Merck, ICMR to conduct joint trials on cervical cancer vaccine
22 Dec 2005
New Delhi: The Indian Council of Medical Research (ICMR) will collaborate with the US-based Merck & Co, Inc, also known as Merck, Sharp & Dohme outside the US, through its Indian subsidiary MSD Pharmaceuticals Pvt Ltd (MSD India), to study the drug multinationl drug firm''s investigational cervical cancer vaccine, Gardasil (quadrivalent human papillomavirus (HPV) types 6, 11, 16, 18, recombinant vaccine) on the Indian population.
The agreement spans a range of activities, starting with the design of a study to assess the use of Gardasil, supplied by Merck, on the Indian population. Upon completion of the study, the two organisations will work together to assess the efficacy of HPV vaccine on the Indian population.
According to professor N K Ganguly, director general, ICMR, "The rate of cervical cancer in India is extremely high." The disease accounts for an estimated 24 per cent of India's cancer cases among women, compared with 20 per cent for breast cancer. "Through this partnership with Merck, we hope to determine the role vaccination may play in reducing the burden of cervical cancer in India," he added.
Of the 510,000 cases of cervical cancer reported each year globally nearly 80 per cent occur in developing countries. Cervical cancer is the commonest cancer among Indian women, with HPV infection posing a major risk factor. According to WHO more than 130,000 new cases are reported each year and an estimated 74,000 women die from it annually. "We are pleased to begin this partnership with the ICMR and are committed to supporting efforts to study potential ways to help reduce the threat cervical cancer poses to India''s female population," said Leonard Tauro, managing director, MSD India.
The clinical trials with Merck's HPV vaccine would test its role in controlling the spread of the disease in India. If found successful, it may open a feasible option for MSD to market the drug in other developing countries.
"Our hope is to work closely with fellow collaborators to establish a model in India that can be adapted for use in the many developing nations world-wide." added Mark Feinberg, vice president, public policy and medical affairs, Merck vaccine division
Merck says that collaborative partnerships between industry, NGOs and individual governments are critical in determining the best approach to the introduction of investigational medicines and vaccines in the public sector of low income countries.
Gardasil is Merck's investigational cervical cancer vaccine and the company says that it is designed to protect against four types of human papillomavirus — types 16 and 18, which account for an estimated 70 per cent of cervical cancer cases and HPV types 6 and 11 which account for an estimated 90 per cent of genital wart cases.
ICMR is one of the oldest medical research councils in the world. It started in 1911 as the Indian Research Fund Association (IRFA) and was renamed ICMR in 1950, soon after Independence, on the recommendations of the ''health survey and development committee, headed by Sir Joseph Bhore. IT has a network of 26 institutes and over 70 field stations in various parts of the country, and has an annual budget of Rs231 crore.