PTP Profile Thera.

    Immediate Release                                                 28 April 2004

                           Profile Therapeutics plc                            

  Prodose AAD system receives US regulatory approval & update on offer talks   

Profile Therapeutics plc ("Profile"), which develops and commercialises
specialist inhaled therapies, is pleased to announce that, as expected, it has
received regulatory approval from the US Food and Drug Administration ("FDA")
for its Prodose(tm) Adaptive Aerosol Delivery ("AAD�") system.

Prodose is already launched in Europe to deliver Promixin(tm), an inhaled
antibiotic for treatment of patients with cystic fibrosis, and Ventavis�,
Schering AG's product for pulmonary hypertension. It has also been selected by
CoTherix, Inc. for development of their inhaled Iloprost for pulmonary
hypertension.

Prodose is Profile's second-generation AAD system. The third generation system,
Prodose HandHeld, is in its final stages of development and planned to be
available to patients for the first time later this year.

It was announced on 18 March 2004, that Profile was in discussions, which may
or may not lead to a formal offer being made for the Company. Profile would
like to confirm that these discussions are ongoing and further announcements
will be made in due course.

John Lisle, Profile's Chief Executive, said

"The FDA approval for Prodose is an important step forward in our regulatory
strategy in the US and paves the way for our regulatory submission for Prodose
HandHeld later this year."

                                   - ENDS -                                    

For further information, please contact:

Profile Therapeutics                                                           
                                                                               
John Lisle, Chief Executive Officer                          Tel: 0870 770 2000
                                                                               
Buchanan Communications                                      Tel: 020 7466 5000
                                                                               
Tim Anderson                                                                   
                                                                               
James Strong                                                                   

Notes to Editors:

Profile Therapeutics plc develops and commercialises specialist inhaled
therapies to improve the treatment of respiratory patients. Profile's core
patient groups are the young, the elderly and individuals with severe
respiratory impairment. The diseases targeted by Profile include: cystic
fibrosis, primary pulmonary hypertension, asthma, emphysema, chronic
bronchitis, sleep disorders and Chronic Obstructive Pulmonary Disease ("COPD").

Profile has developed proprietary innovative delivery systems using its
"intelligent inhaler" technology known as Adaptive Aerosol delivery or AAD�.
These systems automatically respond to individual patients' breathing patterns
to deliver a precise dose and have been shown under long-term clinical trials
to significantly enhance patient compliance to therapy.

Profile's first drug PromixinTM, an inhaled antibiotic for patients with cystic
fibrosis, was launched in the UK in March 2003. Profile's AAD systems are also
used for the delivery of Schering's Ventavis� for Primary Pulmonary
Hypertension and in the development of an equivalent product with CoTherix Inc
for the US market. Profile has also formed a joint venture with Breath Ltd to
develop a range of respiratory medicines for the US market for delivery via
Profile's intelligent inhalers. The initial products will be albuterol (for
asthma/COPD), ipratropium (COPD), albuterol/ipratropium combination and an
inhaled corticosteroid (asthma).



END

Profile Thera. (LSE:PTP)
Historical Stock Chart
From Oct 2024 to Nov 2024

Profile Thera. (LSE:PTP)
Historical Stock Chart
From Nov 2023 to Nov 2024