Jazz Pharmaceuticals plc and Concert Pharmaceuticals

Announce Worldwide Licensing Agreement to Develop and

Commercialize Deuterium-Modified Sodium Oxybate
DUBLIN as well as LEXINGTON, Mass.--(BUSINESS WIRE)--Jazz Pharmaceuticals plc (Nasdaq:
JAZZ) as well as Concert Pharmaceuticals, Inc. today announced an exclusive license agreement
which provides Jazz Pharmaceuticals worldwide rights for you to develop and also commercialize
Concert's deuterium-modified sodium oxybate (D-SXB) compounds, which includes C-10323.
Sodium oxybate may always be the active ingredient inside Xyrem, the prescription medicine
marketed inside the Usa simply by Jazz Pharmaceuticals to treat a couple of involving the key the
indicators of narcolepsy, a new significant neurological disorder which affects approximately
157,000 folks in the United States.
Under your agreement, Jazz Pharmaceuticals may have worldwide commercial legal rights to be able
to C-10323, too as principal duty for ongoing development activities. Concert will receive an upfront
payment and it is qualified in order to obtain further milestone payments also as tiered royalties
depending on prospective worldwide revenue regarding any D-SXB products.
"This collaboration reflects our deep dedication to patients using narcolepsy and in addition to
improving their particular treatment using safe as well as successful treatment method options,"
stated Jeffrey Tobias, MD, executive vice president associated with study along with development
along with chief health-related officer of Jazz Pharmaceuticals. "Our agreement with Concert around
the D-SXB plan provides an superb chance for most associated with us to discover the potential of
deuterium technology within this crucial area. We appear forward to be able to advancing this
program into clinical testing so as to help expand evaluate its possible ways to supply advantages
with regard to patients along with narcolepsy."
"Preclinical data indicate that will selective deuterium incorporation can stabilize sodium oxybate
inside vivo as well as we get been eager in order to see how this improvement within metabolic
properties will be reflected within the clinical performance involving D-SXB," said Roger Tung,
Ph.D., president and also chief executive officer of Concert Pharmaceuticals. "This collaboration
using Jazz Pharmaceuticals we can progress our deuterium-modified sodium oxybate program with a
companion which includes extensive development as well as commercial expertise and can end up
being a leader within the narcolepsy field."
Through Concert's DCE Platform (Deuterated Chemical Entity), Concert provides developed a
quantity of deuterium-containing analogs involving sodium oxybate. C-10323 provides emerged since
the lead compound depending on within vivo preclinical screening that demonstrated prolonged
pharmacokinetic profile and also reduced variability like a result of its certain deuterium
modification pattern. Your companies strategy to always be able to submit an investigational new
drug (IND) application regarding C-10323 later on this year.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc is a new specialty biopharmaceutical business centered on improving
patients' lives by identifying, creating along with commercializing innovative items that address
unmet medical needs. The Actual organization features a diverse portfolio of merchandise in the
places of narcolepsy, oncology, pain and psychiatry. The Particular company's U.S. marketed goods
during these locations include: Xyrem (sodium oxybate) oral solution, Erwinaze
(asparaginase Erwinia chrysanthemi), Prialt (ziconotide) intrathecal infusion, Luvox CR
(fluvoxamine maleate), FazaClo (clozapine, USP) HD along with FazaClo LD. Outside in the
U.S., Jazz Pharmaceuticals also has a number of goods marketed by simply its EUSA Pharma
division. Regarding further information, see www.jazzpharmaceuticals.com.
About Concert Pharmaceuticals
Concert Pharmaceuticals is a clinical stage biotechnology company centered on applying the
particular company's DCE Platform (deuterated chemical entity platform) to generate novel and
also differentiated little molecule drugs. Concert's approach leverages decades regarding
pharmaceutical and clinical encounter to reduce your time, danger and also expense needed to
produce essential new medicines. the company has a diverse study pipeline addressing renal
disease, hematologic disorders, CNS disorders along using other therapeutic areas. Founded
throughout 2006, Concert features raised greater than $110 million regarding enterprise as well as
institutional capital. Pertaining To more info in Concert Pharmaceuticals, please visit
www.concertpharma.com.
About Xyrem
Xyrem (sodium oxybate) oral option would be indicated for your remedy involving cataplexy as
well as excessive daytime sleepiness (EDS) inside patients together with narcolepsy and could end
up being dispensed only to patients enrolled inside the Xyrem Achievement Program. Xyrem can
be the only item approved from the FDA for your treatment method associated with cataplexy and
also EDS throughout narcolepsy, the severe neurological disorder. Xyrem had been 1st approved
inside the U.S. within 2002. The Particular Xyrem Good Results Plan is truly a proprietary plan to
guarantee the safe use associated with Xyrem along with reduce your likelihood of abuse, misuse,
and diversion involving sodium oxybate. Xyrem can be acquired just by simply prescription through
physicians enrolled inside the Xyrem Achievement Plan and is dispersed through the single central
pharmacy straight to patients. The Particular labeling for Xyrem contains any boxed warning with
regards to CNS depression, abuse, along with misuse. Within managed clinical trials, one with the
most widespread adverse reactions seen (incidence >= 5% as well as twice your charge seen
together with placebo) throughout Xyrem-treated patients were nausea, dizziness, vomiting,
somnolence, enuresis, and also tremor.
"Safe Harbor" Statement beneath your Private Securities Litigation Reform Act associated with 1995
This press launch contains forward-looking statements, including, however, not limited to,
statements associated in order to Jazz Pharmaceuticals' future exploration of the deuterium-modified
sodium oxybate (D-SXB) technologies and also progression of D-SXB compounds, which includes C-
10323, the extended run clinical testing involving D-SXB in order to measure the compounds'
therapeutic and commercial potential, as well as the strategy to submit an investigational new drug
application for C-10323. These kind of forward-looking statements are generally according to Jazz
Pharmaceuticals' existing anticipations along with inherently involve significant risks as well as
uncertainties. Real results and the timing involving events could differ materially coming from those
anticipated in these forward looking statements as getting a results of these risks as well as
uncertainties, which usually include, without having limitation, risks and also uncertainties related
with almost all the timing as well as results with the exploration in the D-SXB technology; the actual
companies' capability to file an IND with regard to C-10323 as currently contemplated; the actual
uncertainty associated with clinical achievement along with therapeutic value of D-SXB compounds,
including C-10323; the particular uncertainty associated with regulatory approval; the trouble within
integrating your D-SXB goods in to be able to the company's product portfolio and the possibility
that will the company could don't understand the anticipated advantages (commercial as well as
otherwise) coming from this license; as well as those risks together with respect to analyze and also
development and also clinical trials thorough via time-to-time under the caption "Risk Factors" along
with elsewhere inside Jazz Pharmaceuticals' Securities as well as Exchange Commission filings
along with reports (Commission File No. 001-33500), which includes within the Quarterly Statement
in Form 10-Q for your quarter ended September 30, 2012 and long term filings along with studies
through the company, which includes the actual Annual Record on Form 10-K for the year
ended December 31, 2012. Jazz Pharmaceuticals undertakes absolutely no duty or even
obligation to update just about any forward-looking statements contained within this launch like a
results of new information, long term events or even alterations in its expectations.
Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform tend to be
registered trademarks regarding Concert Pharmaceuticals, Inc.