Roche offers HIV drug expertise to poor nations

Swiss pharmaceutical giant Roche announced transfer technology to generic drug manufacturers in the least developed countries and sub-Saharan Africa to produce versions of the HIV drug saquinavir.

As part of its new Technology Transfer Initiative, Roche has announced further expansion of its current activities within sub-Saharan Africa and the world's Least Developed Countries by providing local manufacturers with the technical expertise for producing generic HIV medicines.

These countries are home for 69 percent of the HIV/AIDS population in the world.

Saquinavir is a protease inhibitor, one of a class of drugs that work by blocking part of the virus and preventing it from replicating itself.

Protease inhibitors are used in combination with other anti-HIV drugs in so-called treatment cocktails, which aim to reduce the amount of HIV in the body.

AIDS campaigners have been pushing drug companies to offer second-line treatment at lower prices, following discounts offered on the first-line products.

Roche said it would make its HIV protease inhibitors Invirase and Viracept available at no-profit prices for direct supplies from Roche Basel to LDCs and sub-Saharan Africa.

The transfer of expertise model will be based on the processes to manufacture saquinavir, the HIV protease inhibitor medicine recommended by the World Health Organization as a second line treatment in resource-limited settings.

William M. Burns, CEO Division Roche Pharmaceuticals, said, "With international funding now available, Africa will be the world's biggest user of HIV medicine. We have taken this unique step to help ensure that the right medicines in the right formulation are locally available. We want to use the knowledge we have developed to help strengthen local manufacturing capability and hope to help as many manufacturers as possible in these hardest hit countries by sharing our knowledge, so that they can learn and benefit from our technology."

A new Roche team, to be operational from the second quarter of 2006, will be based in part on the ground in Africa. As much of the knowledge and skill sharing will be undertaken on site at the generic manufacturer's facilities, and part of it at the Roche global headquarters in Basel, Switzerland.

With the growth of efforts resulting in increased access to first-line treatment in resource-limited settings such as sub-Saharan Africa, the need and subsequently the demand for second line treatments will continue to grow. As a result, increasing manufacturing knowledge and capacity within these regions could play a vital role in treatment delivery, Roche said.

Under Roche’s Technology Transfer Initiative, Roche will not enforce its patents on HIV drugs in sub-Saharan Africa and the Least Developed Countries wishing to produce generic saquinavir for use in these countries.

Unconvinced

However, the Bern Declaration, an NGO, was unconvinced by Roche's announcement.

The NGO's Julien Reinhard was quoted by the Swiss news agency as saying that it seemed to be a PR move. "This decision is coming a bit late because saquinavir's patent is starting to expire in an increasing number of countries," said Reinhard.

Furthermore, most of the countries named by Roche – with the exception of South Africa and Bangadesh – do not have the capacity to manufacture medications, he added.

He said it would have been better for Roche to renounce its patents in these countries.

Reinhard also claimed that saquinavir was never prescribed on its own, but usually in combination with the drug Ritonavir, which is manufactured by Abbott, so questioned the merits of manufacturing it alone.