Serum Institute to launch dengue vaccine in 3-4 years
Mumbai: Home-grown vaccine maker Serum Institute of India plans to launch its biologic drug for dengue in two years and a dengue vaccine in three to four years, chief executive Adar Poonawalla said on Tuesday.
“For dengue we are coming out with a vaccine that is preventive so that you do not get it and a monoclonal antibody for those who are not protected. Vaccine will take some time. What’s coming earlier is the monoclonal,” Poonawalla said.
“What we have done is paid a huge sum to a US company called Visterra and exclusively tied up with them for developing the monoclonal for dengue,” he said.
Currently, there are no vaccines available for dengue in India.
Sanofi SA has launched a dengue vaccine in some markets overseas, but it is not approved in India.
Serum Institute will start phase-1 clinical trials for the dengue biologic drug in Singapore next month.
“We couldn’t do it (develop the dengue vaccine) in India as it would have taken us a very long time. As a norm, we will have to do a study in India but based on a larger study done in Singapore, we are hoping to get permission to do just a small bridging trial to prove that we are replicating the same thing in India,” Poonawalla said.
In 2015, Serum Institute of India had sought fast-track approval from the Indian drug regulator to launch a dengue treatment but that did not come through.
On Tuesday, the Pune-based firm launched its rotavirus vaccine Rotasiil for prevention of severe diarrhoea in babies and biologic drug Rabishield for rabies. “Our new drug—Rabishield—is a first-of-its-kind product for passive immunization against Rabies. Since the drug will be 25% cheaper than the existing rabies immunoglobulins, it would meet the needs of poor countries,” Poonawalla said.
Rabies is reported to cause two deaths every hour in India, while around 100,000 deaths occur in the country due to rotavirus-related ailments.
Over the next three years, the firm plans to launch 3-4 vaccines, including HPV for cervical cancer, pneumococcal polysaccharide conjugate and pentavalent meningitis.
Serum Institute plans to enter European markets by 2020 and also start some product filings in the US, which is expected to boost revenue, he said.
In the next five years, Poonawalla expects the company’s revenue to reach Rs10,000 crore from about Rs4,000 crore currently, driven by product launches and entry into regulated markets.
Since 2010, the company’s revenue and profit have both witnessed a compound annual growth rate (CAGR) of 30%. On an annual basis, it spends around Rs300-400 crore on research and development (R&D) and almost the same amount on capital expenditure, Poonawalla said.