The Mumbai-based pharmaceutical company Sun Pharma
will collaborate with International Centre for Genetic Engineering and Biotechnology (ICGEB) to develop a dengue
vaccine, targeted against all the four serotypes of dengue
virus (DENV) that cause disease in humans. ICGEB
has developed a tailored recombinant virus-like-particle (VLP) based tetravalent dengue
vaccine, containing host-receptor binding domain of envelope protein of all the four DENV serotypes. ICGEB
has conducted pre-clinical studies over the past seven years and developed the existing know-how and patents for this dengue vaccine
This is the second collaboration between Sun Pharma
focusing on dengue. The first one announced in May 2016 was related to the development of a botanical drug for treatment of dengue. The current collaboration is focussed on developing a novel, safe & effective vaccine
for the prevention of dengue.
“Our new collaboration with ICGEB
for developing an affordable dengue vaccine
is part of our broader commitment for developing new and improved vaccines and drugs against flaviviruses that are of significant health importance to India and rest of the world. Our decision to partner with ICGEB
on dengue vaccine
program followed extensive due diligence and expert consultations on existing dengue vaccine
programs globally,” said Kirti Ganorkar, executive VP & head, global business development, Sun Pharma.
Initial findings of ICGEB’s dengue vaccine
indicate that the candidate induces serotype-specific non-cross-reactive and strongly neutralising antibodies without disease enhancing concerns. These features of the candidate vaccine
differentiate this vaccine
development programme from other vaccine
programs that are developed or in development globally. This vaccine
development will focus on suitability for all target population whether previously affected or non-affected, including paediatric and adults and traveller population.
Dr Salunke, director, International Centre for Genetic Engineering and Biotechnology, added, “Despite recent approval of a dengue vaccine
and several candidates being at advance stage of clinical trials, the development of a safe, affordable and efficacious dengue vaccine
still faces major challenges. I am pleased that the dengue vaccine
development program led by Dr Navin Khanna at ICGEB
is now proceeding to clinical development phase with Sun Pharma. The initial support from DBT and subsequent funding from Wellcome Trust has enabled ICGEB
to bring this vaccine
candidate at the stage it is today. Our pre-clinical data is very encouraging and this could be an ideal dengue vaccine
candidate for all target populations.”
As per the agreement, Sun Pharma
will fund & support further development of the vaccine
candidate and existing ICGEB
know-how and patents. ICGEB
will grant Sun Pharma
exclusive rights and licenses for development and commercialisation of this vaccine
globally. In turn, ICGEB
will receive pre-defined royalty & milestone payments.
will set-up a dengue vaccine
advisory group to provide technical and regulatory support to the vaccine
development programme. It will also be exclusively responsible for all regulatory filings for the product globally including, without limitation, CDSCO-India, WHO, USFDA, EMA, MHRA etc. The company will explore commercialisation opportunities to provide this vaccine
to patients across India, emerging markets, Western Europe, Japan and USA at affordable costs post regulatory approvals in these markets. The immediate priority of this partnership is to complete the toxicology studies for further development of the program.
Sun Pharma, which invests over $ 300 million annually on research and development in pharmaceuticals
and biologics, will use its in-house expertise as well as expertise of its associate company, ARTES Biotechnology GmbH, in development of dengue
vaccine. ARTES will add their experience and proprietary know-how in production of VLP based vaccines from yeast production cell lines.