Positive Phase IIb Data from Jazz Pharma

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Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Earlier this week, Jazz Pharmaceuticals (JAZZ) announced that JZP-110 met all primary and secondary endpoints in a phase IIb double-blind, placebo-controlled, parallel-group study for the treatment of excessive daytime sleepiness (EDS) in adults suffering from narcolepsy.

We remind investors that Jazz Pharma acquired worldwide development, manufacturing and commercial rights to JZP-110 (previously known as ADX-N05) from Aerial BioPharma in Jan 2014.

Based on the results from the phase IIb study, Jazz Pharma intends to initiate phase III studies on JZP-110 for this indication. The company expects to meet the FDA shortly to discuss development plans for JZP-110. Additionally, Jazz Pharma intends to conduct phase III studies on JZP-110 for EDS in patients suffering from obstructive sleep apnea (:OSA).

Jazz Pharma already possesses a robust development and commercial expertise in the field of narcolepsy and sleep. One of the company’s lead marketed products is Xyrem, which is the only FDA-approved product for the treatment of both cataplexy and EDS in narcolepsy patients. In accordance with a Pediatric Written Request from the FDA, Jazz Pharma is looking to conduct a phase III study on Xyrem in children and adolescents (7 to 17 years) who have narcolepsy with cataplexy.

Additionally, Jazz Pharma intends to initiate a study on its second marketed product, Erwinaze, in patients (18 to 39 years) suffering from acute lymphoblastic leukemia (ALL) who are hypersensitive to E. coli-derived asparaginase, shortly. The company has submitted a supplemental biologic license application (sBLA) for the intravenous administration of Erwinaze to the FDA. A response is expected by Dec 28.

Jazz Pharma holds a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Grifols, S.A. (GRFS), Gilead Sciences Inc. (GILD) and Alexion Pharmaceuticals, Inc. (ALXN). While Grifols and Gilead carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).

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