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

DUBLIN, Dec. 10, 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.

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