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Jazz Sleep Disorder Drug Positive in Phase III Studies

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Jazz Pharmaceuticals plc (JAZZ - Free Report) recently announced positive efficacy results from two phase III studies evaluating the safety and efficacy of its lead pipeline candidate JZP-110 for the treatment of excessive sleepiness (ES) associated with obstructive sleep apnea (OSA).

Jazz’s shares have traded above the Zacks classified Medical-Drugs industry so far this year. Shares of the company gained 32.2% while the industry registered an increase of 4.7%.

The company acquired the worldwide development, manufacturing and commercial rights to JZP-110 from Aerial BioPharma in Jan 2014.

JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in late-stage development for the treatment of ES in adult patients.

The program comprises two phase III studies, 14-003 (TONES 3) and 14-004 (TONES 4). A total of 652 patients have been enrolled in the studies. The 14-003 study evaluated four doses of JZP-110 in comparison to placebo, over a 12-week period. The 14-004 study, on the other hand, is a six-week, flexible-dose, randomized withdrawal study.

The co-primary endpoints of the two studies were the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. Both the studies met their primary end points, which demonstrated highly statistically significant differences in the co-primary efficacy endpoints in the TONES 3 study at the 300 mg, 150 mg, 75 mg and 37.5 mg dose arms and in the TONES 4 study in the combined JZP-110 treatment arm (300 mg, 150 mg, and 75 mg doses) compared to placebo.

We note that JZP-110 enjoys Orphan Drug designation in the U.S. for narcolepsy.

The company is also expected to announce preliminary results from its  phase III TONES 2 study evaluating JZP-110 in excessive sleepiness associated with narcolepsy in the second quarter of 2017. Subject to final data analysis and regulatory discussions with the FDA, the company continues to target NDA submission in late 2017.

We note that Jazz Pharma already has one approved therapy – Xyrem – for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients suffering from narcolepsy. Xyrem is currently sold in 21 countries by UCB, a multinational biopharmaceutical company (which has rights to market Xyrem in 54 countries). The product is sold in Canada by Valeant Pharmaceuticals International, Inc. (VRX - Free Report) . The successful development and commercialization of a second EDS treatment should strengthen Jazz Pharma’s EDS portfolio and help boost its top line.

Zacks Rank & Key Picks

Jazzcurrently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Addus HomeCare Corporation (ADUS - Free Report) and The Advisory Board Company . Each of these stocks carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Addus HomeCare’s earnings per share estimates increased from $1.38 to $1.41 for 2017 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 10.10%.

The Advisory Board’s earnings per share estimates increased from $1.41 to $1.49 for 2017 over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 33.41%.

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