Jazz Pharmaceuticals plc (NASDAQ: JAZZ) and Concert
Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the initiation
of the first Phase 1 clinical trial of JZP-386, a
deuterium-containing analog of sodium oxybate—the active ingredient
in Xyrem® (sodium oxybate) oral solution.
The Phase 1 clinical trial is designed to assess the safety,
pharmacokinetics (PK), and pharmacodynamics (PD) of JZP-386, and
includes Xyrem as an active control. The study is expected to
enroll up to 28 healthy subjects at a single center in Europe. The
results of the study are intended to assess the PK/PD profile of
JZP-386 to identify a safe and tolerable dose or doses of JZP-386
that could be used in subsequent clinical trials and to determine
whether JZP-386 is suitable for once nightly dosing.
“Initiating this first-in-human Phase 1 study with JZP-386 is an
important milestone in our development program and will provide
valuable information on the potential benefit of this
deuterium-containing analog of sodium oxybate. This study reflects
our ongoing commitment to addressing the unmet medical needs of
patients with narcolepsy and to further advancing our understanding
of sodium oxybate.” said Jeffrey Tobias, M.D., executive vice
president and chief medical officer of Jazz Pharmaceuticals.
“We are pleased to see JZP-386 advancing to clinical evaluation
under our collaboration with Jazz Pharmaceuticals. We look forward
to evaluating JZP-386 and seeing the results from this
first-in-human clinical trial,” said Roger Tung, Ph.D., President
and Chief Executive Officer of Concert Pharmaceuticals.
Under its 2013 agreement with Concert, Jazz Pharmaceuticals has
worldwide rights to develop and commercialize JZP-386. Concert has
the potential to realize milestone payments upon meeting
development objectives and tiered royalties on any worldwide sales.
Jazz Pharmaceuticals and Concert are working collaboratively on
development of JZP-386, and Concert is responsible for conducting
clinical activities for JZP-386 through Phase 1.
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 plcJazz 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 PharmaceuticalsConcert 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.
About XyremXyrem® (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 1995This press
release contains forward-looking statements, including, but not
limited to, statements related to future events in the Phase 1
clinical trial of JZP-386, 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 uncertainty of clinical trials and 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
March 31, 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
StatementsAny statements in this press release about our future
expectations, plans and prospects, including statements about the
potential effectiveness of JZP-386, our plans and timelines for the
clinical development of JZP-386, the Company’s potential to realize
milestone payments upon meeting development objectives 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 Annual
Report on Form 10-Q filed with the Securities and Exchange
Commission on May 14, 2014 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
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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
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