Pushing the frontiers of disease prevention

Wayne Pisano runs the largest company in the world devoted entirely to human vaccines. As CEO of sanofi pasteur, he knows more than most about the importance of vaccines as an essential tool in preventative healthcare. Here, he tells NGP about leading the worldwide fight against life-threatening infectious disease.

Today, vaccines are an important healthcare tool, but it wasn’t always that way. Before the causes of disease and recovery were properly understood, people noticed that if you contracted a disease and then recovered, you were immune if exposed to the same disease again. The Chinese were the first to experiment with a type of vaccination, by injecting healthy people with material taken from smallpox lesions, a method which was brought to England in the 1700s.

Not long after, Edward Jenner, an English country doctor, used the Chinese method to infect patients with a bovine disease known as ‘cow pox’, which then rendered them immune to the smallpox virus. This process became known as ‘vaccination’ after ‘vacca’, the Latin word for cow. Almost one hundred years later, Louis Pasteur discovered immunisation against rabies.

Since then, vaccination has saved the lives of thousands of people and helped to prevent the spread of diseases that once caused widespread suffering and even death, and has become an indispensable element of the modern healthcare arsenal. Wayne Pisano, President and CEO of sanofi pasteur, knows this better than most. The steel and glass headquarters of sanofi pasteur in Lyon, France, may seem a million miles away from the simple experiments of Jenner and Pasteur (from whom the company takes part of its name), but they are intimately connected. Sanofi Pasteur is the largest company in the world – and the only company in Europe – dedicated entirely to the production of human vaccines.

As well as the location in Lyon, the company also has major operations in Swiftwater, Pennsylvania; Toronto, Canada; and Marcy L’Etoile and Val de Reuil, France, and is present in more than 100 other countries. Pisano, who took over as CEO in August 2007, has led the development and implementation of sanofi pasteur’s commercial strategy since 2003. His responsibilities also include overseeing the activities of sanofi pasteur MSD, a 50-50 joint venture between sanofi pasteur and Merck & Co, which markets sanofi pasteur’s vaccines in 19 European countries.

So what does the future hold for this very modern company waging the fight against some of mankind’s most serious diseases? In his office overlooking the Rhône river, Pisano leans forward in his chair and considers a moment before replying. “This broad base allows us to have a multi-faceted strategy to meet the future outlook of the global vaccine marketplace,” he explains. “Our R&D team is pushing forward into new frontiers with new vaccines that will benefit global health.”

Fighting disease
Sanofi Pasteur offers a broad range of vaccines that protect against 20 bacterial and viral diseases, including pertussis, diphtheria, typhoid fever, poliomyelitis, influenza and mumps. Combination vaccines (several antigens, the active components of the vaccine, in a single injection) are another of the strengths of the company’s product range, offering the advantage of simplifying immunisation schedules, decreasing costs and ensuring a higher level of comfort.

The company also has 25 vaccines at various stages of development. Although the old scourges of humanity may be under control – at least in the western world – there are still many killer diseases waiting in the wings. The company’s researchers are currently working on vaccines against dengue – the second most wide spread tropical disease after malaria – and Japanese encephalitis, a disease that can cause lasting damage to the central nervous system in endemic regions of Asia.

“We are also developing next generation, post-exposure prophylaxis for rabies as well as potential vaccine candidates against tuberculosis and malaria,” says Pisano. “On top of this we have a strong development program for therapeutic vaccines against cancer, utilising the therapeutic expertise of our parent, sanofi-aventis, one of the leaders in oncology and more generally in the pharmaceutical industry worldwide.”

In terms of vaccines already on the market, Pisano says the company will continue to build up capacities in order to produce more doses to respond to the growing demand in countries such as China, Mexico, Brazil, Russia, India, and other fast-growing economies. Sanofi Pasteur produced over 1.6 billion doses of vaccines in 2007. “We will use our new capacities to produce more of our existing vaccines but also new vaccines such as our intra-dermal flu vaccine, new pediatric combination vaccines, or our dengue vaccine when it is fully developed,” he adds.

But continuing the company’s success is about more than just producing a lot of vaccines. As Pisano highlights, building strong relationships with customers is key. “We already have and will continue to build a strong understanding of our customers’ needs. We will continue to build on our relationships with health-care professionals, governments, and policy makers to provide the right vaccines and to support stronger vaccine recommendations and their implementation, making sure that the vaccines get to the people who need them. We will also push forward with key stakeholders to identify improved funding mechanisms for the vaccines we have today and the vaccines of the future.”

Innovative products
Another crucial element is ensuring strong growth in markets beyond North America.
Sanofi Pasteur has a broad reach with significant operations in Europe, North America, Asia, and Latin America, and a strong growth potential in China, Mexico, Brazil, Russia, India, and other fast-growing economies.

According to Pisano, the company plans to retain a quarter of the vaccine market by growing its existing core assets and increasing capacities to answer medical needs in new markets. “We will also bring innovative products (such as new delivery methods and new pediatric combinations) to existing markets and new markets. And we plan to launch new vaccines against deadly, global diseases such as dengue, West Nile virus, and malaria, as well as second-generation vaccines for rabies and tuberculosis.”

As an example of this success, sanofi pasteur currently provides about 40 percent of the influenza vaccines on the market worldwide. This has been made possible thanks to its significant investment in capacity expansions in Europe and in the US. Its commitment to the flu vaccine market, for example, allowed it to produce more than 180 million doses of influenza vaccines in 2007, with a projected capacity of more than 300 million doses by 2016. There is also capacity for expansions in Europe, the United States, China and other parts of the world.

