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Jazz's Defibrotide under FDA Priority Review, Shares Up

Jazz Pharmaceuticals Public Limited Company 's JAZZ shares jumped 6.4% after the company announced that its new drug application for defibrotide (EU trade name: Defitelio) has been accepted for priority review by the FDA. The company is looking to get Defitelio approved for the treatment of patients suffering from hepatic veno-occlusive disease (VOD; also known as sinusoidal obstruction syndrome) with evidence of multi-organ dysfunction (MOD) following hematopoietic stem-cell transplantation (HSCT).

With the FDA granting priority review status, a response should be out by Mar 31, 2016. We note that the FDA grants priority review status to candidates that have the potential to bring significant improvements in treatment or provide a treatment where no adequate therapy exists.

Defitelio enjoys both Fast Track and orphan status in the U.S.

We note that Defitelio is already approved in the EU for the treatment of severe hepatic VOD in patients over one month of age undergoing HSCT transplantation therapy. The drug became a part of Jazz's portfolio following the Jan 2014 acquisition of Gentium.

Considering the lack of FDA-approved therapies for the treatment of patients with hepatic VOD with evidence of MOD and the disease having a mortality rate exceeding 80%, there is a strong unmet need for drugs addressing the disease.

Defitelio registered sales of $32.6 million in the first half of 2015. Approval in the U.S. would boost the drug's sales further. Meanwhile, Jazz is exploring the possibility of developing Defitelio for additional indications.

Jazz is a Zacks Rank #5 (Sell) stock. Some better-ranked stocks in the health care sector include Regeneron Pharmaceuticals, Inc. REGN , Endo International plc ENDP and Ohr Pharmaceutical, Inc. OHRP . All three hold a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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