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Jazz Pharma Closes Enrollment In OSA Drug Phase III Trial

ByZacks Investment Research
Published 09/27/2016, 10:05 PM
Updated 07/09/2023, 06:31 AM
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Jazz Pharmaceuticals Public Limited Company (NASDAQ:JAZZ) announced the completion of patient enrollment in 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).
The company had 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 and 14-004. The total number of patients enrolled in the studies is 654. The 14-003 study will evaluate four doses of JZP-110 in comparison to placebo, over a 12-week period, while 14-004 is a six-week, flexible-dose, randomized withdrawal study.
The co-primary endpoints of the two studies is the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale, which will measure the progress achieved by patients in terms of their ability to stay awake and their sleepiness, respectively.
We note that JZP-110 enjoys Orphan Drug designation in the U.S. for narcolepsy.
Top-line data from the two studies should be out in the first quarter of 2017. Positive data from these studies would allow the company to file for its approval in late 2017.
According to Jazz Pharmaceuticals, there is significant unmet need in the fields of narcolepsy and OSA, with about 175-300K patients demonstrating inadequate response to current wake-promoting therapies. More than 50% of the patients fail one or more stimulants or wake-promoting agents.

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Zacks Rank & Key Picks

Jazz Pharmaceuticals currently carries a Zacks Rank #5 (Strong Sell). Investors interested in the health care sector may consider stocks like Anika Therapeutics Inc (NASDAQ:ANIK) , ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Abbott Laboratories (NYSE:ABT) .

Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 12.6% and 14% over the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters with an average beat of 42.19%. Its share price has jumped 22% year to date. Anika Therapeutics currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

ANI Pharmaceuticals has a Zacks Rank #1 as well. The company witnessed an increase of 9.5% and 4.7% in its earnings estimates for 2016 and 2017, respectively, in the last 60 days. It has beaten earnings estimates twice in the last four quarters, bringing the average positive surprise to 46.85%. The company’s share price has surged 54.8% year to date.

Abbott Laboratories carries a Zacks Rank #2 (Buy). It has delivered a positive earnings surprise in all of the four quarters, resulting in an average beat of 3.11%.

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