Jazz Submits NDA to FDA for JZP-110 to Cure Sleep Disorder

Jazz Pharmaceuticals plc JAZZ announced that it has submitted a new drug application to the FDA for its lead pipeline candidate, JZP-110 (solriamfetol), for treatment of excessive sleepiness (“ES”) in adult patients with narcolepsy or obstructive sleep apnea (“OSA”).

JZP-110 is being evaluated in a phase III TONES program for treatment of OSA and narcolepsy. The TONES program comprises four studies. Data generated on JZP-110 from the phase III studies looks encouraging. The company announced positive results from the two OSA trials (TONES 3 & TONES 4) in March and from the ES associated with narcolepsy program (TONES 2) in June.

Jazz’s shares have traded above the industry so far this year. The stock has rallied 22.5% compared with the industry’s increase of 8.1%.

 

 

We remind investors that Jazz acquired worldwide development, manufacturing and commercial rights to JZP-110 from Aerial BioPharma in January 2014.

The above candidate is also being evaluated in phase II study for ES in Parkinson’s disease. We note that JZP-110 enjoys an Orphan Drug designation in the United States for narcolepsy.

Per Jazz, there is a significant unmet need in narcolepsy and OSA with many patients showing inadequate response to the current wake-promoting therapies. Narcolepsy with ES affects approximately 2,000 people in the United States. More than 50% of patients fail to respond to one or more stimulants or wake-promoting agents. Hence, approval of the drug will provide the company with access to a potential market of patients looking for a meaningful treatment option to check the disease.

Notably, Jazz already has one approved therapy called Xyrem for treating cataplexy and excessive daytime sleepiness in patients suffering from narcolepsy. Xyrem is currently sold across 21 countries by UCB Pharma, a multinational biopharmaceutical company with rights to market Xyrem in 54 countries. The product is sold in Canada by Valeant Pharmaceuticals International, Inc. VRX.

Significantly, successful development and commercialization of JZP-110 should strengthen Jazz's sleep disorder portfolio and help boost its top line.

However, there are a number of branded and generic products in the market for treating OSA and narcolepsy including Novartis AG's NVS Ritalin-SR.

Jazz Pharmaceuticals PLC Price

 

Jazz Pharmaceuticals PLC Price | Jazz Pharmaceuticals PLC Quote

Zacks Rank & Key Pick

Jazz carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Corcept Therapeutics Incorporated CORT, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Corcept’s earnings per share estimates have been revised upward from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 14.32%. Its share price has skyrocketed 141.2% year to date.

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