM2000 was developed to be a modern smallpox vaccine with a safety and efficacy profile comparable to the previous US vaccine but manufactured using advanced production capabilities. Until the development of ACAM2000, smallpox vaccines were last manufactured in the US in 1982 and were produced from calf lymph.

ACAM2000, which is a single-dose vaccine, is the primary smallpox vaccine for use in an emergency and forms the majority of the US Government's smallpox vaccine stockpile.

The clinical trials data generated on ACAM2000 were reviewed by the FDA Vaccines and Related Biological Products Advisory Committee in May 2007, which voted unanimously (11-0) in favor of the vaccine's safety and efficacy. In addition to being stockpiled for emergency use, ACAM2000 will be used by the US Department of Defense for protection of military personnel.

Important safety information

ACAM2000 may not protect all persons exposed to smallpox. ACAM2000 is contraindicated for individuals with severe immunodeficiency who are not expected to benefit from the vaccine. These individuals may include persons who are undergoing bone marrow transplantation or persons with primary or acquired immunodeficiency states who require isolation.

- The most serious adverse events associated with smallpox vaccination are myocarditis, pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, and erythema multiforme major (including STEVENS-JOHNSON SYNDROME) and eczema vaccinatum resulting in permanent sequelae or death, ocular complications, blindness, and fetal death have occurred following either primary vaccination or revaccination with smallpox vaccines.

- The most common side effects following smallpox vaccination include itching, swollen lymph nodes, sore arm, fever, headache, body ache, mild rash, and fatigue.

Full prescribing information may be obtained by calling Acambis at +1-866-440-9440 (toll free) or +1-617-866-4500.

About smallpox

Smallpox is a highly contagious disease caused by the variola virus, a member of the Orthopox virus family. It is one of the most devastating diseases known to humanity, with a mortality rate as high as 30%. In 1967, the World Health Organization embarked upon an intensified vaccination campaign to eliminate smallpox, which culminated in the successful eradication of the disease globally by 1980.(1)

By the mid-1980s, there were only two known repositories of variola virus: the Institute of Virus Preparations in Russia, and the US CDC. The events in the US in September and October 2001 highlighted the risk that the variola virus might be used as an agent of bioterrorism.(2) Governments around the world are taking precautionary measures to be ready to deal with a potential smallpox outbreak.

About ACAM2000

- ACAM2000 is a live, vaccinia virus smallpox vaccine indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

- It is a single-dose vaccine administered percutaneously.

- It was derived by plaque purification from Dryvax(R), the licensed calf lymph-produced vaccine that was extensively used in the smallpox eradication program.

- ACAM2000 is manufactured in Vero cells using modern cell-culture techniques designed to comply with current Good Manufacturing Practice standards.

- Acambis has supplied more than 200 million doses of ACAM2000 under an FDA Investigational New Drug application to 15 governments around the world, including the US.

Notes and references (1) WHO: http://www.who.int/mediacentre/factsheets/smallpox/en/ (2) CDC: http://www.bt.cdc.gov/agent/smallpox/overview/disease-facts.asp About Acambis

Acambis is a leading vaccine company developing novel vaccines that address significant unmet medical needs or substantially improve standards of care. ChimeriVax(TM)-JE, Acambis' most advanced vaccine candidate in its non-biodefense pipeline, has completed Phase 3 trials, and is currently undergoing pediatric trials in India. It 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 Acambis' ChimeriVax-West Nile vaccine candidate, 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. Acambis' influenza program aims to develop a universal vaccine against influenza, for which a universal 'A' strain vaccine, ACAM-FLU-A(TM), is currently being tested in a Phase 1 trial, and also includes various further vaccine candidates in the research and pre-clinical stages.

Recognised internationally as the leading producer of smallpox vaccines, Acambis manufactured its smallpox vaccine, ACAM2000, for emergency-use stockpiles held by the US Government and 14 others governments around the world under a US FDA IND application. ACAM2000 is licensed for active immunization of persons determined to be at high risk for smallpox infection.

Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is listed on the London Stock Exchange (ACM). More information is available at http://www.acambis.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

The statements in the 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, and the need for and the availability of additional capital. For a discussion of these and other risks and uncertainties, see the relevant risk sections in the Company's latest Annual Report, in addition to those detailed on the Company's website and in the Company's filing made with the Securities and Exchange Commission prior to Acambis' deregistration. 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.

Acambis plc
CONTACT: Enquiries: Acambis, Ian Garland, Chief Executive Officer,Elizabeth Brown, Acting Chief Financial Officer, Lyndsay Wright, VP,Communications and IR, Tel: +44-(0)-1223-275-300; Brunswick (financialpress enquiries), Jon Coles / Justine McIlroy / Margherita Lupi, Tel:+44-(0)-20-7404-5959; Northbank Communications (trade press enquiries),Lorna Cuddon, Gemma Price, Katie Odgaard, Tel: +44-(0)-20-7268-3002, Email:g.price@northbankcommunications.com