Zydus Cadila receives orphan drug status from USFDA for anti-malarial compound

Pharmaceutical firm Zydus Cadila said on Thursday that its antimalarial compound ZY19489′, which is currently being developed with the Medicines for Malaria Venture (MMV), has received an ‘orphan drug designation’ from the US Food and Drug Administration.

The orphan drug designation confers eligibility for certain development incentives, including tax credits for qualified clinical trials, prescription drug user fee waivers, and seven years of marketing exclusivity upon USFDA approval. The Medicines for Malaria Venture (MMV) is a leading product development partnership in anti-malarial drug research.

ZY19489 is a novel antimalarial compound active against all existing clinical strains of the malaria-causing microorganism ‘P’. falciparum’ and ‘P. vivax’, including drug-resistant strains, Cadila Healthcare said in a regulatory filing. In phase I studies, the compound has demonstrated a long half-life and potential for a single-dose treatment for malaria. It has also demonstrated potent anti-malarial activity following single-dose oral administration in a separate malaria challenge trial.

Pankaj R Patel, Chairman, Zydus Group, said, “As a global community facing threats from rapidly changing malaria strains and increasing cases of artemisinin resistance, we need to be prepared with novel therapeutic drugs. ZY- 19489 A potential single-dose radical treatment for P. falciparum and P. vivax malaria, a major global health risk today. Timothy Wells, Chief Scientific Officer of MMV, said, “ZY19489 is a potent, first in class molecule, Originally discovered and expanded in India. It has tremendous potential as part of a new generation of therapies and is fully active against drug-resistant strains of malaria, which are increasingly of concern.”