Re Agreement
12 Oktober 2006 - 9:01AM
UK Regulatory
RNS Number:3291K
Evolutec Group PLC
12 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 novel
products for the treatment of allergic, inflammatory and autoimmune diseases, is
pleased to announce that it has signed an agreement with Wacker Biotech GmbH
("Wacker Biotech") to produce rEV576, Evolutec's second product development
candidate, in preparation for clinical trials which are expected to commence in
2007.
The agreement follows a successful feasibility study in which Wacker Biotech
demonstrated that its proprietary secretion technology enabled the production of
rEV576 in E. coli.
The agreement includes process development work leading to a robust scaleable
method for the production of current Good Manufacturing Practice ("cGMP") grade
rEV576. This material is required for the intended clinical trials. The
agreement then provides for Wacker Biotech to scale-up the cGMP process.
rEV576 is a complement inhibitor and has demonstrated preclinical activity
against 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: "Promising
preclinical data and progress made by Wacker Biotech points to the commercial
potential of rEV576. We look forward to maintaining this momentum in the
development programme."
Dr. Thomas Maier, Managing Director of Wacker Biotech, commented: "We are
pleased to be working with Evolutec and using our proprietary secretion
technology in the development of rEV576."
ENDS
For further information:
Evolutec 0118 922 4480
Mark Carnegie Brown, Chief Executive Officer
Nicholas Badman, Chief Financial Officer
www.evolutec.co.uk
Financial Dynamics 020 7831 3113
Ben Brewerton / Nicola Daley
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 autoimmune 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 45 minutes of administration. This
product candidate is now in a Phase IIb allergic rhinitis trial and a Phase II
post-cataract inflammation trial. In addition to these trials, Evolutec also
intends to complete a proof of concept Phase II trial in dry eye in 2007.
Following positive preclinical data, Evolutec intends to undertake a Phase I
trial with rEV131 in asthma in 2007.
The Company has a further two product development candidates in preclinical
development: rEV576, a complement inhibitor, and rEV598, which binds serotonin
and histamine. rEV576 has demonstrated preclinical activity against the
autoimmune diseases myasthenia gravis and Guillain-Barre Syndrome, asthma and
acute myocardial infarction ("AMI") (heart attack). Evolutec has established a
research collaboration with Case Western Reserve University, Cleveland, Ohio, to
undertake further preclinical work with rEV576 in myasthenia gravis. rEV598 is
being evaluated in chemotherapy-induced nausea and vomiting (CINV).
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 AIM market of 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.
About Wacker Biotech
Wacker Biotech is an experienced full-service contract manufacturer of
biopharmaceuticals derived from microbial systems. Wacker Biotech's proprietary
E. coli secretion system is a well-established technology for cost-efficient
production of proteins and antibody fragments. The core of the technology is
Wacker Biotech's proprietary E. coli K12 strain, which is capable of secreting
recombinant proteins in their native form into the fermentation broth during
cultivation. Extracellular production facilitates straightforward purification
of recombinant products, eliminates tedious refolding steps and makes the whole
manufacturing process more efficient and cost effective.
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 tractions, 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
END
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