March 15 /PRNewswire/ -- Oxford GlycoSciences Plc (LSE: OGS, Nasdaq: OGSI) today announces preliminary unaudited results for the year ended 31 December 2000.
Highlights
Vevesca(TM):
-- Published first clinical trial results on Vevesca(TM) (formerly known
as OGT 918) for Gaucher disease in The Lancet.
-- Received fast track designation for Vevesca(TM) in Gaucher disease from
the US Food and Drug Administration (FDA), and orphan drug designation
from the FDA and the European Commission.
-- In February 2001, preliminary results of a six month study of
Vevesca(TM) indicated that patients were successfully maintained on
oral therapy alone during the study period.
-- Also in February, announced plans to file a new drug application in the
US and marketing authorisation application in Europe in mid-2001.
Proteomics:
-- Filed patent applications relating to more than 1,500 disease-
associated proteins and their uses in the treatment or diagnosis of
diseases, in important areas of unmet medical need such as breast,
prostate and primary liver cancers, Alzheimer's disease and other
neurological disorders, and rheumatoid arthritis.
-- Signed research collaboration agreements with Bayer AG, Glaxo Research
and Development Limited (Glaxo) and Pfizer Inc to identify disease-
associated proteins as potential targets for drug discovery and
clinical markers of disease.
-- Awarded a major US patent broadly covering computer-assisted methods
and instruments essential to the practice of high-throughput,
industrialised proteomics.
-- Formed alliances with Applera Corporation, Cambridge Antibody
Technology Plc and Packard BioScience Company for new technology
development and improvements.
Drug discovery and development:
-- Formed an alliance with Medarex Inc to develop novel therapeutic
antibody products, and to convert up to 30 antigens discovered by OGS
into a substantial pipeline for clinical development.
-- Announced the discovery of a novel heparanase gene and its protein;
research programme underway for the targeting of heparanase with small
molecule inhibitors and antibodies.
-- Initiated PMT-1 antifungal new chemical entity (NCE) programme. PMT-1
is found in species of Candida, and therefore could represent a good
target for the discovery of new antifungal agents.
Commercial and financial:
-- Completed new, custom-designed proteomics facility at Milton Park,
Oxfordshire, UK.
-- Dr C Moyses, Dr S B Parker, Dr J F Hill and Dr D L Drakeman appointed
to the Board.
-- Listed on the Nasdaq exchange in December 2000.
-- Raised net proceeds of pounds 190.3 million from two major
fundraisings.
-- Financial results;
-- revenue pounds 8.9 million (1999: pounds 8.7 million)
-- loss for the year pounds 15.6 million (1999 restated: pounds 10.4
million)
-- year end cash balance pounds 203.9 million (1999: pounds 26.0
million)
Collaborations with Glaxo and Pfizer Inc were signed late in 2000
therefore little revenue was recognised for these agreements in the
year, however they should contribute fully in 2001.
Michael Kranda, Chief Executive Officer, commented: ``The first year of the new millennium proved to be a very important and exciting one for OGS. We made major strides in our efforts to apply our proteomics technology to the discovery and development of new drugs and diagnostics. Today's results describe substantial progress on all fronts - continued technology leadership, building momentum with our pharmaceutical partners, strengthening our shareholder base and balance sheet and, most importantly, building a pipeline that now includes a robust antibody programme, proprietary small molecule programmes, bio-markers and our late-stage clinical compound, Vevesca(TM).''
A presentation for analysts will take place today at 9.30am at the offices of Financial Dynamics, Holborn Gate, 26 Southampton Buildings, WC2, followed by a conference call and webcast at 4.00pm. Please call Mo Noonan on 020 7831 3113 for further details.
Review of Operations
Vevesca(TM): a new approach to the treatment of Gaucher disease Vevesca(TM) is a small molecule candidate being developed by OGS, which is in late-stage clinical trials for the oral treatment of Gaucher disease. In this rare inherited condition, which affects between 10,000 and 20,000 people worldwide, reduced activity of an enzyme responsible for degrading glycosphingolipids (GSL; a subclass of fats) results in an accumulation of unmetabolised GSL in tissues throughout the body. This storage leads to enlargement of the liver and spleen, low haemoglobin and platelet counts, and bone disease.
The first clinical results with Vevesca(TM) were published in The Lancet in April 2000. The study concluded that this therapy given for one year improved key clinical features of the most common form of Gaucher disease (Type 1), was well tolerated, ``could be used as monotherapy and has an additional potential as a treatment combined with enzyme replacement.''
