Information  X 
Enter a valid email address

Oxford Glycosciences (OGS)

  Print   

Tuesday 25 March, 2003

Oxford Glycosciences

Regulatory Application

Oxford Glycosciences PLC
25 March 2003

PRESS RELEASE



For further information please contact:



Oxford GlycoSciences Plc

David Ebsworth, Ph.D., Chief Executive Officer

Chris Moyses, M.D., Chief Medical Officer

Tel: +44 (0) 1235 208 000

Website: www.ogs.com



Financial Dynamics

UK Media and Investors

Melanie Toyne-Sewell

Francetta Carr

Tel: +44 (0) 20 7831 3113



US Media and Investors

Leslie Wolf-Creutzfeldt

Deborah Ardern Jones

Tel: +1 212 850 5626







               OGS Submits Amendment to the New Drug Application
                      for Zavesca(R) (miglustat) to the FDA



Oxford, UK, 25 March, 2003 -- Oxford GlycoSciences Plc (LSE: OGS, Nasdaq: OGSI)
today announces that it has submitted an amendment to its New Drug Application
(NDA) for Zavesca to the U.S. Food and Drug Administration (FDA).



The FDA stated that the original NDA, submitted in August 2001, might only be
approved if a number of issues were addressed and further clinical studies were
conducted to provide sufficient support for the safety and efficacy of Zavesca.
Following an End-of-Review meeting in September 2002, the FDA indicated that it
believed that management of benefit/risk ratio could be achieved through
restricted use of the drug.



OGS believes that the amendment to the NDA addresses the FDA's comments. It
includes data that were gathered after the original NDA submission and that were
part of the submission to the European regulatory authorities. The FDA has
informed OGS that it considers this submission a Complete Response to the Action
Letter received in June 2002 and that a further review cycle has begun.



David Ebsworth Ph.D., Chief Executive Officer of OGS said, 'We are committed to
gaining regulatory approval in the US.  We are confident that the information
now supplied provides evidence that a positive benefit/risk ratio can be
achieved for Zavesca.  We look forward to a response from the FDA on this latest
submission.'



Zavesca received EU marketing approval in November 2002 for the treatment of
patients with mild to moderate type 1 Gaucher disease for whom enzyme
replacement therapy is unsuitable.  The product was launched in the UK on 3
March by Actelion Ltd. under the terms of a worldwide licensing agreement (with
the exception of Israel).  A named-patient program is also in place, which
allows commercial access to the drug through an international pharmacy, if so
permitted by local regulations.  Actelion expects to begin making Zavesca
available throughout the European Union in the coming months.



                                      ###





Notes to Editors



Zavesca regulatory background



OGS submitted an NDA for Zavesca for the treatment of patients with type 1
Gaucher disease in August 2001.  In June 2002, the FDA issued a complete
response letter indicating that the product was not approvable based on the
FDA's opinion that OGS had not provided sufficient support of safety and
efficacy of the drug.  In accordance with FDA procedure, OGS requested and
received a hearing on whether there were grounds for denying approval of the
application.



Gaucher disease



Gaucher disease is a rare genetic disorder, which results from reduced activity
of glucocerebrosidase, an enzyme responsible for glycosphingolipid (GSL - a
subclass of fats) metabolism.  Symptoms include enlargement of spleen and liver,
bone disease and anaemia.



Treating Gaucher disease with Zavesca



Zavesca is an oral inhibitor of glucosylceramide synthase, a key enzyme involved
in GSL biosynthesis. The rationale for the use of Zavesca is to help balance the
overall level of GSLs by inhibiting their production or synthesis - termed '
substrate reduction'.



Oxford GlycoSciences



OGS is a research and product development company with three distinct business
units - proteomics, inherited storage disorders and oncology.  In proteomics,
the comprehensive study of proteins, OGS has developed a patented technology
platform, integrating high-throughput proteomics with genomics. OGS has
proteomics collaborations with Bayer, Pioneer Hi-Bred/DuPont, GlaxoSmithKline,
Pfizer, the Center for Drug Evaluation and Research of the FDA, and the Cystic
Fibrosis Foundation.  OGS also has a joint venture, Confirmant Limited, to
develop the Protein Atlas of the Human GenomeTM. The second business unit is
focused on the development of therapeutics to treat inherited GSL storage
disorders. In addition to type 1 Gaucher disease, Zavesca is also undergoing
further clinical investigations in other GSL storage disorders, including Late
Onset Tay Sachs, Niemann-Pick type C and type 3 Gaucher disease.  In oncology,
OGS is developing a pipeline of projects and has drug discovery and development
alliances with Medarex, NeoGenesis and BioInvent.





This release contains forward-looking statements, such as the commercial
potential and success of OGS' collaborations and drug candidates. Factors that
could cause actual results to vary significantly from those expressed or implied
by these and other forward-looking statements include the success of OGS'
research and development strategies, the validity of its technologies and
intellectual property position and strategies, the medical conclusions on which
Zavesca (miglustat) is based and uncertainties related to the regulatory
process.




                      This information is provided by RNS
            The company news service from the London Stock Exchange                                                                                                                                    

a d v e r t i s e m e n t