Jazz Pharmaceuticals plc (NASDAQ:JAZZ) and Concert
Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that Phase 1
clinical data generated to date supports completing the Phase 1
evaluation of JZP-386 at the originally planned highest dose, which
was not administered in the first Phase 1 trial due to a technical
dosing issue. The existing Phase 1 clinical data was generated in a
first-in-human trial evaluating the safety, pharmacokinetics, and
pharmacodynamics of JZP-386; enrollment was completed in the third
quarter. A second Phase 1 trial evaluating JZP-386 at the
originally planned highest dose is expected to be initiated in the
first quarter of 2015, with data expected in the second quarter of
2015.
JZP-386 is a deuterium-containing analog of sodium oxybate. The
Phase 1 program is comparing JZP-386 to sodium oxybate versus
placebo in healthy volunteers. The companies expect that the
results from the upcoming Phase 1 trial will inform the next steps
in the development program for JZP-386.
Sodium oxybate is the active ingredient in Xyrem®, a
prescription medicine marketed in the United States by Jazz
Pharmaceuticals to treat cataplexy and excessive daytime sleepiness
in patients with narcolepsy, a serious neurological disorder that
affects approximately 1 in 2000 people in the United States.
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a specialty
biopharmaceutical company focused on improving patients' lives by
identifying, developing and commercializing differentiated products
that address unmet medical needs. The company has a diverse
portfolio of products and/or product candidates in the areas of
sleep, hematology/oncology, pain and psychiatry. The company's U.S.
marketed products in these areas include: Xyrem® (sodium oxybate)
oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi),
Prialt® (ziconotide) intrathecal infusion, Versacloz® (clozapine)
oral suspension, FazaClo® (clozapine, USP) HD and FazaClo LD. Jazz
Pharmaceuticals also has a number of products marketed outside the
United States, including Erwinase® and Defitelio® (defibrotide).
For more information, please visit www.jazzpharmaceuticals.com.
About Concert Pharmaceuticals
Concert Pharmaceuticals is a clinical stage biopharmaceutical
company focused on applying its DCE Platform® (deuterated chemical
entity platform) to create novel small molecule drugs. This
approach starts with approved drugs, advanced clinical candidates
or previously studied compounds that have the potential to be
improved with deuterium substitution to enhance clinical safety,
tolerability and efficacy. The Company is developing a broad
pipeline targeting CNS disorders, renal disease, inflammation and
cancer. For more information, please visit
www.concertpharma.com.
About Xyrem
Xyrem® (sodium oxybate) oral solution, CIII, is indicated for
the treatment of cataplexy in narcolepsy and for the treatment of
EDS in narcolepsy. Xyrem may only be dispensed to patients enrolled
in the Xyrem Success Program®. Xyrem was first approved in the
United States in 2002. Safety and effectiveness in pediatric
patients have not been established.
IMPORTANT SAFETY INFORMATION
XYREM is a Central Nervous System (CNS)
depressant. In clinical trials at recommended doses, obtundation
and clinically significant respiratory depression occurred in
XYREM-treated patients. Almost all of the patients who received
XYREM during clinical trials in narcolepsy were receiving CNS
stimulants.
XYREM is the sodium salt of gamma
hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination
with other CNS depressants, is associated with CNS adverse
reactions, including seizure, respiratory depression, decreases in
the level of consciousness, coma, and death.
Because of the risks of CNS depression,
abuse, and misuse, XYREM is available only through a restricted
distribution program called the XYREM Success Program®, using a
centralized pharmacy. Prescribers and patients must enroll in the
program. For further information go to www.XYREM.com
or call 1-866-XYREM88®(1-866-997-3688).
Xyrem is contraindicated in combination with sedative hypnotics
or alcohol and in patients with succinic semialdehyde dehydrogenase
deficiency. Use caution when considering the concurrent use of
Xyrem with other CNS depressants. Healthcare providers should
caution patients against hazardous activities requiring complete
mental alertness or motor coordination within the first 6 hours of
dosing or after first initiating treatment until certain that Xyrem
does not affect them adversely. Xyrem is a Schedule III controlled
substance. The rapid onset of sedation, coupled with the amnestic
features of Xyrem, particularly when combined with alcohol, has
proven to be dangerous for the voluntary and involuntary user (e.g.
assault victim). Monitor patients for emergent or increased
depression and suicidality and for impaired motor/cognitive
function. Episodes of sleepwalking should be fully evaluated and
appropriate interventions considered. Consider the amount of daily
sodium intake in each dose of Xyrem in patients sensitive to salt
intake.
Jazz Pharmaceuticals plc "Safe Harbor" Statement under the
Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements,
including, but not limited to, statements related to future events
in the Phase 1 clinical program for JZP-386, the timing of the
second Phase 1 clinical trial, the therapeutic potential of JZP-386
and other statements that are not historical facts. These
forward-looking statements are based on Jazz Pharmaceuticals’
current expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with the timing and conduct of clinical trials and the therapeutic
value of JZP-386; the uncertainty of regulatory approval; and those
risks with respect to research and development and clinical trials
detailed from time-to-time under the caption “Risk Factors” and
elsewhere in Jazz Pharmaceuticals plc’s Securities and Exchange
Commission filings and reports (Commission File No. 001-33500),
including the Quarterly Report on Form 10-Q for the quarter ended
September 30, 2014, and future filings and reports by Jazz
Pharmaceuticals. Jazz Pharmaceuticals undertakes no duty or
obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or
changes in its expectations.
Concert Pharmaceuticals Cautionary Note on Forward Looking
Statements
Any statements in this press release about our future
expectations, plans and prospects, including statements about the
future clinical development of JZP-386, the potential effectiveness
of JZP-386, our plans and timelines for the clinical development of
JZP-386 and other statements containing the words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “would,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the
uncertainties inherent in the initiation of future clinical trials,
availability and timing of data from ongoing and future clinical
trials and the results of such trials, whether preliminary results
from a clinical trial will be predictive of the final results of
that trial or whether results of early clinical trials will be
indicative of the results of later clinical trials, expectations
for regulatory approvals and other factors discussed in the " Risk
Factors" section of our most recent Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission and in other
filings that we make with the Securities and Exchange Commission.
In addition, any forward-looking statements included in this press
release represent our views only as of the date of this release and
should not be relied upon as representing our views as of any
subsequent date. We specifically disclaim any obligation to update
any forward-looking statements included in this press release.
Concert Pharmaceuticals Inc., the CoNCERT
Pharmaceuticals Inc. logo and DCE Platform are registered
trademarks of Concert Pharmaceuticals, Inc.
Jazz Pharmaceuticals and the Jazz
Pharmaceuticals logo are registered trademarks of Jazz
Pharmaceuticals plc or its subsidiaries.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20141209005304/en/
Jazz Pharmaceuticals plc(investors)Katherine Littrell,
PhD, RN, U.S. + 650-496-2717Ireland + 353 1 634
7887investorinfo@jazzpharma.comor(media)Laurie Hurley, U.S. +
1-650-496-2796Ireland + 353 1 634 7894orConcert
Pharmaceuticals(investors)Justine Koenigsberg, U.S. +
781-674-5284ir@concertpharma.comor(media)The Yates NetworkKathryn
Morris, U.S. + 845-635-9828
Jazz Pharmaceuticals (NASDAQ:JAZZ)
Historical Stock Chart
From Mar 2024 to Apr 2024
Jazz Pharmaceuticals (NASDAQ:JAZZ)
Historical Stock Chart
From Apr 2023 to Apr 2024