EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, announced that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Erwinase (L-asparaginase derived from Erwinia chrysanthemi) for use in the treatment of acute lymphoblastic leukaemia in patients with hypersensitivity to E. coli-derived asparaginase. Erwinase 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.

EUSA Pharma submitted its Erwinase BLA on a rolling basis, following receipt of Fast Track designation from the FDA. The completed BLA submission requests Priority Review status, which can reduce the regulatory assessment period to six months for major treatment advances. Additionally, the FDA has awarded Erwinase orphan drug designation, which provides a seven-year period of market exclusivity upon approval.

Dr Tim Corn, EUSA Pharma's chief medical officer, commented, "The submission of our Erwinase BLA is a major step towards our goal of making this important therapy available as rapidly as possible. Many children with acute lymphoblastic leukaemia develop allergy to current asparaginase products, and Erwinase provides a key therapeutic alternative for this gravely ill group in several countries around the world. By applying for Priority Review status, we hope to shorten the period before EUSA can launch Erwinase in the US, and reduce the time before physicians can provide this potentially life-saving drug to those who may benefit from it."

"Completing the BLA filing for Erwinase marks a major strategic milestone for EUSA," said Bryan Morton, EUSA Pharma's president and chief executive officer. "Based on new study results and existing clinical experience, we believe Erwinase has the potential to enhance the treatment of acute lymphoblastic leukaemia significantly, both in the US 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."

Acute lymphoblastic leukaemia (ALL) is the most commonly diagnosed childhood cancer . ALL predominantly affects children and adolescents, who account for over 60% of the more than 5,000 new cases diagnosed in the US each year. ALL treatment is complex, involving a number of stages and many drugs, and includes asparaginase as an essential component of current protocols. Paediatric 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 leukaemia .

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 leukaemia. Asparaginase products are derived from bacteria, and up to 60% of patients develop antibodies to those produced by Escherichia coli. 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 Haematology in December 2010.

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, oncology supportive care and critical care products.