Navigation Links
EUSA Pharma Submits ERWINASE(R) Biologics License Application (BLA) for Treatment of Acute Lymphoblastic Leukemia

EUSA Pharma Submits ERWINASE(R) Biologics License Application (BLA) for Treatment... -- LANGHORNE, Pennsylvania and OXFORD, England, November 9, 2010 /PRNewswire/ --

Advanced Search Search

  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Health Care & Hospitals, Medical Pharmaceuticals, Pharmaceuticals, Clinical Trials & Medical Discoveries, FDA Approval Click to view news release full screen  

EUSA Pharma Submits ERWINASE(R) Biologics License Application (BLA) for Treatment of Acute Lymphoblastic Leukemia


LANGHORNE, Pennsylvania and OXFORD, England, November 9, 2010 /PRNewswire/ -- 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 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 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 [1]. 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 [2]. 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 [1].


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 [3]. 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.


[1] U.S. National Cancer Institute. Childhood acute lymphoblastic leukemia treatment (PDQ(R)).

[2] U.S. National Cancer Institute. Surveillance Epidemiology and End Results. Stat Fact Sheets: Acute Lymphocytic Leukemia.

[3] 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. Contacts Bryan Morton Chief Executive EUSA Pharma Tel: +44(0)1865-784255 Rob Budge RJB Communications Tel: +44(0)1865-760969 Mobile: +44(0)7710-741241

Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Arena Pharmaceuticals Announces Third Quarter 2010 Financial Results and Reviews Recent Developments
2. Anadys Pharmaceuticals Reports Third Quarter 2010 Financial Results and Highlights
3. How IT Helps Solve Pharmas R&D Problems: in silico Drug Discovery
4. UK Pharmaceutical Market Overview - Pricing and reimbursement challenges dampen future growth
5. Opportunities in Emerging Pharma Markets: Strategies for Optimizing Growth in Key Regions and Therapeutic Areas
6. Tianyin Pharmaceutical Co., Inc. to Host First Quarter of Fiscal Year 2011 Earnings Conference Call on Thursday, November 11, 2010 at 9:00 a.m. ET
7. ShangPharma Announces Appointment of Benson Tsang as a Member of the Board of Directors and Audit Committee
8. NovaSperse(SM) Nanoparticle Innovator, PharmaNova, Inc., Awarded Four Government Grants Toward Development of New Therapeutic Products Under Congressional Qualifying Therapeutic Discovery Project Initiative
9. WuXi PharmaTech Awarded GLP Certificate from SFDA for Suzhou Toxicology Facility
10. EnVivo Pharmaceuticals Research Shows EVP-6124 Acts as Acetylcholine Co-Agonist
11. Cadence Pharmaceuticals Reports Third Quarter 2010 Financial Results
Post Your Comments:
(Date:11/26/2015)... , 26 november 2015 ... kondigt de geplande investering aan van ten ... de laboratoria en het mondiale hoofdkantoor in ... uitbreiding zal resulteren in extra kantoorruimte en ... aan de groeiende behoeften van de farmaceutische ...
(Date:11/26/2015)... -- --> --> Juntendo ... optimal contrast weighting of MRI for patients with Multiple ... research agreement with SyntheticMR in order to use SyMRI in ... possible to generate multiple contrast images from a single scan ... thus making it possible to both fine tune images and ...
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Japanese therapeutic drug monitoring ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, Vitalalert ... Organizations, One Beat ” campaign. The partnership between the two groups began in 2014 ... MAP International’s cause. , MAP International was founded in 1954 and is an international ...
(Date:11/25/2015)... ... November 25, 2015 , ... On November 25, 2015, officials of ... Narconon network, announced the release of a new cutting edge recovery program that has ... been working with drug- and alcohol-addicted individuals with the purpose to free addicts from ...
(Date:11/25/2015)... ... , ... Smiles by Stevens is pleased to announce the addition ... many patients are aware of the benefits of Botox® in the treatment of moderate ... with discomfort, soreness, and pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) ...
(Date:11/25/2015)... ... , ... In an ongoing Clinical Study conducted by an independent physician, Andrew ... is evaluating the efficacy of its product and its disinfection protocol. This study is ... May 2014 through October 2015 at a 360-bed, acute-care, academic medical center located in ...
(Date:11/25/2015)... Silver Spring, Md (PRWEB) , ... November 25, ... ... the Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups ... the history of this disease. The Periwinkle Pioneers, nominated by the public, will ...
Breaking Medicine News(10 mins):