12th Oct 2006 07:00
Evolutec Group PLC12 October 2006 12 October 2006 EVOLUTEC GROUP PLC ("Evolutec" or the "Company") Agreement signed with Wacker biotech to develop a commercial manufacturing process for rEV576 Clinical Trials Expected to Commence in 2007 Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novelproducts for the treatment of allergic, inflammatory and autoimmune diseases, ispleased to announce that it has signed an agreement with Wacker Biotech GmbH ("Wacker Biotech") to produce rEV576, Evolutec's second product developmentcandidate, in preparation for clinical trials which are expected to commence in2007. The agreement follows a successful feasibility study in which Wacker Biotechdemonstrated that its proprietary secretion technology enabled the production ofrEV576 in E. coli. The agreement includes process development work leading to a robust scaleablemethod for the production of current Good Manufacturing Practice ("cGMP") graderEV576. This material is required for the intended clinical trials. Theagreement then provides for Wacker Biotech to scale-up the cGMP process. rEV576 is a complement inhibitor and has demonstrated preclinical activityagainst the autoimmune diseases myasthenia gravis and Guillain-Barre Syndrome.Promising preclinical activity has also been seen in asthma. Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: "Promisingpreclinical data and progress made by Wacker Biotech points to the commercialpotential of rEV576. We look forward to maintaining this momentum in thedevelopment programme." Dr. Thomas Maier, Managing Director of Wacker Biotech, commented: "We arepleased to be working with Evolutec and using our proprietary secretiontechnology in the development of rEV576." ENDS For further information: Evolutec 0118 922 4480Mark Carnegie Brown, Chief Executive OfficerNicholas Badman, Chief Financial Officerwww.evolutec.co.uk Financial Dynamics 020 7831 3113Ben Brewerton / Nicola Daley Notes for Editors: About Evolutec Evolutec, which is based in Reading, UK, is a clinical stage biopharmaceuticalcompany with a focus on allergy, inflammation and autoimmune diseases. The Company has completed a positive 112 patient proof of concept Phase IIaclinical trial with rEV131, its lead product development candidate, in allergicrhinitis. rEV131 met the primary endpoint of reducing the sum of symptom scoresat statistically significant levels within 45 minutes of administration. Thisproduct candidate is now in a Phase IIb allergic rhinitis trial and a Phase IIpost-cataract inflammation trial. In addition to these trials, Evolutec alsointends to complete a proof of concept Phase II trial in dry eye in 2007.Following positive preclinical data, Evolutec intends to undertake a Phase Itrial with rEV131 in asthma in 2007. The Company has a further two product development candidates in preclinicaldevelopment: rEV576, a complement inhibitor, and rEV598, which binds serotoninand histamine. rEV576 has demonstrated preclinical activity against theautoimmune diseases myasthenia gravis and Guillain-Barre Syndrome, asthma andacute myocardial infarction ("AMI") (heart attack). Evolutec has established aresearch collaboration with Case Western Reserve University, Cleveland, Ohio, toundertake further preclinical work with rEV576 in myasthenia gravis. rEV598 isbeing evaluated in chemotherapy-induced nausea and vomiting (CINV). The rights to Evolutec's vaccine technology for animals are partnered withMerial. Merial is currently undertaking work in tick-borne diseases. Evolutec is listed on the AIM market of the London Stock Exchange and developstherapeutics originally isolated from the saliva of ticks. The tick remainsundetected by its hosts, including humans, by injecting an array of moleculesinto the skin that suppresses host immunity. These stealth molecules haveundergone millions of years of natural evolution to select a promising efficacy,potency and safety profile. Evolutec employs the tick's evolutionary stealthtechnology to offer the potential of treating human diseases. About Wacker Biotech Wacker Biotech is an experienced full-service contract manufacturer ofbiopharmaceuticals derived from microbial systems. Wacker Biotech's proprietaryE. coli secretion system is a well-established technology for cost-efficientproduction of proteins and antibody fragments. The core of the technology isWacker Biotech's proprietary E. coli K12 strain, which is capable of secretingrecombinant proteins in their native form into the fermentation broth duringcultivation. Extracellular production facilitates straightforward purificationof recombinant products, eliminates tedious refolding steps and makes the wholemanufacturing process more efficient and cost effective. Safe Harbour statement: this news release may contain forward-looking statementsthat reflect the current expectations of the Company regarding future events.Forward-looking statements involve risks and uncertainties. Actual events coulddiffer materially from those projected herein and depend on a number of factorsincluding the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion of clinicalstudies, the uncertainties related to the regulatory process, the successfulintegration of completed mergers and acquisitions and achievement of expectedsynergies from such tractions, and the ability of the Company to identify andconsummate suitable strategic and business combination transactions. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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