For Subscribers

Get the complete article now!

TWST: (AVEP.PA)Can we start with an overview of the vaccine market?

Mr. Williams: Today, the vaccine market is somewhere in the neighborhood of seven billion dollars. We expect it to grow to almost 20 billion dollars over the next decade. So vaccines are a relatively small – but important and interesting -- part of the pharmaceutical market. The four major players in vaccines – Aventis Pasteur, GlaxoSmithKline, Merck and Wyeth, representing 80% of global vaccine sales – are drawn from the three out of the top five and four out of the top ten pharmaceutical companies. The vaccine industry has some interesting attributes. It has good sustainable growth and contributes towards profitability. There are high barriers to entry. For example, one of the more relevant aspects is that both within the EMEA and the FDA there’s no ANDA equivalent, to use the FDA term. That means that there is no shortcut to the licensing of vaccines. You have to perform either a large-scale immunogenicity study, when seeking to license something comparable to an already licensed product, or do an efficacy trial, if there is neither a marker nor comparative for efficacy. It’s almost like developing the vaccine for the first time even if you’re the second or third entry. Vaccines are difficult to master, as production involves complex, biological processes. Additionally, there are still some unmet medical needs, so there’s room for innovation. The vaccine market has been growing quickly. If you take a look at the last ten years, it’s grown by more than 12 %. We’ve been a major player in making that happen.

TWST: Can you give me examples of how you have moved that growth and give us an overview of the things that you’re doing now?

Mr. Williams: If you take a look at the drivers over the last decade, it started with a real push to increase influenza immunization, which we were instrumental in moving and which continues today. Additionally, important vaccines were brought to market – Haemophilus influenzae type b, known as Hib, for which we first received a license in 1987, followed by the first acellular pertussis vaccine for infants a few years later. We’ve been at the center of the shift from the oral to the injectable polio vaccine in parts of the world where the disease has been eradicated since we’re the major global producer of injectable Polio vaccine, known as IPV. This is a major policy shift, which we think is the right shift from a public health point-of-view and one that also has helped to drive the growth in the injectable market. Others have helped grow the market as well, Wyeth’s Prevnar being a recent example. Moving forward, we think that the next decade could be just as strong as the last. We will play a role in that by moving a number of products forward, including Menactra for meningococcal disease and for which we should file for a license in the U.S. later this year. Next year, we intend to submit an application for Adacel, to protect adolescents and adults against diphtheria, tetanus and pertussis, as well as Pentacel, the next in a series of combination products. Pentacel provides protection against diphtheria, tetanus, pertussis, Hib disease and polio all in a single shot for infants. Toward the end of the decade, there will be new antigens targeting RSV and Dengue fever. Beyond that, we hope to see some of the fruits of our labors in oncology, where we have proof-of-concept studies going on for therapeutic use, or HIV, come to pass. The emergence of new diseases is an interesting phenomenon. I’m sure you’re following the story of SARS and if you live in much of the U.S., you’re familiar with West Nile Virus, both of which are of interest to us.