Roche has granted a sub-license to the Indian company Hetero Drugs for the production of oseltamivir (Tamiflu), as part of continued efforts to increase and speed up availability of the medicine for influenza pandemic planning world wide. The agreement with Hetero is focused on providing oseltamivir for government pandemic use and will have an immediate effect on the availability in India and developing countries both directly and through further agreements with local companies, states a Roche release.
David Reddy, Roche's pandemic taskforce leader, said, "As a result of a period of intense production planning, we are pleased to announce the partnership with Hetero Drugs as the latest step in our scale-up efforts to meet the needs of governments in preparing for the potential public health threat posed by avian influenza. This is another demonstration of Roche's commitment to working as a collaborative and responsible partner with governments and the World Health Organization (WHO) to assist in pandemic planning".
Whilst Roche remains on schedule to meet the current orders received from over 50 governments, the collaboration with Hetero will enhance the supply of oseltamivir in some of the world's poorest countries, resulting in earlier than anticipated delivery timelines and more capacity for further orders. Hetero is the first company that was identified to be able to speed up agreed delivery timelines in the first half of 2006. Following two and a half years of work, Hetero recently received approval to manufacture the medicine, have demonstrated that they meet the criteria which Roche defined in terms of technical ability, capacity and the speed of bringing that capacity on stream, added the release.
With this agreement, Hetero is respecting Roche's and Gilead's intellectual property on Tamiflu in India. The medicine would never have been invented without strong patent systems in place. The recognition of intellectual property in India through this partnership with Hetero therefore is very significant as it respects the new Indian patent legislation which came into effect on January 1, 2005.
Tamiflu is designed to be active against all clinically relevant influenza viruses and key international research groups have demonstrated, using animal models of influenza that Tamiflu is effective against the avian H5N1 strain circulating in the Far East.