The vaccine is targeted against all the four serotypes of Dengue virus that cause disease in humans and is being developed to commercialize in Indian and international markets.
A serotype is a serologically distinguishable strain of a microorganism.
Currently, half of the global population lives under dengue threat; and an estimated 390 million infections occur worldwide every year with approx. 100 million cases of clinical disease and over 25,000 deaths. All four dengue virus serotypes are now endemic in India.
Currently, there are no available antivirals, which presents a public health challenge in India and other parts of the world, including developed nations. There is no specific treatment other than supportive clinical care, which is extremely difficult in developing countries with poor resources.
“Our new collaboration with ICGEB for developing an affordable dengue vaccine is part of our programme for developing new and improved vaccines and drugs against flaviviruses that are of significant health importance to India and rest of the world,” said Kirti Ganorkar, Executive VP & Head, Global Business Development, Sun Pharma.
International Centre for Genetic Engineering and Biotechnology (ICGEB) has developed a dengue vaccine based on a tailored recombinant virus-like-particle (VLP). The vaccine contains host-receptor binding domain of envelope protein of all the four dengue virus serotypes.
According to the agreement signed, ICGEB shall disclose and make available to Sun Pharma all such existing ICGEB know-how as well as effective completion of technology transfer by ICGEB to Sun Pharma within stipulated timeframe. 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 and it will receive pre-defined royalty & payments.
The Company has past experience in development of Hep-B and Typhoid vaccines, as well as complex vaccines, such as HPV and Malaria.
Dengue is a neglected mosquito-borne viral disease that is rapidly spreading globally. Dengue incidence has increased by more than 30-fold in the past 50 years.
The Sun Pharma – ICGEB dengue vaccine candidate is expected to provide a competitive edge over others in all three critical parameters of Safety, Efficacy & Affordability that define an ideal dengue vaccine.
ICGEB has conducted pre-clinical studies over the past seven years and developed the existing Know-How and Patents for this dengue vaccine candidate.
“The immediate priority of this partnership is to complete the Toxicology studies for further development of the program,” Sun Pharma said.
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 safe & effective vaccine for the prevention of dengue.
Initial findings of ICGEB’s dengue vaccine indicate that the candidate induces serotype specific non-cross-reactive and strongly neutralizing 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 (ICGEB) said, “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. Our pre-clinical data is very encouraging and this could be an ideal dengue vaccine candidate for all target populations.”
Sun Pharma is the world’s fifth largest specialty generic pharmaceutical company and one of India’s largest pharmaceutical company.
It provides affordable medicines in over 150 countries across the world.
Sun Pharma’s global presence is supported by 47 manufacturing facilities spread across 6 continents. The consolidated revenues for 12 months ending March 2016 are approximately U$ 4.3 billion.
It has 32 brands and 14 API manufacturing facilities across the globe.
The International Centre for Genetic Engineering and Biotechnology is an international, non-profit research organization.
The ICGEB provides a scientific and educational environment and conducts innovative research in life sciences for the benefit of developing countries. It strengthens the research capability of its Members through training and funding programmes and advisory services and promotes biotechnology internationally.
The Centre is dedicated to advanced research and training in molecular biology and biotechnology and applies the latest techniques in the fields of biomedicine, crop improvement, environmental protection/remediation, biopharmaceuticals and biopesticide production.