[Ip-health] Novartis vaccines institute sets sights on developing world diseases

[Sarah Rimmington]

http://www.in-pharmatechnologist.com/news/ng.asp?n=83547-novartis-vaccine-tropical-disease

Novartis vaccines institute sets sights on developing world diseases
By Pete Mansell


27-Feb-2008 - 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.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/