We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Jazz's Xyrem Follow-On Drug Succeeds in Phase III Study
Read MoreHide Full Article
Jazz Pharmaceuticals plc (JAZZ - Free Report) announced positive top-line data from a phase III study evaluating its sleep disorder candidate, JZP-258. Data showed that treatment with the candidate achieved clinically meaningful maintenance of efficacy in adult patients suffering from cataplexy and excessive daytime sleepiness (“EDS”) with narcolepsy.
JZP-258 is an oxybate product candidate with 92% less sodium content than its marketed product Xyrem (sodium oxybate). Xyrem is currently approved for narcolepsy with cataplexy and EDS.
Jazz’s shares have increased 10.1% so far this year compared with the industry’s rise of 15.2%.
The phase III study evaluated JZP-258 for change in weekly cataplexy attacks compared to a placebo in adult patients with narcolepsy as its primary endpoint. It was mainly initiated to reduce sodium intake in narcolepsy patients associated with Xyrem. Data from the study demonstrated highly statistically significant differences in the number of cataplexy attacks as well as in the key secondary endpoint of change in Epworth Sleepiness Scale (ESS) score for JZP-258 versus placebo. The candidate has a safety profile similar to Xyrem.
Detailed data from the study will be presented at an upcoming medical meeting. Top-line data from the phase III study along with interim data from an ongoing 24-week open-label safety study will form the basis for the new drug application (“NDA”) for JZP-258.
Xyrem generates significant revenues for Jazz with sales from the drug expected to cross $1.5 billion in 2019. Earlier this month, the FDA approved Sunosi (solriamfetol) as a treatment to improve wakefulness and reduce EDS. Potential approval to JZP-258 will boost Jazz’s sleep disorder portfolio further.
Moreover, JZP-258 is likely to expand the patient population for Jazz as it will include patients ineligible for Xyrem as they are at risk for high sodium intake-related consequences, including hypertension and other cardiovascular diseases. The highest approved dose of Xyrem of 9 grams per night contains 1,640 mg of sodium, which is almost 70% of the recommended daily sodium intake for a healthy adult per an article published on FDA’s website.
The generic version of Xyrem is set to hit the market starting 2023. The low sodium content of JZP-258 and a similar safety profile is likely to largely offset the decline in Xyrem sales once generic versions enter the market.
A few other pharma companies are also developing treatment for narcolepsy, which includes Avadel Pharmaceuticals (AVDL - Free Report) . Approved drugs for narcolepsy include Teva Pharma’s (TEVA - Free Report) Provigil and Novartis’ (NVS - Free Report) Ritalin-SR.
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2018, while the S&P 500 gained +15.8%, five of our screens returned +38.0%, +61.3%, +61.6%, +68.1%, and +98.3%.
This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.
Image: Bigstock
Jazz's Xyrem Follow-On Drug Succeeds in Phase III Study
Jazz Pharmaceuticals plc (JAZZ - Free Report) announced positive top-line data from a phase III study evaluating its sleep disorder candidate, JZP-258. Data showed that treatment with the candidate achieved clinically meaningful maintenance of efficacy in adult patients suffering from cataplexy and excessive daytime sleepiness (“EDS”) with narcolepsy.
JZP-258 is an oxybate product candidate with 92% less sodium content than its marketed product Xyrem (sodium oxybate). Xyrem is currently approved for narcolepsy with cataplexy and EDS.
Jazz’s shares have increased 10.1% so far this year compared with the industry’s rise of 15.2%.
The phase III study evaluated JZP-258 for change in weekly cataplexy attacks compared to a placebo in adult patients with narcolepsy as its primary endpoint. It was mainly initiated to reduce sodium intake in narcolepsy patients associated with Xyrem. Data from the study demonstrated highly statistically significant differences in the number of cataplexy attacks as well as in the key secondary endpoint of change in Epworth Sleepiness Scale (ESS) score for JZP-258 versus placebo. The candidate has a safety profile similar to Xyrem.
Detailed data from the study will be presented at an upcoming medical meeting. Top-line data from the phase III study along with interim data from an ongoing 24-week open-label safety study will form the basis for the new drug application (“NDA”) for JZP-258.
Xyrem generates significant revenues for Jazz with sales from the drug expected to cross $1.5 billion in 2019. Earlier this month, the FDA approved Sunosi (solriamfetol) as a treatment to improve wakefulness and reduce EDS. Potential approval to JZP-258 will boost Jazz’s sleep disorder portfolio further.
Moreover, JZP-258 is likely to expand the patient population for Jazz as it will include patients ineligible for Xyrem as they are at risk for high sodium intake-related consequences, including hypertension and other cardiovascular diseases. The highest approved dose of Xyrem of 9 grams per night contains 1,640 mg of sodium, which is almost 70% of the recommended daily sodium intake for a healthy adult per an article published on FDA’s website.
The generic version of Xyrem is set to hit the market starting 2023. The low sodium content of JZP-258 and a similar safety profile is likely to largely offset the decline in Xyrem sales once generic versions enter the market.
A few other pharma companies are also developing treatment for narcolepsy, which includes Avadel Pharmaceuticals (AVDL - Free Report) . Approved drugs for narcolepsy include Teva Pharma’s (TEVA - Free Report) Provigil and Novartis’ (NVS - Free Report) Ritalin-SR.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC Price | Jazz Pharmaceuticals PLC Quote
Zacks Rank
Jazz currently has Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2018, while the S&P 500 gained +15.8%, five of our screens returned +38.0%, +61.3%, +61.6%, +68.1%, and +98.3%.
This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.
See their latest picks free >>