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EUSA Pharma Submits ERWINASE(R) Biologics License Application (BLA) for Treatment of Acute Lymphoblastic Leukemia
Date:11/9/2010

antly, both in the U.S. and further afield. In the coming months, EUSA plans to achieve pan-European authorization for ERWINASE, and our partners are pursuing regulatory approval in Japan and elsewhere. As a result, ERWINASE has the opportunity to become EUSA's second global product, marking the company's rapid transformation into a leading player in the specialty oncology field."

About acute lymphoblastic leukemia

Acute lymphoblastic leukemia (ALL) is the most commonly diagnosed childhood cancer [1]. ALL predominantly affects children and adolescents, who account for over 60% of the more than 5,000 new cases diagnosed in the U.S. each year [2]. ALL treatment is complex, involving a number of stages and many drugs, and includes asparaginase as an essential component of current protocols. Pediatric treatment is often highly successful, with remission rates of over 95% and 75 - 85% of treated children surviving for at least five years without recurrence of leukemia [1].

About ERWINASE

ERWINASE is an asparaginase enzyme that depletes the level of the amino acid asparagine in the bloodstream. Asparagine is essential for cell growth, and its removal from the blood inhibits the growth of cells associated with acute lymphoblastic leukemia. Asparaginase products are derived from bacteria, and up to 60% of patients develop antibodies to those produced by Escherichia coli [3]. ERWINASE, which is produced by Erwinia chrysanthemi, is immunologically distinct from these therapies and is suitable for patients with hypersensitivity to E. coli-derived treatments*. The BLA submission for ERWINASE includes data from a recent study in children with hypersensitivity to pegylated E. coli asparaginase, which will be presented at the American Society of Hematology in December 2010.

About EUSA Pharma

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage onc
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SOURCE EUSA Pharma
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