Preparing for the worst
Mention influenza, and many people’s thoughts will turn to the possibility of a global flu pandemic. And there is good reason to worry: pandemics in the last century occurred in 1918, 1957 and 1968. The 1918 pandemic of ‘Spanish flu’ killed at least 20 million people around the world; in England and Wales alone, it was responsible for 200,000 deaths – the impact on death rates was so severe that average life expectancy was decreased by 10 years.

It’s essential to be prepared, as Pisano explains. “We are a leader in pandemic preparedness, with the largest capacities to produce a pandemic vaccine, should the world need one, and a strong research program to constantly improve our pandemic vaccine candidates. Sanofi Pasteur H5N1 vaccine was the first to be licensed by the Food and Drug Administration last year in the United States.”

Industrial and scientific expertise have enabled the company to produce pre-pandemic vaccines for a number of countries, including the United States, France and Italy, within the framework of pandemic preparedness and research programs. Supply agreements have also been signed with several countries to provide vaccines in the event of a pandemic being declared, once the pandemic virus strain is identified.

Sanofi Pasteur is leading the fight against another potentially deadly disease, meningitis. Babies and teenagers are at most risk from meningitis (inflammation of the lining of the brain) or septicaemia (blood poisoning) caused by the meningococcal group C type of bacteria. Both are very serious, life threatening illnesses. The majority of cases of disease caused by meningococcal group C can be prevented by vaccines.

“Meningitis is a deadly disease in which we see significant serotype shifting. We believe that our quadravalent vaccine, Menactra, is the best suited to meet North America’s – and in the future worldwide – needs for ACYW-135 vaccine. We are expanding capacity to meet the future needs of North America and other regions of the world, such as Europe, in the next decade.”

The company was also a pioneer in the combination technology for pediatric vaccination. Pediatric combinations allow for a reduction in the number of injections, a simplification of the schedule of vaccination and better compliance. The company manufactures a unique range of products that fulfil public-health needs, while offering a choice aimed at achieving an optimal fit with regional needs. Its portfolio is tailored to the health needs of various countries and regions of the world; this tailored approach is a centerpiece of the sanofi pasteur’s global health strategy.

Successful partnerships
Forging creative partnerships in order to accelerate the development and distribution of new and innovative products is also high on sanofi pasteur’s agenda. According to Pisano, “The aims of our current partnerships with biotech companies are centered on either the introduction of new vaccine products or the application of new technologies to enhance our current vaccine products.”

One example of a collaboration that has supported those aims is the company’s partnership with Acambis on the development of a dengue vaccine, which is now in phase II of clinical development. This partnership has recently been extended to target Japanese encephalitis and West Nile virus. These projects are in phase III and phase II, respectively.

Sanofi Pasteur has also partnered with Becton Dickinson on an Intradermal delivery, resulting in an ID-administered flu vaccine being recently submitted to the EMEA and accepted for review; and with Crucell on a cell culture-based influenza vaccine, which is also in phase II of clinical development, and rabies monoclonal antibodies, the next-generation biological product against a disease that each year causes over 55,000 death worldwide.

Not that this success has always come easy. Bringing new vaccines to the market is a long, costly and complex process, and there are always challenges to be faced along the way. As Pisano says, “Product development in the vaccines industry is indeed challenging. We along with the other industry leaders face a series of operational issues with the development of each new vaccine, as well as with the enhancement of existing vaccines.

“In fact, today it is routine for the vaccine development cycle to take 10-12 years at a cost of several hundred million euros. Key drivers include increasing regulatory requirements that increase both the pre-clinical and clinical data needed to support licensure, as well as very significant post-licensure commitments. This is further supported by the zero-risk tolerance around vaccines as they are being administered to prevent disease (not treat) in healthy individuals. Other key challenges relate to the fact that we are dealing with complex, biological processes and we must meet rigorous industrial standards to ensure control of our processes and ensure product consistency.”

Another challenge is that most of the ‘low hanging fruit’, or easy targets, have already been picked. As companies look to the existing universe of targets, they know they will need more complex vaccines that require new technologies, including vaccine platforms and adjuvants. This will certainly increase costs and length of development, in order to ensure safety and efficacy.

The way forward
On the flipside, there are still exciting advances to be made. For example, vaccinogenomics, the integration of pathogen and host genomics in vaccine research, is likely to revolutionise the way scientists approach the discovery of safe and effective vaccines. Is genome-based research the way of the future?

“Genomics and genomic technologies have and will remain important in vaccine R&D efforts,” Pisano asserts. “We have seen this most certainly in antigen discovery and validation efforts, both with vaccines for infectious disease and cancer. Examples in the infectious disease area include pandemic flu, Chlamydia, pneumococcus, and meningococcus. Furthermore, genomic technologies will certainly facilitate assessment of vaccines in the preclinical and possibly clinical settings, as well as providing ways to characterise and test vaccines in vitro.”

Although no one can really predict what will happen in global disease prevention, Pisano at least has a clear view of his company’s goals for the future. “Our vision is of a world in which no one suffers or dies from a vaccine-preventable disease. We see a rise in global awareness of the value of vaccines among governments, non-governmental and international organisations. The prevention effect of vaccines is now well understood by health authorities worldwide, which have new tools to protect people against infectious disease and reduce the cost of treating such diseases. We also see new funding mechanisms being created to guarantee that vaccines get to the people who need them in the developing world. At sanofi pasteur, we are determined to bring new and innovative immunisation solutions to the market and help fulfill our vision of ‘one world, protected’.”

It’s good to know the world of vaccines is still advancing, ready to take on new diseases and save new lives. Edward Jenner and Louis Pasteur would have approved.

Wayne Pisano has been President and CEO of sanofi pasteur, the vaccines division of sanofi-aventis Group, since August 2007. He joined the company as VP US Marketing in 1997, and in 2003 was promoted to SVP Global Commercial Operations and since then he has led the development and implementation of sanofi pasteur’s commercial strategy.