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Sanofi takes rotavirus vax into Phase III with eye on Indian market

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Sanofi Pasteur CEO Olivier Charmeil--Courtesy of Sanofi

India's rotavirus vaccines market is headed for a shake-up, and Sanofi's ($SNY) angling to get in on the action. It got one step closer this week, with its Indian affiliate commencing Phase III clinical trials for its own investigational vaccine.

Hyderabad-based Shantha Biotechnics has started a study designed to show noninferiority against a currently licensed vaccine through use of three orally administered liquid doses, beginning from 6 to 8 weeks of age, the French drugmaker said Tuesday. The company hopes to recruit 1,200 volunteers across 12 clinical trial sites in India to help it test the candidate, which includes antigens against serotypes G1, G2, G3 and G4.

As Sanofi Pasteur President and CEO Olivier Charmeil said in a statement, Sanofi--an emerging markets expert, as multinational drugmakers go--is aiming to provide an affordable vaccine for use in developing countries like India through organizations like GAVI.

"Sanofi Pasteur wants to be in the position to target a major role in the growing rotavirus market in developing countries, with a key focus on the GAVI market, in public markets for non-GAVI countries, as well as private segments in emerging markets," he said.

But Sanofi isn't the only one with plans for a low-cost rotavirus vaccine in India. In 2011, Indian company Bharat Biotech pledged to offer its own prospect--Rotavac--at $1 a dose, undercutting even discounted vaccines from GlaxoSmithKline ($GSK) and Merck ($MRK). Following positive Phase III results for the vaccine last May, this July, Indian Prime Minister Narendra Modi announced Rotavac would be provided to all Indian children as part of the country's Universal Immunization Program.

- read the release

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