MUMBAI:
Asia's largest vaccine maker,
Pune-based Serum Institute
will develop a biologic drug to treat all four strains of the dengue
virus, and is in the process of applying to the Ministry of Science and
Technology for a "fast-track approval" to roll-out the treatment in the
country. The biologic treatment (monoclonal anti-body) once rolled out
will be given as an injection to cure dengue, and cost between Rs
5,000-10,000 for a single dose. Only one dose will be required.
Serum, which has tied up with US-based biotechnology company Visterra to
use its technology to develop the monoclonal antibody, hopes to
commercialize the treatment within 12-18 months of getting the
regulatory approvals, Serum Institute CEO Adar Poonawalla told TOI.
While Serum's biologic drug could become one of the first treatments to
roll out, other biggies like Sanofi and Novartis are also in the race
to launch a vaccine may happen over the next few years.
"We hope
that the government will give a fast-track approval to our application
as dengue has assumed alarming proportions, and could become a public
health crisis", Poonawalla told TOI, adding, it would then initiate
clinical trials to prove its safety and efficacy on a few 100 to 1000
subjects. If the trials are successful, Serum could perhaps become
the first company to offer a cure for the dreaded infection which has
shown the worst outbreak, with several deaths, and cases doubling this
year.
Under the terms of the agreement, Serum Institute has an
exclusive license to commercialize the treatment for the Indian
subcontinent, including India, Pakistan, Bangladesh, Nepal, Bhutan,
Maldives, and Sri Lanka. It has paid Visterra a $5 million upfront
payment, and up to $34 million based on the achievement of certain
development and commercial milestones.
Serum Institute will fund
and be responsible for the clinical development of VIS513 in the
licensed territories, including the filing of regulatory applications.
The companies will establish a joint steering committee to coordinate
the development for the Indian subcontinent.
The Pune-based
company is also working on a dengue vaccine, like the other global
biggies to be given as a preventive. The development of a vaccine will
take three to four years, as it has to be tested on a wide-range and
number of subjects, he added.
Amongst the vaccines, Sanofi has emerged as a front-runner, having completed Phase II trials, a company official said.
About half the world's population is at risk of contracting the virus,
with no specific treatment for dengue/ severe dengue, but early
detection and access to proper medical care lowers fatality rates below
1%, according to the World Health Organization.
The market for
the vaccine could be huge, and reach $400 million in 2020, according to
GlobalData estimates, while others say it could more than triple, and
bring in $1.4 billion a year at its peak.
Visterra's humanized
monoclonal antibody, VIS513 has reportedly worked to neutralize all four
serotypes of dengue virus, with the "animal model" studies showing
promising results, he added. The US company is already running its own
trials in Singapore, Serum will need to do clinical studies here on
Indian subjects by importing the clone.
