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Agency / Source: Biocompatibles UK Ltd / BTG Plc

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BTG Plc – FDA Accepts Biologics License Application File for Voraxaze® [glucarpidase] and Grants Priority Review - BTG plc (LSE: BGC), the specialist healthcare company, announces that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) file for glucarpidase and has granted a Priority Review - BTCplc.com
BTG Plc – FDA Accepts Biologics License Application File for Voraxaze® [glucarpidase] and Grants Priority Review

 

PRZOOM - /newswire/ - London, United Kingdom, 2011/09/20 - BTG plc (LSE: BGC), the specialist healthcare company, announces that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) file for glucarpidase and has granted a Priority Review - BTCplc.com. LSE: BTG

   
 
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The FDA has stated that its preliminary review of the BLA has not identified any potential review issues with the filing at the current time and it has also determined that as glucarpidase has orphan drug designation it is exempt from pediatric assessments.

Glucarpidase is an experimental treatment for the rapid and sustained reduction of toxic methotrexate levels due to impaired renal function. High dose methotrexate chemotherapy is used to treat or prevent the recurrence of certain types of cancer such as leukaemia, lymphoma and osteosarcoma. Patients may be considered at risk of methotrexate toxicity if either they have impaired renal function, which can lead to a delay in elimination from the body or if they have evidence of delayed elimination. Glucarpidase is not yet approved in any country. Glucarpidase is currently available in the US under an expanded access IND and cost recovery programme and in selected countries outside the US on a named patient basis.

For further information contact:
BTG
Rolf Soderstrom, Chief Financial Officer - T: +44 (0)20 7575 0000

Financial Dynamics
Ben Atwell - T+44 (0)20 7831 3113

About BTG
BTG (btgplc.com) is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The company is seeking to acquire new products to develop and market to specialist physicians, and is building a sustainable business financed by revenues from sales of its own marketed products and from royalties and milestone payments on partnered products.

 
 
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Agency / Source: Biocompatibles UK Ltd / BTG Plc

 
 

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BTG Plc – FDA Accepts Biologics License Application File for Voraxaze® [glucarpidase] and Grants Priority Review

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BTG Plc |
Contact: Ashley Tapp - BTGplc.com 
+44(0)20 7575 1513 media[.]btgplc.com
 
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IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Biocompatibles UK Ltd / BTG Plc securities in any jurisdiction including any other companies listed or named in this release.

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