Nov 1, 2007: 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. Based in Cambridge, UK and Cambridge, Massachusetts, US, this London Stock Exchange-listed company has a development-stage pipeline that includes a number of vaccines that could either offer improvements over existing products or target unmet medical needs. In an interview with BioSpectrum Mr Ian Garland, CEO, Acambis, throws light on how the company is forging ahead.  

You have recently taken up the position of CEO at Acambis. How are you steering the company to leverage its potential?
Since joining Acambis five months ago, one of my principal areas of focus was reviewing our strategy with the new management team and our Board. We concluded that Acambis’ strategy is fundamentally sound—that is to build Acambis into a robust, independent vaccine company, financed by revenues from our recently licensed ACAM2000 smallpox vaccine and by partnering selected programs in our pipeline. The question was: “how are we going to implement this strategy?” And we rolled out our implementation plan to investors and analysts. We have also outlined ways to finance our strategy and put in a new management team in place to drive the implementation of the strategy.

Can you outline Acambis’ vaccine portfolio?
Overall, we have a portfolio of vaccines at various stages of development, including two with blockbuster potential.

Our C. difficile vaccine candidate is a pipeline priority that we believe can be a transformational program for Acambis. C. difficile is an anaerobic bacterium that disrupts the colon and causes diarrhoea, colitis and other complications. The levels of C. difficile-associated disease (CDAD) have grown rapidly in recent years, with a number of particularly severe outbreaks in Canada, the UK and Japan, and the cost of treating CDAD is now estimated to be over $1 billion a year in the US and around $4.5 billion in Europe.

This is a particularly exciting opportunity because ours is the only C. difficile vaccine to have been evaluated in clinical trials thus far. We’re planning to pursue prophylactic and therapeutic vaccine approaches and, strategically, intend to retain the rights to this program for as long as possible.

Our universal influenza vaccine program also represents a significant potential value driver, given that the influenza market is one of the most attractive opportunities for vaccine developers and our universal vaccine approach is potentially very competitive. ACAM-FLU-A is the most advanced of the influenza vaccine candidates we are developing as part of our multiple-approach universal influenza vaccine program. We believe we may be best able to optimize value for shareholders by partnering this program at a relatively early stage and intend to explore the potential for partnering when we obtain data from the ongoing phase 1 trial of ACAM-FLU-A.

The other potential blockbuster in our pipeline, alongside our C. difficile vaccine, is a vaccine candidate against dengue fever, which is being developed by our partner, sanofi pasteur. We were delighted to see very positive news coming from sanofi pasteur recently, who reported 100 percent seroconversion to all four dengue virus serotypes, which had proved to be a huge technical hurdle in the past. Sanofi pasteur plans to take the vaccine into phase III in 2008. It also raised the estimates of the market potential to over €1 billion due to increased incidence of dengue cases.

We have another program partnered with sanofi pasteur: ChimeriVax-JE. This uses the same technology as the dengue vaccine but is targeted against Japanese encephalitis, a mosquito-borne virus that is a major problem in Asia. We’ve already completed pivotal phase III trials with this vaccine and reported excellent safety and efficacy data, including showing statistical superiority of our vaccine compared to the licensed vaccine, JE-VAX. While this is a middle-tier market opportunity, this is an important project for us because it is now at an advanced stage of development.

We have already successfully taken one vaccine all the way through from research to licensure. In August 2007, our ACAM2000 smallpox vaccine became the first new biodefence vaccine to be licensed by the FDA since 9/11. This is a major achievement for a company of Acambis’ stage of development and clearly validates our in-house capabilities and competencies. With the ACAM2000 licence in place, we’re now pursuing finalization of a long-term, warm-base manufacturing contract with the US government that can provide us with sustained annual revenues.

The other vaccine candidate in our portfolio is our West Nile vaccine candidate, which is the leading vaccine against this disease that landed in the US in 1999 and has since swept throughout the mainland states. Our vaccine is currently in phase II trials in the target population of those aged 50 and above. In parallel with the trials, we’re conducting partnership discussions. The market potential of this vaccine is still evolving as the disease burden in the US continues to develop year-on-year and we believe this program is best suited to being partnered with a vaccine company that has an established position within the US market.

What kind of presence does the company have in India?
Our JE vaccine is the first product we have developed ourselves that is directly applicable to India. JE is endemic in this part of the world and in India, children in high-risk areas are vaccinated using either first-generation vaccines, which are mouse brain-derived and do not have a good safety profile, or locally produced vaccines. The World Health Organization has identified a clear need for new, modern JE vaccines and ours is the only single-dose vaccine in development. Being a single-dose vaccine, it can offer huge benefits in terms of compliance and reduced healthcare costs. We’ve already shown in trials that our vaccine generates an immune response within 14 days and that immunity lasts for at least three years.

We have a manufacturing and marketing agreement with Hyderabad-based Bharat Biotech International and, in January2007, started a paediatric clinical trial of our vaccine in India to test it in children for the first time. We want to get this vaccine to market as quickly as possible, to tackle a serious disease that is inadequately addressed by current vaccines.

Any expansion plans in the horizon?
We look at in-licensing and M&A opportunities as a day-to-day part of our business because we see the potential for M&A and in-licensing to accelerate our strategy to build Acambis into a robust, independent vaccines business.

With our core assets—vaccines expertise, product development capability and manufacturing facilities—we believe we have a very attractive proposition for companies looking for licensing partners. We want to use in-licensing as a tool to supplement our research activities and to deliver our goal of achieving one new IND a year. In addition, we will review M&A opportunities where these can generate value for shareholders and represent a good fit within our organization and expertise.

How do you view the future of the vaccine business and how is the company positioned to meet the future demands?
The vaccines sector has experienced a renaissance in the last decade and has become a highly attractive area thanks to improved pricing, higher coverage rates and expansion into new markets. In addition, more funding is available to support developing world vaccination and technical advances mean more diseases can be targeted through vaccination. All this is also making the vaccines sector a major focus for the world’s leading pharmaceutical companies. On the other hand, the regulatory hurdles are ever increasing, which make it even more important for companies to have in place the kind of expertise and competencies we’ve been able to establish in-house.

We believe we are well-positioned to capitalize on this renaissance, particularly given our attractive vaccine pipeline, our proven R&D capabilities and the manufacturing facilities that give us control over the whole production process—bulk production, purification and fill/finish.