MSD India, the Indian subsidiary of Merck & Co Inc., has announced a first of its kind medical research alliance with Indian Council of Medical Research (ICMR) here yesterday. As per the agreement, Merck and ICMR will jointly carry out phase III clinical trials of Merck's investigational cervical cancer vaccine, Gardasil (quadrivalent human papillomavirus types 6,11,16,18, recombinant vaccine) in the Indian population. MSD India has given a commitment to ICMR to make the vaccine available at affordable rates to public sector establishments for treating the poor patients of the country. The details of the clinical research are being worked out.

Declaring the commencement of the partnership at a press conference, Leonard Tauro, managing director, MSD India, said, “The company hopes to work closely with fellow collaborators to establish a public-private partnership model in India that can be adapted for use in many developing nations worldwide."

The collaborative research agreement was the result of one-and-a-half year's parleys with Merck, Dr N K Ganguly, director general, ICMR informed. Pointing out that the incidence of cervical cancer is very high in the country; Dr Ganguly said that ICMR was having discussions with all the vaccine manufacturers who were working on prevention methods for cervical cancer.

"We had discussions with all the manufacturers who are in the process of developing cervical cancer vaccine. However, it was Merck that agreed to our conditions to provide us vaccines at affordable rates for public health programmes," said Dr. Ganguly.

The agreement spans a range of activities, starting with the design of a study to assess the use of Gardasil in the Indian population. In addition to assistance with the study design, Merck will supply Gardasil for use in the study. Upon the completion of the study, the two partners will work together to assess the role of HPV vaccine in the population of India and identify ways of providing access to HPV vaccine.

Dr Ganguly said that the agreement had generated lot of interest among funding agencies in the health sector.

"We are having discussions with the Bill and Melinda Gates Foundation for supporting the larger clinical trial studies of the vaccine," he informed.

ICMR intends to carry out two studies, one a short term study for less than two years, and another a larger study spanning four years to understand the effect of the vaccine in Indian population.

"Cervical cancer is the most common cancer among women in India. Infection with Human Papillomavirus (HPV) is a major risk factor that leads to cervical cancer. The clinical trials with HPV vaccine in India would test its role in the control of cervical cancer in India. If found successful, it may open a feasible option for the control of cervical cancer in developing countries," Dr Ganguly said.

According to Dr. Ganguly, the ICMR has identified a list of probable clinical trial sites in Delhi, Ahmedabad, Mumbai, Hyderabad and Tamil Nadu which are known to be having the capability to take up the task. A medical committee comprising international and national experts is to visit all these sites before finalising them. The preparations are likely to be over in a year. The result of the trials should be ready within four years.

Meanwhile, Merck has already filed an application for marketing approval of the vaccine in the United States. The United States Food and Drug Administration is likely to complete the regulatory proceedings within a year.