Roche announced that it 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 worldwide influenza pandemic planning.
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.
David Reddy, Roche's Pandemic Taskforce Leader, commented: "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."
While 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.
Roche has been working with many governments over the last few years to determine their needs for stockpiling of Tamiflu and has received and/or fulfilled orders from around 50 countries.
Roche has also pledged to donate 3 million treatments to the WHO for use where an influenza pandemic may start. This amount, based on mathematical modeling, could contain or stop the spread of a potential pandemic at the source of the outbreak.
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.
It works by blocking the action of the neuraminidase (NAI) enzyme on the surface of the virus. When neuraminidase is inhibited, the virus is not able to spread to and infect other cells in the body.
Most avian influenza viruses are not infectious to humans, but, should an avian and a human influenza virus co-infect a human or a pig, the virus strains can join, mutate and create a completely new virus, which may be transmissible from animals to humans, and from humans to humans. Such a strain would be entirely new in composition, so vaccines developed and administered to date to protect humans during seasonal epidemics, would be ineffective against this new strain, leaving the population vulnerable to infection. Experts believe the next influenza pandemic could result from such a mutation of virus strains.
© 2006 mydna.com