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Prevention not cure

Vaccines offer promising therapeutic potential and long-term healthcare savings, but the marketing challenges they present should not be underestimated

The once low-growth, low-margin vaccines sector has attracted swathes of media attention over recent months, whetting the appetite of market analysts who are only too happy to wax lyrical about the importance of this branch of pharmaceuticals in significantly reducing future healthcare spending and rendering some diseases dormant.

While the future is likely to be bright for vaccines in terms of improving public health, marketing these products, in particular those for sexually transmitted diseases will not be easy.

In November 2002, the Wall Street Journal ran a story outlining the obstacles facing Merck in its early marketing plans for Gardasil, the world's first vaccine against human papilloma virus (HPV). At the time, the drug didn't even have a name, but it had produced encouraging results from an interim study that suggested the sexually transmitted virus could be halted in its tracks.

The problem was that for a vaccine to really be useful, various stakeholders ñ parents, politicians, doctors ñ would all have to buy into the idea of vaccination. Moreover, the fact that HPV spreads via sexual activity would mean vaccinating girls before they were even interested in boys ñ potentially pitting parents against doctors. There was also the question of what to do about the boys who, at that time, would receive no benefit other than the knowledge they were conferring greater protection against cancer to their female sexual partners.

The WSJ article revealed that the marketing dilemmas surrounding the drug were so great its development was nearly stopped. "The many questions surrounding the distribution and use of an HPV vaccine initially led some Merck executives to debate whether investing in the project made economic sense," it stated.

That debate led to some interesting developments, the results of which we can see today. A decision to formulate the vaccine to block all four of the most common strains of sexually transmitted HPV, even though only two can lead to cervical cancer, was said to be a direct result of trying to make the vaccine easier to market for young boys by granting some protection against genital warts.

Another marketing consideration that can be seen today is sensitivity to the natural reluctance on the part of parents to embrace their children's pubescent sexuality. In November 2006, a few months after Gardasil was licensed in the US market, a national print, television and online advertising campaign was launched that steers clear of this moral minefield.

The campaign's central concept is that girls should aim to be 'one less' victim of the virus. "Because the vaccine is targeted at girls as young as nine, the 'one less' campaign focuses on the benefits of prevention, rather than stopping the carrier of the disease," says Bill Kelly of Atos Consulting.

Jane Kidd, principal analyst at Wood Mackenzie, agrees the campaign has been cleverly formulated and that a similar approach can be seen in the UK. "Sex is always a tricky area to cover. If you drill down into the company's literature, it does say HPV is a sexually transmitted virus but there is more emphasis on it as a virus that leads to cancer that can be prevented."

In February, it appeared that some of the initial marketing fears may be realised when Merck announced it was no longer going to lobby for mandated use of Gardasil in the US. "This is an interesting twist, says Kidd. Merck will need to focus back on clinical, evidence-based information and advertising to continue to hit the message home."

In the UK, public awareness of HPV as a cause of cervical cancer and also of the failings of current screening methods to beat the disease can be seen. Most national newspapers ran a story in January 2007 highlighting that the number of women in the UK attending cervical cancer screening programmes is falling fast.

It is natural to assume that this and other stories about cervical cancer stem from Sanofi Pasteur MSD, the company responsible for marketing the vaccine in the UK. But deputy managing director, Veronique Walsh, perhaps guided by the US experience, refutes this, saying media interest is natural in a product that has such enormous implications for public health. "Around 80 per cent of the sexually active population has had contact with HPV," she notes. "Not all women go on to develop cervical cancer but you can't find another medicine that has such an enormous public health benefit. Of course, journalists ask questions."

Unified message
Prevention is better than cure is the message not only from Sanofi Pasteur MSD but all the vaccine makers at a time when the market is booming for a number of reasons, not least because the development of vaccines has been revolutionised in recent years. Dr Rino Rappuoli, global head of research at Novartis Vaccines, explains on the Phacilitate website, how genomics has provided a quantum leap when it comes to antigen discovery in a process known as 'reverse vaccinology'.

"With genomics you have, from the very beginning, access to the entire repertoire of antigens and you can find ways of screening all of them at once with the same effort that you would have used to characterise only one in the past," Rappuoli explains. "All you have to do is to go to the computer, get a sequence and that's it. It is a huge advance."

Yet, while the science has made vast strides in opening up market opportunities, formidable challenges remain. The main ones are financial and, in the UK, involve persuading the Joint Committee on Vaccination and Immunisation (JCVI) that a particular vaccine represents value for money. The JCVI, an independent committee of health experts, advises the government and has its own staff to evaluate the cost-effectiveness of any new vaccine programme and make recommendations accordingly. So, even though GPs can theoretically prescribe Gardasil, following its approval in October 2006, the vast majority will wait until the JCVI has made its decision.

If a product is accepted as part of national policy, significant revenues are guaranteed. But even when they offer new therapeutic benefits, those revenues can take some time to flow in.

Wyeth's Prevenar, the world's first pneumococcal vaccine, was approved in the UK in 2003. However, lengthy deliberation by the JCVI, coupled with negotiations between the Department of Health and the British Medical Association as to how GPs would be paid for administering it, meant it was only approved for the UK childhood vaccination programme in September 2006.