In February 2001, OGS announced the completion of a six month study to investigate Vevesca(TM) as a potential oral treatment in patients with Gaucher disease, who have been receiving enzyme therapy. The initial results indicate that patients were successfully maintained on oral therapy alone during the study period.
Clinical trials with Vevesca(TM) in Gaucher disease are ongoing and OGS plans to file a new drug application in the US and a marketing authorisation application in Europe for this indication in 2001. The US FDA has given Vevesca(TM) 'fast track' designation. This is granted to facilitate the development and expedite the regulatory review of new drugs, that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Vevesca(TM) is also under clinical investigation in an initial exploratory study in Fabry disease, another glycolipid storage disorder. In the US, OGS has been granted orphan drug designation for the use of Vevesca(TM) in both Gaucher and Fabry diseases, which allows seven years' marketing exclusivity after approval of the product by the US FDA. Similarly, Vevesca(TM) has been designated an orphan medicinal product by the European Commission, for the treatment of Gaucher disease, which allows ten years' marketing exclusivity following approval.
Proteomics
OGS's primary aim is to use proteomics and glycobiology techniques for the discovery, development and commercialisation of therapeutic and diagnostic products. We have established a technology platform that enables us to identify disease-associated proteins quickly and reliably.
In September 2000, we moved into our new, custom-designed facility at Milton Park in Oxfordshire, UK. Here we operate what we believe is the world's most sophisticated combined proteomics and genomics 'data factory'. In order to interpret and analyse the massive flow of information coming from this facility, we have built substantial computing power in-house and developed unique software which provides a powerful tool for data searching, interrogation and interpretation.
During 2000, we entered into agreements with major pharmaceutical companies to utilise our proteomics expertise:
* Our collaboration with Bayer AG established a multi-year programme to identify disease-associated proteins that are new potential targets for intervention in respiratory diseases.
* In collaboration with Glaxo we aim to find novel bio-markers in several disease areas in which Glaxo currently markets pharmaceutical products or is building major franchises.
* We extended our agreement with Pfizer Inc to investigate bio-markers and protein targets for Alzheimer's disease and atherosclerosis. Our initial collaboration began in 1998 and has resulted in a number of patent filings.
* We revised our agreement with Incyte Pharmaceuticals Inc which resulted in better economics for OGS as well as greater freedom to operate in the database product arena.
In addition, in 2000 we entered into major technology development collaborations with Applera Corporation (TOF TOF mass spectrometry), Cambridge Antibody Technology Plc (antibody based microarrays) and Packard BioScience Company (protein biochips). These agreements should allow OGS to stay ahead of competitors by ensuring access to leading edge technology.
Establishing intellectual property
By the end of the 2000, we had exceeded our target of filing patent applications relating to over 1,500 disease-associated proteins or their uses as diagnostics, as targets for small molecule drug development or possibly as protein therapeutic products.
In May 2000, OGS was issued a major US patent, broadly covering computer- assisted methods and instruments essential to the practice of high throughput, industrialised proteomics. This patent provides a strong objective confirmation of our technology, our position in the field and our competitive advantage.
Drug discovery and development
The continued development of technologies in glycobiology and glycochemistry form a key part of our strategy for drug discovery. For selected target proteins, the drug candidates will be small molecules discovered and optimised through our glycochemistry and high throughput screening. These drug candidates are in various stages of pre-clinical research. Another promising area for OGS is the identification of protein targets for therapeutic antibodies.
Through our new alliance with Medarex Inc, we plan jointly to discover, develop and commercialise fully human monoclonal antibodies as therapeutics. By 'tagging' proteins on the external surfaces of intact cells, for example, we are able to selectively extract cell surface proteins and identify them using our proteomics platform. This technique has enabled us to discover cell surface proteins that are expressed differently in breast cancer patients and may be used as antigens to develop novel therapeutic antibodies.
In October, we announced the discovery of a novel heparanase gene and its protein (HpA2). Heparanase is a key target for cancer therapy; we have identified a novel series of small molecule inhibitors, which are able to block the growth of tumour cells and the growth of activated blood cells (angiogenesis). OGS has also successfully cloned the gene for the enzyme peptide mannosyl transferase 1 (PMT-1), which is found in species of Candida. The enzyme PMT-1 may be required for key stages in the growth and infection of people by Candida, and therefore could represent a good target for the discovery of new antifungal agents... |
