Æterna Zentaris Inc. has received Colombian Food and Drug Agency approval for Impavido (miltefosine), to treat the cutaneous form of leishmaniasis, a severe parasitic skin disease estimated to affect millions of people worldwide. This is the first-ever approval of Impavido for this form of leishmaniasis.

The approval also applies for the visceral form (black fever) of leishmaniasis for which Impavido had already received approval by the Indian and German Regulatory Authorities. Impavido thus becomes the first orally- administered, breakthrough therapy for both visceral and cutaneous leishmaniasis.

Impavido, or miltefosine, is an alkylphospholipid that has been marketed in India since 2003 through cooperation with the Zydus Cadila Group and is available in Germany via Æterna Zentaris' partner Paesel + Lorei. In order to optimize Latin American distribution of Impavido following the approval, Æterna Zentaris has granted distribution rights for Colombia to Tecnofarma, a leading Latin American pharmaceutical company. Tecnofarma thus holds rights to the drug for the entire Latin American territory excluding only Brazil, where Roche has been granted marketing rights.

Prof. Jürgen Engel, executive VP, Gobal R&D and COO at Æterna Zentaris said, "We were hoping that German approval of Impavido, received only in December last year, could form the basis for registration in other countries where leishmaniasis is endemic, such as Colombia. Only three months later, we are proud to deliver on that expectation. It is our goal to place Impavido as a worldwide standard therapy for both cutaneous and visceral leishmaniasis."

Leishmaniasis is a severe tropical disease, second only to malaria. Transmitted by sand flies, leishmaniasis affects millions of people and is, according to the World Health Organisation, endemic in 88 countries throughout the world with nearly 350 million people at risk. It is estimated that 12 million people currently suffer from this disease with 1-1.5 million new cases reported annually.