) 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
) 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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