Innovative Partnership To Create Another Patent-Free Malaria Drug

By Catherine Saez
After an innovative partnership between a non-governmental group and a pharmaceutical company led to a new cheap non-patented drug against malaria being available in Africa in 2007, the model is being implemented again with another new non-patented anti-malarial drug being delivered to South American patients.

The Drugs for Neglected Diseases initiative (DNDi), which partnered with French pharmaceutical company Sanofi-Aventis in 2007, has this time created a partnership with Farmanguinhos/Fiocruz, the largest Brazilian public pharmaceutical company.

This partnership is the second phase of the DNDi’s Fixed-Dose Artesunate-based Combination Therapies (FACT) project, a multi-partner consortium started in 2002 under the umbrella of Médecins sans Frontières (MSF) with financial support from the European Union, the Agence Française de Développement, the Dutch, Spanish and United Kingdom governments, and MSF. The partners include Farmanguinhos/Fiocruz, French, UK and Thai universities, the Centre National de Recherche et de Formation sur le Paludisme in Burkina Faso and the World Health Organization Special Programme for Research and Training in Tropical Diseases in Switzerland.

The new drug, launched on 17 April in Rio de Janeiro, is named ASMQ after its two components: artesunate (AS) and mefloquine (MQ). It is a new unpatented combination drug targeted toward patients suffering from uncomplicated falciparum malaria in Latin America and Asia. The combination is one of the four recommended by the World Health Organization, said DNDi, and is effective in Latin America and Asia because there is no mefloquine resistance in those continents. The combination drug is easier to use than two separate treatments, and ensures that both drugs are taken together and in correct proportion, DNDi said.

Alternative to Market-based Drug Model

The FACT project, whose 2007 drug was called ASAQ (IPW, Public Health, 5 March 2007), is primarily backed by financing from non-profit organisations, public institutions and governments. ASMQ is a new model as it has been produced as a “non-exclusive, not-for-profit public good” said DNDi.

The ASAQ combination is now being widely used by MSF. “Putting the tablets together made a huge difference,” said Tido von Schoen of MSF. “It is possible to go without patent” he said, to make a drug a public good.

Drug research and development being carried out under public funding is a new model that should lead the way, Ann-Marie Sevcsik, DNDi scientific communications manager, told Intellectual Property Watch. “Research and development should be ‘needs-driven’ instead of profit-driven, and not only for neglected diseases but for neglected patients, like cancer patients in the developing world,” she said.

ASMQ is now available in Brazil, although the Brazilian government, due to existing stocks and the registration process will continue using Coartem, the previously used drug, in 2008. Anti-malarial treatments are not sold in the private sector in Brazil as they are sold only through the public distribution system, DNDi said, but there is an extensive intervention study being conducted by national authorities, which provides medicines to patients through testing. Already 20,000 patients have been successfully treated in the Amazon Basin, which is the location of about 90 percent of Brazilian malaria patients. Since treatment began there has been a drop of about 70 percent in malaria cases among those patients. There are an estimated 200,000 malaria patients in Brazil, according to DNDi.

Through 2008, more patients will be included in this study and will be able to receive ASMQ. It will later be available for all patients in Brazil free of charge. Patients in other Latin America countries will be able to receive ASMQ by the end of 2008, depending on individual country registration processed by their regulatory authority.

Patent-free South-South Technology Transfer

According to Jean-René Keichel, DNDi project manager, the FACT project has encouraged capacity building of the different partners. In Brazil, for example, it led to the first new molecule developed and registered by a Brazilian pharmaceutical company. The transfer agreement that is being carried out between Farmanguinhos/Fiocruz and India’s generic pharmaceutical company Cipla is the first between Brazil and India on malaria. It is also the first technology transfer project involving a public pharmaceutical company and a private pharmaceutical company, he said.

Cipla will address the Asian market and will provide the product at the at-cost price to the public sector in Asia. The product will be patent-free.

Farmanguinhos/Fiocruz, with facilitation provided by DNDi, will transfer information on development and production to Cipla to manufacture ASMQ. The partners are then expected to share results on ongoing work and new studies.

Keichel said that the decision to forego patenting on ASAQ and ASMQ had been made after some discussions within DNDi as there is a risk the drug could be copied and patented by a private company who could then prevent DNDi from using it. But they still decided that the FACT project drugs would remain patent-free, he said.

Sevcsik said DNDi now is sponsoring study in Tanzania to begin by the end of 2008 to test ASMQ in Africa.

Catherine Saez may be reached at csaez@ip-watch.ch.