Pluristem Therapeutics Inc. (PSTI - Free Report) announced that the FDA has granted its placental-derived (PLX-PAD) cells Orphan Drug designation for the treatment of severe preeclampsia.
Orphan drug designation is given to drugs being developed for rare diseases/disorders that affect less than 200,000 people in the U.S. Incentives that come with orphan drug status include close guidance from the FDA that may accelerate time to marketing approval, orphan drug grants, tax credits and a 7-year market exclusivity upon marketing approval.
As per estimates, 1% pregnant women suffer from preeclampsia in the Western countries. This disease is expected to cost the global health care system about $3 billion on an annual basis. Pluristem develops placenta-based cell therapy products. Its patented PLX (PLacental eXpanded) cells are being evaluated in multiple indications.
Meanwhile, a study in an animal model to confirm the efficacy of PLX-PAD as requested by the FDA is currently is ongoing in an additional therapeutic pathway and data from the study is expected in the first half of 2016.
We note that Pluristem received safety clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for PLX-PAD cells for use in clinical studies in Japan. This will allow the company to commence a phase II study on PLX-PAD for the treatment of critical limb ischemia (CLI) through Japan’s accelerated regulatory pathway for regenerative medicine.
The company plans to initiate trials on PLX-PAD for the treatment of CLI in 2016 with the aim of obtaining initial approval in 2018.
Pluristem carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Baxalta Inc. , Juno Therapeutics , and AstraZeneca PLC (AZN - Free Report) . All three carry a Zacks Rank #1 (Strong Buy).
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