LANGHORNE, Pennsylvania and OXFORD, England, Jan. 5 /CNW/ - 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 ERWINAZE(R) (L-asparaginase
derived from Erwinia chrysanthemi) has been accepted for filing and
awarded Priority Review status by the U.S. Food and Drug Administration
(FDA). Additionally, the FDA has previously awarded ERWINAZE orphan
drug designation, which provides a seven-year period of market
exclusivity upon approval.
EUSA Pharma completed the rolling submission of its ERWINAZE 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 ERWINAZE 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 ERWINAZE is another important step
towards making this potentially life-saving therapy available as
quickly as possible. We believe that ERWINAZE 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
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
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(R)/Erwinaze(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
 U.S. National Cancer Institute. Childhood acute lymphoblastic
leukemia treatment (PDQ(R)).
 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.
SOURCE EUSA Pharma Inc.
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