Oncology company MEI Pharma
announced that the FDA has granted orphan drug designation for Pracinostat, an
investigational drug for the treatment of acute myeloid leukemia (AML). MEI
Pharma owns the exclusive global rights to Pracinostat.
Currently, very few broadly
effective treatments exist for AML, which is a particularly devastating cancer.
Through developing Pracinostat, MEI Pharma hopes to address the significant
unmet medical need of AML patients.
The Orphan Drug Designation
program of the FDA gives orphan status to drugs that have been defined as being
intended for safe and effective treatment, diagnosis or prevention of rare
diseases affecting fewer than 200,000 people in the United States. Receiving
orphan designation qualifies the sponsor of the drug, in this case MEI Pharma,
for certain development incentives, such as tax credits for qualified clinical
testing, prescription drug user fee exemption, and seven-year marketing
exclusivity once the drug is approved by the FDA.
Based in San Diego, Calif.,
MEI Pharma is an oncology company focused on the clinical development of novel
cancer therapies. Pracinostat is the company’s lead drug candidate. The company
expects data from three ongoing Phase II clinical trials of Pracinostat to be
received by the end of 2014.
For more information about
MEI Pharma and its pipeline of drug candidates, visit www.meipharma.com
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