Ph IIb Hay Fever Trial Starts

Evolutec Group PLC 13 June 2006 For immediate release 13 June 2006 EVOLUTEC GROUP PLC ('Evolutec' or 'the Company') COMMENCEMENT OF PHASE IIb ALLERGIC RHINITIS (HAY FEVER) TRIAL Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novel products for the treatment of allergic, inflammatory and autoimmune diseases, is pleased to announce the commencement of a 300 patient Phase IIb trial of rEV131 in allergic rhinitis. This follows receipt of an unconditional 'No Objection Letter' from Health Canada, the Canadian regulatory authority. This multi-dose double-blind trial is being undertaken by Allied Research International ('Allied') in Toronto, Canada, under the leadership of Dr. Pyush Patel. This trial aims to build on the commercial differentiation of rEV131 from existing therapies and follows Evolutec's Phase IIa single dose study which demonstrated the rapid onset of action of rEV131 in a nasal allergen challenge format. In particular, this study will determine the duration of action of rEV131, which is being administered as a nasal spray. The trial will be conducted using Allied's Environmental Exposure Chamber in which patients will be exposed to high levels of ragweed pollen for periods in excess of 12 hours. The primary endpoint of the trial is the sum of symptom scores after 7 days of twice daily dosing. There are some 35 million allergic rhinitis patients in the US alone and the US allergic rhinitis market is estimated to be worth in excess of $6.6 billion. Surveys indicate that more than 70% of patients in the US are interested in adopting new treatments, one reason for which is patients' desire to move away from steroid-based medications. rEV131 is a recombinant derived from a naturally occurring molecule identified in ticks, parasites whose saliva contains immuno-suppressive and immuno-modulatory molecules over which Evolutec has strong patent protection. Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: 'The start of this pivotal trial and the result, expected by the end of this calendar year, are important milestones in the commercialization of rEV131.' ENDS For further information: Evolutec 0118 922 4480 Mark Carnegie Brown, Chief Executive Officer Nicholas Badman, Chief Financial Officer www.evolutec.co.uk Buchanan Communications 020 7466 5000 Mark Court/Tim Anderson/Mary-Jane Johnson Notes for Editors: About Evolutec Evolutec, which is based in Reading, UK, is a clinical stage biopharmaceutical company with a focus on allergy, inflammation and auto-immune diseases. The Company has completed a positive 112 patient proof of concept Phase IIa clinical trial with rEV131, its lead product development candidate, in allergic rhinitis. rEV131 met the primary endpoint of reducing the sum of symptom scores at statistically significant levels within 45mins of administration. Evolutec intends to complete proof of concept Phase II trials in post-cataract surgery in 2006 and dry eye in 2006/7. Positive pre-clinical data has also been generated in asthma. Through binding histamine, rEV131 has a unique product profile with effects on both early and late stage inflammation. The Company has a further two product development candidates in pre-clinical development: rEV576, a complement inhibitor, and rEV598, which is being evaluated in CINV (chemotherapy-induced nausea and vomiting). rEV576 has demonstrated preclinical activity against the autoimmune disease myasthenia gravis and in acute myocardial infarction ('AMI') (heart attack). Evolutec has a research collaboration with Case Western Reserve University, Cleveland, Ohio, to carryout further preclinical testing of rEV576 in myasthenia gravis. The rights to Evolutec's vaccine technology for animals are partnered with Merial. Merial is currently undertaking work in tick-borne diseases. Evolutec is listed on the London Stock Exchange and develops therapeutics originally isolated from the saliva of ticks. The tick remains undetected by its hosts, including humans, by injecting an array of molecules into the skin that suppresses host immunity. These stealth molecules have undergone millions of years of natural evolution to select a promising efficacy, potency and safety profile. Evolutec employs the tick's evolutionary stealth technology to offer the potential of treating human diseases. Safe Harbour statement: this news release may contain forward-looking statements that reflect the current expectations of the Company regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions. This information is provided by RNS The company news service from the London Stock Exchange
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