Novartis has lent impetus to the growing trend towards philanthropic R&D in the pharmaceutical industry by opening a new research institute in Siena, Italy "with a non-profit mission to exclusively focus on the development of vaccines for diseases of the developing world".
Modelled on the existing Novartis Institute for Tropical Diseases (NITD) in Singapore, the Novartis Vaccines Institute for Global Health (NVGH) is the first set-up of its kind by a major vaccines manufacturer, the Swiss company says.
The Institute was first incorporated more than a year ago in Siena, Italy, site of the Novartis Vaccines and Diagnostics division's global research centre. The first employee, business development manager Mae Shieh, came from the Novartis Institute for Tropical Diseases. As of this month, the Institute had a total of eight staff - five of them scientists - and that number will grow to around 15 by the end of 2008. The plan is then to expand to about 80 staff over the next few years.
The NVGH will draw on the technology and expertise of the vaccines and diagnostics arm in Siena, and its activities will be part of the overarching Novartis corporate research programme. At the same time, though, the Institute will function as an independent entity, with a dedicated management team, resources and scientists, and with its projects handled separately from those of the commercial vaccines operation.
The goal is to address the unmet medical need for vaccines against diseases of the developing world by researching vaccines specifically tailored to those needs and launching them first in developing countries. The NVGH will operate as a public-private partnership, working with universities, research institutes and other public or private organisations to establish the scientific basis for vaccines development.
According to Novartis spokesperson Satoshi Sugimoto, the company is providing the (unspecified) funding for core staff, research and infrastructure at the new institute. It is also "actively seeking funding from the public, private and philanthropic organisations to partner its efforts to develop vaccines through proof of concept in humans".
Only diseases that are commercially neglected will be targeted. Once past the discovery and initial development stages, the NVGH will license "a third party" to develop further and distribute the vaccines at "an affordable and accessible price" to the relevant populations.
In this respect, the NVGH intends to collaborate with donor and related organisations such as the Gates Foundation, the Global Alliance for Vaccines and Immunization, Unicef and the World Health Organization to help identify areas of need and make sure the vaccines reach these populations. The Institute will also nurture relationships with the governments of target countries to facilitate distribution of the vaccines.
The head of the NVGH is Allen Saul, who joined Novartis from the malaria and vector research laboratory at the US National Institute of Allergy and Infectious Diseases. Saul has a strong background in vaccines, and specifically translational vaccines, research.
This is relevant as Novartis sees the NVGH's as closing the "translational gap" between basic research and technical product development, which in the case of high-risk and relatively commercially unattractive vaccines projects has too often left promising leads or antigens stranded in the laboratory.
The NVGH will "bridge an existing gap between the discovery of promising vaccine candidates, often from academia and research institutes, and manufacturing and distribution of vaccines, by providing the means and expertise for pilot-scale vaccine production and human proof-of-concept studies", Novartis explained.
The initial focus for most of the research activities at the Institute will be conjugate vaccines for enteric diseases. These include Salmonella enterica serovar Typhi (S. typhi), Salmonella paratyphi A and non-typhoidal salmonellae (NTS), all of which especially affect children in the developing world.
In Africa, multidrug-resistant non-typhoidal salmonella is one of the leading causes of morbidity and high mortality in children under five years of age, second only in importance to pneumococcal disease, Novartis pointed out. With more than 4.5 billion cases per year, diarrhoeal diseases are "ubiquitous around the globe", it added.
"NVGH will aim to become a centre of excellence for vaccines for neglected diseases," commented Paul Herrling, the company's head of corporate research. "Novartis has already set-up a similar research institute dedicated to neglected tropical diseases for pharmaceutical drugs, and similarly to that, accessibility to and affordability of NVGH products will be the priority, not commercial value or profit potential."
Pharmaceutical companies have long been criticised for training the vast bulk of their research efforts on diseases of the developed world, where intellectual property (IP) is less contentious and healthcare systems are more able to absorb premium drug prices.
Novartis itself points out that, at present, only about 10 per cent of the world's medical research is devoted to conditions that account for 90 per cent of the global disease burden. One sixth of the world's population is affected by neglected diseases, "yet the drug and vaccine pipeline for these diseases is almost dry", it comments.
Recent years have seen a more palpable effort to address these inequities through public-private partnerships (PPPs) between pharmaceutical companies and charities, governments and research or relief organisations.
Last May the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said research-based companies were now working on 17 new drugs for tuberculosis and more than 20 for malaria, as well as some vaccines for the same conditions. More than 40 research projects were also directed at worm infestations and other tropical poverty-related diseases, the association noted.
At the same time, there has been an increasing tendency for philanthropic organisations to build their own R&D pipelines. This has raised questions about whether these initiatives will take the heat off industry by complementing its more commercially oriented research, or whether they could eventually challenge the industry's traditional dominance of the R&D agenda.
In a report last year, IMS urged pharmaceutical companies to "stay in the game" by working in synergy with the Gates Foundation and other PPPs. "The alternative is for pharma to allow itself to be perceived as indifferent to global health concerns - or to be unseated in the pursuit of advances in world health," it warned.
The wider political and economic context is that globalisation is already pushing conditions more associated with developed countries, such as diabetes and cardiovascular disease, increasingly into the developing world as diets change, urbanization/industrialization takes hold and a tentative middle class emerges. As such, the pharmaceutical industry has an interest in ensuring that its relationship with what could be the markets of the future is less prone to controversy.
Moreover, non-profit initiatives in developing countries, particularly in respect of R&D investment, give the industry more leverage in defending higher prices charged for new drugs in mainstream markets such as Europe and the US, where healthcare payers are bearing down inexorably on costs. They also help to justify the exercise of patent rights in countries with traditionally weaker IP systems and/or a history of compulsory licensing to ensure drug access.
Novartis has been in the front line of this debate, with its much-criticised challenge to India's Patents (Amendment) Act, 2005 over rights to a beta-crystal form of the company's anticancer Glivec (imatinib mesylate). The case was dismissed by the Indian High Court in August 2007.
Whether the licensed-out vaccines from the NVGH will be Novartis-branded is open to question. "Novartis would like to receive recognition for its contribution to the ultimate vaccine product that results from NVGH's efforts," Sugimoto commented. "How exactly that will be accomplished will still need to be evaluated and discussed with downstream partners."
The new institute in Siena also reflects the recent surge of interest in vaccines among pharmaceutical multinationals, with major investments from companies such as the UK's GlaxoSmithKline. With a range spanning influenza, meningococcal, paediatric and travel vaccines, Novartis Vaccines claims to be the world's fifth-largest manufacturer in the category and the second-largest supplier of influenza vaccines to the US.