Jazz Pharmaceuticals Announces Presentation Of Largest Safety Trial To Date Of Patients Treated With Erwinaze®

Jazz Pharmaceuticals Announces Presentation Of Largest Safety Trial To Date Of
                       Patients Treated With Erwinaze®

  PR Newswire

  DUBLIN, Dec. 11, 2012

-- Data from Compassionate Use Protocol Presented at the 2012 American Society
of Hematology Annual Meeting --

DUBLIN, Dec. 11, 2012 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ)
today announced that data from the largest safety trial to date of patients
treated with Erwinaze ® (asparaginase Erwinia chrysanthemi ) have been
presented at the American Society of Hematology Annual Meeting and Exposition
taking place in Atlanta, Georgia. The poster, titled "L-Asparaginase(L-ASP)
Related Toxicities with Asparaginase Erwinia Chrysanthemi in a Large
Compassionate Use Protocol," was presented by Paul V. Plourde, M.D., senior
vice president of clinical oncology at Jazz Pharmaceuticals.

The poster presentation is based on results of a compassionate use protocol in
patients who received Erwinaze as part of a multi-agent chemotherapeutic
regimen for acute lymphoblastic leukemia who developed a hypersensitivity to
E.coli -derived asparaginase. The poster summarizes the safety results in 940
patients at participating U.S. oncology treatment centers between February
2006 and November 2011, when Erwinaze was available under a compassionate use
protocol prior to its approval by the U.S. Food and Drug Administration in
November 2011. The trial includes additional follow up data that further
describe the incidence of adverse events associated with Erwinaze treatment,
which are consistent with the known safety profile of Erwinaze.

"The extensive information collected in this study provides important
information that further evaluates the safety profile of Erwinaze," stated
Jeffrey Tobias, MD, executive vice president of research and development and
chief medical officer of Jazz Pharmaceuticals. "This additional information
may help physicians as they make important treatment decisions related to
Erwinaze."

About Erwinaze: Indication and Important Safety Information

Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen
for the treatment of patients with acute lymphoblastic leukemia (ALL) who have
developed hypersensitivity to E.coli -derived asparaginase. Erwinaze was
originally discovered by the UK Health Protection Agency. Erwinaze was
approved by the U.S. Food and Drug Administration in November 2011.

Erwinaze is contraindicated in patients with a history of serious
hypersensitivity to Erwinaze, including anaphylaxis; history of serious
pancreatitis, thrombosis or hemorrhage with prior L-asparaginase therapy.
Discontinue if serious hypersensitivity, including anaphylaxis, or severe or
hemorrhagic pancreatitis occur. Monitor glucose at baseline and periodically
during treatment since intolerance may not be reversible. With thrombosis and
hemorrhage, discontinue until resolved. Use in pregnant women only if clearly
needed. Do not use in lactating women. The most common adverse reactions (≥
1%) are serious hypersensitivity, including anaphylaxis, pancreatitis,
abnormal transaminases, coagulation abnormalities, nausea, vomiting, and
hyperglycemia.

Please see full Prescribing Information at www.erwinaze.com .

About Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia affects approximately 6,000 Americans, 60 percent
of whom are children. ALL is the most common form of childhood cancer, with
the peak incidence between two and five years of age. ALL can be
life-threatening and progresses quickly if left untreated. A majority of
asparaginase treatments derive from E. coli; however, approximately 15 to 20
percent of ALL patients develop hypersensitivity to E. coli- derived
asparaginase regimens.

About Jazz Pharmaceuticals

Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on
improving patients' lives by identifying, developing and commercializing
innovative products that address unmet medical needs. The company has a
diverse portfolio of products in the areas of narcolepsy, 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, Luvox CR®
(fluvoxamine maleate), FazaClo® (clozapine, USP) HD and FazaClo LD. Outside of
the U.S.,Jazz Pharmaceuticalsalso has a number of products marketed by its
international division, EUSA Pharma.

"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 treatment decisions involving the
potential use of Erwinaze 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 effectively commercializing Erwinaze, risks related to market
acceptance of Erwinaze by physicians and the medical community, and those
other risks detailed from time to time under the caption "Risk Factors" and
elsewhere in Jazz Pharmaceuticals' filings and reports with the Securities and
Exchange Commission (Commission File No. 001-33500), including in Jazz
Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter ended September
30, 2012 and future filings and reports by the company. 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.

Website: http://www.erwinaze.com/
Contact: Ami Knoefler, Executive Director, Investor Relations & Corporate
Communications, Jazz Pharmaceuticals plc, + 353 1 638 1032 (Ireland), + 1 650
496 2947 (US)
 
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