Roche and Æterna Laboratories Inc. announced a partnership for the marketing in Brazil of Impavido (Miltefosine), the breakthrough oral therapy of leishmaniasis. The agreement was signed between Produtos Roche QFSA in Sao Paulo and Zentaris GmbH in Frankfurt, a 100 per cent subsidiary of Æterna Laboratories Inc.

Under this agreement, Roche will support Zentaris in the registration process and will market the product for Zentaris in Brazil. Furthermore, Zentaris will supply Impavido to Roche. Brazil is the country in South America that is most affected with the deadly visceral leishmaniasis (black fever) and the painful cutaneous leishmaniasis (parasitic skin disease). Both parties will immediately start clinical bridging trials, as requested from the Brazilian health authorities.

The registration of the first oral treatment for leishmaniasis in Brazil would be a breakthrough in fighting this awful disease. It is estimated that, every year, up to 50,000 people are newly infected in Brazil, 10 per cent of them with the deadly visceral form. Because of these numbers, there is an urgent need for new treatments for leishmaniasis and Impavido in Brazil.

"The drug has proven to be safe and effective in India for visceral leishmaniasis and in clinical trials for cutaneous leishmaniasis in Colombia and Guatemala," said Prof Jürgen Engel, managing director of Zentaris GmbH, executive vice president, Global R&D and chief operating officer at Æterna. "The partnership with Roche is the best opportunity to make the drug available very fast in Brazil where it is urgently needed."

Leishmaniasis is a tropical disease caused by the leishmania parasite. According to the World Health Organization (WHO), more than 12 million people are affected worldwide, with an infection rate of 2 million new cases per year. Impavido has recently been approved in India for the treatment of the visceral form of this disease.