NGO-Industry Drug For Poor Countries Sets Non-Patent Standard

By Tove Iren S. Gerhardsen
A new anti-malarial, non-patented drug available cheaply to the public sector is being hailed as proof that it is possible for the private and public sectors to overcome differences over patents and reach concrete results for public health in poor countries.

The not-for-profit research organisation, Drugs for Neglected Diseases initiative (DNDi), and the French pharmaceutical company, Sanofi-Aventis, are the partners behind the new drug, which soon will be available “non-patented for the public” in Sub-Saharan Africa and elsewhere, a DNDi spokesperson told Intellectual Property Watch.

Robert Sebbag, vice president of the Sanofi-Aventis access to medicines department, told Intellectual Property Watch that this was an “original partnership,” and the process had been a “discovery” for both partners. The idea had been to develop a malaria product that would be available for less than US$1, without filing a patent, and all three had now been achieved.

The drug (to be named “ASAQ”) will be available at production cost to the public, meaning national public health systems, non-governmental and intergovernmental organisations, the DNDi spokesperson said. For this sector, it will be available cheaply (less than $0.50 per treatment for children under 5 years old, and less than $1 for older children and adults).

Sanofi-Aventis also will sell it under a brand name (“Coarsucam”) in the private sector, meaning private hospitals and private pharmacies, with a third production cost version available in private markets in low-income countries such as Madagascar, Burkina Faso and Cameroon, Sebbag said.
The drug will be available in three versions under different packaging, which NGOs such as Médecins Sans Frontières (MSF) have helped develop, the spokesperson said.

For the private markets there also will be no patent, he said, adding that the idea is that “the rich have to pay for the poor,” he said. But even in the private market, big revenues are not expected, he said.

The drug will be produced at Sanofi-Aventis’s manufacturing plant in Morocco, and the first orders are already underway to Africa. Ten countries in Sub-Saharan Africa have registered the drug and three are in the process, the DNDi spokesperson said.

Sebbag said that the “needs are enormous” as there are half a billion malaria attacks per year, and the company’s strategy is “no profit-no loss,” meaning that these products are sold at production price. He said any generics company interested in producing the drug could have the file and do so, provided they met certain quality standards.

In 2004, DNDi and Sanofi-Aventis brought together their dossiers that led to the new drug, but DNDi will manage the project, including looking into its benefits in India and Indonesia and following up with safety and efficacy, or pharmacovigilance, studies, the DNDi spokesperson said.

“We are impressed that Sanofi-Aventis was willing to make this agreement,” the spokesperson said, adding that this bodes well for the prospects of the industry entering similar partnerships in the future.

This is the first drug launched by DNDi, and the patent-free model will be the standard model for other projects as well. The spokesperson said that DNDi has no intention of allowing a patent to go through, as there is “no space for patents” in the realm of neglected diseases.

The new product is a combination of two well-known drugs (artesunate and amodiaquine) and easier to administer than the older ones. ASAQ stands for: “Adapted” to patient needs of all ages, a fixed combination of two well-known drugs and following WHO recommendations, “Simple” as a once-a-day regimen easy to manage for the prescriber and the patient, “Accessible” as a non-patented drug, at an affordable price, “Quality” in terms of galenical (natural-substance derived) development, manufacturing and storage, the DNDi said.

DNDi was set up in 2002 and is a partnership between public research institutions in Brazil, India, Kenya and Malaysia, the Institut Pasteur, MSF and the WHO Special Programme for Research and Training in Tropical Diseases, as a permanent observer.

DNDi aims to deliver 6 to 8 new treatments for neglected diseases by 2015, it said. ASAQ is the first drug in a special research partnership, for which has received support from the European Union and Oxford University, among others.

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.