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Working Towards Affordable Care

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Hilleman Labs, a new joint venture (JV) for vaccine research in India between US drug maker Merck & Co. and UK's Wellcome Trust, has kicked off its first project — a potential vaccine for childhood diarrhoea that would need no cold storage and can be taken orally.

Developing such a vaccine could take between two and four years after which the lab will potentially start discussions with manufacturers for technology transfer for further development and commercialisation, says Akshay Goel, Hilleman's chief scientific officer. The vaccine will specifically immunise against the rotavirus. Over 500,000 children (under five) die each year from rotaviral diarrhoea globally.

The JV's objective is to research "affordable vaccines for developing country needs," says Altaf Lal, Hilleman's CEO. "Affordability comes not just from the price but also the cost associated with the vaccine's use." Vaccines currently in use need to be stored at a specific low temperature until they are used. A so-called "temperature-stable" technology could reduce vaccine wastage from gaps in the cold chain.

Hilleman has a grant commitment of about Rs 600 crore from its two founders over seven years. It is a non-profit venture, so any income from licensing its research will be ploughed back into its operations.

Hilleman is by no means the first Big Pharma effort to come up with affordable solutions for developing-country diseases. Swiss drug maker Novartis launched the Novartis Institute for Tropical Diseases in Singapore in 2004, which researches cures for diseases such as dengue and has committed to make them available without profit in needy countries. AstraZeneca has been engaged in tuberculosis research in its Bangalore laboratory since 2001.

Yet it has its own set of advantages and challenges. Hilleman starts off on a strong footing. Its grant averages Rs 90 crore every year, more than what some mid-sized Indian drug companies spend annually on research and development (R&D). It also benefits from the R&D "externalisation" that has increasingly been adopted by global pharma companies, allowing it to look outside its own portals for ways to speed up research and make it more productive.

For its first project, Hilleman has partnered with Medicine in Need, a Boston area non-profit for oral thin films or rapidly-dissolving granules technology that can be applied to components of an existing injectible diarrhoea vaccine from Merck. Being in India also has its advantages. One, it is a cost-effective research base. Two, it has a large population suffering from diseases like diarrhoea, which will allow potential vaccine candidates to be tested speedily. Its private sector firms also have a track record in low-cost manufacturing and are interested in linkages that allow them to exploit the market more fully. For instance, Pune's Serum Institute has partnered a NGO to develop and produce a low-cost meningitis vaccine for Africa.

But there are challenges, too. Indian scientists are known more for their chemistry and process development skills than for biology, making recruitment a challenge. The idea of heat-stable vaccines, though attractive, is still a work in progress. It was in 2003 that the Bill and Melinda Gates Foundation identified the need   for vaccines that require no refrigeration and are needle-free as two of 14 ‘Grand Challenges in Global Health', a grants initiative to spur innovation for key global health challenges.
Hilleman is operating a tight ship. Staffed with about 14 scientists, engineers and others hired from within and outside India, it expects to employ about 60 at its peak. It is open to partnerships with government, academia and non-profits, and will lean heavily on a ‘high-level' scientific advisory group. "Our optimism will guide us through the challenges," says Lal.

(This story was published in Businessworld Issue Dated 14-02-2011)