Cadila Healthcare on Thursday announced that its antimalarial compound ZY19489 (MMV253), has received Orphan Drug Designation from the USFDA.
Orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.Cadila said the Phase I study of ZY19489 demonstrated long half-life and potential for a single-dose cure for malaria.
Speaking on the development, Pankaj R. Patel, chairman of Zydus Group said, As a global community facing threats from rapidly mutating malaria strains and the rise in artemisinin resistance cases, we have to be prepared with novel therapeutic drugs. ZY-19489 is a potential single dose radical cure for P. falciparum and P. vivax malaria which is a major global health risk today.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company's consolidated net profit surged 608.10% to Rs 2,999.60 crore on 2.4% increase in net sales to Rs 3,687 crore in Q2 FY22 over Q2 FY21.
Shares of Cadila Healthcare were trading 0.32% lower at Rs 464.20 on BSE.
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