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Jazz Initiates Erwinaze Trial

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Jazz Pharmaceuticals (JAZZ - Free Report) recently initiated a study on Erwinaze (asparaginase Erwinia chrysanthemi) for the treatment of patients suffering from acute lymphoblastic leukemia (ALL) with hypersensitivity to E. coli-derived asparaginase therapy.

Erwinaze offers an intravenous and alternative method of administration for the treatment of ALL. Jazz Pharma expects to enroll around 25 patients with ALL in the US and Canada for the study. The patients must have a documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase and are yet to complete their full courses of prescribed asparaginase therapy.

Jazz Pharma expects preliminary pharmacokinetic data from the study in the second half of 2013.

We note that Jazz Pharma added Erwinaze to its portfolio after its EUSA Pharma acquisition. The $680 million EUSA Pharma acquisition was closed in June this year. Jazz Pharma will be paying an additional $50 million if net sales from Erwinaze exceed or equal $124.5 million in the US in 2013.

Jazz Pharma reported Erwinaze sales of $31.7 million in the third quarter this year. Notably, in November 2011, Erwinaze was approved by the US Food and Drug Administration for the treatment of ALL, under a biological license application. The drug is also being sold under marketing authorizations, named patient programs, temporary use authorizations or similar authorizations in the EU and other countries.

We note that players like ARIAD Pharmaceuticals are looking to enter the ALL market.

Currently, we have a Neutral recommendation on Jazz Pharmaceuticals. The stock carries a Zacks #4 Rank (Sell).

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