Merck & Co, known as MSD India, has entered into a collaboration with the Indian Council of Medical Research (ICMR) to conduct studies on the former's investigational cervical cancer drug, Gardasil.//
This is the first public-private partnership in vaccine development in India. Under the agreement, clinical trials will be conducted for a human pappiloma virus (HPV) vaccine that causes cervical cancer.
The vaccine that has been developed by Merck and will be tried on 30 to 40,000 women in two phases. The volunteers will be between 17 and 18 years of age.
While the first phase will take two years, the second will take four years to complete and the cost of the trials is estimated to be around $45 million.
The Indian trials will be carried out to see if it's safe and equally efficacious for women in a tropical country.
Upon completion of the study in India, the two partners will work together to assess the efficacy of the vaccine in the Indian population and identifying ways of providing the same.
The New Jersey-headquartered pharma company has already applied for permission from the Food and Drug Administration (FDA) to launch the vaccine in the US market and is likely to apply for regulatory approval for the EU region soon.
This study is in addition to the Phase III clinical trials that have to be completed for any drug to be approved by the regulator. Dr Leonard Tauro, MD, MSD India says, "We want to know how the vaccine would respond to the Indian conditions."
The company will supply the vaccine free of cost for its use in the study. Gardasil is designed to protect against four types of human papillomavirus (HPV) - 6, 11, 16 and 18. Besides Merck, GSK too is working on a similar vaccine.
About 5.1 lakh cases of cervical cancer are reported every year the world over, with nearly 80 per cent occurring in developing countries. The World Health Organization terms cervical cancer the moPage: 1 2 Related medicine news :1
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