Aspen’s oral single dosage plant in Port Elizabeth has concluded a major manufacturing agreement with Roche to produce a generic version of oseltamivir – also known as Tamiflu – for Africa.

This forms part of Roche’s efforts to increase and speed up availability of the medicine for influenza pandemic planning following the world wide outbreak of avian flu.

The manufacturing agreement focuses on providing oseltamivir for pandemic use to further help address the needs of governments and other not-for-profit organisations on the continent.

Stavros Nicolaou, Aspen’s senior executive for strategic trade development, said he could not pin a value to the manufacturing agreement as the manufacturing scale depended on the outbreak of a flu pandemic.

The agreement, he said, comprised four parts: a licence to manufacture the medicine, technology transfer, manufacturing and distribution.

The agreement also allows for the supply of active pharmaceutical ingredient (API) by Roche to Aspen.

Aspen group chief executive Stephen Saad said the confidence placed in Aspen by Roche endorsed the international approval of Aspen’s quality manufacturing and its ability to provide solutions for the African continent.

The agreement follows an investment of R150-million in 2004 in Aspen’s OSD plant in Port Elizabeth, which is the largest generic drugs manufacturing facility on the African continent.

An additional R30-million was invested last year to increase capacity by 40% to meet demand.

The plant currently produces four billion tablets a year.

The strong demand from this plant is based on Aspen’s winning a large part of the government’s ARV roll-out programme, but is also due to additional contracts and production rights for an increasing range of Aids drugs.

Nicolaou said the agreement came as a direct result of these investments.

“The threat of avian flu is that you can have a global pandemic. Roche identified partners worldwide with the capacity and quality standards to manufacture the medicine. If we had not invested in our infrastructure or quality we wouldn’t have been selected,” he said.

Nicolaou said he was sure this agreement would not be the last one as there was still room for expansion at the North End plant.

Roche’s pandemic taskforce leader David Reddy 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.”

Roche is in a non-exclusive partnership with governments and the World Health Organisation to assist in pandemic planning.