New Delhi: India represents nearly 50 percent of the global population estimated to be at risk of dengue. Severe dengue, which is potentially fatal, correlates with very high virus load, reduction in platelet counts and haemorrhage. Antiviral therapy to reduce high virus load may be beneficial in attenuating disease severity.
Therefore, as a major example of unique public private partnership programme, the International Centre for Genetic Engineering and Biotechnology (ICGEB) and Sun Pharma on May 4, 2016 signed an agreement to develop a novel botanical drug for treatment of dengue. Through this agreement, Sun Pharma commits development of Cissampelos pariera (Cipa), a botanical drug in collaboration with ICGEB. Through this agreement Sun Pharma will follow up on earlier pre-clinical collaboration between ICGEB and erstwhile Ranbaxy Laboratories Sun Pharma will develop Cipa, a botanical drug following a drug registration process similar to a new chemical entity, consisting of all required in-vitro, in-vivo, pre-clinical and clinical studies meeting all regulatory standards of India and other regulatory agencies worldwide.
According to Dr Dinakar M Salunke, Director International Centre for Genetic Engineering and Biotechnology , New Delhi, “Dengue, a mosquito-borne viral disease, poses a significant global public health risk. In tropical countries such as India where periodic dengue outbreaks can be correlated to the high prevalence of the mosquito vector, circulation of all four dengue viruses (DENVs) and the high population density, a drug for dengue is being increasingly recognized as an unmet public health need. Using the knowledge of traditional Indian medicine, we explored the indigenous herbal bio-resource to identify plants with pan-DENV inhibitory activity and identified CIPA as a safe, affordable and effective solution.”
Sun Pharma will fund entire development programme as well pay royalty following commercialization of the drug. Also while ICGEB will provide the technical know-how and pre-clinical expertise, Sun will develop this drug with appropriate pre-clinical & clinical studies to register it in India and other global markets.
Commenting on the company’s partnership with ICGEB, Mr Kirti Ganorkar, Senior Vice President – Business Development & Portfolio Management, Sun Pharma said, “Dengue poses a significant global public health risk. In tropical countries like India where dengue outbreaks are significantly intense, a drug for dengue is recognized as an unmet public health need. Our partnership with ICGEB aims to develop Cipa as a safe, effective & affordable botanical drug for treatment of dengue.”
“Dr Naveen Khanna’s continuous efforts in Dengue research are appreciable and I wish best to the team driving this initiative,” said Dr K VijayRaghavan, Secretary, Department of Biotechnology who was the Chief Guest at the event.
Dr Navin Khanna at ICGEB has been the Principal Investigator (PI) for this project. He will continue in this role as part of the current collaboration. He is a Senior Scientist and Group Leader at ICGEB. He holds a Doctoral Degree in Biochemistry from All India Institute of Medical Sciences (AIIMS), New Delhi. For more than 20 years, he has been working on genetically engineered bio-molecules of medical use at ICGEB, New Delhi. Dr Khanna’s current research focuses on finding solutions to the Dengue menace. His latest contribution is the rapid Dengue Day-1 kit for accurate and early detection of the dengue virus infection.
The terms of this agreement permits Sun Pharma’s access to all the intellectual properties of this drug cross 17 countries. ICGEB will establish assay systems for development of Cipa for treatment of dengue infection for a pre-defined period of time. ICGEB will work exclusively with Sun Pharma for the development of this drug and clinical treatment strategies based on botanical and phyto-pharmaceuticals. Sun Pharma will pay royalties on sales post commercialisation. Other financial details of this agreement are confidential.
A botanical drug is a plant-derived medicinal product that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. These medicines are based on complex botanical compounds and can offer multiple agent solution, selectively and differentially affecting various target tissues. These characteristics make botanical drugs safe and effective. As any other new drug, Sun Pharma will scientifically substantiate the safety and effectiveness, manufacture under appropriate standards and build a strong intellectual property base to support commercialization of its botanical dengue drug.
ICGEB and Sun Pharma through this collaboration are developing innovative botanical opportunities to identify herbal options that could be source of dengue inhibitory activity. The developmental efforts of this collaboration will aim to explore how the extract prepared from Cipa Linn can inhibit the replication of virus in living cells against dengue infection.
The high and growing burden of Dengue in India suggests a pressing need to improve its public health efforts. It is estimated the cost of medical care for those who get infected with dengue is equal to nearly $550 million annually. Additional indirect economic costs, which are borne by patients and their families, lost wages, will be another US$ 550 million. It is thus believed that dengue costs India over $1.1 billion annually.