First Drug Approval

RNS Number:8976H
Profile Therapeutics PLC
25 February 2003


For Immediate Release:                          7am, Tuesday 25th February 2003



                              Profile Therapeutics


         UK Marketing Authorisation Received for first drug - Promixin



Profile Therapeutics plc ("Profile"), which develops and commercialises
specialist inhaled therapies to improve treatment for respiratory patients,
announces that its pharmaceutical subsidiary, Profile Pharma Ltd, has been
granted a UK Marketing Authorisation for Promixin. Promixin is an inhaled
antibiotic for the treatment of chronic lung infection in cystic fibrosis
patients - this is Profile's first drug approval and marks a significant step in
the Company's development and future prospects.



Promixin (colistimethate sodium) is one of the two principal antibiotics
delivered by nebuliser direct to the site of infection in the lungs of cystic
fibrosis patients. Patients commonly take the therapy daily to control
colonisation of the lungs by the bacterium Pseudomonas aeruginosa.



Profile will launch Promixin into the UK in early March this year. Patients who
are prescribed the drug for long-term use will have access to Profile's
proprietary intelligent inhaler system, the Prodose AAD System, and a full
support programme.



Now that UK Authorisation has been granted, Profile intends to obtain Marketing
Authorisations in other EU territories under the EU Mutual Recognition
Procedure. It is anticipated that, subject to due process, the first such
authorisation will be granted in approximately 12 months time, with others
following on from that.



Commenting on the announcement, John Lisle, Chief Executive Officer of Profile,
said:



"Gaining our first drug licence represents a significant step for Profile. We
are delighted to be able to provide our first specialist pharmaceutical to the
UK cystic fibrosis community, with overseas launches following on in due 
course."



                                    - ENDS -



For further information, please call:

Profile Therapeutics
John Lisle                                                Tel: [phone]
Simon Shaw                                                Tel:  [phone]

Buchanan Communications
Nicola How / James Strong                                 Tel:  [phone]



Notes to editors

Profile Therapeutics plc develops and commercialises specialist inhaled
therapies to improve the treatment of respiratory patients.



Cystic fibrosis is the most common terminal genetic condition amongst
Caucasians, with some 60,000 patients in the US and Europe.  Death from cystic
fibrosis is due mainly to pulmonary complications.  The condition is commonly
treated with inhaled medications that aim to minimise infection of the lung.  It
is estimated that the potential world market for antibiotics in the treatment of
cystic fibrosis is in the region of $200-300 million per annum.


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