FDA awards stem cell co Pluristem orphan drug status

Zami Aberman

The Israeli company received FDA orphan drug status for its PLX-PAD cells preeclampsia pregnancy treatment.

Israeli placenta-based cell therapy developer Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has been awarded orphan drug status by the US Food and Drug Administration (FDA) for its PLX-PAD cells treatment for severe preeclampsia.

Preeclampsia is among the most common medical complications of pregnancy and a leading cause of premature births, stillbirths and neonatal and maternal deaths. There is no cure except delivery. Due to high risks to the mother, women diagnosed with severe preeclampsia are usually delivered promptly, even if the baby will be born prematurely and may suffer permanent disabilities as a result. Severe preeclampsia occurs in approximately 1% of pregnancies in Western countries.

Benefits of Orphan Drug Designation for PLX-PAD cells include close guidance that may accelerate time to marketing approval, orphan drug grants, tax credits, and a 7-year market exclusivity upon marketing approval. It is estimated by different sources that preeclampsia costs the global health care system about $3 billion annually.

Pluristem chairman and CEO Zami Aberman said, “Attainment of Orphan Drug Designation for our cells in severe preeclampsia exemplifies our global strategy of bringing cell therapies to patients through accelerated approval pathways. We are encouraged by the US FDA designation that demonstrates Pluristem’s commitment to the program and the potential promise it holds to address a serious, unmet medical need faced by pregnant women every year."

The company's share price was up 26% in afternoon trading on the Tel Aviv Stock Exchange.

Published by Globes [online], Israel business news - www.globes-online.com - on December 31, 2015

© Copyright of Globes Publisher Itonut (1983) Ltd. 2015

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