Non-Traditional Model to Product Launch-Dengue Vaccines

Reproducing, in relevant parts, herewith an interesting article, lifted out from a news article, by SURESH KUMAR, Executive Vice President External Affairs of Sanofi viz:

Innovative medicines are traditionally developed and launched first for at-risk populations in the US and Europe. Later, once innovation costs have been paid for, the new medicines are then made available to endemic nations.

This model works but it has some serious limitations: namely, a delay in access to innovation in these endemic nations. There is also the risk that unmet medical needs in these countries are left neglected as they are not driving the innovation agenda of the pharmaceutical industry.

As of today, dengue remains on the World Health Organisation’s list of neglected diseases, despite the fact that it threatens half the world’s population.

Clearly, a new solution is needed – particularly for emerging markets and middle-income countries that have the capacity technical expertise, as well as disease knowledge to participate in clinical development programmes and also approve and regulate new medicines for use by their citizens.

Dengue provides a particularly well-suited case in point, since it is not a public health threat in the US and Europe but it is a major priority in endemic countries in South-East Asia and Latin America.

About 20 years ago, Sanofi set out to develop an innovative vaccine against dengue, one that would be effective in preventing the illness caused by all four dengue strains. Since then dengue has spread from a handful of countries to being endemic in over 120 worldwide and is recognised by the WHO as the fastest growing mosquito-borne disease in the world today.

The WHO has also called for a dengue vaccine to be used in conjunction with other dengue prevention efforts like vector control and education to help achieve its objectives to reduce dengue mortality by 50% and morbidity by 25% by 2020.

Sanofi set out to do both, develop and launch its dengue vaccine first in endemic countries where it could have the greatest impact on disease burden and quickly achieve these WHO objectives.

To be able to realise this “flipping the model” approach to new vaccine access, the company invested 300mil euros to build a dedicated production facility for the dengue vaccine that would eventually attain a full capacity of 100 million doses annually.

The company made this investment in 2009, at considerable risk given that the results of its Phase III clinical development programme were not yet known. Now, the Phase III programme has successfully reached its efficacy endpoints and the dengue vaccine candidate is currently under regulatory review in a number of endemic countries both in Latin America and in South-East Asia.

This is in keeping with the company’s long-standing commitment to launch the vaccine first in these nations rather than in Europe or the US, where its traditionally done.

But forging a new access model is not something that a pharmaceutical company can do on its own.

In order to be successful, Sanofi has worked hard to collaborate with endemic governments and public health bodies, as well as the global development and vaccine policy community, to build acceptance and support for this new approach.

If the dengue vaccine introduction model is to succeed, it will be necessary for Sanofi to be able to make the vaccine available, upon approval, for a fair and equitable price that balances innovation costs against sustainable access in endemic countries.

New ways of funding access to such an innovation in these countries, as well as mechanisms to help strengthen their healthcare infrastructure to be able to successfully implement the vaccine, will be needed.

Sanofi intends to work closely with governments, funding bodies and the vaccine policy universe to broker the successful introduction of the dengue vaccine upon approval. We know that more is at stake here than the launch of the world’s first dengue vaccine.

If this model succeeds, industry as a whole may be more inclined to be proactive in addressing the unmet medical needs of low and middle-income countries as a priority rather than as a second phase of medical innovation access.

Diseases like dengue disrupt economic growth and development of endemic countries and investments in controlling and eliminating this disease burden can help to further the economic stability and growth potential of these nations.

/theSTAR 08-08-2015

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