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India's Serum Institute Seeks Government Approval To Launch Dengue Drug

by Shirley Johanna on  September 23, 2015 at 6:25 PM Drug News   - G J E 4
Pune-based Serum Institute of India, which is Asia's largest vaccine maker, plans to file for fast-track approval to launch a dengue treatment in India, said its chief executive. Globally, the firm becomes the first to launch a drug for the mosquito-borne virus.
India's Serum Institute Seeks Government Approval To Launch Dengue Drug
India's Serum Institute Seeks Government Approval To Launch Dengue Drug
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Dengue cases are on the rise in India and the capital, New Delhi faces the worst outbreak of the virus in five years. Dengue cases generally peak in October after the monsoon rains.

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In a deal worth up to $39 million, Serum bought exclusive rights from US biotech Visterra to sell monoclonal antibody, VIS513, as a treatment for dengue in India.

Serum Institute of India, owned by the billionaire Cyrus Poonawalla, has sought the government's approval to import the antibody and conduct clinical trials in India, its chief executive Adar Poonawalla said in an interview.

The antibody has been tested on animals. "Once you inject this into a patient who has dengue, they should show a result within three or four days, or even sooner. It won't be a normal vaccine trial that needs to go into thousands of thousands of patients to prove its safety and efficacy. Approvals to launch new drugs generally take about three to four years in India," said Poonawalla.

"We are trying to make that into a year or maximum a year and a half if we can get quickly the permissions and do a trial to prove that the virus is being neutralized in humans," said Poonawalla.

According to the World Health Organization, the number of dengue cases in India has been steadily rising since 2007, except for a dip in 2011.

There is no treatment for dengue, infected patients are asked to rest, drink fluids and given paracetamol to bring down fever and reduce joint pains.

"We would have to wait to see how the drug reacts in humans, as it has only been tested in animals so far. There are other companies globally developing therapeutic antibodies," said a senior virologist with a government research institute, declining to be named.

French drugmaker Sanofi SA hopes to win approval for the world's first dengue vaccine soon.

"Serum, the world's fifth-largest vaccines maker by volume, will price its dengue treatment between Rs 5,000 ($75.85) and Rs 10,000 per injection with expected annual sales of at least Rs 50 crore to Rs 100 crore," said Poonawalla.

Source: Medindia
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