LANGHORNE, PA and OXFORD, ENGLAND, Nov. 9 /CNW/ - EUSA Pharma, a
transatlantic specialty pharmaceutical company focused on oncology,
oncology supportive care and critical care, today announced that it has
submitted a Biologics License Application (BLA) to the U.S. Food and
Drug Administration (FDA) for ERWINASE(R) (L-asparaginase derived from
Erwinia chrysanthemi) for use in the treatment of acute lymphoblastic
leukemia 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
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 leukemia 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 U.S., 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 leukemia significantly, 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 . 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 . 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 .
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 . 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
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(R) and Kidrolase(R) for the treatment of acute
lymphoblastic leukemia, Caphosol(R) for the treatment of oral
mucositis, a common and debilitating side-effect of radiation therapy
and high dose chemotherapy, Collatamp(R) G, a surgical implant
impregnated with the antibiotic gentamicin, ProstaScint(R) for imaging
the extent and spread of prostate cancer and Quadramet(R) 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(R)).
 U.S. National Cancer Institute. Surveillance Epidemiology and End
Results. Stat Fact Sheets: Acute Lymphocytic Leukemia.
 Pieters R et al. Cancer, 2010 Sep 7 (Epub ahead of print).
* In those countries where ERWINASE is authorized for use.
** Not all products are approved currently for use in the U.S.
SOURCE EUSA PHARMA INC.
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