EUSA Pharma Announces Priority Review Status for ERWINASE BLA

Jan 05 2011

LANGHORNE, Pennsylvania and OXFORD, United Kingdom – EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that its Biologics License Application (BLA) for ERWINASE® (L-asparaginase derived
from Erwinia chrysanthemi) has been accepted for filing and awarded Priority Review status bythe U.S. Food and Drug Administration (FDA). Additionally, the FDA has previously awarded ERWINASE orphan drug designation, which provides a seven-year period of market exclusivity upon approval.

EUSA Pharma completed the rolling submission of its ERWINASE BLA on 1 November 2010, after receiving Fast Track designation from the FDA. Priority Review reduces the target regulatory assessment period to six months from the date of submission. EUSA Pharma is seeking marketing approval for ERWINASE for use in the treatment of acute lymphoblastic leukemia in patients with hypersensitivity to E. coli-derived asparaginase. The product is
currently approved in a number of countries, including Canada, the UK and several European Union member states, and is supplied in the United States under a treatment IND. 

Dr Tim Corn, EUSA Pharma’s Chief Medical Officer, commented, “The award of Priority Review status for ERWINASE is another important step towards making this potentially life-saving therapy available as quickly as possible. We believe that ERWINASE has the potential to enhance the treatment of acute lymphoblastic leukemia greatly, and hope that the ongoing Priority Review will shorten the period before U.S. oncologists can offer this key therapeutic
alternative to their patients.”

About acute lymphoblastic leukemia
Acute lymphoblastic leukemia is the most commonly diagnosed childhood cancer [1]. 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].

ERWINASE is an asparaginase enzyme that depletes the level of 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 [2]. 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*.

About EUSA Pharma
EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care products. The company has an established commercial infrastructure in the U.S., a pan-European presence and a wider distribution network in numerous additional territories. EUSA currently has a total of 10 specialist hospital products, which are sold in over 80 countries globally**. These include Erwinase®/Erwinaze® and Kidrolase® for the treatment of acute lymphoblastic leukemia, Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy, Collatamp® G, a surgical implant impregnated with the antibiotic
gentamicin, ProstaScint® for imaging the extent and spread of prostate cancer and Quadramet® for the treatment of pain in patients whose cancer has spread to the bones. The company also has several products in late-stage development.

[1] U.S. National Cancer Institute. Childhood acute lymphoblastic leukemia treatment (PDQ®).
[2] Pieters R et al. Cancer, 2010 Sep 7 (Epub ahead of print).

* In countries where authorized for use.
** Not all are approved for use in the U.S.

Bryan Morton
Chief Executive
EUSA Pharma Tel: +44 (0)1865 784255