Aspen, South Africa’s largest listed pharmaceutical company, on Tuesday announced that it has reached an agreement with Roche to produce a generic version of oseltamivir for Africa. The drug is currently marketed by Roche under the trade name Tamiflu.
This complements Roche’s continued efforts to increase and speed up availability of the medicine for worldwide influenza pandemic planning. The agreement focuses on providing oseltamivir for pandemic use to further help to address the needs of governments and other not for profit organisations in the African sub- continent.
Roche will provide technical know-how (technical, pre-clinical and clinical data) to assist Aspen to help them expedite their production and the registration.
The agreement also allows the supply of the active pharmaceutical ingredient from Roche to Aspen.
Stephen Saad, Aspen Group CEO, said: “This product will be manufactured in Aspen’s Port Elizabeth-based oral solid dose facility which was approved by the US Food and Drug Administration in 2004.”
David Reddy, Roche’s pandemic taskforce leader, said: “We are pleased to announce the partnership with Aspen 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 Organisation to assist in pandemic planning.”
While Roche remains on schedule to meet all orders from African governments by early 2007, the collaboration with Aspen will further enhance the supply of oseltamivir for Africa. The agreement is non-exclusive and will mean that Roche and other sub-licensees will be able to work on pandemic orders within Africa. – I-Net Bridge