At the time, Prevenar was already a blockbuster product. It earned just under USD 2bn worldwide in 2006, which was 18 per cent higher than a consensus forecast of five leading analysts in December 2005, according to EvaluatePharma.

Other potential blockbuster vaccines ñ either marketed or in the pipeline ñ include products that work against HPV, HIV, rotavirus, meningitis, pneumococcal infections, varicella, seasonal influenza, pandemic influenza, H5N1 avian influenza, shingles and various combinations of childhood vaccinations.

These are all vaccines against infection. The lion's share of the research money, however, is said to lie in therapeutic vaccines and especially those that are cancer-related. These work not by preventing a responsible virus such as HPV from taking hold, but by enhancing the body's immune system to attack tumours. One of the most advanced is Stimuvax, the first vaccine for lung cancer under development by Merck KGaA.

In both cases, the marketing challenges are novel and, according to Kelly, not to be underestimated. He points out that with the cancer vaccines, established lifestyle issues involved in developing either lung or cervical cancer may signal moral debates about how much money should be spent on prevention or treatment. "Where prevention alone is concerned, as with traditional vaccines, the benefits for healthcare systems will come in the future," he adds. "And history shows governments are not terribly interested in savings that accrue in the future." The major marketing challenge, he concludes, lies in managing public opinion.

Marketing segmentationÖ
As players crowd into potentially huge markets, public opinion becomes increasingly important. The influenza market, for example, relies heavily on medical experts being convinced of the value of vaccines, whether they are designed to work against seasonal flu, pandemic flu or avian flu.

The Times reported in October 2006 that the Department of Health had ordered 15.2 million doses of seasonal flu jabs, one million more than in 2005. The cost in England alone amounts to more than GBP 150m plus GBP 1.5m spent on advertising. However, as the virus mutates each year, and because of the difficulty in distinguishing between flu and flu-like symptoms, some eminent doctors are questioning the value of this spend.

Tom Jefferson, coordinator of the vaccines field at the Cochrane Collaboration, said there was little clinical evidence the vaccines had any effect on length of hospital stay, time taken off work or the likelihood of death in adults, regardless of whether people were otherwise healthy or had conditions such as asthma. Greater public vigilance over spending coupled with intense competition brings new marketing challenges. The EvaluatePharma database currently lists more than 10 marketed vaccines, four that have been filed, and one in phase III. "What we are seeing is a lot of segmentation into niche markets for the elderly, children, the seasonal market, delivery devices, or ease of manufacturing or storage," says Kidd. "The idea is to tap into a segment that is poorly served for one reason or another."

Which segment will pay the highest dividends depends on factors unique to the vaccine market. Ian Strickland of EvaluatePharma points out that the world's first nasal flu vaccine, MedImmune's Flumist, had worldwide sales of just USD 35.7m in 2006 ñ far short of the USD 593m it had been forecast to earn in January 2003. This shortfall is despite its proven efficacy, as well as novelty value: it is twice the price of traditional vaccines, it is not approved for either the elderly (over 49) or the young (under five) and the original formulation had to be frozen, creating storage and transportation problems.

Investing in the futureÖ
Pfizer, meanwhile, is investing in logistical advantages. Its entry into the vaccine market came via its acquisition of UK biotech business PowderMed in 2006. "One of the reasons we acquired PowderMed is because we believe its DNA-based technology platform has potential advantages over traditional egg-based vaccines," says a spokesperson for Pfizer Global R&D. "As well as the prospect of doing away with injections, it could lead to vaccines that are stable at room temperature and do not need cold storage. Producing flu vaccine inside chicken eggs is time-consuming, which places constraints on manufacturing output and means it takes time to build up supplies."

A further reason, which still has to be proven, is that the technology addresses the most convincing argument against vaccines: adaptability. Pfizer believes it might be able to more quickly adapt to new strains of influenza virus.

Pfizer joins the five big vaccine players ñ GlaxoSmithKline (GSK), Merck & Co, Sanofi Pasteur MSD, Novartis (since buying Chiron) and Wyeth ñ for a slice of a market that is forecast to grow by 14 per cent by 2012. While the collective marketing challenge is to persuade the public and governments of the value of preventing (rather than treating) illness, the trick will be doing so while not, at the same time, giving the competition too much of an edge.

In this respect it is interesting to observe Gardasil and its archrival, GSK's Ceravix, jockey for position in the HPV vaccine market. Gardasil had a few unexpected extra months to establish itself as market leader after Ceravix failed to get a licence at the first attempt late last year. GSK is by no means defeated, however. In January, it announced a one-year head-to-head US study among 1,042 women, aged 18-45, to show how the two vaccines perform.

This is a bold move by GSK and one can expect the evidence to be disputed strongly when it arrives next year. What both companies ñ and indeed all the vaccine players ñ are united in is the collective idea that prevention is better than cure. The key battles ñ in market segmentation and winning public opinion ñ promise to be both interesting and intense with significant rewards going to companies that can find the right balance between promoting the collective and the specific messages.

Jackie Law is a freelance pharmaceutical and healthcare journalist

26th April 2007

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