RNS Number:5924L
K.S. Biomedix Holdings PLC
28 May 2003

            
Embargoed until 0700                                                28 May 2003

KS Biomedix Holdings plc                                            Tel: +44 (0) 1483 307500
Dr Steven Powell, Chief Executive Officer

Weber Shandwick Square Mile                                         Tel: +44 (0) 20 7067 0700
Kevin Smith/Graham Herring



FDA Grants Orphan Drug Designation to KS Biomedix's KSB303 for the Treatment of Pancreatic Cancer

Guildford, UK... KS Biomedix Holdings plc ("KSB" or "the Company") (LSE: KSB) today announced that the US Food & Drug
Administration ("FDA") has granted Orphan Drug Status to KSB303, the Company's most advanced high affinity antibody
product, for the treatment of pancreatic cancer.

KSB303 is a high affinity, radiolabelled monoclonal antibody, which is being developed for a range of cancer
indications.  KSB has completed a Phase I imaging study of KSB303 in patients with metastatic colorectal cancer in
which the antibody was well tolerated and demonstrated specific targeting and prolonged retention at metastatic
tumours.  A Phase I/II trial of KSB303 in pancreatic cancer is ongoing in clinical centres in Europe.

Pancreatic cancer represents a significant unmet medical need.  The incidence of pancreatic cancer is approximately
30,000 new cases per year in the USA and 38,000 cases in Europe.  The majority of patients present with advanced
disease and, with current therapeutic approaches, the median survival time is only about six months.  The prognosis in
these patients is very poor with an overall long-term survival rate of only 0.4%.

The US Orphan Drug Act was signed into law in 1983 with the intent to stimulate research and development of innovative
products that treat rare diseases.  The benefits provided by orphan drug status include seven years of marketing
exclusivity after approval of the product, tax incentives for related clinical research expenditure, a waiver on FDA
user fees and clinical development assistance from the FDA.

Dr Steven Powell, CEO of KS Biomedix Holdings plc, commented: "The award of US Orphan Drug Status is a further
milestone in the development of KSB303 and follows the recent grant of similar status in Europe.  We believe that
KSB303's high affinity properties and its ability to bind to the target antigen for prolonged periods mean it has
significant value as a therapeutic for use in pancreatic and colorectal cancer, areas that are poorly served by current
therapies.  Award of US Orphan Status underscores the importance placed by the FDA on the development of innovative new
therapies for niche cancer indications and will help streamline the regulatory approval process."



                                                       - Ends -




Notes to Editors

KS Biomedix Holdings Plc (Guildford, UK) is a biopharmaceutical company headquartered in the UK that is developing a
late-stage pipeline of drugs for a range of cancer indications.  In addition, it has a number of technology platforms
based on its range of receptor-based targeting technologies one of which is KSB's super high-affinity monoclonal
antibodies (SMAs).  The Company has six active clinical programmes, including TransMID-107RTM for the treatment of
adult, recurrent, inoperable high-grade gliomas (brain tumours) and KSB303, an anti-CEA antibody for the diagnosis and
treatment of cancer.

For further details on KS Biomedix please visit www.ksbiomedix.com








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

MSCDGGZKLNKGFZM