NEW DELHI: Indian pharmaceutical giant Sun PharmaBSE -0.19 % has partnered with International Centre for Genetic Engineering and Biotechnology (ICGEB) to develop a dengue vaccine that would be safe, effective and affordable. This is their second collaboration focussed on the mosquito-borne virus, the first being their pact to develop a botanical drug ‘Cipa’.
In the latest agreement, Sun Pharma will fund and support further development of the vaccine candidate—DSV4—that targets all four serotypes (variations) of the dengue virus as well as existing ICGEB know-how and patents.
DSV4 is expected to take much less time to develop than vaccines like Sanofi’s Dengvaxia, according to Navin Khanna, who led the development of the vaccine candidate at ICGEB over the last decade. Pre-clinical studies on the vaccine have been conducted so far and the toxicology studies on animals are expected to begin next before it is taken to the clinical trial phase, he said.
Sun Pharma will get exclusive rights and licences to develop and commercialise this vaccine globally, while ICGEB will receive pre-defined royalty and milestone payments, said the drug maker. It didn’t disclose the amount it would invest in this partnership.
Dinakar Salunke, Director, ICGEB noted that despite the recent approval of a dengue vaccine and several candidates at an advanced stage of clinical trials, a safe, affordable and efficacious dengue vaccine still faces major challenges. “Our pre-clinical data is very encouraging and this could be an ideal dengue vaccine candidate for all target populations,” he said.
“This first step, which is a very major bottleneck, has been resolved with the signing of this agreement and hopefully we will see, in the next year or two, a candidate vaccine emerging,” said Soumya Swaminathan, Director General, Indian Council of Medical Research. Modeling exercises show estimates for new dengue cases in India vary greatly from six million to 44 million, she said.
India has reported 51,731 cases and 93 dengue-related deaths so far in 2016.
The latest deal is part of a broader commitment to developing vaccines and drugs against flaviviruses that are of significant health importance in India and globally, said Kirti Ganorkar, Head, Global Business Development, Sun Pharma. “Our decision to partner with ICGEB on dengue vaccine program followed extensive due to diligence and expert consultations on existing dengue vaccine programs globally,” he said.
Unlike existing dengue vaccines, experts say DSV4 is a tailored recombinant virus-like-particle-based vaccine—it doesn’t use a live attenuated virus in its development. Instead, it is made in yeast—a generally safe organism which circumvents associated safety concerns of a live virus and lowers the risk of adverse effects, according to Sun Pharma.
The vaccine is expected to be more effective and affordable because of this design, according to the company.
There is currently no proper treatment for dengue and rest, plenty of fluids and certain painkillers are the only ways to reduce the impact of the virus, according to the World Health Organisation. It is estimated that there are over 50-100 million cases of dengue worldwide each year, it stated.
Sanofi’s Dengvaxia, the only vaccine to prevent dengue so far, has still not been able to launch in India as a high-level government committee held back approvals in April citing the need for additional clinical trial data. This vaccine has already been launched in a few dengue-endemic countries.
