The Food and Drug Administration has granted Roche approval of an additional capsule manufacturing site in the US for the supply of the influenza antiviral Tamiflu (oseltamivir), expanding its already significantly increased worldwide production capacity. This facility is part of a network of more than a dozen production sites for Tamiflu worldwide, more than half of which are with third party manufacturers.
William M. Burns, CEO Roche Pharma Division stated, “For Tamiflu, the key need today is the rapid expansion of production capacity. Patients' needs in case of a pandemic remain our top priority. We have already significantly expanded production capacity internally and by working in close collaboration with other companies, and we will continue to do so. In addition, we are prepared to discuss all available options, including granting sub-licenses, with any government or private company who approach us to manufacture Tamiflu or collaborate with us in its manufacturing. In support of the global effort to fight a potential pandemic, we would be prepared to discuss such sub-licenses to increase the manufacturing of Tamiflu, provided such groups can realistically produce substantial amounts of the medicine for emergency pandemic use, in accordance with appropriate quality specifications, safety and regulatory guidelines".
Tamiflu is designed to be active against all clinically relevant influenza viruses. 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.
The 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. As a result, more governments are stockpiling Tamiflu therefore Roche is expanding a collaborative production network to meet the increasing demand. The manufacturing process for Tamiflu is complex and lengthy, states a company release.
Roche has been working with many governments over the last few months to determine their needs for stockpiling of Tamiflu and has received and fulfilled orders from around 40 countries.