 "Sun Pharma & ICGEB to jointly develop dengue vaccine")
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 candidate.
This is the second collaboration between Sun Pharma and ICGEB 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.
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Sun Pharma 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.