Trading Statement
January 08 2004 - 1:01AM
UK Regulatory
Immediate Release 8 January 2004
Profile Therapeutics plc
Trading Update for 6 months ended 31 December 2003
Revenues ahead of budget at over �7m (unaudited)
Profile Therapeutics plc ("Profile"), which develops and commercialises
specialist inhaled therapies, is pleased to announce the following key
highlights for the 6 months ended 31 December 2003:
* Group revenues are likely to be above �7.0m (2002: �6.3m).
* Cash balances at 31 December 2003 were �3.3m and no drawdown has been made
on Profile's credit facility with the Bank of Scotland.
* PromixinTM, Profile's inhaled antibiotic for patients with cystic fibrosis,
is progressing through the European Mutual Recognition Procedure with
licences anticipated in summer 2004 and marketing partners identified in
significant territories.
* The regulatory approach for the US joint venture products for asthma and
COPD has been finalised and a meeting with FDA is planned for H1 2004; we
continue to review candidates as marketing partners for the joint venture.
* Development of Prodose HandHeld has progressed successfully to the tooling
phase and the first units are planned to be with patients in the summer of
2004.
* Good progress with commercial business development, including announced
deals with Schering and CoTherix.
Profile will announce their interim results on 15 March 2004, and will host
analyst and press meetings at 9.30am and 11.00am respectively on the day at the
offices of Buchanan Communications, 107 Cheapside, EC2. If you wish to attend
one of these meetings please contact Buchanan Communications.
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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