OXFORD, UK, July 12 /PRNewswire/ -- Oxford GlycoSciences Plc (LSE: OGS, Nasdaq: OGSI) today announced that its Marketing Authorisation Application (``MAA'') for Vevesca(TM) (OGT 918) for the oral treatment of type 1 Gaucher disease has been submitted to the European Agency for the Evaluation of Medicinal Products (``EMEA'') and accepted for review. The submission includes data on the use of Vevesca (OGT 918) as oral monotherapy, in combination with Cerezyme (R) and switch/maintenance after Cerezyme®. The Company confirmed that it is currently submitting its New Drug Application (``NDA'') to the US Food and Drug Administration (``FDA'') as a Step-Wise submission (Rolling NDA). This began in March 2001, and the Company expects to complete this submission in the coming weeks.
Dr Chris Moyses, Clinical and Development Director of OGS, said, ``Vevesca (OGT 918) has been developed in an international programme involving leaders in the clinical investigation of glycolipid storage disorders. The package contains data on 82 patients in three separate studies in type 1 Gaucher disease and additional safety data collected on more than 200 patients in the USA in other indications. OGS plans a series of presentations and publications on the data in the autumn.''
Michael Kranda, Chief Executive Officer of OGS, commented, ``We are extremely pleased to have hit our deadline. I am very proud of the team's work, which has elevated us into the elite group of biotech companies that have submitted a drug for regulatory approval.''
Notes to Editors
OGS has developed a proprietary technology platform in the emerging field of proteomics, the comprehensive study of proteins, integrating proteomics with genomics to create an innovative drug discovery platform. OGS' proteomics collaborations with major pharmaceutical and biotechnology companies include Bayer, Pioneer Hi-Bred/DuPont, Medarex, GlaxoSmithKline, and Pfizer. OGS has technology development collaborations with Applera, Cambridge Antibody Technology and Packard BioScience.
OGS recently announced a joint venture with Marconi plc, called Confirmant. Confirmant will provide broadband managed hosting facilities to biotech companies and will market OGS' proteomics databases, notably the Protein Atlas of the Human Genome(TM). OGS also recently announced a high throughput ``targets to leads'' collaboration with NeoGenesis Inc., of Cambridge, Massachusetts.
OGS has drug research discovery programmes in cancer, infectious disease and glycosphingolipid (``GSL'') storage disorders.
Gaucher disease
Gaucher disease is a GSL storage disorder in which individuals have a specific genetic abnormality (enzyme defect) in their metabolism that leads to accumulation of un-metabolised material in tissues within structures known as lysosomes. This disease is sometimes referred to as a lysosomal storage disease. Gaucher disease causes a range of debilitating symptoms and in some cases premature death.
Treating glycolipid storage diseases with Vevesca
Vevesca (OGT 918) has a novel mode of action as an oral inhibitor of glucosylceramide synthase, a key enzyme involved in GSL biosynthesis. The rationale for the use of Vevesca (OGT 918) is to help balance the overall level of GSLs by inhibiting the production or synthesis of GSLs. A wide variety of preclinical studies have demonstrated that Vevesca (OGT 918) provides an effective control over the rate of GSL synthesis.
Orphan Drug Designation for Vevesca (OGT 918)
In the European Union (EU), Vevesca (OGT 918) has been designated as an Orphan Medicinal Product for the treatment of Gaucher disease by the European Commission. Designation of Vevesca (OGT 918) as an Orphan product in the EU allows direct access into the European Agency for the Evaluation of Medicinal Products' Centralised Procedure for Marketing Authorisation Application and may provide for a partial or total application fees waiver. Also, the designation allows for a ten-year marketing exclusivity period in the EU, following approval of Vevesca (OGT 918).
Fast Track Designation for Vevesca (OGT 918)
Fast Track designation is granted by the FDA to potential new drugs in order to facilitate their development and expedite subsequent regulatory review of compounds that are intended to treat serious or life threatening conditions, and that demonstrate the potential to address unmet medical needs. The US FDA policy 21 CFR 314.106b specifically covers the use of foreign data as the sole basis for approval and this has been successfully achieved for a variety of products since the early 1990s, e.g. Ortho-McNeil Pharmaceutical Haldol®(haloperidol decanoate).
Miglustat is the proposed INN (International Non-proprietary Name) for Vevesca (OGT 918).
Cerezyme (R) is a registered trademark of Genzyme Corp.
This release contains forward-looking statements, such as OGS' plan to complete its NDA filing for Vevesca (OGT 918), the preparations for marketing of Vevesca (OGT 918) once approved and Vevesca (OGT 918) providing effective control over the rate of GSL synthesis. 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 other trials and research involving Vevesca (OGT 918), acceptance by the scientific and medical communities of OGS' conclusions as to the results of trials, the validity of the technologies and medical conclusions on which Vevesca (OGT 918) is based and uncertainties related to the regulatory process. Vevesca (OGT 918) is an investigational drug and has not received approval for marketing in any country... |
