Langhorne, PA and Oxford, UK – 3 August 2011 EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that it has been informed that the US Food and Drug Administration (FDA) is continuing to review the company’s Biologics License Application (BLA) for ERWINAZETM. As a result, the FDA did not send EUSA an action letter by the Prescription Drug User Fee Act goal date of August 2, 2011.
“We are continuing our positive collaboration with the FDA, and look forward to the conclusion of the BLA review for ERWINAZE,” said Dr Tim Corn, EUSA Pharma’s Chief Medical Officer. “Given the additional information requested previously by the Agency, we respect the need for further time to complete the review. We remain optimistic and continue to believe strongly in the value this leukemia treatment alternative can provide in an important area of unmet medical need”.
ERWINAZE (L-asparaginase derived from Erwinia chrysanthemi) is currently approved for the treatment of acute lymphoblastic leukemia in patients with hypersensitivity to E. coli-derived asparaginase in a number of countries, including Canada, the UK and several European Union member states. The product is supplied in the United States under a treatment IND and has been awarded orphan drug designation by the FDA, providing a seven-year period of market exclusivity upon approval.
About acute lymphoblastic leukemia
Acute lymphoblastic leukemia is the most commonly diagnosed childhood cancer . 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 .
ERWINAZE 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 . ERWINAZE, 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.
 U.S. National Cancer Institute. Childhood acute lymphoblastic leukemia treatment (PDQ®).
 Pieters, R., Hunger, S. P., Boos, J., Rizzari, C., Silverman, L., Baruchel, A., Goekbuget, N., Schrappe, M. and Pui, C.-H. (2011), L-asparaginase treatment in acute lymphoblastic leukemia. Cancer, 117: 238–249. doi: 10.1002/cncr.25489.
* In countries where authorized for use.
** Not all are approved for use in the U.S.