Roche to share know-how in making protease inhibitors with poorest countries

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Roche, the manufacturer of saquinavir (Invirase), announced yesterday that it will share its know how about making the drug with any pharmaceutical manufacturer in sub-Saharan African and other Least Developed Countries that wants to begin making the drug for use as a second-line HIV treatment. Roche’s technology transfer programme will begin in the second quarter of 2006 subject to approaches from interested companies.

Roche already has a policy of non-enforcement of patent rights for HIV medicines in least developed countries, which means that no action would be taken against any company that wanted to copy saquinavir or nelfinavir. The company has also pledged not to file patents on new HIV/AIDS medicines in least developed countries and sub-Saharan Africa.

However yesterday’s announcement is the first attempt by a manufacturer in the HIV field to give away the know how to make copies of its medicines, and has important implications for all other companies that hold patents on protease inhibitors.

Glossary

second-line treatment

The second preferred therapy for a particular condition, used after first-line treatment fails or if a person cannot tolerate first-line drugs.

boosting agent

Booster drugs are used to ‘boost’ the effects of protease inhibitors and some other antiretrovirals. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective.

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

first-line therapy

The regimen used when starting treatment for the first time.

middle income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. There are around 50 lower-middle income countries (mostly in Africa and Asia) and around 60 upper-middle income countries (in Africa, Eastern Europe, Asia, Latin America and the Caribbean).

“We are sharing the technological expertise we have in making protease inhibitors. This should give manufacturers the skills to make other HIV medicines as they choose, and Roche is attaching no conditions [to the technology transfer]”, said Maria Vigneau of Roche.

“Patents are not in place for other second-line treatments, so it’s up to these companies to decide how to use this technology in making other protease inhibitors.”

Saquinavir is recommended as a second-line HIV treatment in combination with low dose ritonavir (Norvir) in resource-limited settings by the World Health Organization. Although ritonavir is sold at a no-profit price by manufacturer Abbott Laboratories, the drug is unpatented in all African countries. All second-line protease inhibitor-based therapies are reliant on ritonavir as a booster.

However, the development of a generic version of ritonavir at a price lower than Abbott’s current offer of $83 for a year’s supply of the drug as a booster dose would require substantial economies of scale and highlights the chief problem for the development of cheap second-line therapies: the need for large, predictable volumes in order to bring prices down.

In contrast with the first-line antiretroviral market, where volumes can be predicted with reliability, the second-line market is beset with uncertainty because no one knows what proportion of patients are likely to need second-line treatment over any given period of follow-up. Estimates are based on rates of failure seen in cohorts from South Africa and Kenya, and vary from 5-30% of patients after two to three years of treatment.

Other protease inhibitors that might be used in second-line treatment are Kaletra (lopinavir/ritonavir), which is offered to least developed and sub-Saharan countries at $500 a year by Abbott Laboratories, Reyataz (atazanavir) boosted with ritonavir, and Telzir or Lexiva (fosamprenavir) boosted with ritonavir. Atazanavir and fosamprenavir are not yet recommended by the World Health Organization for second-line use in resource-limited settings because they are too new to have been used in Africa or Asia, and because their use is currently restricted due to a lack of differential pricing of the products (manufactured by Bristol Myers-Squibb and Glaxo SmithKline respectively).

Roche's announcement does not cover middle-income countries like Thailand, Russia or the Latin American nations.